ASERNIP-S Review of Policies and Processes for the ... · Health technology assessment ... introduction of new interventional procedures into clinical practice, with the aim of determining:

Review

A review of policies and processes for the introduction of new interventional

procedures

ASERNIP-S REPORT NO. 58

July 2007

Australian Safety & Efficacy Register of New Interventional Procedures – Surgical

The Royal Australasian College of Surgeons

ASERNIP S Australian Safety

and Efficacy

Register of New

Interventional

Procedures-Surgical

A review of policies and processes for the introduction of new interventional procedures

ISBN 0 909844 80 1

Published July 2007

This report should be cited in the following manner:

Thavaneswaran P, et al. A review of policies and processes for the introduction of new interventional procedures. ASERNIP-S Report No. 58. Adelaide, South Australia: ASERNIP-S, July 2007.

Copies of these reports can be obtained from:

ASERNIP-S PO Box 553, Stepney, SA 5069 AUSTRALIA Ph: 61-8-8363 7513 Fax: 61-8-8362 2077 E-Mail: [email protected] http://www.surgeons.org/asernip-s

The review of policies and processes for the introduction of

new interventional procedures

was ratified by:

The ASERNIP-S Management Committee in

June 2007

and

The Council of the Royal Australasian College of Surgeons on

July 2007

- ASERNIP-S REVIEW OF POLICIES AND PROCESSES FOR THE INTRODUCTION OF NEW INTERVENTIONAL PROCEDURES JULY 2007 -

i

Table of Contents

Executive Summary .......................................................................................... iv The ASERNIP-S Review Group ...................................................................... vii 1. Introduction ............................................................................................... 1

Objective...............................................................................................................................1 Introduction .........................................................................................................................1

What is meant by a new interventional procedure?..................................................1 Clinical governance .............................................................................................................2

Current clinical governance models............................................................................3 Factors influencing decision-making ................................................................................4

Health technology assessment .....................................................................................5 Summary ...............................................................................................................................6

2. Methodology .............................................................................................. 7 Literature search protocol ..................................................................................................7

Inclusion criteria ............................................................................................................7 Literature search strategies .................................................................................................8

Databases to be searched and search terms to be used ...........................................8 Handsearching ...............................................................................................................8 Website searches............................................................................................................9 Literature database and exclusions..............................................................................9

Data extraction and analysis ..............................................................................................9 Search Results ................................................................................................................... 10

3. Results ....................................................................................................... 11 Description of included policies and processes ........................................................... 11

Australia ....................................................................................................................... 11 Canada.......................................................................................................................... 12 Denmark ...................................................................................................................... 15 United Kingdom......................................................................................................... 16

Decision-making criteria.................................................................................................. 18 Clinical need and burden of disease......................................................................... 18 Evidence of safety, efficacy and clinical effectiveness .......................................... 21 Cost considerations .................................................................................................... 24 Training requirements................................................................................................ 27 Patient information and informed consent ............................................................ 28


ii

Monitoring and evaluation ........................................................................................ 30 Outcomes of policies and processes.............................................................................. 33

Australia ....................................................................................................................... 33 Canada.......................................................................................................................... 34 United Kingdom......................................................................................................... 35

Priorities in decision-making .......................................................................................... 37 4. Discussion.................................................................................................41 References ........................................................................................................ 45


iii

List of Tables

Table 1 Information required on the clinical need and burden of disease of new interventional procedures ..........................................................................................................20

Table 2 Information required on the evidence of safety, efficacy and clinical effectiveness of new interventional procedures ..................................................................................................23

Table 3 Information required on cost considerations of new interventional procedures........26

Table 4 Information required on training requirements of new interventional procedures....28

Table 5 Information required on patient information and informed consent for new interventional procedures ..........................................................................................................30

Table 6 Information required on monitoring and evaluation of new interventional procedures....................................................................................................................................32

Table 7 Outcomes of policies and processes ..................................................................................36


iv

Executive Summary

Objective To identify and review both Australian and international policies and processes for the introduction of new interventional procedures into clinical practice, with the aim of determining:

(1) how decisions about the adoption of new interventional procedures are made

(2) the extent to which evidence-based information, particularly health technology assessments (HTAs), is used in the decision-making process.

Methods Search strategy – Literature pertaining to policies and processes for the introduction of new interventional procedures was identified by searching MEDLINE, EMBASE, CINAHL, Current Contents and PubMed from inception to February 2007. Relevant journals including the British Medical Journal, Lancet, Health Technology Assessment, International Journal of Technology Assessment in Healthcare and Health Policy were hand-searched from 2000 to February 2007. In addition, relevant online sources were also searched.

Study selection – Documents outlining specific policies and processes were selected for inclusion in the review if they evaluated the clinical need, safety, efficacy, clinical effectiveness and/or financial implications of a new interventional procedure. Where outcomes were reported for specific policies, these policies were given preference for inclusion in the review. In addition, studies that examined the use of HTAs in decision-making about the adoption of new interventional procedures were also included.

Data collection and analysis – Data from all included documents was extracted by one researcher and checked by a second using standardised data extraction tables that have been developed a priori. Data for the main outcomes was reported narratively.

Results Searches of the published literature revealed only one paper outlining relevant policy information. Targeted website searches were more fruitful, and uncovered a large number of relevant policy documents, the vast majority of which were from NHS Trusts in the UK. A total of six policies, two Australian, two Canadian, and one each from Denmark and the UK, were selected for inclusion in this review. Each of the included polices contained a clearly defined purpose and an explicit description of the approval process, including the role of relevant clinical governance structures.

Five of the six included policies employ an application form as part of the approval process; while the McGill University Health Centre in Canada bases its policy decisions largely on the recommendations of Technology Assessments produced by its own Technology Assessment Unit. These Technology Assessments evaluate the safety, efficacy and cost-effectiveness of


v

the new technology, as well any ethical and legal implications its introduction may have for the organisation. Information on clinical outcomes, including the clinical need and burden of disease, as well as the safety, efficacy and effectiveness of the procedure were required by all five policies that incorporated application forms as part of their approval process, as was information on organisational outcomes including the cost considerations and training requirements of the procedure. Both Australian policies required patient information sheets and informed consent forms as part of their approval process. Similarly, the policy of the Luton and Dunstable NHS Trust in the UK also required that the issues of patient information and informed consent be addressed, however these issues were not addressed by the Canadian or Danish policies.

Three studies that have evaluated the outcomes of specific polices in Australia, Canada and the UK were uncovered through searches of the published literature, while targeted website searches revealed one document describing the outcomes of a second Australian policy. These studies have focused largely on the number and type of procedures that have been approved since the implementation of specific policies; however two studies have provided additional information on their organisational impact.

Searches of the published literature uncovered three studies, two in Israel and one in Denmark, that have examined decision-making at the hospital level, while targeted website searches revealed one document describing District Health Board decision-making processes in New Zealand. The results from these studies have shown that while the safety, efficacy and clinical and cost-effectiveness of new health technologies are important considerations in the decision-making process, a number of other factors also play an important role, and decisions are never based solely on the findings of HTAs. A lack of access to relevant and timely HTAs has been identified as an important barrier to an optimal decision-making process.

Conclusions Increasing numbers of healthcare organisations, both in Australia and internationally, are establishing formal policies and processes for the safe introduction of new interventional procedures into clinical practice. Decision-making about the adoption of such procedures appears to be focused largely on clinical outcomes such as the clinical need and burden of disease and the safety, efficacy and effectiveness of the procedure, as well as organisational outcomes such as the cost considerations and training requirements of the procedure. Few organisations have reported their experience with such policies and processes however and there is a paucity of information on the outcomes and organisational impact of these initiatives. While it is clear that evidence-based information, such as HTAs, is frequently used in decision-making about the adoption of new interventional procedures, a lack of access to relevant and timely HTAs has been identified as an important barrier to optimal decision-making. Therefore, greater effort needs to be put into establishing information infrastructure in order to make evidence more readily available to decision makers.


vi

Important note The information contained in this report is a distillation of the best available evidence located at the time the searches were completed as stated in the protocol.


vii

The ASERNIP-S Review Group

ASERNIP-S Director

Professor Guy Maddern ASERNIP-S Royal Australasian College of Surgeons Stepney SA 5069

Review Group Member Professor Allan Spigelman UNSW St Vincents Hospital Clinical School Victoria Street Darlinghurst NSW 2010

Review Group Member Professor Chris Baggoley SA Department of Health PO Box 287 Rundle Mall Adelaide SA 5000

Review Group Member Dr Helen O’Connell Royal Melbourne Hospital Parkville VIC 3050

ASERNIP-S Researcher Ms Prema Thavaneswaran ASERNIP-S Royal Australasian College of Surgeons Stepney SA 5069


INTRODUCTION 1

1. Introduction

Objective To identify and review both Australian and international policies and processes for the introduction of new interventional procedures into clinical practice, with the aim of determining:

(1) how decisions about the adoption of new interventional procedures are made

(2) the extent to which evidence-based information, particularly health technology assessments (HTAs), is used in the decision-making process.

Introduction The introduction of new drugs and items of equipment into clinical practice is accompanied by rigorous assessment and testing. In Australia, new drugs must demonstrate evidence of quality, safety and efficacy to the Therapeutic Goods Administration, as well as evidence of clinical and cost-effectiveness to the Pharmaceutical Benefits Advisory Committee (PBAC). Only after licensing, including clear stipulations about the indications for use, can these products be used in routine clinical practice. Medical devices have also been subject to strict systems of control relating to quality and performance for many years. Therefore, it seems somewhat surprising that until recently, no such systems existed for the evaluation and control of new interventional procedures (Campbell and Maddern, 2003). As a result, a large number of new interventional procedures have been able to diffuse through the healthcare system before their safety, efficacy, clinical effectiveness and cost have been properly evaluated. This haphazard and uncontrolled adoption of procedures was brought to public attention most recently by the unseemly haste with which laparoscopic surgical techniques were adopted, the associated cases of severe complications and the increased costs (Lam, Murray and Cuschieri, 1996). Changing consumer expectations, together with the aforementioned public concern in response to press reports of an increase in adverse events following the introduction of some new interventional procedures, have highlighted the need for more formal evaluation of such procedures before their introduction into the health system. Further to this, a need exists to ensure that the outcomes of such procedures are monitored.

What is meant by a new interventional procedure? It is necessary to define what constitutes an ‘interventional procedure’, and also the difference between a ‘new’ and an ‘old’ technique. For the purposes of this review, an interventional procedure, as defined by the National Institute for Clinical and Health Excellence (NICE), is one used for diagnosis or treatment that involves one of the following (NICE, 2004):


2 INTRODUCTION

• Making a cut or a hole to gain access to the inside of a patient’s body – for example, when carrying out an operation or inserting a tube into a blood vessel.

• Gaining access to a body cavity (such as digestive system, lungs, uterus or bladder) without cutting into the body – for example, examining or carrying out treatment on the inside of the stomach using an instrument inserted via the mouth.

• Using electromagnetic energy (which includes X-rays, lasers, gamma-rays and ultraviolet light) or ultrasound – for example, using a laser to treat eye problems.

Thus, an interventional procedure is one used for treatment (including prostheses, implantable devices, and medical or surgical procedures) or diagnosis, which involves incision, puncture, or entry into a body cavity, or use of electromagnetic or acoustic energy. Specifically for surgical procedures, which are a subset of those described above, the Australian Safety and Efficacy Register of New Interventional Procedures-Surgical (ASERNIP-S) has used the following definition: the alteration of tissue volumes, implantation of devices through an incision, ablation through an incision, transplantation and other interventional procedures with the intention of treating the patient.

Few procedures are totally novel and many are modifications of existing practice, perhaps involving a new approach (for example laparoscopic rather than open surgery) or applying established technology to a new indication (for example laser or radiofrequency ablation used for the treatment of different diseases). For the purposes of this review, an interventional procedure is considered to be new if it is considered by a reasonable body of medical opinion to be significantly different from existing clinical practice. This would include procedures that have not before been performed in a hospital or Area Health Service, as well as any variation to existing procedures where a new device, item of equipment or medication is introduced. In recent years, there has been a significant increase in the number of new interventional procedures available to clinicians, which has highlighted the need for formal processes for the safe introduction of such procedures into hospitals and Area Health Services.

Clinical governance Clinical governance as defined by the Australian Council on Healthcare Standards (ACHS) is “the system by which the governing body, managers and clinicians share responsibility and are held accountable for patient care, minimising risks to consumers and for continuously monitoring and improving the quality of clinical care”.

The successful implementation of clinical governance requires that patients, clinicians and managers understand that the introduction of a new interventional procedure into a public health service is supported by evidence of safety, effectiveness and cost effectiveness, and also that it can be safely performed in that health service given the available resources (NSW Health, 1999). This is dependent upon the provision of a formal approval process, which outlines a framework for the assessment of new


INTRODUCTION 3

interventional procedures before it is introduced into a public health service (NSW Health, 1999). Such a process would ensure that:

• both the clinical and financial effects of the procedure are considered

• all staff receive appropriate training so that new procedures can performed safely

• patients are offered the opportunity to give consent to a new procedure

• the uptake of new procedures into clinical practice is monitored.

Until recently however, such formal evaluation and approval processes have been lacking.

Current clinical governance models The UK was the first country in the world to establish a system for the introduction of new interventional procedures into clinical practice (Spigelman, 2006). Centralised vetting systems were installed in response to reports of a rise in the rate of adverse intraoperative events, such as bile duct injury during laparoscopic cholecystectomy, which occurred despite early recognition of the need for training to reduce the ‘significant’ learning curve (Jones et al., 1991; Hawasli and Lloyd, 1991). Although the Safety and Efficacy Register for New Interventional Procedures (SERNIP) was established in the UK in 1996, its impact was limited. In response to increasing concerns about patient safety, specifically the Kennedy Report into the Bristol Affair (Kennedy, 2001), the Department of Health instructed NICE to develop a programme for the introduction of new interventional procedures (NICE, 2004).

NICE is responsible for the assessment of the safety and efficacy of new interventional procedures. It has published a national process for overseeing the introduction of new interventions (NICE, 2004). The Department of Health launched the NICE Interventional Procedures Programme in November 2003 (Department of Health, UK, 2003), since which time it has been mandatory for all clinicians intending to undertake a new interventional procedure to notify NICE. Once notified NICE prepares an overview of reported research on the procedure and seeks advice from specialists. Its Interventional Procedures Advisory Committee then considers the safety and efficacy of the procedure, and drafts guidance about its use within the NHS, including any special restrictions (NICE, 2004). If there are doubts about the quality and/or quantity of supporting evidence it is recommended that patients are provided with clear information to allow them make as informed a choice as possible on whether or not to accept the new method. Particularly thorough audit is advised, with local review of outcomes, and NICE may recommend collection of data on all patients undergoing the procedure in the form of registries established by national specialist societies that are themselves asked to formulate training standards for selected operations. Recommendations stipulate that local clinical governance heads must be informed before a procedure is adopted, so that hospitals are aware when novel techniques are being employed (NICE, 2004). This


4 INTRODUCTION

guidance aims to help clinicians to innovate in a responsible way, and to offer patients the opportunity of well informed choice.

In Australia, the introduction of new interventional procedures is controlled by a variety of processes, involving advisory committees at the state and national level, as well as hospital or health service based committees (Australian Government Productivity Commission Research Report, 2005). At the national level, the Medical Services Advisory Committee (MSAC) assesses the safety, clinical effectiveness and cost-effectiveness of new and existing medical procedures, diagnostics tests and devices. MSAC makes recommendations to the Minister on whether a new procedure should receive public funding, including listing on the Medicare Benefits Schedule (MBS). This lists and describes the medical and diagnostic services for which a Medicare benefit is payable by the Australian Government, the amount of that benefit, and any conditions on the use of that service (Australian Government Productivity Commission Research Report, 2005). MSAC may also recommend interim funding for promising technologies that require further data collection to establish their safety and effectiveness.

Factors influencing decision-making Decisions about the adoption of new interventional procedures are made in an extremely complex environment. A wide variety of factors influence decision-making about the adoption of new health interventions, including cost, evidence of safety and effectiveness, political factors, lobbying, consumer expectations, marketing by suppliers, funding constraints and risk minimisation. For a variety of reasons there is growing interest in these decisions among politicians, policy makers, managers, advocacy groups and the general public.

Research has shown that decisions about health interventions (particularly in secondary and tertiary care) tend to be made, or be highly influenced by, clinicians (National Advisory Committee on Health and Disability, New Zealand, 2006). This reflects the traditional approach of Western medicine where clinicians are seen as having specific expertise about healthcare provision and being the appropriate people to make decisions about the health services that patients receive. The transition of a new procedure into everyday clinical practice is dependent on clinicians’ aspirations to improve the quality of care they provide and, for some, the intrinsic appeal a novel procedure holds. Product champions and opinion leaders pioneer the introduction of new technologies into clinical practice and their early observational reports may lead to a situation where more widespread diffusion of such technologies occurs, as was the case with laparoscopic cholecystectomy (ACOST, 1993). Such novel procedures may diffuse rapidly before they can be adequately evaluated.

Commercial issues may be important: there are financial motives on the part of industry to encourage the use of new devices. Astute marketing can trump good risk management. Media claims that are often promoted by clinical enthusiasts may stimulate public demand for a procedure even in the face of inadequate scientific evidence (Banta 1993). Media coverage undoubtedly has an influence although it is difficult to predict its


INTRODUCTION 5

effect. One possible mode of influence is through generating favourable publicity about new, unevaluated health technologies, which can lead to immediate patient or physician demands for the new technique; such was the case for laparoscopic cholecystectomy, with its apparent benefits of a smaller scar, less postoperative pain, reduced hospital stay, and a more rapid recovery (Banta 1993; White 1993).

There are also disincentives to using a new procedure, including a fear of litigation if things go wrong, and reluctance of both private and public healthcare organizations to fund novel techniques due to their often higher initial cost.

Health technology assessment HTA involves the evaluation of an intervention through the production, synthesis, and/or systematic review of a range of scientific and non-scientific evidence and can help to determine whether an intervention is safe, effective and cost-effective and socially, legally and ethically acceptable (Mowatt et al., 1997). HTA is one source of information that can be used to inform decisions about new health interventions. A major objective of HTA is to provide patients and clinicians with information on patient care alternatives, and to provide policy decision makers and healthcare managers with information on alternatives (Donaldson and Sox, 1992). Until recently, most of the responsibility for the adoption of new interventional procedures was delegated to individual clinicians and local research ethics committees, who have had to make decisions in the absence of any solid information of safety, effectiveness and cost-effectiveness.

The implications for policy makers are that significant new interventional procedures need to be identified as they emerge, possibly through some form of horizon scanning mechanism, so that they can be prioritised and steps can be taken to assess them in an appropriate manner as early as is possible. If this does not occur, there is a danger that a combination of technology ‘push’, pioneer enthusiasm, and media publicity may accelerate the diffusion of new technologies into routine clinical practice before they have been adequately evaluated. In 1999, ASERNIP-S, together with the Royal Australasian College of Surgeons’ New Technology Committee, established an Australian based horizon scanning project: NET-S (New and Emerging Techniques-Surgical) to provide an early warning system for identifying new and emerging surgical techniques and technologies into Australian healthcare. In 2003, surgical horizon scanning became part of the Australia and New Zealand Horizon Scanning Network (ANZHSN) which was established under the auspices of the Department of Health and Ageing (DoHA), the Australian Health Ministers Advisory Council (AHMAC) and MSAC, to provide advance notice of significant new and emerging technologies to health departments in Australia and New Zealand (Australian Government Productivity Commission Research Report, 2005). The Health Policy Advisory Committee (HealthPACT), which is a subcommittee of MSAC, is central to the operation of the ANZHSN and is comprised of representatives from State and Territory government health departments, the Australian Government Department of Health and Ageing, MSAC and the New Zealand


6 INTRODUCTION

Ministry of Health. Horizon scanning prioritising summaries and reports presented at HealthPACT meetings are then disseminated to committees at the state, health service and hospital level for use in their decision-making processes.

The establishment of local policies and processes will help to ensure that new interventional procedures are considered in a structured manner before any decision is made to adopt them. Healthcare managers and clinicians also need to be aware of the results of assessments that may have already been carried out on new interventional procedures whose introduction they are considering.

Summary The uncontrolled introduction of new interventional procedures into public health services has been implicated in the rising costs of healthcare including those costs stemming from adverse events. Some argue that the sustainability of the health system depends partly on its ability to control their use (Australian Government Productivity Commission Research Report, 2005). One option is to control the diffusion of these new procedures into the health system while research is conducted to assess their safety and clinical and cost effectiveness. However, the pressures for diffusion created by the media, public demand, manufacturers, professional enthusiasm and provider competitiveness make such control difficult. If the adoption of new interventional procedures is to be managed appropriately in the interest of patients and clinicians, then formal approval processes for their introduction into health services must be developed and effectively applied. Thus, the aim of this review was to identify both local and international policies and processes for the introduction of new interventional procedures into clinical practice, in order to determine the principles governing decision-making about the adoption of these new procedures. This review has also attempted to determine the extent to which evidence-based information, in particular HTAs, is used in the decision-making process.

- ASERNIP-S REVIEW OF POLICIES AND PROCESSES FOR THE INTRODUCTION OF NEW INTEREVENTIONAL PROCEDURES JULY 2007 -

METHODOLOGY 7

2. Methodology

Literature search protocol

Inclusion criteria Documents outlining specific policies or processes were selected for inclusion in this review on the basis of the following criteria.

Outcomes Policies or processes that evaluated at least one of the following outcomes of interest were included:

Clinical need of the new interventional procedure, which included, but was not limited to:

• clinical indication/disease/condition for new procedure • patient population and projected demand for new procedure • health outcomes for new procedure • classification of new procedure • ethical issues surrounding introduction of new procedure • workforce requirements of new procedure • clinical infrastructure requirements of new procedure.

Safety, efficacy and clinical effectiveness of the new interventional procedure, which included, but was not limited to:

• regulatory approval of new procedure • evidence of safety of new procedure • evidence of clinical effectiveness of new procedure.

Financial implications of the new interventional procedure, which included, but was not limited to:

• specific costings of new procedure • evidence of cost effectiveness of new procedure.

Language restriction Searches were conducted without language restriction. Foreign language papers were subsequently excluded unless the findings provided additional information over that reported in well designed studies published in the English language.


8 METHODOLOGY

Literature search strategies

Databases to be searched and search terms to be used This review incorporated a broad search strategy in the following databases in an attempt to identify a wide variety of literature pertaining to policies and processes for the introduction of new interventional procedures:

• Ovid MEDLINE from 1966 to 25/02/07 • Ovid EMBASE from 1980 to 25/02/07 • Ovid CINAHL from 1982 to 25/02/07 • ISI Current Contents Connect 25/02/07 • Entrez-PubMed to 25/02/07

Search terms For MEDLINE, EMBASE, CINAHL and Current Contents Connect the following search terms will be used:

1. Guid$ 2. Polic$ 3. Proc$ 4. 1 OR 2 OR 3 5. New interventional procedur$ 6. New health technolog$ 7. 5 OR 6 8. Introduc$ 9. 7 AND 8 10. 4 AND 9

The NHS CRD databases were also searched using the above terms.

Note: * is a truncation character that retrieves all possible suffix variations of the root word e.g. surg* retrieves surgery, surgical, surgeon, etc. In Cochrane the truncation character is *; in Current Contents, EMBASE, CINAHL and MEDLINE (Ovid) it is $. # is a wildcard symbol that substitutes for one required character in Current Contents, EMBASE, CINAHL and MEDLINE (Ovid).

Handsearching Relevant journals were hand-searched from 2000 to February 2007 for germane articles, which were retrieved as appropriate. Journals searched included:

• British Medical Journal • Lancet • Health Technology Assessment • International Journal of Technology Assessment in Healthcare • Health policy


METHODOLOGY 9

Website searches Relevant online sources were also searched, including:

• National Institute for Health and Clinical Excellence (www.nice.org.uk) • South Australian Department of Health (www.health.sa.gov.au) • Western Australia Department of Health (www.health.wa.gov.au) • Victorian Department of Health (www.health.vic.gov.au) • New South Wales Department of Health (www.health.nsw.gov.au) • Queensland Department of Health (www.health.qld.gov.au) • Tasmania Department of Health and Human Services (www.dhhs.tas.gov.au) • Northern Territory Department of Health and Community Services

(www.health.nt.gov.au) • Australian Capital Territory Department of Health (www.health.act.gov.au) • Google (www.google.com) • Calgary Health Region Department of Surgery

(www.calgaryhealthregion.ca/surgery) • Hunter Area Health Service (www.hunter.health.nsw.gov.au) • The Luton and Dunstable Hospital NHS Trust (www.ldh.nhs.uk) • Darlington Primary Care NHS Trust (www.darlingtonpct.nhs.uk) • Northumbria Healthcare NHS Trust (www.northumbria.nhs.uk) • Salisbury NHS Foundation Trust (www.salisbury.nhs.uk) • South Tees Hospitals NHS Trust (www.southtees.nhs.uk) • Ashford and St Peter’s Hospitals NHS Trust (www.ashfordstpeters.nhs.uk) • Brent Teaching Primary Care NHS Trust (www.brentpct.nhs.uk) • South and East Dorset Primary Care NHS Trust (www.dorset-pct.nhs.uk) • McGill University Health Centre Technology Assessment Unit

(www.mcgill.ca/tau) • Danish Centre for Evaluation and Health Technology Assessment

(DACEHTA) (www.sst.dk) • National Health Committee New Zealand (www.nhc.govt.nz) • New Zealand Ministry of Health (www.moh.govt.nz)

Literature database and exclusions Documents outlining specific policies and processes were retrieved if they were judged to possibly meet the inclusion criteria. Two ASERNIP-S researchers independently applied the selection criteria and any differences were resolved through discussion. Publications subsequently found to not meet the inclusion criteria were excluded and reasons were documented when this occurred. The bibliographies of all publications retrieved were manually searched for relevant references that may have been missed in the database search (pearling).

Data extraction and analysis Data from all included documents was extracted by one researcher and checked by a second using standardised data extraction tables that have been developed a priori. Data for the main outcomes was reported narratively.


10 METHODOLOGY

Search Results Details of the searching and retrieval process are as follows:

Abstracts inspected n=12

Full text articles inspected and included in review

n=1

• Peer-reviewed publication reporting outcomes for a specific policy (n=1)

Excluded n=11**

Identified on handsearching of relevant journals

n=5

• Peer-reviewed publications reporting outcomes for specific policies (n=2)

• Peer-reviewed publications reporting priorities for decision making (n=3)

Identified on targeted searching of websites

n=8

• Documents outlining specific policies and processes (n=6)*

• Documents reporting outcomes for specific policies (n=1)

• Documents reporting priorities for decision making (n=1)

• 6 documents outlining specific policies and processes: Australia (n=2), Canada (n=2), Denmark (n=1), UK (n=1)

• 4 peer-reviewed publications/documents reporting outcomes for specific policies: Australia (n=2), Canada (n=1), UK (n=1)

• 4 peer-reviewed publications/documents reporting priorities for decision making: Denmark (n=1), Israel (n=1), New Zealand (n=1)

*Where outcomes were reported for specific policies, these policies were given preference for inclusion in the review.

**None of these articles outlined specific policies or processes or reported on the outcomes of such policies.

Identified on searching of electronic databases

n=12


RESULTS 11

3. Results

Description of included policies and processes

Australia New Technology/Clinical Practice Program (Department of Human Services, Victoria)

Policy Historically in Victoria, each health service has been responsible for deciding what technology or clinical practice is introduced and how it is funded, with no dedicated central process or funding to support its introduction. This has, at times, led to fragmented and unregulated introduction of technology/clinical practice within the Victorian public health sector. Ten years ago the Department of Human Services (DHS) developed a program to support and fund the introduction of new technology/clinical practice in public hospitals. The New Technology Program was established in 1997 with recurrent funding to support the introduction of new technology that would be incorporated into routine clinical practice. Health services were invited annually to submit requests to the Department for review and consideration of funding the introduction of the new technology. One of the annual challenges for the Department was coping with the volume of submissions seeking funding for new items, which exceeded 300 in one year. Many of these were for the same item (sometimes from up to 10 different health services). This impacted on the time to analyse and consider submissions and allocate funding, which often eventuated well into the financial year for which funding was meant to be provided. In 2005 the DHS developed a process to enable a more systematic approach to fund and coordinate the introduction of new technology and clinical practice in public health services on a state-wide basis (Department of Human Services, Victoria, 2007a). This included the commencement of an external committee, the Victorian Policy Advisory Committee on Clinical Practice and Technology (VPACT) and a revised submission process.

Process Health services/hospitals seeking funding from the Department to introduce a technology/clinical practice must make a submission using the proforma endorsed by VPACT. Where more than one health service wants to introduce the same new technology/clinical practice, all must collaborate to prepare a single joint submission. Submissions are short-listed against inclusion and exclusion criteria. Departmental officers short-list all submissions for VPACT consideration, and VPACT subsequently endorses these. Short-listed submissions are reviewed in depth by VPACT, which makes a recommendation to accept, reject or defer. After endorsing a VPACT recommendation, the Department consults with health services to agree on funding, monitoring and reporting requirements. Each submission round raises ambiguities and queries as a result


12 RESULTS

of differing interpretations of the information requested through the proforma. The proforma is modified annually to address these issues.

Policy for the introduction of new interventional procedures (Hunter Area Health Service, New South Wales)

Policy This policy was first implemented in 2001, with the aim of ensuring that patients, doctors, other health staff, and the Executive and Board of the Hunter Area Health Service may be confident that any new interventional procedures introduced into Hunter Health facilities are supported by evidence of efficacy, safety and effective resource utilisation (Hunter Area Health Service, 2001). In addition, the policy aims to ensure that there is an agreed process for monitoring outcomes once a procedure has been formally introduced. This policy also applies where a procedure is already performed in a Hunter Health facility and where approval is sought to perform it elsewhere within the Hunter Area Health Service.

Process All new procedures or new applications of current procedures must be formally approved by the Hunter Area Health Service Medical Appointments and Advisory Committee (MAAC) before being used in Hunter Health facilities. Where a clinician is unsure whether a procedure falls within the scope of this Policy, they are advised to first seek clarification from local management, who are then able to obtain further clarification from the Hunter Health Clinical Governance Unit if required. Individual Clinician/s or Units wishing to introduce the new interventional procedure are required to complete an Application Form for the Introduction of a New Interventional Procedure and forward it to their local management, which in turn forwards it to the Director of Clinical Governance. The Clinical Governance Unit then registers the application and submits it to the MAAC for final approval. Local management are responsible for liaising with the relevant clinician and/or clinical team regarding the progress of the application. Applicants are then informed of the outcome of their application and the sponsor/s of an unsuccessful application may appeal to the Director of Clinical Governance or to the Chief Executive Officer.

Canada McGill University Health Centre Technology Assessment Unit (McGill University Health Centre, Quebec)

Policy The purpose of the McGill University Health Centre (MUHC) Technology Assessment Unit (TAU) is to advise the hospital in difficult resource allocation decisions using an approach based on sound, scientific technology assessments and a transparent, fair decision-making process (McGill University Health Centre Technology Assessment Unit, 2007). The TAU, which was established in 2001, develops technology assessments which provide information on the efficacy and costs of a new technology, as well as any legal or ethical issues that may be relevant to its acquisition. In addition, the TAU together with a


RESULTS 13

body that is representative of the hospital community develops policy recommendations regarding the adoption of new health technologies. The TAU is run by a Director who is responsible to an Executive Committee that is representative of the different disciplines and different hospital sites that make up the MUHC. The TAU Committee in turn reports to the MUHC through the Chief Operating Officer.

Process The TAU uses the following process when developing reports:

• Topic choice The topics chosen for review are those that involve a difficult decision, usually due to high costs or uncertain clinical benefits. Suggestions for review topics are invited from the hospital administration, the clinical and administrative departments, and the hospital community.

The decision to accept a topic for review is made by the TAU Committee on the grounds of such factors as contentiousness, a potentially large economic impact, marginal effectiveness, or an unfavourable cost-effectiveness ratio.

Issues will not be reviewed except at the request of, or with the concurrence of, the hospital administration. To avoid duplication of effort, agencies, or any hospitals that might be involved in technology evaluation, will be contacted before a new project is initiated.

• Local involvement At an early stage and throughout the review process, there will be involvement of the department or discipline responsible for the technology in question. Co-option of committee members from that department or discipline for the duration of the study in question may be solicited.

• Technology Assessment Production of a Technology Assessment containing reliable data on the economic impact, effectiveness and cost-effectiveness of the technology concerned is the task of professionals engaged by the TAU. This might be sufficient to guide the existing decision-making process without further involvement of the TAU. Alternatively, the TAU may also be requested to develop Policy Recommendations based on the Technology Assessment.

• Policy Recommendation Before formulating a Policy Recommendation the TAU Committee will co-opt additional representatives of relevant stakeholders. The expanded committee will then review the evidence developed in the Technology Assessment and, if necessary, obtain additional evidence on such issues as opportunity costs, legal or ethical issues, and the feelings and opinion of the hospital community. It will then attempt to develop a Policy Recommendation supported by a substantial consensus.


14 RESULTS

• Communication Technology Assessments or Policy Recommendations are submitted to the hospital authorities via the Chief Operating Officer and are made public to the hospital community (after a delay not exceeding 21 days), with a clear account of the data and reasons on which the recommendations are based. Reports will be made available to organizations and hospitals for which the topic might be relevant. Also, where appropriate, reports will be edited and submitted to professional journals.

• Evaluation The TAU will conduct a regular follow-up of each Technology Assessment or Policy Recommendation that it submits, so as to document their impact, if any, on hospital policy. After a maximum period of four years these follow-ups will be edited and audited by an external reviewer to be named by the Board of Directors of the MUHC, and made public.

Department of Surgery Introduction of New Technology Policy (Calgary Health Region, Alberta)

Policy The Department of Surgery of the Calgary Health Region has developed a decision-support process to assist local decision makers and policy makers to evaluate new technologies (Calgary Health Region, Department of Surgery, 2007). The purpose of the Introduction of New Technology policy, which was first implemented in 2004, is to promote a consistent approach to the acquisition of new technology within the Department of Surgery. This policy states that:

• The introduction of new technology, which has not yet been clinically proven, must be introduced as a clinical trial.

• New technology shall be presented initially to the Department of Surgery Executive.

• Priority will be given to new technology or procedures that will be used in a multidisciplinary fashion, will reduce length of stay or will improve patient well being secondary to the nature of the technology or procedure being introduced.

Process

The introduction of new technology process involves the following steps:

1) Presentation of new technology proposal to Division Applicant must present a new technology proposal to On-Site Division and/or to City-Wide Division monthly meeting.

2) Introduction of New Technology Application Form New Technology proposal approved by the Division and Division Chief needs to be submitted to the Department for further approval. For Departmental submission, the applicant must submit the completed ‘Introduction of New Technology application form’


RESULTS 15

to the Department Head’s office, to schedule a presentation date to Surgical Executive Committee. All signatures must be obtained before a submission is made.

3) Presentation to Surgical Executive Committee Applicants present the new technology proposal to Department of Surgery Surgical Executive Committee.

4) Decision for New Technology Approval Status The decision and recommendations by the Department of Surgery Surgical Executive Committee will be officially communicated in writing to the applicant via the Regional Clinical Department Head. New technology approval status includes the following four decision categories:

• Approved

• Restricted Approval ‘Audit’ - Approved under audit conditions

• Restricted Approval ‘Clinical Trial’ - Approved as a clinical trial

• Not approved

Denmark Mini-HTA (Copenhagen Hospital Corporation)

Policy The Copenhagen Hospital Corporation has developed a mini-HTA for use as a management and decision support tool, when making decisions about the adoption of new health technologies, which was first developed in 2000 (National Health Board, Danish Centre for Evaluation and Health Technology Assessment (DACEHTA), 2005). A mini-HTA is a form or a checklist with several questions concerning the prerequisites for and consequences of using a new health technology, in which:

• The questions are grouped according to the four HTA perspectives: technology, patient, organization, and economy.

• The answers to the questions provide a brief, written basis for decisions (2–5 pages) and takes, based on experience, 5–15 hours, excluding the time spent on information retrieval, assessment and economic calculations.

• The purpose is to provide part of the decision-making basis for a proposal to introduce a specific new health technology or in connection with changes in the indication for the use of existing technology.

Process When a proposal for a new treatment has been described in mini-HTA format, it must be approved by the centre management and the Executive Board of the hospital. It is then submitted to the management board of the Copenhagen Hospital Corporation, which is comparable to a county health service. Finally the proposal is considered by the political governing body, to which the mini-HTA material is submitted for decision-making


16 RESULTS

purposes. The treatments expected to be carried out on patients from other counties will also be presented to the members of the counties’ health committees. If a proposal is approved, the expenses and activities are included in the budgets of the hospital departments, distributed on the Copenhagen Hospital Corporation and county activities. This ensures an overview and economic cover for activities and expenses if the treatment is introduced. As many proposals may result in considerable additional expenditures, the mini-HTA procedure is closely connected with the annual budgeting process in the Copenhagen Hospital Corporation. Unless there are strong arguments for introducing a new treatment quickly, all treatments must be approved politically in connection with the budget negotiations. Therefore a new treatment cannot be introduced until the beginning of the new budget year.

United Kingdom Policy for the introduction of new interventional procedures (Luton and Dunstable Hospital NHS Trust)

Policy This policy was first implemented in 2001, but was revised in 2003, following the introduction of the NICE Interventional Procedure Programme (Luton and Dunstable NHS Trust, 2004). The policy outlines the approach to be followed within the Luton and Dunstable Hospital NHS Trust for the introduction of new interventional procedures, which ensures that the introduction of such procedures is undertaken appropriately, funding arrangements secured and issues addressed to minimise clinical risk to patients and staff. The Interventional Procedure Governance Committee (IPGC) is authorised on behalf of the Trust’s Clinical Governance Committee, to review and ratify all applications submitted by individual practitioners.

Process 1. All applications should be supported by the Clinical Director and General Manager.

2. The practitioner requesting the introduction of a new interventional procedure should complete the standard application proforma and submit electronically to the Chair of the IPGC for consideration.

3. Following review, the Chair of the IPGC will forward the electronic application to the secretary of the IPGC, who will arrange to circulate to all committee members and the Medical Director. Review by the IPGC will take into account the safety and efficacy of introducing the new interventional procedure locally. The practitioner proposing to undertake the new procedure will also need to provide evidence of training and competency which meets externally set standards and which is verified by the named mentor. The practitioner will be required to attend the IPGC meeting to present the application to members present.

4. Where the IPGC agrees with the introduction of the procedure, it will recommend either that the procedure is instituted or developed as a pilot. The committee will


RESULTS 17

advise and provide the applicant with feedback on arrangements for clinical audit and the monitoring of outcomes as part of the ratification process.

5. Where the procedure is ratified by the IPGC, and is not covered by existing or proposed NICE guidance, it is the responsibility of the Chair of the Quality Management Committee (QMC) to notify NICE using the electronic form on its website. If the practitioner proposes to perform the new interventional procedure before NICE issues guidance, the Chief Executive must grant approval.

6. Where the IPGC considers that more information/evidence is required, before a decision can be made; this will be communicated to the practitioner, including details of the next meeting of the IPGC. In cases where the committee has identified several key issues, the practitioner will also be required to attend the meeting and re-present the application.

7. The IPGC will notify the QMC of all new interventional procedures that have been ratified, and will provide details of competency, monitoring and the NICE status.

8. All new interventional procedures ratified by the IPGC will be signed off by the Chair of the QMC and recorded within the committee minutes.

9. The IPGC will maintain a register of such procedures, recording the rate of introduction in the Trust, the arrangements for ongoing audit within the directorate/department and the review date for reporting progress back to the IPGC.


18 RESULTS

Decision-making criteria The Royal Australasian College of Surgeons and the Australian Safety and Efficacy Register of New Interventional Procedures-Surgical (ASERNIP-S) have developed a document to provide guidance to hospitals and health services about the assessment of new procedures and the factors that should be considered prior to their introduction, which are detailed below (Royal Australasian College of Surgeons/ASERNIP-S, 2002). When implementing specific policies and processes for the introduction of new interventional procedures, an application form can serve as a checklist for applicants and assessors, outlining the steps taken to check whether and how the procedure has been evaluated, and evidence that the hospital/health service has suitable facilities for the procedure. As described earlier, the McGill University Health Centre utilises detailed health technology assessments as decision-making tools when deciding whether or not to adopt new health technologies, however the remaining five policies included in this review have incorporated application forms as part of their approval process, and details of these forms are outlined in the tables below.

Clinical need and burden of disease Clinical need, public health significance and patient selection When assessing a new interventional procedure it is important to consider the clinical need for the procedure, the public health significance of the condition to be treated, and the burden of the disease for the community (Medical Services Advisory Committee, 2005). In estimating the impact of a condition on the individual, it may be appropriate to obtain expert opinion from patient support groups or specialists in the area. It is unusual for a procedure to be used in all patients with a disease or condition, and applications should identify the factors that need to be considered in selecting patients for the procedure. It is also important that applications consider any access or equity issues relating to the new procedure, for example the availability or lack of alternative procedures in a particular region, and the availability or lack of alternative treatment(s) for a particular disease or condition.

Choice of comparator procedure The application should identify the current procedure most likely to be replaced or supplemented by the new procedure and describe how the new therapy differs from currently available treatments and its potential advantage (Medical Services Advisory Committee, 2005). If there is no therapy that will be replaced as a result of the introduction of the new service, describe current best conventional care, however for most new procedures, there is probably some therapy or intervention that is currently used to treat the condition.

Estimated utilisation of procedure The application should estimate the likely annual number of patients who will use the new procedure (Medical Services Advisory Committee, 2005). The change in the extent of use of other procedures should also be estimated.


RESULTS 19

All five of the policies included in this review that incorporated application forms as part of their approval process required information about issues of clinical need and burden of disease. Details of the specific information required by each policy are outlined in Table 1.


20 RESULTS

Table 1 Information required on the clinical need and burden of disease of new interventional procedures

Policy Location Information required on Application Form

AUSTRALIA

Clinical indication/Disease/Condition

• Specify the clinical indication/disease/condition that the New Technology/Clinical Practice will treat.

• Provide a brief description of the clinical indication/disease/condition and its clinical progression and prognosis.

• Specify whether the clinical indication/disease/condition is severe, progressive and expected to lead to premature death.

• Provide details concerning the incidence and prevalence of the clinical indication/disease/condition in Australia.

Patient population(s)

• What are the demographic characteristics of the patient population(s) with the clinical indication/disease/condition (e.g. age range, median and mean, gender, ethnicity, occupation, socio-economic status)?

• What is/are the subgroup/s of the patient population(s) that will benefit from the proposed Technology/Practice?

• What factors are taken into account when considering patient selection for use of the proposed Technology/Practice?

• Specify the numbers of paediatric and adult patients who will receive the proposed Technology/Practice?

• If this number is expected to increase over time and/or have a cumulative component due to ongoing follow-up, please specify the predicted numbers of new and follow-up patients by year for 5 years.

Comparison with existing approach(es) to clinical intervention

What existing and approved Technology/Practice(s) is/are used for the clinical indication/disease/condition? Describe how the proposed NTCP differs from this/each of these:

• significant clinical advantages over existing treatment • no worse than existing treatment in terms of

effectiveness or • less effective that the existing treatment.

Health outcomes

New Technology/Clinical Practice Program

Department of Human Services, Victoria

• What are the health outcomes that will be achieved by the proposed NTCP?

• How will these be measured and over what timeframe will these occur?

Policy for the introduction of new interventional procedures

Hunter Area Health Service, New South Wales

• Does this procedure replace current procedures? If YES, does this new procedure have advantages over current procedures? If YES, please attach details.

CANADA

Introduction of new technology policy

Department of Surgery, Calgary Health Region

• Population characteristics – please list the population characteristics and projected utilisation patterns of this technology.


RESULTS 21

• Patients – how many?

DENMARK

Mini-HTA Copenhagen Hospital Corporation

• On which indication will the proposal be used? Please state the indication on which the proposal should be applied.

• In which way is the proposal new compared to usual practice? A proposal often replaces another technology. Thus, please state in which way this proposal is new compared to usual practice in the department. Apart from the fact that a proposal often replaces other existing technology there also may be other alternatives to the new proposal. Consequently the mini-HTA should comprise an assessment of benefits and drawbacks compared to usual practice and any other alternatives.

UNITED KINGDOM


Luton and Dunstable NHS Trust, Luton

• What existing procedure(s) might it replace?

• What are the clinical indications for its use?

• What is the health gain of this procedure?

Evidence of safety, efficacy and clinical effectiveness Most procedures that are new to Australia will have been evaluated or implemented elsewhere in the world first. There are a number of issues that need to be considered regarding the evidence base for the safety, efficacy and clinical effectiveness of the procedure, including (Royal Australasian College of Surgeons/ASERNIP-S, 2002):

Has the procedure been previously evaluated?

An assessment of the evidence to support a new procedure should ideally be based on a consideration of all available data, including unpublished and published studies. If this is not possible, the application should include sufficient data to support the safety and effectiveness of the procedure. All applicants should conduct a search of the published literature to find any reports or clinical trials that support the safety, efficacy or clinical effectiveness of the procedure. The search should be constructed to find clinical trials, industry reports, laboratory testing or animal studies, reports of case series overseas, and reports of experiences of the procedure in Australian facilities. In addition, it is important that establish whether an assessment of the procedure has been done through international or national systematic review or Health Technology Assessment (e.g. INAHTA – International Network of Agencies for health technology assessment, ASERNIP-S – Australian Safety and Efficacy Register of New Interventional Procedures - Surgical, Cochrane Collaboration, and MSAC – Medical Services Advisory Committee).

How reliable is the evaluation?

Interpretation of assessments should include the likely robustness of the evidence e.g. type of study design, were studies large enough to show reliable results for morbidity and mortality; were there possible confounding factors, such as the age of patients?

How wide-ranging or complex is the procedure?

A procedure with a wide application or one that is highly technological is likely to require more intensive consideration and evaluation.


22 RESULTS

All five of the policies included in this review that incorporated application forms as part of their approval process required information about the safety, efficacy and clinical effectiveness of the new procedure. Details of the specific information required by each policy are outlined in Table 2.


RESULTS 23

Table 2 Information required on the evidence of safety, efficacy and clinical effectiveness of new interventional procedures


AUSTRALIA

Regulatory Approval

Provide documentary evidence of approval and approval date for the NTCP for use in Australia for the identified clinical problem(s) by the Therapeutic Goods Administration.

Evidence of Safety

• Provide evidence of safety associated with the use of the NTCP for the proposed clinical indication.

• List nature and incidence of side effects, contraindications, cautions, warnings and adverse effects for NTCP and the proposed indication, and source of this information.

• What are the main differences in the indications, contraindications, cautions, warnings and adverse effects between the proposed NTCP and existing treatments, and source of this information?

Evidence of Efficacy and Clinical Effectiveness



Evidence of efficacy and clinical effectiveness must exist for the proposed NTCP. Please summarise the best available evidence, outlining key aspects, for clinical effectiveness of the NTCP for the defined clinical problem(s). Please indicate the following in your response, specifying details and dates where appropriate:

• Supporting references • Level and source of evidence • Health Technology Assessments undertaken in relation to

clinical effectiveness of the proposed NTCP



Has this procedure been evaluated elsewhere? For example: ASERNIP-S, SERNIP, Professional Colleges or Sections thereof, Medical Services Advisory Committee, Cochrane Collaboration, publications, clinical trials, information from internal and/or external peers. If YES please attach details.

CANADA

Safety

Please indicate the known level of safety: • At least as safe compared to comparator procedure(s) • Unknown – safety has not been determined

Please provide a general description of the safety of the technology, e.g., list expected complications and list known complication rates.

Clinical effectiveness

Introduction of new technology policy


Please indicate the known level of evidence: • Strong – Meta-analysis, systematic reviews, RCTs • Fair – Observational studies, cohorts, case-control • Weak – Case series, case reports, expert opinion

Please provide a general description of the requested technology including the evidence of clinical effectiveness.


24 RESULTS

DENMARK


• Has an assessment of literature been carried out (by the department or by others)? A health technology assessment should primarily be based on documented knowledge. An assessment of the present evidence can benefit from the principles of literature search.

• State the most important references and assess the strength of the evidence. The documentation for the effect of the proposal should be stated giving the most important references at the highest possible level. For the benefit of the reader the evidence level should be stated for each level.

• What is the effect of the proposal for the patients in terms of diagnosis, treatment, care rehabilitation and prevention? Please provide a short summary of the most important conclusions of above references (for instance the effect of the proposal on the mortality, morbidity, functional capacity, quality of life etc. of the patients.

• Does the proposal imply any risks, adverse effects or other adverse events? The risks, adverse effects and other adverse events should be assessed in relation to the benefit. These drawbacks should be compared to the drawbacks of the actual practice and any alternatives.

• Are there any known ongoing studies in other hospitals in Denmark or abroad of the effect of the proposal? Please state any ongoing studies of the effect of the proposal.

• Has the proposal been recommended by the National Board of Health, medical associations etc? If YES, please state institution.

UNITED KINGDOM



• Is this procedure registered with SERNIP* (Safety and Efficacy Register of New Interventional Procedures)?

• Is this procedure part of a clinical trial?

• Please give relevant references for the evidence base for the new procedure.

• Describe possible adverse effects.

• Risk assessment of adverse effects: (Likelihood x consequences). NOTE: *SERNIP has now been superseded by NICE –IPP

Cost considerations The introduction of any new procedure will have an opportunity cost, as the new procedure will consume resources which will be taken from existing services, so the benefit of the new procedure needs to be evaluated with that in mind. It is important to determine how the costs of the new procedure compare with those of existing procedures, and to identify what additional benefits, in terms of patient health outcomes, are generated by use of the new procedure. All applicants should conduct a search of the published literature to find any reports or clinical trials that support the cost-effectiveness of the new procedure. Both the present and future costs of the new procedure should be estimated as accurately as possible, as the initially high costs of most new procedures will reduce over time. It is also important to consider whether the new procedure will be sufficiently supported by adequate resources and facilities in the hospital or health facility into which it is being introduced.


RESULTS 25

All five of the policies included in this review that incorporated application forms as part of their approval process required information about the cost considerations of the new procedure. Details of the specific information required by each policy are outlined in Table 3.


26 RESULTS

Table 3 Information required on cost considerations of new interventional procedures


AUSTRALIA

Evidence of cost effectiveness New Technology/Clinical Practice Program


Evidence of cost effectiveness for the proposed NTCP, where available, must be provided. Please summarise the best available evidence, outlining key aspects, for cost effectiveness of the NTCP for the defined clinical problem(s) and patient group. Applicants may wish to report results of their own cost-effectiveness/cost-utility study (usually undertaken alongside a clinical trial) or report for a model of costs and effectiveness based on data from the published literature. A number of different approaches to consideration of the evidence around cost effectiveness can be adopted and include:

• Cost effectiveness analysis • Cost benefit analysis • Cost-utility analysis • Systematic review • Descriptive study • Review article • Other (specify)



Have direct and indirect costs been considered? If YES, please attach details of the cost-effectiveness.

CANADA

Operating Costs Introduction of new technology policy


Please describe the projected costs of implementing this new technology:

• Direct costs – i.e. cost of equipment, supplies • Indirect costs – i.e. cost of personnel • Ongoing costs – i.e. yearly cost

DENMARK


• Are there any start-up costs of equipment, rebuilding, training etc? Please state the expected start-up costs. The costs may cover rebuilding, new equipment, training, preparation of guidelines or patient information etc.

• What are the consequences in terms of activities for the next couple of years? Please state the consequences in terms of activities per year, for instance how many patients the proposal is expected to involve within the next couple of years (the number of patients is often lower the first year due to a start-up phase). Depending on circumstances, consequences in terms of activity may be assessed based on number of patients, number of discharges, number of outpatient clinic visits, number of bed days, casemix etc.

• What is the additional or saved annual cost per patient for the hospital? Please state the direct additional or less expenditure per patient per year for the hospital is the proposal is carried out.

• What is the total additional or saved cost for the hospital in the next couple of years? Please multiply the number of patients with the additional/less expenditure per patient, resulting in the total additional/less expenditure.

• Which additional or saved cost can be expected for other


RESULTS 27

hospitals, sectors etc? If the proposal changes results in expenditure or a saving for other hospital regions, the primary sector or the patients etc. please state this.

• Which uncertainties apply to these calculations? Please state if above calculations are uncertain.

UNITED KINGDOM



Describe the support and resources required.

Training requirements Training needs to take into consideration all professionals who will be involved in the new procedure, including junior medical staff, nursing staff, allied health and support staff who may be involved in the sterilising or setting up of the equipment. There are a number of issues that need to be considered regarding the training requirements of the new procedure (Royal Australasian College of Surgeons/ASERNIP-S, 2002), including:

Training and experience

• What previous experience does the institution have in similar procedures?

• Have staff members any training and experience in the procedure from other institutions?

Predicted throughput It is important to consider whether the hospital or health service will be able to do enough procedures per year to maintain necessary skill levels.

Learning curve There should be a general principle of more experienced practitioners undertaking new procedures, and avoiding the use of practitioners in the early stages of their learning curve for the new procedure. The typical asymptote (flattening of the learning curve) for the new procedure may be available from published studies or experience from other centres, and this could be used as a threshold e.g. a requirement for a surgeon to carry out a certain number of similar procedures or a certain number of easier cases before fully undertaking the new procedure.

All five of the policies included in this review that incorporated application forms as part of their approval process required information about the training requirements of the new procedure. Details of the specific information required by each policy are outlined in Table 4.


28 RESULTS

Table 4 Information required on training requirements of new interventional procedures


AUSTRALIA

Clinical Personnel and Expertise

• Please specify the type of clinical personnel required to implement the NTCP.

• Detail the existing clinical personnel and expertise required to implement the NTCP.

• Is additional clinical personnel and expertise required to implement the NTCP? If so please specify?

Operator Competency



Specify what credentialing and competency assurance is needed to ensure safe implementation of the NTCP. Has this been undertaken? If not, how and when will this occur?



Are there discrete training requirements for the proposed procedure? If YES, please attach details. On a separate sheet please list:

• the name/s • qualifications • evidence of relevant training and courses attended

of those individuals who wish to be credentialed for this procedure.

Please indicate the number of cases anticipated to be performed per year.

CANADA Staff training Introduction of new technology

policy Department of Surgery, Calgary Health Region • Are there implications for operating suite staff training?

• Are there implications for post-operative nursing care training?

• Are there implications for surgeon training? DENMARK


What are the effects of the proposal on the staff in terms of information, training or working environment? Please state the derived staff-related aspects of the proposal, including which staff groups will be affected by the implementation of the proposal. Possible consequences should be stated in relation to need for information and training and influence of working environment.

UNITED KINGDOM



• Is training necessary to undertake the procedure? Give details.

• Please provide evidence of completed training, including assessment of competency to perform the new procedure within the Trust.

Patient information and informed consent Patient information and informed consent forms need to be developed at the time of application (Royal Australasian College of Surgeons/ASERNIP-S, 2002). It is important that patient information forms outline the potential risks of the procedure as accurately as possible, including any areas of uncertainty. The criteria for selection of patients for the


RESULTS 29

procedure should also be clearly stated. With regard to informed consent, it is important that:

• The patient and their family are advised that the technique is new and/or experimental.

• Patients are provided with information about alternative treatments which are available.

• Patients are able to access information about how many of these procedures have been performed at the hospital and by the surgeon who will perform the procedure.

All patient information and informed consent forms should conform to national privacy principles, which outline the rights of an individual about whom information is collected (National Privacy Principles, 2001). Valid consent requires that the individual knows and understands how the information will be used or disclosed and their rights in accessing that information. Legislation also requires that providers are open about the fact of information collection and also their reason for collecting information.

Three of the five policies included in this review that incorporated application forms as part of their approval process required information about patient information and informed consent. Details of the specific information required by each policy are outlined in Table 5.


30 RESULTS

Table 5 Information required on patient information and informed consent for new interventional procedures


AUSTRALIA



Informed patient consent, supported by plain English written information sheets and a procedure-specific consent form is a departmental expectation.



Has a patient information sheet been developed? If YES, please attach (the patient must indicate their understanding of the procedure by signing and dating the patient information sheet).

UNITED KINGDOM



You must inform patients as part of the consent process that:

• the procedure is new

• anticipated benefits

• possible adverse effects

• alternatives, including no treatment, and record clearly that you have done so.

Please attach a patient information sheet.

Monitoring and evaluation All new interventional procedures need to be monitored after their introduction into a hospital or health service, and the approval process should decide the type of monitoring to be undertaken (Royal Australasian College of Surgeons/ASERNIP-S, 2002). Data collection systems should be established prior to introduction of the procedure, and should then be reviewed by peer groups as well as an independent group. Any adverse events should be reported and the causes reviewed at the local level. There are a number of specific issues that need to be considered regarding the monitoring and evaluation of a procedure once it has been introduced (Royal Australasian College of Surgeons/ASERNIP-S, 2002). Specifically:

• As a minimum, audits of indications and outcomes should be done.

• There should be access to reliable surgical data (local and global), organised in such a way that performance comparisons can be made.

• It is highly desirable that any study designs are coordinated and standardised, e.g. outcomes measured in the same way for case series and audits across hospital services or as done in previous studies.

• If an audit or controlled clinical study is being contemplated, it is useful to consider whether this can be done as part of a multi-centre study.

• Develop or amend internal processes for the reporting of any adverse events from new procedures and consider external processes e.g. as part of multicentre audits or advising the Therapeutic Goods Administration regarding problems with devices.


RESULTS 31

Two of the five policies included in this review that incorporated application forms as part of their approval process required information about monitoring and evaluation of new interventional procedures after their introduction. Details of the specific information required by each policy are outlined in Table 6.


32 RESULTS

Table 6 Information required on monitoring and evaluation of new interventional procedures


AUSTRALIA



Specify how your hospital/Health Service will monitor the NTCP once it is introduced into the clinical setting. Elements that might be considered as part of the monitoring process following the introduction of a NTCP within the clinical setting:

• Learning curve of operator(s)

• Credentialing

• Quality plan

• Stopping rule



• Will outcomes be monitored by a database/registry? If YES, please attach details.

• Will outcomes be reviewed regularly? If YES, please attach details.

• If the procedure carries with it a risk for adverse events are there criteria for reviewing outcomes before any further procedures are performed? If YES, please attach details.


RESULTS 33

Outcomes of policies and processes

Australia New Technology/Clinical Practice Program (Department of Human Services, Victoria)

The New technologies/clinical practices recommended by VPACT for introduction into the Victorian public health sector since 2005 have been reported recently by the Department of Human Services, Victoria (2007b) (Table 7). Since the New Technology/Clinical Practice Program was revised in 2005, there have been fewer submissions, more joint submissions and fewer funded submissions:

• For 2005-06: 26 submissions, 9 short-listed and 4 funded

• For 2006-07: 12 submissions, 6 short-listed and 4 funded

In addition, recent submissions to the New Technology/Clinical Practice Program have also been of a higher quality and, importantly, have detailed a plan for implementing the proposed new technology/clinical practice. This process has allowed for implementation of new technology/clinical practice on a truly state-wide basis with specified monitoring and reporting requirements from the field, which informs consideration about mainstreaming costs in subsequent years.

Policy for the introduction of new interventional procedures (Hunter Area Health Service, New South Wales)

A recent study has described the experience of the Hunter Area Health Service with the implementation of a formal evaluation process for the introduction of new interventional procedures (Spigelman 2006). This study has outlined both the number and nature of applications that were submitted to introduce new interventional procedures into the Hunter Area Health Service between January 2001, when the policy was implemented, and December 2004. Approval for all 29 new procedures submitted from a wide range of clinical disciplines was granted (Table 7):

• For 2001: 8 submissions




Spigelman (2006) has reported that where previous attempts to introduce new technology did not progress through management for budgetary reasons, the Clinical Governance Unit has aided their ultimate introduction by the new interventional procedure process. Rather than inhibiting or stifling innovation, this policy has in fact facilitated it. This formal evaluation process has allowed for an analysis of the evidence together with cost and benefit assessment and final evaluation by the Clinical Governance Unit, taking a strategic whole of organisation view focusing on all components (Spigelman 2006).


34 RESULTS

Canada McGill University Health Centre Technology Assessment Unit (McGill University Health Centre, Quebec)

A recent study evaluated the impact of the reports produced by the McGill University Health Centre Technology Assessment Unit, on institutional policy and budget (McGregor and Brophy, 2005). This unit began producing health technology assessments in 2002, and at the end of 2003, the Quality Management Team of the Health Centre, which was an independent body, evaluated the impact of the first 16 reports produced by the Unit.

Policy Impact The evaluation found that all recommendations of the first 16 reports had been accepted by the McGill University Health Centre and incorporated into policy. The recommendations made in these reports can be summarised as follows:

• Accepted

Five reports recommended acquisition and unrestricted use of technologies because of good evidence that they brought substantial health benefits at relatively low cost or that they caused an increase in productivity or in some cases even cost savings. The breakdown of these reports by clinical specialty is outlined in Table 7.

• Rejected

Seven reports did not recommend the use of the technologies, on grounds either of insufficient proof of benefit or insufficient quantity of health benefit to justify the costs.

• Restricted Four reports recommended that although there were proven clinical benefits, high

opportunity costs of the technology would result in too great a negative impact on existing services, and thus the use of these technologies should be strictly limited. In such cases a utilization algorithm was specified that was considerably more restrictive than the estimated demand, while ensuring that the technology would be allocated to those most likely to receive a health benefit.

Budget Impact An arbitrary estimation of the net budget impact of these reports has been attempted. A comparison was made between costs that were incurred as a result of the recommendations and an estimate of the costs that would have been incurred had the reports not been adopted, for those reports that accepted or rejected a technology. For reports that recommended restricted use of a technology that was already in use, the estimated costs of the restricted use compared with the predicted expenditure that would have resulted from continued unrestricted use were recorded as a saving (McGregor and Brophy, 2005). Where a technology had not yet been introduced, the anticipated cost of its use at the recommended level was recorded as an increased expenditure, despite the fact that the cost of its unrestricted use would have been even greater. Based on these


RESULTS 35

conservative assumptions, the estimated overall net annually recurring budget saving was $3,022,980, with a range of $2,259,530 to $3,778,404 (McGregor and Brophy, 2005).

Diffusion All reports are circulated to all Quebec hospitals larger than 100 beds and to the Quebec Ministry of Health and Social Services, and are published on the organisation’s website in order to promote maximal use of these reports. Between 2004 and 2005, the website was accessed over 20,000 times. McGregor and Brophy (2005) suggest that there is increasing evidence of the usefulness of these reports, both to the hospitals, the Ministry, and to HTA agencies in more distant jurisdictions.

United Kingdom Policy for the introduction of new interventional procedures (Luton and Dunstable Hospital NHS Trust)

A study by Freedman and Swanson (2006) described the implementation of a policy for the introduction of new interventional procedures by the Luton and Dunstable Hospital NHS Trust in 2004, following the introduction of the Interventional Procedure Programme (NICE) and the issue of Department of Health advice. This formal evaluation and approval process has been widely publicised both internally, as well as with external stakeholder organisations through conference events, Clinical Governance Committee membership and Clinical Management Team briefs, increasing awareness. Since it was established in 2004, the Trust’s Interventional Procedure Governance Committee has reviewed and endorsed the introduction of nine new interventional procedures within the Trust (Table 7) and has implemented a systematic process for audit and monitoring of outcomes (Freedman and Swanson 2006). The procedures that have been reviewed cover a range of specialty groups (Table 7), however the majority of procedures have been introduced within interventional radiology i.e. image guided techniques which avoid the need for more conventional surgical techniques to be undertaken, such as percutaneous vertebroplasty, uterine artery embolisation, embolisation of varicocele and Thrombin injection for pseudoaneurysm (Freedman and Swanson 2006).


36 RESULTS

Table 7 Outcomes of policies and processes

Policy Location Period №. of Applications

№. Approved

Specialty Group (n)

AUSTRALIA



2005-2007 38 8 • Obstetrics (1)

• Neurosurgery (1)

• Cardiothoracic surgery(1)

• Gastrointestinal endoscopy (1)

• Radiology (2)

• Anaesthesia (1)

• Gastrointestinal surgery (1)



2001-2004 29 29 • Gynaecology (5)

• Cardiology (3)

• Obstetrics (3)

• Urology (3)

• Pain Management (2)

• Ophthalmology (2)

• Neurology (2)

• Orthopaedics (2)

• Renal (2)

• Gastrointestinal surgery (1)

• Vascular surgery (1)

• Cardiothoracic surgery (1)

• General surgery (1)

• Gastrointestinal endoscopy (1)

CANADA

Technology Assessment Unit McGill University Health Centre, Quebec

2001-2003 16 5 • Gastrointestinal surgery (2)

• Immunology (1)

• Vascular surgery (1)

• Renal (1)

UNITED KINGDOM



2004-2006 9 9 • Interventional Radiology (4)

• Gynaecology (2)

• ENT (1)

• Maxillofacial surgery (1)

• Urology (1)


RESULTS 37

Priorities in decision-making Health technology assessment (HTA) is a policy-oriented form of research designed to inform decision makers on the introduction, use and dissemination of health technologies (Hivon et al., 2005). Recognition of the potential of HTAs to maximise the health benefits that can be realised with limited resources has resulted in a substantial proliferation of national and regional HTA agencies in many countries. The Australian Safety and Efficacy Register of New Interventional Procedures-Surgical (ASERNIP-S) is one such HTA agency, and was first established in 1997 by the Australian federal government. ASERNIP-S, which is administered by the Royal Australasian College of Surgeons, produces systematic reviews, accelerated reviews and horizon scanning summaries and reports of new and emerging surgical procedures. Each year, ASERNIP-S notifies approximately 700 hospitals throughout Australia about the systematic reviews it has completed, and in 2003 these hospitals were surveyed to determine how useful these notifications are and how they have influenced practice. The results of the survey showed that over 60% of respondents found ASERNIP-S notifications useful (Maddern et al., 2006). Around 25% had used them in the credentialing process or to change individual clinical privileges, and a further 25% had allowed or disallowed a procedure based on recommendations of a review. In general, they valued the independent nature of the assessments and used them as tools in the decision-making process (Maddern et al., 2006). To date however, few studies have assessed whether HTAs do in fact influence decision-making about the adoption of new health technologies. This review has identified four studies that have examined the use of HTAs in decision-making about the adoption of new health technologies in several settings worldwide, and the findings of these studies are outlined below.

In New Zealand, District Health Boards (DHBs) make the majority of decisions about the funding of new interventions. In 2004, the National Health Committee (NHC) conducted interviews with health professionals, planning and funding staff, and managers at five DHBs, in order to gather information about DHB decision-making processes (National Advisory Committee on Health and Disability (The National Health Committee), Wellington, New Zealand, 2006). Formal and informal decision-making processes were explored in the interviews, as well as the factors that impact on decision-making, the criteria used, use of HTA information and evidence, and the issues that arise from current decision-making practices. The NHC found that there is very little use of HTA information in formal DHB decision-making processes. Interviews with DHB staff showed that while evidence may be sought as part of the decision-making process, it is only one factor influencing decisions about the adoption of new interventions. Only one DHB was found to generate its own HTA information, while in the remaining four DHBs clinical staff relied on existing HTA information from New Zealand or overseas. While most formal DHB decision-making processes about new interventions require some evidence of effectiveness, in reality this means decisions are often based on one or two articles from reputable journals or clinical trials, rather than a synthesis of all available evidence and information. DHB staff commented that there was no obvious avenue


38 RESULTS

through which to easily access relevant HTA information that has been generated in New Zealand, or from the immense pool of information that exists overseas, or to share results of reviews done and decisions made by other DHBs. Clearly a central repository of such information is required. Decision makers considered a number of other criteria in the decision-making process, including:

• the acceptability of a new intervention to clinicians

• other DHB’s decisions about new interventions

• overseas practice

• whether the adoption of one intervention will enable other interventions to be removed (for instance from the pharmaceutical formulary)

• the number of other alternatives available (hospitals were eager to limit the number of alternative interventions that clinicians could use, without compromising the quality of service)

• the necessity of the purchase (the application of this criterion in the capital expenditure process sees less-urgent applications being accorded a lower priority and often being deferred until the following year)

• the quality of the proposal for the post-adoption evaluation of a new intervention (this is a component of some formal process and decision makers saw this as an important way of ensuring that the effects of an intervention were monitored after its introduction and that continued use was based on its performance).

Two recent studies have examined the considerations relevant to decisions about the acquisition of new medical technologies at the hospital level in the Israeli healthcare system (Greenberg, Pliskin and Peterburg, 2003; Greenberg et al., 2005). A preliminary study conducted in-depth interviews with decision makers at different levels, who were asked to indicate their considerations in acquiring medical technology (Greenberg, Pliskin and Peterburg, 2003). The interviewees were asked to indicate, on a 6-point Likert scale, the relevance of each consideration in the decision-making process (0=completely irrelevant, 5=highly relevant). The research population included general hospital directors. The hospitals included were chosen from a list compiled by the Ministry of Health (MOH), and in all, questionnaires were sent to 31 hospital directors. The most relevant criteria for the adoption of new technologies related to the need for a large capital investment, clinical efficacy of the technology as well as its influence on side effects and complication rates, and a formal approval by the MOH. Most interviewees stated that pressures exerted by the industry, patients, or senior physicians in the hospital are less relevant to decision-making. Directors of government and municipal-government hospitals attached the greatest importance to clinical considerations and implications regarding the new technology. Moreover, in comparison to other hospitals they also attached very high importance to formal approval in acquiring and using new technologies.


RESULTS 39

In a second study, a questionnaire which referred to (i) the considerations for and against adoption of a new technology, (ii) the decision-making process, and (iii) information sources used in the decision-making process, was mailed to 132 hospital executives from 26 acute care hospitals (Greenberg et al., 2005). The most frequently listed consideration in favour of adopting a new technology was increased cost-effectiveness compared with another technology (listed by 58% of respondents), increased efficacy (55%), and a potential decrease in complication rates (45%). Only a few respondents indicated that pressures exerted by patients or the general public may influence the decision-making process. The most frequent considerations against adoption were increased complication rates (64%), increased side-effects (59%), decreased efficacy compared with an existing technology, and decreased cost-effectiveness (57%). Respondents were asked to list the actual and optimal sources of information used when reviewing a new technology and making adoption decisions. Overall, the three most frequently stated sources of information were recommendations of local experts in a specific medical field (54%), participation in scientific conferences and meetings (48%), and leading general medical journals (48%). The lack of timely information was considered one of the most important barriers to an optimal decision-making process. Hospital managers considered the lack of information regarding the safety, the cost-effectiveness and the clinical efficacy as the most important barriers. Other considerations (e.g., legal and administrative barriers inside the hospital) were mentioned less frequently.

One study has analysed the Danish experience with the mini-HTA using three different questionnaires mailed to (i) all county healthcare authorities (ii) all hospital management sections and (iii) all clinical department management teams at departments of anaesthesiology, cardiology, and orthopaedic surgery (Ehlers et al., 2006). The questionnaires aimed to elucidate the use of and the attitudes toward use of the mini-HTA and other types of decision support tools when making decisions about the introduction of new health technologies. This study found that mini-HTAs were being used by 55% of the hospital authorities, 66% of the hospital management sections, and 27% of the department management teams. Respondents saw different advantages of using mini-HTAs. These advantages concern the very HTA principles (i.e., they rest on evidence-based knowledge, interdisciplinary overall assessments oriented toward decision-making problems); the form of the tool, be it a tabular form or a checklist (the collection of information and standardization of decision-making premises); as well as the way the form or checklist is being used (flexibility, openness, and timing). Disadvantages centred largely on insufficiency of the evaluation of the evidence base and the lack of quality control. The study of attitudes toward mini-HTAs at the Copenhagen University Hospital showed that the majority of the responders believed that the mini-HTAs increased the administrative burden of introducing a new health technology. Experience from the Copenhagen University Hospital shows much variation in the quality of mini-HTAs presented during the first year. Many questions were not answered properly or not at all. Sufficient quality was not obtained until management returned the forms demanding that they be filled in properly, suggesting that a quality standard was achieved not by virtue of the questions of the mini-HTA, but through continual dialogue between staff and manager in the process


40 RESULTS

of providing deep and qualified answers to the questions. The questionnaire revealed that no decision makers based their decisions exclusively on mini-HTAs, but rather used them as a supplement.


D I SCUSS ION 41

4. Discussion It has been acknowledged that while recent advances in health technologies have brought with them large benefits, they have also been a major driver of increased health spending (Australian Government Productivity Commission Research Report, 2005). In response to this mounting pressure on the health system, decision makers are often forced to make timely decisions regarding the adoption and utilisation of new health technologies, sometimes even before there is clear evidence regarding their safety and clinical and cost-effectiveness. In addition to the large numbers of new health technology proposals put forward by clinicians, decision makers are also under pressure from patients, the public and the media, which drives the requirement for increased transparency. In response to these increasing demands, many healthcare organisations, both in Australia and internationally, have instituted formal processes for the introduction of new health technologies.

The primary aim of this review was to identify both local and international policies and processes for the introduction of new interventional procedures into clinical practice, in order to determine the principles governing decision-making about the adoption of these procedures. Searches of the published literature revealed only one paper outlining relevant policy information. Targeted website searches were more fruitful, and uncovered a large number of relevant policy documents, the vast majority of which were from NHS Trusts in the UK. Where outcomes were reported for specific policies, these policies were given preference for inclusion, and a total of six policies, two Australian, two Canadian, and one each from Denmark and the UK, were selected for inclusion in this review. Each of the included polices contained a clearly defined purpose and an explicit description of the approval process, including the role of relevant clinical governance structures.

Five of the six included policies employ an application form as part of the approval process; while the McGill University Health Centre bases its policy decisions largely on the recommendations of Technology Assessments produced by its own Technology Assessment Unit. These Technology Assessments evaluate the safety, efficacy and cost-effectiveness of the new technology, as well any ethical and legal implications its introduction may have for the organisation. Information on clinical outcomes, including the clinical need and burden of disease, as well as the safety, efficacy and effectiveness of the procedure were required by all five policies that incorporated application forms as part of their approval process, as was information on organisational outcomes including the cost considerations and training requirements of the procedure. In line with national guidelines for the assessment, approval and introduction of new procedures into a hospital or health service (Royal Australasian College of Surgeons/ASERNIP-S, 2002), both Australian policies required patient information sheets and informed consent forms as part of their approval process. Similarly, the policy of the Luton and Dunstable NHS Trust in the UK also required that the issues of patient information and informed consent be


42 D ISCUSS ION

addressed, in line with NICE guidelines (NICE, 2004), however these issues were not addressed by the Canadian or Danish policies.

While it is clear that large numbers of healthcare organisations both in Australia and internationally have established formal processes for the introduction of new health technologies, there is a paucity of information on the outcomes and organisational impact of such initiatives. Searches of the published literature uncovered three studies that have evaluated the outcomes of specific polices in Australia, Canada and the UK, while targeted website searches revealed one document describing the outcomes of a second Australian policy. These studies have focused largely on the number and type of procedures that have been approved since the implementation of specific policies; however two studies have provided additional information on their organisational impact (Spigelman 2006; McGregor and Brophy, 2005).

The impression persists in some quarters that the goal of instituting specific policies for the introduction of new health technologies is to limit innovation and the diffusion of such technologies (Goodman 1998). Some clinicians view these formal processes as an unnecessary administrative burden, and just another means of cutting costs and taking control of clinical issues out of their hands (Goodman 1998). Spigelman (2006) has reported the experience of the Hunter Area Health Service with the implementation of its policy for the introduction of new interventional procedures. This study has shown that despite initial scepticism and clinician concerns regarding the level of detail required for applications, the implementation of the policy has facilitated rather than inhibited innovation (Spigelman 2006). Similarly, McGregor and Brophy (2005) have reported on the significant impact that policy decisions based largely on in-house technology assessments have had on the adoption of new health technologies, and subsequently on hospital spending, at the McGill University Health Centre in Canada. The budget impact of these policy decisions has been estimated at approximately $3,000,000 of savings per year, which considering that one-third of all healthcare costs are incurred directly by the hospital, would have a significant effect on its spending (McGregor and Brophy, 2005).

In this review, four of the six included policies have addressed either on their application form, or more generally through their approval process, the need for ongoing monitoring and evaluation of procedures following their introduction into a hospital or Area Health Service. However it is difficult to gauge how effective this aspect of the policies has been, as it has not been reported in the published literature. The process of clinical audit has been strongly promoted in the UK by NICE through its Interventional Procedures Programme. Interestingly, surveys within the NHS have demonstrated that although the majority of clinicians have attempted clinical audit, many audits are not completed (Babu et al., 2001), due to a variety of issues including a lack of supervision and support, difficulties with data collection and a perceived lack of time (Babu et al., 2001).

A secondary aim of this review was to determine the extent to which evidence-based information, particularly HTAs, is in fact used in decision-making about the adoption of new health technologies. Searches of the published literature uncovered three studies,


D I SCUSS ION 43

two in Israel and one in Denmark, that have examined decision-making at the hospital level, while targeted website searches revealed one document describing District Health Board decision-making processes in New Zealand. The results from these studies have shown that while the safety, efficacy and clinical and cost-effectiveness of technologies are important considerations in the decision-making process, a number of other factors also play an important role, and decisions are never based solely on the findings of HTAs. A lack of access to relevant and timely HTAs has been identified as an important barrier to an optimal decision-making process. This problem could be addressed, at least in part, by developing HTAs that in addition to focusing on clinical outcomes such as safety, efficacy and effectiveness also assess the organisational impact of new technologies in terms of factors such as staffing implications, impact on related services and set up costs. This may make them more directly relevant to the decision makers at whom they are aimed and thus more likely to be used. This has been achieved at the McGill University Health Centre in Canada, where the high impact of the Technology Assessments is also attributed to the relatively rapid response to requests, taking 3-4 months compared with the usual 12-18 months (Roehrig and Kargus, 2003). A similar in-house HTA unit has been established in Australia, at the Northern Sydney Central Coast Area Health Service. As part of their policy for the introduction of new health technologies, an independent assessment of the new technology is performed. This involves a brief literature review, a cost-benefit analysis, an organisational impact analysis, as well as the identification of and consultation with services that are likely to be affected by the introduction of the health technology. The complexity of the assessment will depend on the level of impact (financial and organisational) that the technology is likely to have.

In summary, many healthcare organisations, both in Australia and internationally, have established formal policies and processes for the safe introduction of new interventional procedures into clinical practice. Decision-making about the adoption of such procedures appears to be focused largely on clinical outcomes such as the clinical need and burden of disease and the safety, efficacy and effectiveness of the procedure, as well as organisational outcomes such as the cost considerations and training requirements of the procedure. Few organisations have reported their experience with such policies and processes however and there is a paucity of information on the outcomes and organisational impact of these initiatives. While it is clear that evidence-based information, such as HTAs, is frequently used in decision-making about the adoption of new interventional procedures, a lack of access to relevant and timely HTAs has been identified as an important barrier to optimal decision-making. Therefore, greater effort needs to be put into establishing information infrastructure in order to make evidence more readily available to decision makers.


44 D ISCUSS ION

Acknowledgments The authors wish to acknowledge Dr Karen Facey, Dr Wendy Babidge and Ms Eliana Della Flora for their assistance during the preparation of this review. The ASERNIP-S project is funded by the Australian Government Department of Health and Ageing and the South Australian Department of Health.


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