Data transferability in CEE countries - government.bg zdr.tehn./16_08...According to the law , the newly established Bulgarian HTA office needs to use local adaptation of all HTA documents

© 2016 Ideas & Solutions H-1118 Budapest, Kelenhegyi út 16/B. [email protected] http://www.i-s.hu

Márk Péter Molnár, MD, MSc

Data transferability in CEE countries

Research report

© 2016 Ideas & Solutions Data transferability in CEE countries 2

Agenda

Conceptual background of health technology assessment and data transferability practices in the European countries

1

2

3

Research results from 5 CEE countries (Poland, Czech Republic, Slovakia, Hungary, Romania)

Conclusions and recommendations


Project background According to the law, the newly established Bulgarian HTA office needs to use local adaptation of all HTA

documents to evaluate drugs. Therefore, pharma companies need to file HTA dossiers with local data (QALY, medical data, epidemiology, etc.) to fulfil this requirement.

However there is a lack of comprehensive local data needed for HTA assessments in most of the CEE countries, and we can assume that this will remain for a longer period of time.

Therefore it is extremely important for local authorities to find a stable balance between scientific clarity and goal-oriented pragmatism – where the goal is to assess medicines as meticulously as it is possible – and to find this balance, it seems reasonable to check the daily practice of other HTA bodies in the region.

In light of this, the goal of this project is to identify across selected CEE countries

o the main barriers that pharma companies have to face at the local adaptation of the HTA documents to submit to local authorities;

o the main barriers that authorities have to face at the local adaptation of submitted HTA documents;

o what authorities expect from the adaptation/localization;

o how authorities handle the adaptations with poor quality due to lack of local data;

o what are the applied rules for data transferability, using data from other countries if local data is missing.


1. CONCEPTUAL BACKGROUND OF HTA AND DATA TRANSFERABILITY PRACTICES


What is HTA and what is it for?

Health technology assessment (HTA) covers all methods for

the systematic evaluation of the comparative value of pharmaceutical products and other health technologies *

linked to pricing & reimbursement decisions by public and private payers

preceding to admission to the formulary and during formulary management.

* Mostly: medical devices, diagnostic tests, surgical interventions, vaccination and other public health programmes


Reimbursement policy Market access

Health technology analysis (HTA)

Critical technology review (CTR)

Public policy perspective Industry perspective

Stra

tegy

(d

ecis

ion)

leve

l M

etho

dolo

gy

(dec

isio

n su

ppor

t) le

vel

Decision level Goal-driven, urge for pragmatism Heuristic approach Integrating cost-effectiveness with

budgetary, ethical & market considerations Heterogeneous methods (qualitative and

quantitative)

Decision support level Focus on methodology, urge for precision Deterministic approach Emphasis on cost-effectiveness Extensive use of statistical and modeling

procedures

Health technology assessment is part of a complex system

Source: Dankó, D. – Molnár, M.P. (2011, ed.): Handbook of Pharmaceutical Reimbursement. Medicina


HTA systems should be pragmatic and sustainable, otherwise they will lead to dysfunctions

Problem-focused, pragmatic and sustainable HTA can…

Complicated, intransparent and unsustainable HTA will

Provide a transparent and structured framework for reimbursement decisions

Contribute to the optimization of resource allocation in health care budgets

Increase the predictability and sustainability of the reimbursement system, minimizing stop-go interventions

Provide baseline for structured and consistent formulary reviews

Fulfill a quality assurance role

Have a mindset-shaping and educational role towards decision-makers by offering a consistent and transparent framework

Act as a barrier to the access to innovative pharmaceuticals

Slow down reimbursement decision-making processes

Lead to reimbursement decisions which are detached from the therapeutic value of drugs

Provide no effective decision aid for higher-level decision-makers

Cause high operating costs to society, and high submission costs to the pharmaceutical industry

Get distorted by the for-profit interests of HTA consultants


What is needed for a successful HTA system?

REALISTIC POLICY GOALS,

ALIGNED WITH LOCAL CONTEXT AND CAPABILITIES

CLEAR, PRAGMATIC, CONCEPT

WITH STRATEGIC APPROACH AND DECISION FOCUS

PROPER IMPLEMENTATION

Improper implementation can discredit an otherwise clear and feasible concept for 5-10 years!


How can we evaluate pharmaceuticals?

Calculate We try to quantify cost-effectiveness by gathering and measuring health benefits and costs.

Categorize We try to characterize drugs along several dimensions, and based on this, we categorize them (or give them a relative score).

Combine We try to combine the strong points of both approaches, while limiting drawbacks and inefficiencies.


Three main paradigms for HTA

1 ECONOMIC EVALUATION

2 QUALITATIVE ASSESSMENT

3 BALANCED ASSESSMENT

Builds on pharmacoeconomics, especially biostatistics and modeling (CUA, CMA, CEA) Submissions (incl. models) typically

assessed by an HTA agency Key metrics: ICER, budget impact Explicit or implicit ICER threshold to

define cost-effectiveness Light or heavy models

Builds on expert judgment commonly found in regulatory agency procedures Importance of collective debate and

decision-making Usually, focus on clinical aspects &

societal impact (economic metrics may even be omitted) Scoring and ranking very common, key

metrics not commonly used

Multi-criteria analyses, integrating economic evaluation and qualitative assessment Aiming at the elimination of

methodological biases Importance of collective decision-

making, traceability and public accessibility of decisions Economic metrics used as inputs to

multi-criteria analysis only Light or heavy models

UK PL HU FR IT JP CA AU SE CZ TW

CALCULATE CATEGORIZE COMBINE


Overview of HTA systems in some European countries

Economic evaluation: UK, Poland, Czech Republic, Hungary, Slovakia, Bulgaria

Qualitative assessment without CEA: France*, Germany

Balanced assessment: Sweden, Netherlands

Qualitative assessment with complementary CEA in the negotiation process: Italy, Spain

* Limited cost-effectiveness analyses applied for innovative drugs (indications) claiming high AMSR-rating and high budget impact

Checklist-based assessment: Romania


Frequent institutional factors in middle-income countries

This speaks for light assessment: simple methodologies applied to existing information.

Several payers, complex decision-making processes

Intuitive, rather than analytical, decision-makers at political levels

Budget impact focus, payer emphasis on financial aspects

Questions around the applicability of economic evaluation

Confidential pricing agreements

CAPABILITY GAP, BANDWAGON EFFECTS

Smaller, more fragmented markets which together cover large populations

Need for pragmatic, no-frills approaches

‚Intertemporal friction’ between HQ expectations and local realities

FROM AN INDUSTRY PERSPECTIVE…


Three main approaches to HTA organizations, based on resource need

Def

initi

on

Com

men

ts

HEAVY MODEL LIGHT MODEL

Single and multiple technology assessments are performed with own academic and research resources

Economic evaluation is always based on primary health economics model

If qualitative assessment is used, it is also based on primary analysis

For large pharmaceutical markets, this is the justified option

But it requires huge investment into capability development

Requires 200-300 people at least

A new institute in Greater Europe does not stand a chance of catching up with NICE, SBU, PBAC or CADTH

Single technology assessments, based on manufacturer submissions, are performed with own resources

Agency-initiated multiple technology assessments do not exist

Economic evaluation is based on primary health economics model

This is the dominant option for non-core-EU countries implementing HTA

Normally justified by nation-specific cost and utility relationships

Added value of national appraisal is often low compared to previous assessments in core-EU countries

Requires 20-40 experts at least, and significant investment into capabilities

IRRATIONAL FOR MID-SIZE PHARMA MARKETS NOT RECOMMENDED

ULTRA-LIGHT MODEL

No health economics model is submitted to the appraisal body

CEA part of economic evaluation is based on international benchmarking of peer appraisals („rational free-riding” w/wo compensation)

BIA and qualitative assessment are carried out as primary analyses

There might be relevant overlap between NICE, SMC, CADTH, PBAC appraisals

National financial considerations can be considered in BIA

Feasible and goal-oriented approach low resource need and quick results compensate for low academic prestige

Relying on peer appraisals may not be socially or politically acceptable

MOST RATIONAL FROM A TECHNOCRATIC PERSPECTIVE

BUT PRONE TO CRITICISM

COSTLY, BUT LESS PRONE TO METHODOLOGICAL CRITIQUE


Building new models versus model adaptation

Building new models Model adaptation

Advantages: Provides a precise description

about the given problem Transparent Less distorting factors

Disadvantages: Time-consuming Costly Requires a lot of data Country-specific

Advantages: Less expensive Faster and easier to implement It demands less resources

Disadvantages: „hybrid” models with many

distorting effects Limited access to relevant data Different health care system

structures and clinical practice

Most of the middle-income countries apply economic evaluation combined with light or ultra-light modeling, that requires local data in each cases (independently from the modeling type)

As HTA in CEE countries tends to be less methodology- & resource-driven and more focused on budget impact, model adaptation seems much reasonable instead of de novo modeling


Possible algorithm for data transferability

Identify the decision problem

Determine the main parameters that should and can be adapted/adjusted

Recalculate these items and provide a clear explanation to the applied methodology with marked sources

Check the consistence and external/internal validity of the model with the updated values

Source: Drummond et al, 2009


What kind of information can be adapted?

Treatment costs

Treatment costs & comparators

Treatment costs & comparators & epidemiology

Treatment costs & comparators & epidemiology & QALY data

Treatment costs & comparators & epidemiology & QALY data & probabilities

Dat

a re

quire

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t


2. RESEARCH RESULTS FROM 5 CEE COUNTRIES


Research methodology

Main steps of HTA process

Dossier submission requirements

Data requirements at HTA

Main barriers of local adaptation

1 4 3 2

In order to collect local information about data transferability practices related to HTA & reimbursement, we developed a questionnaire.

The questionnaire was filled in by 3-5 respondents from each CEE country (Poland, Czech Republic, Slovakia, Hungary and Romania) and followed the same structure in each cases:


POLAND Research results


Overview of reimbursement submission process

Submission of the application for reimbursement

MAH

Formal evaluation of the application

MoH

Verification analysis AOTMIT

Final statement based on the recommendation of

Transparency Committee AOTMIT

Price negotiations MoH Economic

Commission, MAH

Final decision on reimbursement

MoH

There is a formal HTA process in Poland The responsible body for HTA is the Agency for Health Technology

Assessment and Tariff System (AOTMiT) The AOTMiT recommendation is not binding to the MoH, the product can

be still refused or receive reimbursement National guideline for HTA is in place

MAH: marketing authorization holder. MoH: Ministry of Health. AOTMIT: Agency for Health Technology Assessment and Tariff System



Other Budget impact analysis

Pharmacoeconomic analysis Clinical assessment

Epidemiology

Pathophysiology

Disease burden

Unmet need

Summary of clinical studies

Systematic literature review of efficacy and safety evidence

Methodology description

Structure of the model

Input data (costs and effectiveness)

Indirect cost consideration (optional)

Results

Patient numbers

Cost of treatment

Reimbursement outflow

Published pharmacoeconomic analysis in other countries

Information about reimbursement status in other countries

Information about HTA assessment outcomes in other countries


Data requirements at HTA (1) Type of analysis Type of data Is it mandatory to

provide local data? Are local data available?

Source of local data

Clinical assessment Clinical evidence about efficacy from RCTs NO There is no need for local clinical trials.

However local RWE data can serve as an advantage. Clinical assessment Clinical evidence about safety

from RCTs NO

Pharmacoeconomic analysis

Epidemiology YES YES (partially)

National Health Insurance Fund, questionnaires among KOLs, registries if

available, Central Statistical Office


Cost of therapy YES YES (partially)


Cost comparison with relevant treatment alternatives YES YES (partially)


Statistical modelling of results and costs YES YES (partially)


ICER calculation YES YES (partially)


QALY data NO QALY data (if available) are mandatory but there is no need to provide local data


Cost/QALY calculation YES YES (partially) NHIF data





Budget impact analysis Patient number YES YES (partially)

NHIF data, Reimbursement Drug List, expert

interviews

Budget impact analysis Cost of therapy YES YES

Budget impact analysis Cost of treatment alternatives YES YES

Budget impact analysis Cost of AE treatment YES YES

Authorities in Poland require basically every type of data to adapt, except clinical evidence and QALY values

The pharmacoeconomic and budget impact models have to be attached to the reimbursement submission

During the evaluation, AOTMiT uses publicly available data. Estimation of specific populations is based on KOLs' opinion. Sometimes the Agency confirms their calculation by data from National Health Found (NHF).



Although companies are obliged to provide MoH with unlocked version of the models with technical description of the model, very often corporate models are based on data-on-file or data from different sources that are hardly traceable

Polish epidemiological data are very limited or don't exist, therefore KOLs' opinion is necessary;

Different therapy standards and disease management, including best supportive care

Authorities’ aspect Pharma companies’ aspect


CZECH REPUBLIC Research results



Submission of the application for reimbursement

SUKL

Assessment of SUKL and negotiation among

MAH and Insurance companies

Final decision SUKL

*SUKL: State Institute for Drug Control

There is a formal HTA process in Czech Republic The responsible body for HTA is the State Institute for Drug Control (SUKL) SUKL is not an independent body, it belongs to the Ministry of Health In case of positive recommendation, the product can still end up without reimbursement, if the sick

funds (7 in total) appeal against the proposal of SUKL and the Ministry of Health accepts the argumentation

Similarly, MAH can also appeal against a negative decision National guideline for HTA is in place





Epidemiology

Pathophysiology

Disease burden

Unmet need







Results

Sensitivity analysis

Patient numbers

Cost of treatment


Sensitivity analysis



Information about HTA assessment outcomes in other countries (NICE)





Clinical assessment Clinical evidence about efficacy from RCTs NO

Local data preferred but rarely available, EU trials are accepted and mainly used Clinical assessment Clinical evidence about safety

from RCTs NO



Statistical Office, registries, expert opinion, literature



List of reimbursed products, DRG list,

expert panels








QALY data NO

Local data preferred but rarely available, extrapolation from UK accepted, if not

available other EU countries can be used


Cost/QALY calculation YES YES (partially) List of reimbursed products, DRG list





Budget impact analysis Patient number YES YES (partially)

Statistical Office, registries, expert opinion,

literature

Budget impact analysis Cost of therapy YES YES List of reimbursed

products, DRG list, expert panels



Other Treatment guidelines YES YES (partially)

Local guidelines. If not available, EU guidelines

are accepted

In Czech Republic it is preferred to provide local data related to clinical effectiveness and QALY but in these cases European trials and data are accepted. In every other case data should be adapted.

Sensitivity analysis is a must for cost-effectiveness analysis and budget impact model as well SUKL tries to get evidence by itself - literature, questions to expert societies, expert panels; Additional evidence required at highly innovative products - MAH has to run a patient registry for up to 3

years



Products with temporary reimbursement are not considered as relevant comparators – the chosen comparators in the analysis often do not correspond to real practice

Methodological guidelines enable various interpretations for assessment

Models are not available to SUKL, only a description is submitted

Statistics for local epidemiology are missing

Unreliable or inaccessible data from patient registries

Methodoloical guidelines are outdated



SLOVAKIA Research results



Drug evaluation MoH

Recommendations of expert groups

Submission of application, formal control

MoH

Determination of reimbursement & final

decision Reimbursement

Committee

Final approval and signature

Minister of Health

The HTA process is formal in Slovakia but there is no dedicated agency to evaluate the submissions The responsible body for HTA is the Pharmacoeconomic Working Group, who belongs to the Ministry

of Health and is an advisory body to the Reimbursement Committee (within the Ministry of Health) The members of the working group are employees of other independent institutions (e.g. health

insurance companies or university) In case of a negative decision, MAH has a possibility to submit objections against the decision National guideline for HTA is in place





Epidemiology

Pathophysiology

Disease burden

Unmet need







Results

Patient numbers

Cost of treatment




Information about HTA assessment outcomes in other countries (NICE, IQWIG)






Local data are not expected, EU trials are sufficient Clinical assessment Clinical evidence about safety

from RCTs NO



Statistical Office, publications, market

research


Cost of therapy YES YES (partially) Central database of contracts (prices of

hospitalization, price per ambulatory

visits), list of reimbursed drugs,

National Health Data Centre








QALY data YES NO MAH provides international data


Cost/QALY calculation YES YES (partially) List of reimbursed drugs





Budget impact analysis Patient number

YES YES (partially)

National Health Data Centre (not register), own survey via KOL, advisory

boards

Budget impact analysis Cost of therapy YES YES List of reimbursed drugs,

central database of contracts



Data requirements in Slovakia are similar to the previous countries: every type of data has to be adapted – except clinical efficacy and safety.

The main problem with the evaluation of the dossier is that there is no explanation attached to the final decision. For example if the comparator is wrong, it is not explained what to choose instead. Therefore the MAH does not know what to correct or what to submit differently in case of a negative decision



Models are not available to the PE Committee, only selected data and results are submitted

Local data are not easily accessible, there are several data sources that MAH needs to consult about

Pharmaceutical expenditures are not publically available



HUNGARY Research results



Drug evaluation NIPN

Price negotiations NHIF

Decision about reimbursement and its

publication NHIF, but legislative amendment may be

necessary

Submission of application, formal control

NHIF

Determination of reimbursement rate

NHIF

NHIF: National Health Insurance Fund, NIPN: National Institute of Pharmacy and Nutrition

There is a formal HTA process in Hungary with a dedicated HTA agency The responsible body for HTA is the Department of Health Technology Assessment which belongs to

the National Institute of Pharmacy and Nutrition The recommendation of the HTA body and the NHIF is not binding to the Ministry of Health/Ministry

of Finance the product can be still refused or reimbursed National guideline for HTA is in place (currently under revision)





Epidemiology

Pathophysiology

Disease burden

Unmet need







Results

Patient numbers

Cost of treatment




Information about HTA assessment outcomes in other countries






Local data are not expected, EU trials are sufficient Clinical assessment Clinical evidence about safety

from RCTs NO


Epidemiology NO (only recommended) YES (partially)

Central Statistical Office, publications,

market research



NHIF database, public drug list, DRG

database, therapeutic guidelines








QALY data NO International data are accepted


Cost/QALY calculation YES YES (partially) NHIF database, public drug list





Budget impact analysis Patient number

YES YES (partially)

Central Statistical Office, NHIF database,

therapeutic guidelines, expert interviews

Budget impact analysis Cost of therapy YES YES NHIF database, public

drug list, DRG database, therapeutic guidelines



Most local data are publically available in Hungary, however there is not much information about pharmaceuticals used in inpatient care and Hungarian therapeutic guidelines are outdated

Cost-effectiveness and budget impact models have to be submitted or presented to the HTA Bureau at a hearing

In case of poor quality data submitted, the HTA body usually tries to do their own analysis



HE models are usually designed for G5 countries, however treatment pathways and reimbursement environment (i.e. available therapies) could be different in CEE countries

Some of the treatment options might not be reimbursed

Lack of Hungarian HRQoL data Especially in case of pharmaceuticals

applied in inpatient care it is hard to provide a patient number estimation as no public data are available

Company can demonstrate the cost-effectiveness at first line, but NHIF may push to second line or later, regardless of the evidence presented



ROMANIA Research results



Reimbursement file submission as an orphan

drug for a rare disease without any other therapy

NAMMD

Negotiations with a Committee for a MEA

agreement (only if necessary)

Approval and inclusion in the treatment protocol

MoH, NHIH

Submission of pricing dossier and getting price

approval MoH

Reimbursement List update

MoH, NHIH, MoF

MoH: Ministry of Health; NAMMD: National Agency for Medicines and Medical Devices; NHIH: National Health Insurance House

HTA process is formal in Romania as well The responsible body for HTA is the Health Technology Assessment Department at National Drug Agency which

belongs to the Ministry of Health The evaluation of the submissions is based on a scoring system There are 2 types of positive recommendations: unconditional reimbursement (min. 80 points), meaning that the

product is automatically reimbursed, and conditional reimbursement (between 60-79 points), meaning that the reimbursement is conditioned by closing a cost-volume or cost-volume result contracts.

In case of negative decision, the MAH can appeal against the decision by providing additional information National guideline for HTA is in place


Scoring system for pharmaceutical evaluation Checklist for evaluation of each new drug Number of points

The medicine has a positive recommendation from NICE or SMC (UK/Scotland)

No: 15p; With restrictions: 7p

The medicine has a positive recommendation from HAS (France) No: 15p; With restrictions: 7p

The medicine has a positive recommendation from IQWIG (Germany) No: 15p; With restrictions: 7p

The number of EU countries in which the product is reimbursed Max. 25p (points increasing with the nr of countries)

MAH decision to develop a RWD study with NDA approval for the new drug/indication

Max. 45p

Budget Impact calculation Max. 30p

Getting 80 points ensures unconditional reimbursement, between 60- 79 points conditional reimbursement based on a risk sharing agreement (cost-volume or cost-volume-results for a number of patients decided by the ministerial

commission treating that disease)

Special criteria are applied to orphan drugs and drugs dedicated to infectious diseases.

Maximum score: 145 p

Unconditional reimbursement: min. 80 p

Conditional reimbursement: 60-79 p

No reimbursement: under 60 p





Epidemiology

Pathophysiology

Disease burden

Unmet need







Results

Patient numbers

Cost of treatment




Information about HTA assessment outcomes in other countries (NICE, HAS, IQWIG)

Real-world evidence





Clinical assessment Clinical evidence about efficacy from RCTs NO There is no formal clinical assessment

performed. The HTA body reviews the international reports (NICE, IQWIG, HAS) Clinical assessment Clinical evidence about safety

from RCTs NO


Epidemiology NO NO

There is no need for cost-effectiveness model adaptation, because only the

price of the product is considered


Cost of therapy NO NO


Cost comparison with relevant treatment alternatives NO NO


Statistical modelling of results and costs NO NO


ICER calculation NO NO


QALY data NO NO


Cost/QALY calculation NO NO





Budget impact analysis Patient number YES NO NHIH information

Budget impact analysis Cost of therapy YES YES

National Price Catalogue for Drugs (CANAMED)


Budget impact analysis Cost of AE treatment NO

The entire HTA model isn’t based on local data, that's the reason why the score card was implemented, because of the lack of the data from the local market.

No direct evaluation of the clinical value of drug (incremental efficacy, safety, PRO) No local pharmacoeconomic data required The system favors drugs with significant savings in terms of budget impact, even with lower efficacy



Real-world evidence is part of the scoring system (max 45p) but there is no methodology in place for assessing it

Eligible population is established by Specialty Committees from MoH and there is no clear methodology in place regarding the source of data

If there is no reimbursed comparator, the product receives 0 point for budget impact

Only direct costs are considered



3. CONCLUSIONS AND RECOMMENDATIONS


Summary of HTA systems in CEE countries Czech Republic

Is there a formal HTA?

Is there a dedicated HTA agency?

What is the applied HTA paradigm?

Which HTA method is preferred?

Poland Slovakia Hungary Romania

YES YES YES YES YES

YES (Agency for Health Technology Assessment and

Tariff System)

YES (State Institute for Drug Control) NO

YES (HTA Department within

the National Institute of

Pharmacy and Nutrition)

YES (HTA Department at National Drug

Agency)

Economic evaluation

Economic evaluation

Economic evaluation

Economic evaluation

Economic evaluation (without

PE analysis!)

CUA/CEA/CMA + BIM

CUA/CEA/CMA + BIM

CUA/CEA/CMA + BIM

CUA/CEA/CMA + BIM

Only BIM

CUA: cost-utility analysis, CEA: cost-effectiveness analysis, CMA: cost-minimization analysis, BIM: budget impact model


Summary of data requirements

Clinical efficacy

Clinical safety

QALY

Epidemiology/Patient number Cost of therapy Cost of treatment alternatives Cost of AE treatment Statistical modelling of results

and costs ICER calculation

Adaptation is NOT required* Adaptation is required

In general, this is the common evaluation practice in every analyzed CEE country, except Romania, where only budget impact analysis is applied, therefore the only two relevant parameters are patient number and cost of therapy

Usually if data should be adapted and there are no public sources available, local market research is applied (e.g. expert panels, advisory boards, KOL questionnaires)

*Local data are preferred but international studies are also accepted in these cases.


Summary of available data sources for adaptation

Clinical data Pharmaco-economic data

Budget impact data

International clinical trials

NHIF data Reimbursement Drug

List DRG list KOL questionnaires Advisory boards Central Statistical

Office Registries Literature overview Therapeutic guidelines

NHIF data Reimbursement Drug

List DRG list KOL questionnaires Advisory boards Central Statistical

Office Registries Literature overview Therapeutic guidelines


Main deficiencies of data transferability

Most of the necessary data are collected but usually they are only privately available, databases are not synchronized

Lack of patient registries – therefore expert panels and advisory boards are inevitable to determine the target patient pool

Economic models are not available to the HTA Agency, only a technical description and results are submitted (except Poland and Hungary)

Different therapy standards and disease management, including best supportive care


Recommendations and conclusions

Theoretically and from scientific perspective a full scale HTA is always the best solution, though from cost-effectiveness and implementability aspect it

is not reasonable.

No-adaptation is not a preferred option, but due to lack of local data and to limited financial resources and time, it might be considered viable with

limitations in certain cases.

Local adaptation of the international models seems to be the most reasonable option in the region based on good quality local data with the

possibility of using international data when missing local.

The countries in the region need to work on good quality and publicly available databases, and they need to investigate the possibilities of

cooperation on producing regional data.

Documents

Data transferability in CEE countries - government.bg zdr.tehn./16_08...According to the law , the newly established Bulgarian HTA office needs to use local adaptation of all HTA documents