Innovation and Technology Payment 2019/20 · Cluster Headache and Hemicrania Continua) and Medication Overuse Headache in adults •Medtech Innovation Briefing published by NICE in

NHS England and NHS Improvement

Innovation and Technology Payment 2019/20

Hosted by Sharon Priestnall

Innovation, Research and Life Sciences Group

The WebEx will start 5 minutes late to allow participants to join the session. Please MUTE your phones and computers when not asking questions.

This WebEx will be recorded.


• NHS England’s Long Term Plan

• Innovation and Technology Payment (ITP) - programme aims

• Selection Criteria:

Nice support (through a Medtech Innovation Briefing or Guidance)

Positive in-year return on investment

Use in at least three NHS organisations

• Themes for support:

Non-invasive vagus nerve stimulation therapy for the treatment of cluster headaches

Absorbable spacer to reduce rectum radiation exposure during prostate radiation therapy

Placental growth factor test for the rule-out of pre-eclampsia

High sensitivity troponin assay for acute myocardial infarction

• Evidence Generation Fund:

Digital app to support emergency mental health assessment

Interoperable personal health record tool

• Previous ITT/ITP programme: continued support for a further 12 months effective 1st April 2019.



Presenting

GammaCore

Innovation Details

• Vagus Nerve• Longest cranial nerve in the body

• Communication link between the brain and the body

• Affects many important autonomic functions in the brain and in the body, including neurotransmitter levels, inflammation levels, and metabolism

• Vagus Nerve Stimulation• Implanted Vagus Nerve Stimulation (iVNS) has been commercialized for >20 years

• Studied over past 2 decades for its novel anti-inflammatory effects (Cholinergic Anti-inflammatory Pathway)

• gammaCore™ (non-invasive vagus nerve stimulator)• In 2010, we developed the ability to administer vagus nerve stimulation non-invasively

(nVNS)

• A proprietary signal is delivered through the skin to either the right or the left branches of the vagus nerve in the neck

• gammaCore completely revolutionizes the accessibility of VNS, removing the prohibitive cost and safety restrictions associated with implanted VNS

Background

•Age of onset is typically between ages of 20 and 40 years1

•Attacks last between 15-180 minutes1

•Attacks may occur once every other day to 8 times a day1

•Pain is severe and strictly unilateral1

•Most patients have eCH, 10% to 20% have cCH1

•Frequently nicknamed “suicide headache” due to its severity1

•Recently been recognised by the NHS as one of the top 20 most painful conditions known to man2

Burden of Cluster Headache

• It affects approximately 66,000 people in the U.K.3

•Estimated to cost the NHS more than £10,000 per year per patient4

Effects of Cluster Headache in the UK

•Currently no prospect of a curative treatment

•Treatment goal is attack cessation or suppression

•The majority of drug therapies prescribed for cluster headache are used outside of their licensed indications5

•Currently several pharmacological therapies and surgical interventions undergoing clinical trials for cluster headache, however none are yet licensed

Shortcomings of current treatment options

Benefits of gammaCore

Benefits of gammaCore therapy

• Reduces cluster headache frequency, severity and duration

• Has the potential to return financial savings into NHS

• Non-invasive, hand-held, self-administered

• Delivers up to 30 stimulations a day

• Reloadable and rechargeable

• NICE raises ‘no major concerns’ regarding the safety of gammaCore

Significant reduction in use of acute treatments6

Significant reductions in the use of subcutaneous sumatriptan and inhaled oxygen

• During the randomized phase, the SoC + gammaCore (nVNS) group had a 57% decrease in frequency of acute medication use (P<0.001)

Experience

• gammaCore currently holds five CE marks for use in the EU in the following indications; primary headache, bronchoconstriction, epilepsy, gastric motility disorders, and depression and anxiety

• gammaCore and gammaCore Sapphire are indicated for the acute and/or prophylactic treatment of primary headaches (Migraine, Cluster Headache and Hemicrania Continua) and Medication Overuse Headache in adults

• Medtech Innovation Briefing published by NICE in October 2018, gammaCore for Cluster Headache3

• Interventional Procedures Guidance published by NICE in March 2016, Transcutaneous stimulation of the cervical branch of the vagus nerve for cluster headache and migraine8

NICE / Regulatory

• Multiple clinical trials published

• Ongoing studies into migraine and other headache disorders

Clinical trials

• Headache teams in over 25 NHS Trusts are utilising gammaCore

• Over 80 Individual Funding Requests approved by different CCGs

Real-world use of gammaCore in the UK

Using gammaCore in the clinic

• Authorisation from a GMC registered doctor is required to use gammaCore

• Training is provided for all HCPs who may have to train new gammaCore patients via our ‘Train the trainer’ program

• gammaCore is delivered directly to the patient’s door

• Full training guides are available online, and via video call services see gammaCore.co.uk for more details

• gammaCore refill cards (93-days) must be authorised by a member of the patients’ headache team

Contact

•Email: [email protected]

•Telephone: 07739911610

Iain Strickland, Managing Director

•Email: [email protected]

•Telephone: 0800 678 5632

Customer Service

•electroCore.com

•gammaCore.co.uk

Websites

References: 1. British Association for the Society of Headaches. Guidelines for All Healthcare Professionals in the Diagnosis and Management of migraine, tension-type headache, cluster headache and medication overuse headache. http://www.bash.org.uk/wp-content/uploads/2012/07/10102-BASH-Guidelines-update-2_v5-1-indd.pdf.2. NHS Choices. 20 Painful Health Conditions. https://www.nhs.uk/live-well/healthy-body/20-painful-health-conditions/3. National Institute for Health and Care Excellence. Medtech Innovation Briefing. gammaCore for cluster headache. https://www.nice.org.uk/advice/mib1624. Gaul, C., Finken, J., Biermann, J., Mostardt, S., et al. Treatment costs and indirect costs of cluster headache: A health economics analysis. Cephalalgia 2011; 31 (16): 1664–1672.5. National Institute for Health and Care Excellence. Headaches in over 12s: diagnosis and management. https://www.nice.org.uk/guidance/cg150 6. Gaul, C., Diener, H., Silver, N., Magis, D., et al. and on behalf of the PREVA study group. Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study. Cephalalgia 2016; 36(6) 534–546.7. National Institute for Health and Care Excellence. Interventional Procedures Guidance. Transcutaneous stimulation of the cervical branch of the vagus nerve for cluster headache and migraine. https://www.nice.org.uk/guidance/ipg552



GammaCore

Q&A



Presenting

SpaceOAR Hydrogel

ITP 2019/2020SpaceOAR™

Hydrogel

1

BACKGROUND TO OUR INNOVATION

Prostate Cancer in the UK1

• 47,151 new cases in 2015 (UK)

• Average age of diagnosis is 65 – 69 year old

• 84% survive prostate cancer for 10 or more years

(2010-11, England and Wales)

One in 8 men will be diagnosed with

prostate cancer in their lifetime

1Prostate Cancer UK, Cancer Research UK

2

TREATMENT OPTIONS AND THE PATIENT DILEMMA

Prostate Radiotherapy in the UK

National Prostate Cancer Audit 2018:

One in 10 men will suffer a severe

gastrointestinal complication within 2 years of their radiotherapy1

Rectal toxicity side-effects include:▪ Radiation proctitis▪ Rectal bleeding▪ Urgency▪ Loose stools and diarrhoea

ACTIVE SURVEILLANCE

SURGERY

RADIOTHERAPY

▪ May cause worry▪ Increased monitoring ▪ Repeat biopsies

▪ Invasive▪ Sexual dysfunction▪ Urinary incontinence

▪ Rectal toxicity▪ Urinary incontinence▪ Sexual dysfunction

1 https://www.npca.org.uk/reports/npca-annual-report-2018/

SPACEOAR HYDROGEL

Transperineal hydrogel injection into space between prostate and rectum

Gel maintains separation between rectum and prostate during radiotherapy, and is then naturally absorbed in around 6 months

RectumProstate

Bladder

SpaceOAR hydrogel temporarily positions the rectum away from the prostate during radiotherapy, to minimize urinary, sexual and bowel side effects for prostate cancer patients undergoing radiation therapy

3

POWDER VIAL DILUENT SYRINGE

ACCELERATOR SYRINGEY-CONNECTOR (MIXER)

18G NEEDLE PLUNGER CAP

SYRINGE HOLDER

SPACEOAR HYDROGEL KIT

◼ Single use, disposable

◼ 24 month shelf life

◼ Prepared in minutes

SPACEOAR HYDROGEL KIT

◼ Ultrasound unit with side-fire

trans-rectal ultrasound probe

◼ Stepper stabilisation system

REQUIRED EQUIPMENT

◼ Training and certification

programme comprising

classroom training and

guidance during the procedure

TRAINING

◼ Can be carried out under local or

general anaesthesia

◼ Can be implanted along with

fiducial markers

PROCEDURE

4

5

CLINICALLY PROVEN

60+ clinical publications including a 222 patient prospective multicentre randomised clinical study with 3-year follow up data.

SpaceOAR patients experienced Control patients experienced

73%Relative reduction in

rectal V701

67%Maintained potency compared to 38% in

control group3

0%Grade 2 + late rectal

toxicity2

8xMore likely to have a

decline in bowel, urinary and sexual

quality of life2,4

1 Average dose reduction when comparing pre and post spacer treatment plans, Mariados N, et al. Hydrogel spacer prospective multicenter randomized controlled pivotal trial: Dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):971-7.2 Hamstra DA, et al. Continued benefit to rectal separation for prostate radiation therapy: Final results of a phase III trial. Int J Radiat Oncol Biol Phys. 2017 Apr 1;97(5):976-85.3 Of men who had erections sufficient for intercourse at baseline; median 3 years, Hamstra DA, et al. Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial. Pract Radiat Oncol. 2018 Jan - Feb;8(1):e7-e15.4 Compared to SpaceOAR patients

6

UK EXPERIENCEUsed in 9 NHS hospitals

24 doctors trained14 doctors certified

Centres include University College London Hospitals NHS Foundation Trust, Maidstone and Tunbridge Wells NHS Trust, Royal Marsden

NHS Foundation Trust, University Hospital of Leicester NHS Trust

and others

JAPAN

AUSTRALIA35,000+

PROSTATE CANCER PATIENTS TREATED WORLDWIDE

GLOBAL EXPERIENCEUsed in many leading cancer centres in US, Europe, Japan and Australia

EUROPE

USA

ABOUT US

Augmenix Inc., was founded in 2007 with a mission to improve the life of cancer patients by decreasing unintended radiation damage to normal organs during radiation therapy using hydrogel technology.

The Company was acquired in October 2018 by Boston Scientific.

Kenneth HallField Clinical [email protected]: +44 7791 501 321

Mark BuckleyInternational Marketing Manager - [email protected]: +44 7920 834 458

Stephen McGillVP and General Manager International – [email protected]: +44 7920 834 451

Emily WoodwardDirector of International Market Access and Reimbursement - [email protected]: +41 79 533 15 15

7

Your ITP Contacts

mailto:[email protected]






SpaceOAR Hydrogel

Q&A



Presenting

QUIDEL Triage PLGF

226 SLIDE DECK (PROVIDER / COMMISSIONER)

QUIDEL Triage PLGFPlacental Growth Factor (PlGF)

The Problem

o Women with suspected pre-eclampsia are evaluated with

imperfect clinical markers (BP, protein dipstick, PET bloods)

o Clinical uncertainty can lead to over-diagnosis and

unnecessary care, but also a delay in care

o Creates service inefficiency, unnecessary cost, anxiety and

inconvenience for providers & patients

The Solution – use a “placental” biomarker

o PlGF is sensitive & specific to the root cause of preterm pre-

eclampsia, impaired placentation†

†Chappell, LC. Circulation. 2013 Nov 5;128(19):2121-31 ‡ Duhig, K. The Lancet. Apr 2019

Triage PLGF is supported by NICE

(DG23) and ITP 2019/20

Intended use is to aid in the

diagnosis of pre-eclampsia and

prognosis for required delivery

within 14 days in pregnant

women <35 weeks’ gestation

Validated to be safe & effective

for the intended use in the target

population‡

23

Quidel Triage PLGF Key components, protocol,

and ITP pricing


Centrifugation of EDTA

whole blood to obtain

EDTA plasma sample

Triage MeterPro

SKU 55071

£1,400 + VAT22.5 x 19 x 7 cm (D x W x H)

Electronic QC device (daily)

Used daily to check laser

alignment and

Calibration

STORE: Ambient

PlGF device kit

SKU 98800EU (25 tests)

List price £1,750 + VAT

£70 per individual test

STORE: 2-8°C

KEY COMPONENTS

PROCEDURE (LIQUID QC TESTS (WEEKLY) / PATIENT TESTS) – CAN BE PERFORMED NEAR-PATIENT

Quantitative immunoassay

Multi-level menu (Supervisor/User)

Mains / battery powered

RS232 port for HIS/LIS connectivity

Bar code reader (Sample, Patient, User)

15 – 20 minutes to test result

PlGF concentration is Interpreted against two cutoffs (<12 and 100 pg/mL)

Throughput approx. 10 patients per week for a typical Day Assessment Unit

PlGF Control kit (1 & 2) (weekly)

SKUs 98813EU & 98814EU (5 vials each)

Each sufficient for one QC test

List price £100 + VAT

STORE: ≤ -20°C

24

Quidel Triage PLGF What are the benefits of

PlGF-based testing?


REVISED PATHWAY

Provides greater certainty as

to how to manage women

with suspected pre-eclampsia

presenting <35 weeks’

gestation

PLGF-guided care

CURRENT PATHWAY

Considerable uncertainty as

to how to manage women

with suspected pre-eclampsia

presenting <35 weeks’

gestation

SOC

‡ Duhig, K. The Lancet. Apr 2019

Accurate detection of placental dysfunction as a root cause of the

presenting signs & symptoms in pre-eclampsia

Accurate determination of which women will be *safe (or not safe) for

the next 14 days (96% sensitivity, 98% negative predictive value)†

When integrated into a clinical management guideline, can deliver safe

outcomes for the mother AND baby‡

SOC markers alone SOC markers + PLGF

Could this be evolving pre-

eclampsia?

Could it be another condition?

(renal, pre-existing

hypertension, etc.)

Where, when, and how to

deliver care?

†Chappell, LC. Circulation. 2013 Nov 5;128(19):2121-31

PLGF can be measured near-patient

and interpreted alongside SOC markers

(BP, protein dipstick, PET bloods)

*require delivery for pre-eclampsia

Rule-out

25

Quidel Triage PLGF Validated within England


Cost effective

Safe (mothers &

babies)

‡ Duhig, K. The Lancet. Apr 2019

64% faster recognition &

diagnosis of pre-

eclampsia

20% reduced incidence of severe

adverse maternal

events (5% to 4%)

No increase in iatrogenic preterm

births or adverse

neonatal outcomes

Better

targeting of

scans (16% vs.

9% had a UA-PI

above the 95th

centile)

35% reduction in out-patient

hospital

attendances

(6.1 vs. 9.4) 37% fewer neonatal intensive &

high-dependency

care nights (15.2 vs.

24.2)

PROVEN

IMPACT

PARROT intervention trialMulti-centre trial (11 centres)

Evaluated in over 1,000 pregnant women

Outcomes:• Triage PLGF is safe for the mother AND the

baby‡

• Triage PLGF is cost effective – saves

money and re-allocates resources to the

right women (accepted for publication)

Develop an Options

Appraisal Comparing

Pathways / Platforms

Decision to Implement

Preferred Pathway /

Platform

Business Justification and

Technology Assessment

for POC

Write a Laboratory

Verification Protocol /

Complete Validation

Clinical / Lab Training

(Train-the-Trainer)

Accreditation

Agree an Implementation

Plan with All Parties

Clinically-led, team

assessment of the

options available.

Lab-led, team completes a business

justification for PlGF tests at the POC.

Lab-led, team reviews Quidel

verification report, develops an

internal verification protocol, and

evaluates the POC test.

COMMENCE SERVICE

Options Appraisal

Lab Verification Protocols (SOPs) / PathwaysBusiness Justification

Adapted to support local policy / governance

Quidel Triage PLGF Toolkit to support implementation

6 SLIDE DECK (PROVIDER / COMMISSIONER) 26

27

Quidel PLGF testing ensures safe and appropriate care to the right women


KNOWLEDGE BASE

11 Clinical Leads

H

S

S

S

Laboratory

Hub or Spoke

DAU

LAB

Day Assessment Unit

or Hospital Lab

Customer enquiries:

Tel: +44 (800) 3688248 (Option 1 for Customer Service)

Web: https://www.quidel.com/support/customer-support

E-mail: [email protected]

AHSN, AAC, or ITP enquiries:

[email protected]

[email protected]

Brief credentials (globally):

16,000+ Triage placements

1,200 employees

10-year journey with PLGF

No unnecessary sample shipping

to a central lab

Suitable for lab or

near-patient use

PLGF-guided clinical management

enabled earlier recognition of pre-

eclampsia and more appropriate

targeting of available interventions,

with concomitant improvement in

clinical outcomes‡

Professor Andrew Shennan OBE MBBS MD

FRCOG, Professor of Obstetrics, Clinical

Director South London CRN, Department of

Women and Children’s Health, School of Life

Course Sciences, FoLSM, Kings College London.

VALIDATED IN A MULTI-CENTRE

INTERVENTION TRIAL IN ENGLAND



QUIDEL Triage PLGF

Q&A



Presenting

Roche Elecsys® sFlt-1/PlGF ratio test for the short-term prediction of pre-eclampsia

Innovation details

The Roche Elecsys® sFlt-1/PlGF ratio test is a simple blood test that allows direct measurement of two proteins linked to

the development of new blood vessels in the placenta1. Low levels of PlGF and high levels of sFlt-1 indicate a problem with

the development of the placenta, which is believed to cause pre-eclampsia (PE)2.

PE is hard to diagnose and manage. Current diagnosis relies on blood pressure measurement and urinalysis for protein,

both of which are poor predictors of PE1. The Elecsys® sFlt-1/PlGF can rule out women who will not develop PE within 7

days with a NPV of 99.3% and up to 14 days with a NPV of 97.9% effectively reducing unnecessary hospitalisation1.

1. Zeisler, Harald, et al. "Predictive value of the sFlt-1: PlGF ratio in women with suspected preeclampsia." New England Journal of Medicine 374.1 (2016): 13-22.

2. Levine, Richard J., et al. "Circulating angiogenic factors and the risk of preeclampsia." New England journal of medicine350.7 (2004): 672-683.

Background

Can affect 10% of all pregnancies3. Over 65,000 women are admitted for suspicion of pre-eclampsia3 but only 2-3% of women go on to develop pre-eclampsia4

This highlights the importance of a more accurate test leading to increased patient safety

Problems with diagnosing pre-eclampsia:→ Non-specific signs and symptoms → Gold standard for diagnosis

• Blood pressure• Proteinuria

→ Poor predictive value and low sensitivity→ High degree of suspicion for PE and a low threshold

to admit pregnant women with suspected PE

3. NICE DG23 PlGF-based testing to help diagnose suspected pre-eclampsia (Triage PlGF test, Elecsys immunoassay sFlt-1/PlGF ratio, DELFIA Xpress PlGF 1-2-3 test, and BRAHMS

sFlt-1 Kryptor/BRAHMS PlGF plus Kryptor PE ratio): https://www.nice.org.uk/guidance/dg23. Resource impact template: https://www.nice.org.uk/guidance/dg23/resources

4. Purde, Mette-Triin, et al. "Incidence of preeclampsia in pregnant Swiss women." Swiss medical weekly 145.w14175 (2015): w14175.

https://www.nice.org.uk/guidance/dg23

https://www.nice.org.uk/guidance/dg23/resources

Solutions

Roche Elecsys® sFlt-1/PlGF ratio test

1. Zeisler, Harald, et al. "Predictive value of the sFlt-1: PlGF ratio in women with suspected preeclampsia." New England Journal of Medicine 374.1 (2016): 13-22.

2. Levine, Richard J., et al. "Circulating angiogenic factors and the risk of preeclampsia." New England journal of medicine350.7 (2004): 672-683.

3. NICE DG23 PlGF-based testing to help diagnose suspected pre-eclampsia (Triage PlGF test, Elecsys immunoassay sFlt-1/PlGF ratio, DELFIA Xpress PlGF 1-2-3 test, and BRAHMS sFlt-1 Kryptor/BRAHMS PlGF

plus Kryptor PE ratio): https://www.nice.org.uk/guidance/dg23

5. Zeisler, Llurba et al, The sFLT-1/PlGF: ruling out pre-eclampsia for up to 4 weeks and the value of retesting. Ultrasound in Obstetrics and Gynecology 53(3) July 2016.

for ruling outpre-eclampsia within 7 days1

Within 14 days – NPV 97.9%5

99.3% NPV=

https://www.nice.org.uk/guidance/dg23

✓ Improved patient safety through accurate diagnosis on the suspicion of PE.6

✓ Reduced (unnecessary) admissions for suspected PE.

✓ Improved maternity capacity due to needing to monitor fewer women.6

✓ Improved community midwifery capacity due to reduction in follow-on appointments.

✓ Reduced direct costs to the system relating to inpatient monitoring tests for woman

and fetus. This includes keeping more women on the most appropriate treatment

pathway (standard, intermediate or intensive) avoiding PE-related escalation and

related cost pressures.6

✓ Fewer pre-term or emergency deliveries and consequent positive impact on workload

and costs incurred by both maternity and pediatric services.*

Roche Diagnostics supported several national and international clinical trials to generate the clinical evidence to support the efficacy

of the sFlt-1:PlGF test

Experience

Positive impacts from implementing an sFlt-1:PlGF test pathway

*The magnitude of each impact varies by hospital relating to their pathways, structure and birth rate.

6. Oxford case study available at: https://www.oxfordahsn.org/our-work/impact-case-studies/

https://www.oxfordahsn.org/our-work/impact-case-studies/

Process action plan

Interest - Consider your stakeholders and their requirements to enable them to provide the innovation.- Identify a lead who can help communicate the value of the innovation internally and what it brings.- We will support you in mapping the stakeholders using previous experience, attend meetings when required

and provide answers to FAQs.

Evaluation - Educate and engage the stakeholder group, champion internally and gain permission to proceed and understand the process to do so.

- We will personalise the potential for you, connect to external references and satisfy evidence needs.

Decision - To proceed with the ITP, work together to follow the identified process and implement the change, address internal barriers.

- We will support with relevant information to overcome internal barriers.

Adoption - ITP contracting process, addressing any training needs and mobilising all stakeholders to embed the revised clinical pathway.

- We will support change management, mobilising Roche stakeholders to go live – lab/clinical training, supply provision.

Recognition - Reflecting on the change, capturing the impact the implementation has had on the trust, clinicians and patients, demonstrating the value of the change internally and to the wider healthcare network.

Contact details

Dedicated Accelerated AccessCollaborative inbox:

[email protected]

© 2019 Roche Diagnostics Limited. All rights reserved

ELECSYS is a trademark of Roche. All other trademarks or brand names are the property of their respective owners.

Roche Diagnostics Limited. Charles Avenue, Burgess Hill, West Sussex, RH15 9RY, United Kingdom. Company Registration Number: 571546

Date of preparation: March 2019. Material Number: MC-UK-00155

For use in the UK and Ireland only

https://www.roche.co.uk/

https://www.roche.co.uk/



Roche Elecsys® sFlt-1/PlGF ratio test

Q&A



Presenting

Elecsys® Troponin T-hs assay

Accelerated Access Collaborative

Adoption of rapid algorithms using Elecsys® Troponin T-hs assay

Thomas Marshall, David Martin

39 1 April 2019 | © 2019 Roche Diagnostics Limited. All rights reserved. For healthcare professional use in the UK and Ireland. Not for distribution.


1. National Institute for Health and Care Excellence (NICE). Diagnostics Guidance: Myocardial infarction (acute): Early rule out using high-sensitivity troponin tests (Elecsys Troponin T high-sensitive, ARCHITECT STAT High Sensitive Troponin-I and AccuTnI+3 assays) DG15. 2014. 2. Calculated based on Hospital Accident and Emergency Activity 2016-17 Summary Report. NHS England and NHS Digital. 17th October 2017. 3. European Society of Cardiology. ESC Clinical Practice Guidelines: Acute Coronary Syndromes (ACS) in patients presenting without persistent ST-segment elevation. 2015.4. Ambavane A, Lindahl B, Giannitis E, Roiz J, Mendivil J, Frankenstein L, et al. Economic evaluation of the one-hour rule-out and rule-in algorithm for acute myocardial infarction using the high-sensitivity cardiac troponin T assay in the emergency department. Plos One. 2017;12(11)

• Chest pain is responsible for around 700,000 emergency department attendances per year and over 253,765 emergency admissions in England and Wales, which accounts for approximately 5% of all emergency admissions1,2

• Timely diagnosis and appropriate management, in line with guidance recommendations, are crucial in ensuring effective treatment and improving patient outcomes3

• Reducing emergency department waiting times could avoid fines, improve patient flow, and allow healthcare professionals to focus care where it is needed most1,4

1 April 2019 | © 2019 Roche Diagnostics Limited. All rights reserved. For healthcare professional use in the UK and Ireland. Not for distribution. 40

1. European Society of Cardiology. ESC Clinical Practice Guidelines: Acute Coronary Syndromes (ACS) in patients presenting without persistent ST-segment elevation. 2015.2. Kristian Thygesen, Joseph S Alpert, Allan S Jaffe, Bernard R Chaitman, Jeroen J Bax, David A Morrow, Harvey D White, ESC Scientific Document Group, Fourth universal definition of myocardial infarction (2018), European Heart Journal, Volume 40, Issue 3, 14 January 2019, Pages 237–269,

https://doi.org/10.1093/eurheartj/ehy4623. National Institute for Health and Care Excellence (NICE). Diagnostics Guidance: Chest pain of recent onset: assessment and diagnosis Clinical Guideline 95 Published 2010. Updated Aug 2016.4. European Society of Cardiology. ESC Clinical Practice Guidelines: Acute Coronary Syndromes (ACS) in patients presenting without persistent ST-segment elevation. 2015.5. National Institute for Health and Care Excellence (NICE). Diagnostics Guidance: Myocardial infarction (acute): Early rule out using high-sensitivity troponin tests (Elecsys Troponin T high-sensitive, ARCHITECT STAT High Sensitive Troponin-I and AccuTnI+3 assays) DG15. 2014.

To diagnose a myocardial infarction (MI) (in conjunction with ECG and clinical symptoms):

• High sensitive troponin should be measured1

• Clinicians should use the universal definition of MI2. Detection of the rise and/or fall in

troponin values with at least one value above the 99th percentile of the upper reference

limit3,4

• To detect for these dynamic changes in troponin, a number of different testing algorithms

can be followed with regards to timings of when the samples are taken3,4,5



*Diagram references 1, 2, 3, 5

1 hourTRAPID-AMI with Roche Elecsys®Troponin T-hsassay

3 hoursHigh sensitive troponin test

6 hoursConventional test

Observation time for heart attack

diagnosis

Guideline approved high sensitive troponin can be incorporated into a rapid algorithm1,2,3

There are benefits of this proven approach to hospitals, clinicians and patients through:

• Reduced length of stay for patients rapidly ruled out4,5

• Faster decision making for clinicians4,5

• Reduced costs to the health economy1-4

1. National Institute for Health and Care Excellence (NICE). Diagnostics Guidance: Myocardial infarction (acute): Early rule out using high-sensitivity troponin tests (Elecsys Troponin T high-sensitive, ARCHITECT STAT High Sensitive Troponin-I and AccuTnI+3 assays) DG15. 2014. 2. National Institute for Health and Care Excellence (NICE). Diagnostics Guidance: Chest pain of recent onset: assessment and diagnosis Clinical Guideline 95 Published 2010. Updated Aug 2016.3. European Society of Cardiology. ESC Clinical Practice Guidelines: Acute Coronary Syndromes (ACS) in patients presenting without persistent ST-segment elevation. 2015.4. Ambavane A, Lindahl B, Giannitis E, Roiz J, Mendivil J, Frankenstein L, et al. Economic evaluation of the one-hour rule-out and rule-in algorithm for acute myocardial infarction using the high-sensitivity cardiac troponin T assay in the emergency department. Plos One. 2017;12(11).5. Mueller C, Giannitsis E, Christ M, Ordóñez-Llanos J, Defilippi C, Mccord J, et al. Multicenter Evaluation of a 0-Hour/1-Hour Algorithm in the Diagnosis of Myocardial Infarction With High-Sensitivity Cardiac Troponin T. Annals of Emergency Medicine. 2016;68(1).



NICE DG15 recommends Elecsys®

Troponin T-hs assay as an option for the early rule-out of NSTEMI in

people presenting to an emergency department with chest pain and

suspected acute coronary syndrome4


Elecsys® Troponin T-hs assay has been used in over 1000 publications since its launch in 20091. It is the most widely used and most widely studied assay on the market2

A single Elecsys® Troponin T-hs assay cut-off, regardless of analyser or patient sex3, simplifies result interpretation for clinicians, even across multi-site networks

Roche Elecsys® Troponin T-hs assay is recommended by NICE and European Society of Cardiology for early rule-out of myocardial infarction4,5early rule-out of Myocardial Infarction1, 4

1. Pubmed literature scan December 20192. Roche data on file3. Elecsys® Troponin T-hs pack insert 20184. National Institute for Health and Care Excellence (NICE). Diagnostics Guidance: Myocardial infarction (acute): Early rule out using high-sensitivity troponin tests (Elecsys Troponin T high-sensitive, ARCHITECT STAT High Sensitive

Troponin-I and AccuTnI+3 assays) DG15. 2014.5. European Society of Cardiology. ESC Clinical Practice Guidelines: Acute Coronary Syndromes (ACS) in patients presenting without persistent ST-segment elevation. 2015.

43 1 April 2019 | © 2019 Roche Diagnostics Limited. All rights reserved. For healthcare professional use in the UK and Ireland. Not for distribution.


Collaboration to deliver

change

Roche Elecsys® Troponin T-hs assay is widely used, however adoption of the guideline recommended algorithms remains inconsistent.

Hospitals that have implemented fast algorithms have realised the full benefit of change through:

• Close collaboration between stakeholders (e.g. emergency medicine, cardiology and laboratory)

• Recognising the value of a rapid algorithm and what that can bring to the health economy to drive change - it’s not just about troponin!

• Releasing capacity to deliver change, including the development of a patient pathway and training end users


Roche contact details

Dedicated Accelerated Access Collaborative inbox:

[email protected]




Elecsys® Troponin T-hs assay

Q&A



Presenting

S12 Solutions

• Frustrated by the assessment set-up process

• Certain technology could help

Independent Review of the Mental Health Act

“AMHPS and courts are often left to ‘dial around’ looking for doctors over the phone […] Many parts of

the country struggle to find doctors who can and are willing to perform this function, perhaps linked to

the payments they receive.”

The Long Term Plan

• Recommendations for embedding urgent and emergency mental health waiting time standards

• Only 50% of community teams can offer 24/7 crisis care

• Just 14% of service users satisfied with crisis care

Background

▪ Extensive research

▪ App and website

▪ Assessment set-up – connecting AMHPs with available, local s.12

doctors

▪ Claim form creation and submission

✓Quicker, easier communication between whole system

✓ Timely access to treatment with the best available team

✓ Easier, fairer access to s.12 work for doctors

✓ Reduce police and secure transport provider time

✓ Claim forms are quicker and easier for everyone

✓ Personal information more secure

The Solution

• 2 x 6 month pilots – 218 users

• Broader doctor networks (29 and 22) – evidence invited to assessment

• Assessments sooner than expected

• Best-fit assessments

• Fewer referrals passed back to day team

• More assessments during the day (23 < 57%) and fewer out of hours (44 > 26%)

• 12% reduction in the number of assessments with 2 doctors, where clinically appropriate

• Both commissioned the platform

• Scheduled to go live – Southampton, Hampshire, Surrey, Peterborough and Cambridgeshire, Sussex

• Part of 2019’s NHS Innovation Accelerator (NIA)

• Part of the Innovation and Technology Payment (ITP) evidence generation fund

Experience

• Minimum 12 / 8 week implementation

• Contracting and assemble project team

• IT requirements – smart phones (iPhone, Android), latest software, up to date security patches and browsers, pin

code/biometric authentication

• S12 Solutions can support sites with IG documentation

• S12 Solutions team responsible for training/launch (6 weeks’ notice)

• Account management/customer service team – get the most from the platform, support individuals users

The process

Get in touch

[email protected]

01761 235777

s12solutions.com/contact/

@S12Solutions

@S12Solutions

Linkedin.com/company/s12-solutions




S12 Solutions

Q&A


AHSN/ITP Leads

Product AHSN CD appointed Lead ITP WG appointed Lead

SpaceOAR Hydrogel [email protected] [email protected]

GammaCore [email protected] [email protected]

Quidel Triage PLGF test – Pre-eclampsia [email protected] [email protected]

Roche Elecsys Troponin T-hs assay [email protected] [email protected]

Roche Elecsys sFlt-1/PlGF ratio test [email protected] [email protected]

S12 Solutions [email protected] TBC













ITP zero cost model


ITP Reporting and InformationMinimum Data Sets - Providers and Commissioners requirement:

• Information requirements specific to each product

• Central Support Unit, Arden & Gem to collect MDS monthly

Further information can be found within the ITP Technical Guidance notes at:

https://www.england.nhs.uk/ourwork/innovation/innovation-and-technology-payment-itp-2019-20/

Queries contact: NHS England Innovation, Research and Life Sciences Group at:

[email protected]

https://www.england.nhs.uk/ourwork/innovation/innovation-and-technology-payment-itp-2019-20/


Documents

Innovation and Technology Payment 2019/20 · Cluster Headache and Hemicrania Continua) and Medication Overuse Headache in adults •Medtech Innovation Briefing published by NICE in