Innovation and Technology Payment 2019/20 - AHSN NENC• Innovation and Technology Payment (ITP) -...
Transcript of Innovation and Technology Payment 2019/20 - AHSN NENC• Innovation and Technology Payment (ITP) -...
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
Hosted by Sharon Priestnall
Innovation, Research and Life Sciences Group
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NHS England and NHS Improvement
• 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.
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
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
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
GammaCore
Q&A
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
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
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Your ITP Contacts
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
SpaceOAR Hydrogel
Q&A
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
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‡
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Quidel Triage PLGF Key components, protocol,
and ITP pricing
6 SLIDE DECK (PROVIDER / COMMISSIONER)
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
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Quidel Triage PLGF What are the benefits of
PlGF-based testing?
6 SLIDE DECK (PROVIDER / COMMISSIONER)
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
6 SLIDE DECK (PROVIDER / COMMISSIONER)
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
6 SLIDE DECK (PROVIDER / COMMISSIONER)
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:
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
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
QUIDEL Triage PLGF
Q&A
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
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.
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=
✓ 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/
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:
© 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/
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
Roche Elecsys® sFlt-1/PlGF ratio test
Q&A
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
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.
Adoption of rapid algorithms using Elecsys® Troponin T-hs assay
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
Adoption of rapid algorithms using Elecsys® Troponin T-hs assay
1 April 2019 | © 2019 Roche Diagnostics Limited. All rights reserved. For healthcare professional use in the UK and Ireland. Not for distribution. 41
*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).
Adoption of rapid algorithms using Elecsys® Troponin T-hs assay
1 April 2019 | © 2019 Roche Diagnostics Limited. All rights reserved. For healthcare professional use in the UK and Ireland. Not for distribution. 42
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
Adoption of rapid algorithms using Elecsys® Troponin T-hs assay
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.
Adoption of rapid algorithms using Elecsys® Troponin T-hs assay
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
1 April 2019 | © 2019 Roche Diagnostics Limited. All rights reserved. For healthcare professional use in the UK and Ireland. Not for distribution. 44
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Adoption of rapid algorithms using Elecsys® Troponin T-hs assay
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
Elecsys® Troponin T-hs assay
Q&A
NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
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
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NHS England and NHS Improvement
Innovation and Technology Payment 2019/20
S12 Solutions
Q&A
NHS England and NHS Improvement
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
NHS England and NHS Improvement
ITP zero cost model
NHS England and NHS Improvement
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: