Reimbursement in Europe. Tues 5 th Dec 11.00am
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2 Reimbursement in Europe Tues 5 th Dec 11.00am
3 Overview of Session Introduction to Reimbursement In Europe Session James Rose The EU Health MAPPS Project Erwin Heeneman Supporting start-ups & SMEs in expanding their markets (Go Global MedTech Accelerator) Joerg Trinkwalter CRAASH: EIT Health Moebio Bootcamp Raquel Riera Panel Discussion and Q & A All Session close
4 Introduction to Reimbursement in Europe Dr James Rose Oxford AHSN
5 Trends in European Healthcare Ageing population Escalating burden of chronic disease Increased expectation of healthcare Ballooning healthcare expenditure
6 Trends in European Healthcare Life Science Industy Healthcare leaders are looking to innovators for support in reshaping healthcare Improved Outcomes Healthcare Improved Efficiency Reduced Cost Academia
7 Emerging sectors expected to provide part of the answer Precision Medicine Pharma Regenerative Medicine MedTech Digital Health
8 A long and expensive journey for SMEs Development Regulation Reimbursement Adoption Proof of Concept Quality, Safety and Efficacy Health Technology Assessment Payers must approve use Doctors, HCPs or Patients must want to use Only then can product or service impact Patient health
9 Regulatory processes harmonised across EU Regulation Medicines: EU wide requirements around quality, safety, and efficacy EU-wide processes Med Tech: Directives replaced by Medical Device Regulations Data: Directives being replaced by GDPR
10 Reimbursement handled at Member State level Reimbursement Several National HTA processes HTA agencies each with different: decision criteria processes timelines submission requirements
11 Divergence in decision making criteria Outcomes Clinical Effectiveness Cost Effectiveness Budget Impact HRQoL SOC Comparators Real World Data Innovation Key Requirement Nice to Have Not required
12 Variations in capacity and decisions on value Source: Allen et al. Frontiers in Pharmacology 2017
13 Same dataset results in different decisions Crizotinib (Xalkori) non-small cell lung cancer Rejected Reimbursed (ASMR III) Added Benefit not proven Approved with conditions Reimbursed with conditions Eribulin (Halaven) metastatic breast cancer Rejected Approved with restrictions (ASMR IV) Added Benefit not proven Approved with conditions No recommendation Ipilimumab (Yervoy ) advanced melanoma Approved with PAS Approved (ASMR III) Added Benefit Approved Rejected Source: Akehurst et al, Value in Health, 2016
14 Time delay (in days) to market access Delays to Reimbursement decisions vary Germany UK Netherlands Average number of days from regulatory approval to published reimbursement decision (medicines) Sweden 272 France 316 Italy Spain Source: Akehurst et al, Value in Health 2016
15 Early Access Pathways for Innovative Products Medicines Early Access to Medicines Scheme Rapid access to patients Not reimbursed Potentially prioritised HTA Accelerated mandate for commissioning Temporary Authorization for Use (ATU) Product reimbursed at manufacturers price HTA after ATU period Reimbursement decision based on SMR Price renegotiated on ASMR rating
16 Early Access Pathways for Innovative Products Medical Devices NUB Payments Significant lead time to establish new code Hospitals apply for reimbursement during that period Innovation and Technology Tariff / Payment Innovative medical devices and digital tech Can lead to complete system wide reimbursement Support in spread across England from AHSNs
17 Widespread adoption very rarely automatic Adoption and Access Patient access often decided at the regional or local level Requires significant payer/clinician engagement Multitude of Regional and Local Processes Source: NHS Digital Innovation Scorecard, July 2017
18 Summary Reimbursement across Europe is complex No Silver Bullet Important to use networks, advice and support Need for tools and programmes that can support SMEs in signposting, navigation, networking and knowledge sharing
19 THANK YOU! eithealth.eu
20 Supporting small businesses with market access The emaps Project Erwin Heeneman Go Global MedTech Accelerator Joerg Trinkwalter CRAASH: Moebio Bootcamp Raquel Riera
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