HOW READY ARE EUROPEAN PAYERS FOR EMA ADAPTIVE PATHWAYS?

Author(s)

Macaulay R
PAREXEL Access Consulting, London, UK

OBJECTIVES: In April 2014, the European Medicines Agency (EMA) announced an adaptive pathways pilot enabling initial approval of a medicine for a restricted patient population with very high unmet need based on early clinical studies. Progressive adaptations of the marketing authorisation would expand access to broader patient populations based on subsequent data. However, such an adaptive license may pose a problem for payer bodies, many of which currently require a long time period to review medicines under strict clinical and economic criteria. This research aims to evaluate how ready major European current payer systems would be to encompass EMA adaptive pathways. METHODS: Key European payer bodies from the EU5 (NICE, SMC, HAS, IQWiG/G-BA, AIFA and AEMPS were scored by PAREXEL’s Commercialization panel of pricing and reimbursement experts on 4 key criteria: (1) speed of appraisal, (2) flexibility to clinical data appraisal approach, (3) flexibility to economic data appraisal approach, and (4) no additional local/regional access hurdles as either high (2 points), medium (1 point) or low (0 points). RESULTS: Out of a possible 8 points, HAS scored the highest (7) followed by SMC (6), AIFA (5), AEMPS (5), IQWiG (4) with NICE the lowest (2). Low scores for NICE were driven by its long duration for decision-making alongside rigid adherence to ICER thresholds. Higher scores for SMC were based on their much faster appraisals and flexibility through the new PACE process. AIFA and AEMPS both scored moderately with positive flexibility in their approaches tempered by additional local/regional access hurdles. In Germany, rigid adherence to direct comparative trial data versus the relevant comparator limited positive scoring. CONCLUSIONS: some payers (most notably NICE) will need to make significant changes to their appraisal processes In order for early market approval under adaptive pathways to translate into early reimbursement and payer access

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

EA1

Topic

Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment, Study Approaches

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways, Decision & Deliberative Processes, Health Care Research, Health Disparities & Equity, Pricing Policy & Schemes, Registries, Reimbursement & Access Policy

Disease

Multiple Diseases

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