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Market access framework for France Taking effect in 2016, a new regulatory body, the National Agency for the Safety of Medicines and Healthcare Products is likely to require data from active comparator trials. Source: PRMA Insights: Pricing and Reimbursement Success in NSCLC 2nd edition, 2012 Page 6
P&R landscape: France Products will be awarded an ASMR and an SMR rating; ASMR 4 (parity) or ASMR 5 (EU reference pricing for product) would mean no price premium vs existing products. Decision-making process ASMR decision criteria Key trends • SMR rating is based on severity of the disease: • major • important • moderate • minor • insufficient to justify reimbursement • ASMR (incremental benefit vs SOC) is rated between 1 and 5: • major (1) • important (2) • moderate (3) • minor (4) • none (5) 1. Innovative product of significant therapeutic benefit 2. Product of therapeutic benefit in terms of efficacy and/or reduction in side-effect profile 3. Existing product where equivalent pharmaceuticals exist; moderate improvement in terms of efficacy and/or reduction in side-effect profile 4. Minor improvement in terms of efficacy and/or utility 5. No improvement but still granted recommendations to be listed • ASMR ratings are getting lower • SMR ratings are increasingly being used to deny or restrict reimbursement • Importance of incremental clinical benefit (better efficacy or better safety profile, as evidenced in relevant clinical trials) will increase • Innovative technologies will require pharmacoeconomic studies showing that they provide cost-savings and improve disease management • Patient stratification is becoming increasingly important to limit budget impact Page 7
Page 1 and 2: An Introduction to European Market
Page 3 and 4: Pricing Reimbursement and Market Ac
Page 5: Market access framework for the UK
Page 9 and 10: Market access framework for Germany
Page 11 and 12: Market access framework for Italy T
Page 13 and 14: EU M5 payors/HTA authorities Countr
Page 15 and 16: Across Europe, market access terms
Page 17 and 18: Same data, different access Similar
Page 19 and 20: Focus of HTA critiques Across HTAs

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