CANCER DRUGS IN EUROPE- A COMPARISON OF HTA PROCESSES AND DECISIONS FOR NEW AND INNOVATIVE ONCOLOGY THERAPIES IN FRANCE, GERMANY AND THE UK – AN ANALYSIS USING THE PRISMACCESS DATABASE
Author(s)
Droeschel D1, Hartmann M2, Vollmer L1, Walzer S1, de Paz B3
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2European Consulting & Contracting in Oncology, Trier, Germany, 3PRIORITIS Market Access, Paris, France
OBJECTIVES: Since 2006 changes in the EU legislation allow to assess all drug approvals, refusals and withdrawals of new medicines by the European Medicines Agency (EMA). However, patient access to ‘de jure’ promising new therapeutic approaches is still governed at member state level through varying processes of health technology assessment (HTA) and reimbursement modalities. Limited data is available and therefore this study analyses retrospectively HTA outcomes for France, Germany and the UK to identify factors associated with market approval and positive HTA outcomes. METHODS: EMA decisions between January 2011 and December 2015 are analyzed with the Prismaccess database. Key patterns of HTA’s are tabulated and associations between HTA processes, timing, key outcomes, approval characteristics and trial results are reported. RESULTS: Since 2011, EMA issued positive opinions for 48 NMEs; further 6 submission procedures ended with negative outcomes. Of this so far, HTA processes have been started for >75% of all anti-cancer NMEs approved positively by EMA. The analysis revealed that as of yet 23 of the cancer medicines were evaluated by reimbursement authorities in the three target countries. In France 16 decisions were positive (10 ASMR I-III; 6 ASMR IV). 20 were positive in Germany (n=3 ‘significant’; n=6 ‘considerable’; n=9 ‘minor’; n=2 ‘non-quantifiable’ added benefit), and 4 respectively 5 were positive in England and Scotland. HTA outcomes were similar (magnitude) or identical in 8 cases totally only. In case overall survival was the primary endpoint the likelihood was higher in all countries for a positive decision. Key differences in terms of decisions were given in acceptance of ITCs, comparator as standard of care and ratings for cost-effectiveness. CONCLUSIONS: The use of the Prismaccess database facilitated analysis of HTA outcomes and revealed major differences among these countries about their benefit-/value-judgment of new, innovative cancer medicines.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PCN293
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology