Access to the French Market for Oncology Drugs Without Comparative Data Over the Last Ten Years: Putting Into Perspective the Decisions of the HAS and the EMA

Speaker(s)

ABSTRACT WITHDRAWN

OBJECTIVES: To analyze the evolution between 2013 and 2022 of the French market access for oncology drugs by contrasting those based on non-comparative data with those based on comparative data in their evaluation by the French Health Authority (HAS), after obtaining a Marketing Authorization.

METHODS: A retrospective study was conducted of the first indications for oncology drugs by treated disease that received a Marketing Authorization by the European Commission, between January 1st, 2013, and December 31st, 2022. Data were extracted from public databases and regulatory documents.

RESULTS: Between 2013 and 2022, 175 indications received a Marketing Authorization. Out of these, 63 were evaluated based on non-comparative data, and 112 using comparative data. The HAS Transparency Committee reviewed 158 of these indications, with 56 based on non-comparative data and 102 on comparative data.

Of the 56 non-comparative data indications, only 16 received an Important SMR and a II, III, or IV ASMR between 2013 and 2019, year from which a significant shift can be observed, where 100% of the evaluations resulted in a moderate or low SMR.

Out of the 102 indications evaluated with comparative data, 56 received an Important SMR and a II, III, or IV ASMR, distributed more consistently over time.

Therefore, 43% of the indications evaluated with non-comparative data achieved reimbursement, while this rate was higher, at 58%, for indications with comparative data, with significant disparities depending on the delivering route of the drug.

Ultimately, reimbursement was achieved for 43% of the indications evaluated with non-comparative data, while the rate was higher at 58% for indications evaluated with comparative data, with significant disparities depending on the drug delivery route.

CONCLUSIONS: Over time, positive opinion discrepancies have widened between the evaluations of the HAS and the EMA for indications with non-comparative data.

Code

HTA309

Topic

Health Policy & Regulatory, Health Technology Assessment, Study Approaches

Topic Subcategory

Approval & Labeling, Clinical Trials, Decision & Deliberative Processes, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Oncology