Pdg57 Drug Pricing Predictability in France: Which Managed Entry Agreement Suits the Best?

Abstract

(NHIS) introduced the RSA (Risk Sharing Agreement) to ensure patient access to new drugs while holding the pharmaceutical industry responsible for the part of financial burden that could arise from uncertain performance of the drug. Only the prescription drugs indicated for cancer and rare diseases were eligible for the RSA. We aimed to document the outcomes of the RSA to inform the stakeholders of potential changes for cost-effective implementation of RSA. Methods: All the RSAs that the NHIS has finalized until June 1, 2019 were included. They were classified in terms of agreement type, indication, drug class (ATC 5 category), and the origin of the agreement holder. The agreement type was budget cap, fixed amount refund per unit sold and CED (Coverage with Evidence Development). The origin of the agreement holder was either domestic or global. The outcomes of RSA were examined in terms of adoption rates and post-implementation events. Results: As of June 1, 2019, there were 39 RSAs with 4 (10.3%) being expired. Expenditure cap had the highest share (46.2%), followed by refund type (33.3%). The CED (coverage with evidence development) had the lowest share (2.6%). The majority of the drugs had an indication of cancer (71.8%). Most of the RSAs were originated by global companies (82.1%). As for the RSA outcomes, while CED was viewed most desirable, it no longer existed at the end of the study period. As for the expenditure cap RSAs, no RSA exceeded the cap regardless the drug class. Conclusions: The result of this study inform the policy makers of the importance in determining the advantages and disadvantages of RSAs for different types as the pharmaceutical industry demands RSAs for more indications other than cancer and rare conditions.

The assessment and funding processes of drugs in Spain: Where are we and where are we going?

“…The French system uses different financial formulas for medicines depending on the level of ASMR achieved. The main financial formulas are the fixed rebates and the expenditure ceiling 227, 228 . For example, the majority of orphan drugs (ODs) approved up to 2017 were subject to expenditure ceilings (84%) and 67% of oncology drugs were funded under simple rebate agreements 228 .…”