[PHP376] Could European Regulators Contribute to Drug Budget Containment?

[PHP376] Could European Regulators Contribute to Drug Budget Containment?

2016 Value in Health

Rémuzat, C. | Thivolet, M. | Falissard, B. | Toumi, M. | Volume: 19, Issue: 7, Pages: A506,

Background: European regulators recently suggested several measures to contribute to drug budget containment: 1) Fast-track approval for generics and biosimilars; 2) Supporting the development and approval of me-too medicines to stimulate availability of additional treatment options and competition; 3) Enhancing collaboration with health technology assessment (HTA) bodies during drug development to get value evidence generation satisfying both regulators and payers and facilitate collection of post-authorization evidence; 4) Lowering development costs through new licensing approach such as adaptive pathways. This research aims to analyse potential impact of these propositions on drug budget for health insurance. Discussion: It seems obvious that faster entry of generics and biosimilars will have positive impact on drug budget; however today, generic entry is fast and there is almost no room to speed it up, while for biosimilars the issue is more related to the adoption rate. Me-too products could contribute to lower budget if they target expensive products and can stimulate competition; however, when pharmaceutical companies decide not to invest in such products, this is generally more due to pricing and reimbursement issues, rather than regulatory hurdles. Increasing collaboration with regulators and payers allow to better address both side’s needs; however payers remains resistant to uncertainty displayed through accelerated pathways which might lead to deny added value and minimize price premium or even prevent drug reimbursement. Finally, drug price has never been driven by a cost-plus process but by value-based pricing, making irrelevant to improve development efficiency to lower pharmaceutical prices. Conclusion: Regulators’ impact on pharmaceutical prices is very limited with current policies. If regulators are entitled to request additional evidence for payers to be filed in the approval dossier, they may contribute to drug cost-containment mainly by delaying approval more than reducing prices. Approval of products with immature data remains an important payers’ issue.

https://www.doi.org/10.1016/j.jval.2016.09.926