Tuesday, April 16, 2024

Switzerland Implements Reforms to Accelerate Reimbursement for Rare Disease Therapies and Medicines

Similar articles

Switzerland is implementing innovative measures to expedite the reimbursement decision process for vital medicines, rare disease therapies, and complex submissions. In a bid to enhance transparency, pharmaceutical companies can now engage with the Federal Office of Public Health (FOPH) before formally submitting a reimbursement application for new drugs. This early dialogue enables them to seek clarification on submission procedures, reimbursement criteria, and potential requirements, streamlining the process and minimizing unnecessary correspondence.

Additionally, a new early access procedure allows eligible drug manufacturers to apply for specialty list inclusion months earlier than before. This concurrent assessment by FOPH, evaluating effectiveness, appropriateness, and cost-effectiveness, aligns with Swissmedic’s regulatory review, potentially saving up to three months in the drug approval timeline.

Transparency is a key focus, with the government disclosing information about reimbursement applications, status updates, and reasons for negative decisions. Moreover, during the routine three-year reassessment of a drug’s specialty list inclusion, the FOPH will publish the rationale behind economic viability decisions. This move aims to clarify pricing decisions and criteria for effectiveness and appropriateness.

Switzerland, already one of Europe’s quickest countries in terms of reimbursement post-Swissmedic approval, aims to further expedite access decisions for essential medicines, rare disease therapies, and complex submissions. The government is also introducing measures to facilitate off-label prescribing reimbursement and promote the use of generics and biosimilars.

Subscribe to our newsletter

To be updated with all the latest news, offers and special announcements.

Latest article