Swissmedic and FOPH are joining forces next year to provide a simultaneous regulatory and reimbursement review process. 

Written by Marco Crisci, Analyst Email: [email protected]

From 2024, the Swiss regulatory body (Swissmedic) and health technology assessment (HTA) organization (Federal office of public health; FOPH) are introducing a simultaneous reimbursement and regulatory review process, to promote earlier access of medicines. This approach will enable manufacturers to submit both applications at the same time, making it possible to achieve marketing authorization and reimbursement in situ (1). This has been evidenced under a successful pilot with Roche’s Lunsumio (completed in March 2023).  

Current assessment times in Switzerland: 

  • With a ~312-day timeline, the Swissmedic regulatory assessment is currently the 3rd fastest globally, behind the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) (2). 
  • However, Swissmedics’ total processing time for new drugs is~520-days, which is driven by a long labelling process following assessment (2).  
  • In total, it takes on average ~650-days for a drug to receive both marketing authorization and reimbursement in Switzerland, which is amongst the longest combined durations in Europe (3-4). 
  • The process can be ~200-days faster for orphan than non-orphan drugs (3).  

Proposed changes in Switzerland (2024): 

The joint regulatory and HTA procedure is designed to reduce the overall review time by up to 90 days (1). So, manufacturers looking to launch in Switzerland could expect total average review times closer to ~560-days (instead of ~650 days). This still lags-behind other European countries including Germany, France and the UK (3), but is a step in the right direction for timely access!  

Manufacturers of orphan drugs and other ‘potentially life-saving drugs’ will be offered early dialogue with FOPH before the reimbursement application is submitted. This early dialogue is hoped to further expedite the appraisal, as companies will be able to submit pre-discussed content (possibly reducing the chance of rejection). 

The collaborative assessment will be enabled by FOPH and Swissmedic having authority to share data during their evaluations. Manufacturers should also be mindful that additional information will be publicized by FOPH, including grounds for refusing approvals and for price negotiations. 

The bottom-line: 

Swissmedic and FOPH will soon offer a simultaneous regulatory and HTA review process to expedite access. It is anticipated that Switzerland will gain visibility as a possible early launch destination, especially for orphan and other potentially life-saving drugs. However, if fast access is a prerequisite for launch in Europe, Swissmedic-FOPH are not yet up-to-speed with the likes of the EMA and GB-A/HAS (Germany/France) or the MHRA and NICE (UK).  

P4A has been monitoring updates to regulatory and reimbursement processes in Switzerland and other markets, and will continue to do so to best advise our clients how to react, plan, and adapt to the changing environment. Contact P4A to learn more about our services to support with determining ideal access pathways and to remain up to date on how to seize opportunities in an ever-changing space.  






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