Navigating the Swiss healthcare market: Regulatory & access pathways for rare disease drugs

The Swiss regulatory and market access landscape offers multiple pathways for introducing new medicines to the Swiss market, particularly for rare diseases. In this summary, we explain these pathways and explore the importance of strategic planning when navigating them.

Switzerland has developed a comprehensive framework for evaluating and approving new pharmaceutical products, especially those containing novel active substances. This system is designed to ensure that innovative and potentially life-saving medicines can be brought to market efficiently and safely. With frequent regulatory updates to improve efficiency, as for example seen earlier in 2024 with the introduction of “early dialogue”, Switzerland is constantly aiming to speed up access procedures, without losing any quality [1].

In order to benefit from certain special regulatory support measures and counseling services, the company should apply for orphan disease designation (ODD). This can speed up approval and reimbursement of the drug. Obtaining the ODD is crucial as it underscores the drug’s potential to meet significant unmet medical needs. The timing for applying for ODD varies; it may be required before submitting to Swissmedic, or occur concurrently with the regulatory review. Additionally, orphan drugs benefit from waived fees for new authorizations through Swissmedic, providing financial relief and enabling better allocation of development resources. It is essential for companies to understand the criteria and application processes to fully leverage these fee waivers.

Here’s an overview of the main regulatory pathways available via Swissmedic for new medicines in Switzerland:

Standard marketing authorization procedure [2]: This is the conventional pathway for products with new active substances. The process involves a detailed review by Swissmedic and typically takes 330 days.
Fast-track procedure [3]: Targeted at medicines that offer significant therapeutic benefits in areas where there is a lack of effective treatments. Products qualifying for this route benefit from a shortened review period of 140 days, much faster than the standard process.
Temporary authorization [4]: This pathway is available for medicines aimed at life-threatening conditions when full clinical data may not yet be available. It grants temporary authorization for two years, with a review timeline also reduced to 140 days, allowing quicker access to critical treatments.
Prior-notification procedure [5]: Companies that inform Swissmedic in advance about their submission and get pre-approval for this process can have their products reviewed within 264 days. This pathway is somewhat faster than the standard procedure and helps in planning and faster processing.
Authorization via Article 13 of the Therapeutic Products Act (TPA) [6]: This special provision allows for the approval of certain products, including those already approved by recognized international authorities such as the FDA or EMA, by utilizing their evaluations.

Furthermore, the Swiss authority responsible for the authorization and supervision of therapeutic products, Swissmedic, collaborates with global health authorities through initiatives like the Access Consortium [7] and Project Orbis [8]. These collaborations facilitate the simultaneous submission and review of marketing authorization applications, streamlining the process for products launched in multiple regions.

Market access pathways in Switzerland

In Switzerland, the journey to market access for new medicines goes beyond regulatory approval, critically depending on securing reimbursement. At the heart of market access is the Federal Office of Public Health (FOPH), which plays a pivotal role by determining which medicines are included on the pharmaceutical Specialties List (SL). Inclusion is vital to enable insurance coverage for the drug.

Expanded pathways for rare disease drugs and corresponding considerations

Pharmaceutical companies developing therapies for rare diseases must navigate specific regulatory and market access pathways tailored to expedite these critical treatments. Key strategic considerations include:

Early dialogue with FOPH: Pre-submission consultations with the FOPH provide crucial insights into expectations for pricing and reimbursement, aligning the drug’s value proposition with reimbursement criteria to smooth negotiations.
Early access pathway: The FOPH supports an early access discussion process that allows simultaneous review of market authorization and reimbursement inclusion. This pathway can significantly shorten the time for treatments to reach patients, combining approval and reimbursement processes.

Another way to get a treatment reimbursed in Switzerland is through case-by-case reimbursement under Art. 71a-d KVV. For more information about the case-by-case approach, visit our previous blog about Article 71 KVV.

Strategic engagement and planning

The strategic pathway for rare disease drugs in Switzerland, therefore, involves a combination of regulatory savvy, proactive engagement with authorities, and a deep understanding of the unique market access landscape. Aligned effectively, these elements can contribute significantly to the successful introduction and uptake of rare disease therapies in the Swiss market.

Reach out to us for expert guidance on your strategic planning. Together, we can ensure a smooth regulatory and market access process, accelerating the availability of rare disease therapies to patients in need.