SL Insight Newsletter #25

The planned "Day 0" reimbursement is intended to accelerate access to innovative drugs as soon as they are approved by Swissmedic. From the industry's perspective, however, the instrument is ambivalent: while it opens up earlier access to reimbursement, it shifts the most difficult evidence and pricing issues to an even earlier stage of the process and combines this with a strict 24-month time limit. At the same time, the bill also contains a point that could be a real opportunity: the EAK is to be given a stronger scientific focus for this early phase.

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1) Early access – but also early disclosure and early vulnerability

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key message

The provisional list is intended to enable reimbursement from the time of Swissmedic approval. However, the price is only provisional, reimbursement is limited in time, and the application must be prepared very early in the regulatory process. This means that the same issues that are already difficult in the regular admission procedure will come to the fore even earlier: maturity of evidence, clinical uncertainties, approval issues, and pricing logic.

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Typical uncertainties

• The company must engage in a remuneration process at a very early stage, even though regulatory issues are often not yet definitively resolved.
• The SL manual will specify which documents must be submitted. This means that the most sensitive part of the process remains open for the time being.
• From an industry perspective, there is a risk that regulatory issues from the Swissmedic proceedings will be used against the product again in the FOPH proceedings.

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What does this mean for Pharma X?

Pharma X has an innovative product with high medical relevance, but Swissmedic is still asking detailed questions about the data in the approval process. If the company prepares a "Day 0" application at the same time, these very issues could be used in the reimbursement process to assess the efficacy more critically and demand additional concessions.

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2) The 24-month time limit is the real sticking point.

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key message

Provisional access is limited to a maximum of 24 months. If no definitive agreement is reached within this period, the product is removed from the provisional list. For companies, this is not only a price or process risk, but also a considerable reputational risk.

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Typical uncertainties

• The time limit forces an agreement to be reached under time pressure, even though evidence and pricing issues are often particularly difficult, especially with innovative products.
• If definitive admission fails, the relapse from provisional reimbursement is visible to the outside world.
• In such cases, public perception regularly affects the company, even if the causes lie in a deadlocked negotiation situation.

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What does this mean for Pharma X?

Pharma X receives provisional reimbursement for an oncology product upon approval. However, discussions with the FOPH become more difficult over the course of the following months. After 24 months, no agreement has been reached. The product disappears from the provisional list again. From the public's perspective, the impression quickly arises that the company has not made the product accessible.

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3) The early scientific involvement of the EAK: a risk—but also an opportunity

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key message

The proposal aims to give the EAK a more scientific focus for the provisional list. From a business perspective, this can be a double-edged sword: on the one hand, it creates an additional technical filter at a very early stage. On the other hand, it may also be an opportunity to ensure that the decision on inclusion is no longer influenced almost exclusively by the FOPH.

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Where the opportunity lies

• Today, the EAK is often consulted in a rather formal manner in practice; a truly independent, noticeable dissenting voice to the FOPH is hardly discernible.
• If the EAHC focuses more strongly on clinical, scientific, and health economic evaluation in the future, this could lead to a more balanced discussion.

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Where the risk remains

• The criteria for "high medical need" and the assessment model are to be specified in detail in the manual.
• Without clear procedural rules, there is a risk that the EAK will be upgraded in technical terms, but will in fact continue to operate within a framework that is heavily controlled by the BAG.

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What does this mean for Pharma X?

Pharma X is launching a product for a serious rare disease. The FOPH is cautious about the evidence, while clinical experts rate the unmet need and potential benefits highly. In a system in which the EAK is scientifically strengthened and appears to be independent, this difference could actually carry weight in the procedure.