SL Insight Newsletter #23

The consultation on the implementation of KP2 does not only involve technical adjustments to APV/TQV. The actual system change lies in the planned anchoring of a benefit/evidence model in the regulation – with categories for additional benefits, a qualitative evidence assessment, and the announcement that this will be operationalized in the SL manual. For pharmaceutical companies, this means less dispute about figures and more dispute about methodology, comparators, and the weighting of evidence – with harsh legal consequences (temporary inclusion, conditions, limitations, or rejection).

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1) Benefit categories as "gatekeepers": tough consequences on soft grounds

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key message

At first glance, the classification into additional benefit categories appears to be standardization. In practice, however, it remains heavily dependent on the BAG setup (comparator set, overall clinical context, guideline status, practicability). This results in harsh legal consequences from assessments that are interpretive in key areas.

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Typical uncertainties

• Comparative therapy: Even a different comparator can tip the balance.
• Guidelines/standard of care: Time delays and regional differences are effectively becoming criteria for benefit.
• Practicality/feasibility: Suitability for everyday use becomes part of the utility logic, without clear thresholds.

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What does this mean for Pharma X?

Pharma X launches an innovative product with a strong effect in a subgroup. The FOPH chooses a therapy for comparison that is not used uniformly in practice and evaluates the benefit in the "overall context" of the indication. The result: instead of "major added benefit," the product ends up with "minor added benefit" – and Pharma X must prepare for temporary inclusion, additional requirements, or tighter restrictions, even though the core study is solid.

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2) Evidence assessment "using recognized systems": more inputs, more debate about weighting

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key message

The draft opens the door to a broader evidence base: in addition to approval data, RWD, registries, meta-analyses, guidelines, and assessments by foreign authorities are also to be given greater consideration. At the same time, it remains unclear how this evidence will be weighted and which assessment framework will actually be decisive in individual cases.

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Typical uncertainties

• GRADE is mentioned, but not as a binding standard.
• RWD/register data: Admissibility and quality requirements remain unclear.
• "Mixed evidence": When different data sources point in different directions, there is no clear decision-making mechanism.

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What does this mean for Pharma X?

Pharma X has RCT data with a surrogate endpoint plus RWD from a registry that suggests a sustained effect. The FOPH classifies the quality of evidence as "low" because it prioritizes the endpoint differently and weights RWD methodologically with caution. Result: Pharma X becomes embroiled in a methodological discussion (endpoints, MCID, surrogate acceptance, confounding) that can no longer be resolved cleanly with additional figures, but rather through evaluation logic.

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3) Operationalization in the SL manual: the real lever lies in "living guidance"

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key message

The regulation sets the framework. The decisive rules of the game will be specified in detail later in the detailed legislation and in the SL manual: comparator rules, main/additional criteria, evidence criteria, weighting issues, and thresholds, which effectively determine access and pricing logic. For companies, the risk shifts from the wording of the law to its interpretation in practice.

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Typical uncertainties

• Comparator governance: Prioritization rules are missing or remain vague.
• Triggers for legal consequences: When does "insufficient evidence" lead to rejection vs. temporary admission?
• Transparency/justification: How is justification provided when the BAG deviates from EAK/expertise?

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What does this mean for Pharma X?

Pharma X plans to submit its SL application with a globally coordinated evidence strategy. Shortly before or during the process, the manual is clarified, resulting in a different comparator set being considered authoritative or new requirements for RWD being formulated. Result: Pharma X must refine the dossier, provide additional analyses, and adjust its negotiation strategy—with a direct impact on timing, limitation text, and room for negotiation in APV/TQV.