SL Insight Newsletter #24

The KP2 consultation aims to modernize the international price comparison (APV): reference countries should be excluded if prices are not published on an official list or if the product is not reimbursed there in a manner relevant to social security. In addition, if there are indications of discrepancies between list prices and net prices, the FOPH should be able to take into account "actual reimbursed prices" or even "actual reimbursed costs"; the sources permitted for this are to be determined by the FDHA. For pharmaceutical companies, this means that the APV will become less mechanical and more process- and argument-driven, with increased discretion for the FOPH and correspondingly more potential for conflict in SL admission procedures.

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1) Social security relevance as a filter: Country Y counts—or does not count

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key message

In future, the APV will depend not only on figures, but also on whether a country is recognized as an "acceptable" reference basis. The filters "official list" and "social security reimbursement" sound plausible, but in practice they are rarely binary and create new areas of vulnerability.

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Typical uncertainties

• What is considered the "official list" in systems with multiple catalogs (outpatient/inpatient, regional, special programs)?
• When is a product "remunerated" in the case of subpopulations, managed entry agreements, or hospital financing?
• Risk of a "thin APV basis": If countries drop out, the APV becomes volatile and difficult to predict.

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What does this mean for Pharma X?

Pharma X only has hospital-based reimbursement in country A, an MEA for a subpopulation in country B, and a price list without broad cost coverage in country C. In the BAG procedure, the primary dispute is suddenly no longer about the price, but about whether countries A/B/C should be included in the APV at all. Result: APV scenarios become unstable, and the dossier requires more system explanations than price arguments.

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2) Actual reimbursed prices/costs: The net switch with a low trigger

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key message

As soon as there are "indications" that published prices do not correspond to the prices actually reimbursed, the FOPH can/should switch to net levels. This is methodologically understandable, but shifts the APV into an area that is often confidential and difficult to verify.

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Typical uncertainties

• "Indications" is a profound and open trigger: When is evidence sufficient to switch to net?
• "Price" vs. "costs": If "actual reimbursed costs" are taken into account instead of net price, there is a risk of confusion with assumptions about dosage, duration, and setting.
• Net data is often legally non-disclosable: confidentiality clauses, national secrecy, MEA structures.

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What does this mean for Pharma X?

Pharma X is compared with Country D in the APV. Confidential discounts exist in Country D. The FOPH sees "indications" of deviations and requests net information or "effectively reimbursed costs." Pharma X cannot disclose the net conditions. Result: Either Country D is excluded (which shifts the median), or the FOPH works with proxies/estimates, which are then used as the basis for the actual negotiations.

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3) Source authority at the EDI: The dispute shifts to procedural architecture

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key message

The FDHA will determine which data sources are considered "admissible." At the same time, the FOPH can exclude reference countries if they do not cooperate sufficiently. This effectively places the burden of proof more firmly on the company—even in cases where it has no control over data collection.

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Typical uncertainties

• Which sources are accepted (only government publications vs. HTA reports, databases, evaluations, insurer/provider data)?
• Timeliness and granularity: What data is "sufficient" in individual cases?
• Sanction via country exclusion: If net cannot be delivered, there is a risk of disadvantage via exclusion or conservative proxy logic.

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What does this mean for Pharma X?

Pharma X has reliable market information, but no official net source. The BAG does not accept the source or considers it unverifiable. At the same time, cooperation is required in order to keep the country in the APV. Result: Pharma X must not only provide price and value arguments in the proceedings, but also establish its own evidence governance for APV data – including documentation, explanations of system logic, and proactive preparation for source disputes.