Consultation Opened On Amendments To Pharmaceutical Pricing

Switzerland is moving ahead with the implementation of the Cost Containment Package 2: On 18 February 2026, the Federal Council opened the consultation on a third set of significant revisions to the Health Insurance Ordinance ("HIO") and the Ordinance on the Benefits under the Mandatory Health Insurance ("OBHI"). The new provisions implement notable changes in pharmaceutical pricing. They include turnover-based refund models, confidential pricing models, reimbursement as of the marketing authorisation date, and a differentiated assessment of effectiveness, appropriateness and economic efficiency ("WZW"). The consultation is open until 26 May 2026.

Background: Cost Containment Package 2

On 21 March 2025, the Swiss Parliament adopted amendments to the Federal Act on Health Insurance ("HIA") as part of the second package of cost-containment measures, aimed at limiting the growth of costs in the mandatory health insurance scheme. The necessary implementation regulations are issued in three separate sets of revisions.

At its meeting on 18 February 2026, the Federal Council submitted the third set of amendments to the HIO and the OBHI for public consultation. This third set introduces significant provisions on turnover-based refund models, confidential pricing models, provisional reimbursement as of the marketing authorisation date ("Day 0") and a differentiated WZW assessment.

Following the conclusion of the consultation process on 26 May 2026, the Federal Council will adopt the final ordinance texts and set the date for the amended provisions to come into force, currently anticipated for early 2027.

Turnover-based refund model

Article 52e of the revised HIA provides for a compensation mechanism under the Mandatory Health Insurance ("MHI") for medicines with notably high market volumes. If a medicine ex ceeds a threshold of CHF 15 million per calendar year (ex‑fac tory, net of refunds), the proposed Article 65b^septies para. 1 nHIO obliges the marketing authorisation holder to partially reim burse the excess revenue under a turnover-based refund model (Kostenfolgemodell, "KFM"). Exemptions apply for originator products that face generic competition and reference products that face biosimilar competition, as well as off-patent follow-on products whose economic efficiency is assessed solely via a ther apeutic cross-comparison against generics or biosimilars (Article 65b^septies para. 1^bis nHIO).

Sales of chemically identical or similar substances are aggre gated at corporate-group level, potentially expanding exposure across portfolios (Article 65b^octies nHIO). Where a medicine is re imbursed under the MHI for multiple indications, the revenue threshold for market volume increases by CHF 2 million for each additional relevant indication up to a maximum of CHF 50 mil lion (Article 65b^septies para. 3 nHIO).

Reimbursements are calculated in tranches of CHF 5 million, ap plying a starting rate of 15% to the first CHF 5 million above the threshold. The rate then increases by two percentage points for each subsequent tranche, reaching 35% for the CHF 65–70 mil lion band, and is capped at 40% for revenues exceeding CHF 70 million (Article 34c^ter nOBHI).

The Federal Office of Public Health ("FOPH") may reduce or waive the reimbursement if other reimbursement obligations or volume/turnover requirements exist, or if the reimbursement obligation would threaten the economic viability of production or the security of supply in Switzerland (Article 65b^septies nHIO para. 6).

For new Specialties List ("SL") entrants, the KFM will apply from the date the amendment enters into force. For products already listed, the KFM will only take at the next review of their inclusion conditions, no earlier than two-years after the entry into force of this amendment. During this transition period, existing SL products remain exempt from the KFM unless their annual turn over increases compared to the previous year, in which case the increase is already subject to the KFM (Transitional Provisions para. 2 nHIO).

Confidential Pricing Models

The Cost Containment Package 2 has formally embedded pricing models in the law (Article 52b nHIA), establishing them as opera tionalised and legally binding exceptions to the standard price setting framework. Price reimbursements may be required, for example, where the effectiveness of a medicinal product re mains uncertain due to: (still) limited data, in order to mitigate the financial risk borne by mandatory health insurance, or where high list prices are published in multiple reference countries that are not effectively reimbursed but nevertheless must be taken into account for Swiss price setting (Article 34c^quinquies nOBHI).

The draft ordinance provides for five scenarios in which pricing models may be applied: (i) where a higher listed ex-factory price has been agreed upon with the authorization holder; where there is (ii) uncertainty regarding efficacy; (iii) uncertainty re garding appropriateness; (iv) uncertainty regarding reimbursed quantities of the medicinal product and costs incurred, as well as its dosage and duration of therapy; or (v) where there is uncer tainty regarding the cost-benefit ratio. Where pricing models have been established for a combination therapy, the FOPH may allocate reimbursements among the medicinal products in volved in the combination (Art. 65b^quinquies nHIO).

The FOPH may keep price and reimbursement details confidential for six years (Article 52c nHIA), subject to periodic review and possible extension in extraordinary cases. In therapeutic cross-comparisons (TQV), confidential prices may be shared with other marketing authorisation holders, subject to a duty of confidentiality (Article 65b^sexies nHIO).

Provisional Reimbursement ("Day 0")

One of the key innovations introduced by Parliament in the Cost Containment Package 2 is the provisional reimbursement of pharmaceuticals from the date of marketing authorisation by Swissmedic, commonly referred to as "Day 0".

Under the current regime, pharmaceuticals can only be reim bursed under the MHI once the FOPH has completed its full post-authorisation review and admitted the product to the SL. In practice, compliance with the statutory 60-day decision deadline was not always achieved, leading to substantial delays between marketing authorisation and actual SL admission. During this in terim period, patients are dependent on individual case-by-case reimbursement under Articles 71a–71d HIO.

Under Article 52d nHIA and Article 69c nHIO, pharmaceuticals granted provisional listing will be included on a separate list of provisionally reimbursed products, distinct from the SL, for a maximum period of 24 months from the date of inclusion. The FOPH will determine a provisional ex-factory price based on the standard pricing criteria, namely the external reference pricing (APV) and the therapeutic cross-comparison (TQV) (Article 65c^quinquies para. 1 nHIO).  

Where a product is ultimately not included in the SL, individual reimbursement may nevertheless continue for up to five years following its removal from the provisional list (Article 71d para. 7 nHIO).

Differentiated WZW examination

Swiss Parliament and the Federal Council also aim to enhance the security of supply for medicines that might otherwise be withdrawn from the Swiss market due to insufficient profitabil ity. To this end, low-cost, low-revenue medicines reimbursed un der the MHI will no longer be subject to a cost-effectiveness as sessment by the FOPH during the triennial review of effective ness, appropriateness and economic efficiency (WZW) (Article 32 para. 3 nHIA and Article 65d para. 1^bis nHIO). As a result, their prices will no longer be reduced.

In substance, medicines are exempt from the economic effi ciency reassessment if their average Swiss market turnover over three years is below CHF 1 million and the ex-factory price of the highest-selling pack is below CHF 200, or if their turnover is be tween CHF 1 million and CHF 4 million and the cost per WHO-de fined daily dose is below CHF 0.20 (Article 65d para. 1^bis nHIO).

Even where economic efficiency continues to be assessed, price reductions may be waived in exceptional cases, for example where supply would otherwise be jeopardised (Article 65d para. 4^bis nHIO).

Beyond these measures, further amendments to the HIO and OBHI are suggested to promote the provision of lower-cost ge nerics and biosimilars and to simplify the reimbursement pro cess for new vaccines.

Outlook and Conclusion

The ordinance package represents a notable shift in Swiss pharmaceutical pricing. For pharmaceutical companies, the measures create both new challenges and opportunities.

On the one hand, the turnover-based refund models introduce additional price pressure on high-turnover products. On the other, legal certainty regarding pricing models and their confidentiality is strengthened. The differentiated WZW examinations aim to enhance the security of supply for medicines, while bureaucratic hurdles for low-turnover or low cost medicines are reduced.

Overall, the package indicates a move toward more differentiated pricing and regulatory approaches within the Swiss pharmaceutical system. Since the adoption of Switzerland's Cost Containment Package 2, however, the international environment has evolved — most notably with the introduction of "Most Favored Nation" pricing models by the US government. These developments may influence the incentives for introducing innovative medicines in smaller markets such as Switzerland. As patient access to new therapies is already under pressure, any additional cost-reduction measures may add further constraints to market access. 

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