Can Switzerland protect patient access to innovative medicines in era of most-favoured-nation pricing?
The US is reshaping global pharmaceutical pricing. With the introduction of a most-favoured-nation pricing model for new and innovative medicines, the US is seeking to align domestic prices with those paid in other countries. The effects of this change will be felt far beyond American borders. This policy shift, intended to reduce health-care expenditures in the US, has triggered significant international concern with the tangible risk that changes to global pricing dynamics will impact smaller markets such as Switzerland. Switzerland faces a difficult choice: accept substantially higher prices for innovative therapies or forego reimbursement of treatment costs by mandatory health insurance. Both scenarios would be undesirable in terms of patient access, but they are not inevitable.
The US is reshaping global pharmaceutical pricing. With the introduction of a most-favoured-nation pricing model for new and innovative medicines, the US is seeking to align domestic prices with those paid in other countries. The effects of this change will be felt far beyond American borders. This policy shift, intended to reduce health-care expenditures in the US, has triggered significant international concern with the tangible risk that changes to global pricing dynamics will impact smaller markets such as Switzerland. Switzerland faces a difficult choice: accept substantially higher prices for innovative therapies or forego reimbursement of treatment costs by mandatory health insurance. Both scenarios would be undesirable in terms of patient access, but they are not inevitable.
The following article analyses the implications of these changes to the Swiss health-care system, based on a comprehensive assessment of all legal, regulatory, and market-related issues. The article focuses on a specific instrument of Swiss health insurance legislation: individual case reimbursement. The piece also examines how this instrument could cushion the potential adverse effects of US most-favoured-nation pricing on Switzerland, and the legal and strategic options available to safeguard Swiss patients' access to innovative therapies.
In December, Roche presented the results of its Phase III study on giredestrant (RG6171/GDC-9545), an investigational selective oestrogen receptor degrader for the treatment of breast cancer. The study demonstrated that treatment with this compound reduces the risk of recurrence by 30%. Medical societies are already promoting the therapy as the new standard of care for early-stage breast cancer.
A month later, however, Roche CEO Thomas Schinecker stated this new drug may not be available to Swiss patients or that the anticipated high cost of this treatment may not be reimbursed by mandatory health insurance in Switzerland.
Breast cancer is the most common cancer among women in Switzerland. According to the National Cancer Registry, 6,500 women in Switzerland are diagnosed with breast cancer each year and 1,400 die.
If Roche's prediction on mandatory health insurance coverage proves accurate, the consequences for medical care in Switzerland will be far-reaching. Two-tier health care could become a reality if only wealthy private patients can afford this life-prolonging therapy.
Most-favoured-nation pricing in the US
On 10 November 2025, President Donald Trump introduced the GENEROUS model (i.e. Generating Cost Reductions for US Medicaid) whereby the prices of medicinal products paid for by Medicaid are no longer set nationally but determined through international price comparisons. For this purpose, the prices from Canada, Japan, Denmark, France, Germany, Italy, UK, and Switzerland are considered and adjusted according to per capita purchasing power parity.
One month later, President Trump announced a most-favoured-nation agreement with 17 pharmaceutical manufacturers for the American health-care system. This arrangement gives the American system access to innovative medicines at competitive international prices while preventing other countries from benefiting from American investments by paying lower prices than American patients do. The signatories include the Swiss pharmaceutical companies Roche and Novartis.
With annual sales of around USD 634 billion in 2024, the US is the world's largest pharmaceutical market, accounting for 50% of worldwide pharmaceutical sales. New and innovative drugs are frequently launched in the US first since high drug prices enable faster amortisation of substantial research and development costs. US drug prices are therefore critical for research-based pharmaceutical companies. To avoid adverse effects, they feel compelled to either raise prices in comparable European countries or discontinue supply to these markets. Albert Bourla, CEO of Pfizer, expressed a similar view, stating that he would rather stop supplying France than reduce US prices to French levels.
"When [we] do the maths,” Bourla said, “shall we reduce the US price to France's level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices."
Impact on Switzerland
Switzerland is among the countries US authorities will consider for its price comparison. As a small country with an independent approval and reimbursement system, Switzerland will face significant challenges as a result of this development. If pharmaceutical manufacturers are already contemplating discontinuing supplies to a large EU member state such as France, the risk is substantially greater for a smaller country like Switzerland, particularly given Switzerland's lack of membership in any major trading bloc. It may only be a matter of time before certain medicines become unavailable in Switzerland or are only available at prices comparable to those in the US.
Whether Switzerland can maintain access to new and innovative medicines depends substantially on the political framework. Initial statements, however, provide little cause for optimism.
Parliamentary motions have already been submitted to prevent price increases at the expense of Swiss premium payers (see Motions 25.4173 from the Social Democratic Party and 25.4379 Wasserfallen of 26 September 2025: "No drug price increases due to customs dispute with the US"). According to these motions, implementation of cost-containment measures approved by Parliament should neither be delayed nor reversed. Any price increases would undermine the intended relief for premium payers.
The Federal Council has also expressed reservations. In response to a recent interpellation, the Federal Council stated that it currently does not anticipate change in the availability of drugs. The market environment in Switzerland remains favourable. Compared to other European countries, manufacturers can "achieve the highest market prices" here. The Federal Council therefore rejects drug price increases. (See the response of 27 August 2025 to Interpellation 25.3644 Löhr, submitted 18 June 2025: Uncertain geopolitical times. How do we protect our patients?)
"Against this backdrop, measures to increase prices and costs in the pharmaceutical sector would be incomprehensible from a health policy perspective,” according to the Löhr Interpellation, "and no new fundamental regulatory measures are currently under consideration."
Following Roche CEO Schinecker’s comments, doubts have emerged as to whether Switzerland is positioned to respond appropriately to the challenges posed by the new US policy. Experts fear that the level of suffering will increase before politicians are willing to act. Patients bear the consequences, but Switzerland still has time to implement the necessary measures.
Individual case reimbursement as a solution
In its response to the Löhr Interpellation (see above), the Federal Council refers to "the possibility of individual case reimbursement, which is unique in the European context." This remedy is a narrowly defined exception to Swiss health insurance law obliging health insurers to cover the costs of treatment for drugs not included on the list of reimbursable drugs (i.e. List of Specialities).
Legal framework
As a general rule, mandatory health insurance only reimburses treatment costs for drugs listed on the Speciality List. Inclusion on this list requires an application from the pharmaceutical manufacturer, although manufacturers are not obliged to make such an application.
As an exception to this rule, however, health insurers are under certain conditions obligated to reimburse costs for treatment with drugs not included in the Speciality List. This applies where the treatment is expected to provide a significant therapeutic benefit against a potentially fatal disease. Additionally, there must be no therapeutic alternatives, and no other effective and approved treatment method may be available. (For the requirements in greater detail, see Art. 71a para. 1 letter b of the Swiss Healthcare Ordinance). Furthermore, the drug must be approved in Switzerland or another country with an equivalent approval system (Art. 71c para. 1 letter c of the Swiss Healthcare Ordinance).
The respective health insurer must verify whether the reimbursement requirements are met. Unlike drugs on the speciality list, there is no comprehensive review of the reimbursement obligation by a state authority that is binding for all patients. Instead, reviews are conducted on a case-by-case basis, including determining the reimbursement amount to be paid by the health insurer.
Individual case reimbursement was developed through case-law and subsequently incorporated into Swiss health insurance legislation. These exceptions to the general rule are intended to prevent hardships by individual patients, but were not designed to mitigate the systemic effects of international price comparison on Swiss health care.
Consequently, health insurers are entitled to reimburse the costs treatments with drugs that are not included on the specialities list, regardless of whether they have obtained marketing authorisation in Switzerland. The medication may even be imported by a third party other than the marketing authorisation holder.
These considerations also apply in principle to giredestrant as an innovative treatment for breast cancer. Regarding the international price comparison in the US, however, two major uncertainties arise:
- the amount to be reimbursed by the health insurer; and
- the impact on the pricing in the US.
Reimbursement amount
The first challenge is determining the amount to be reimbursed by the health insurer, which is determined by the insurer in consultation with the marketing authorisation holder (see Art. 71b para. 2 of the Swiss Healthcare Ordinance). The pharmaceutical manufacturer is under no obligation to supply the medicinal product, and the supply cannot be enforced. As a result, the manufacturer is not obliged to supply the product at the price set by the health insurer, and it is uncertain whether the manufacturer will supply the medicinal product if the reimbursement is lower than the US price. This highlights a significant uncertainty regarding the extent to which reimbursement provisions guarantee the supply of drugs not subject to individual case reimbursement.
If an agreement cannot be reached with the Swiss marketing authorisation holder, an alternative option is to import the medicinal product from a third country via a hospital pharmacy, with the associated costs covered by the health insurer. The health insurer may instruct the hospital pharmacy to import the drug from a country with lower prices (see Art. 71c para. 2 of the Swiss Healthcare Ordinance). This procedure was developed to bridge temporary supply shortages. It remains questionable whether this can counteract the adverse effects of most-favoured-nation pricing on the supply of medicinal products to Swiss patients.
Innovative and patent-protected medicinal products may not be imported into Switzerland without the manufacturer's consent unless "their price is set by the state in Switzerland or in the country where they are marketed" (see Art. 9a para. 5 Patent Act). Given the effects of most-favoured-nation pricing in the US, it is presumed that prices are not set by the state. This certainly applies in Switzerland and likely other countries affected by most-favoured-nation pricing, such as France, from which the medicinal product could be imported.
Impact on pricing in the US
The greater uncertainty concerns the effect on the assessment in the US. Currently, there is no reliable information on how the most-favoured-nation pricing will be implemented in the US. Hence, it is not possible to conclusively assess how a Swiss health insurer's price in individual cases will be considered by US authorities.
Although individual case reimbursement is not state-determined, it resembles state-set pricing, making its consideration in the context of most-favoured-nation pricing not entirely unreasonable. Consider the following:
- The legal basis for individual case reimbursement is found in the implementing regulations of the Health Insurance Act. The conditions for cost coverage and reimbursement amounts, including price reductions to be granted by manufacturers, are regulated in detail and are legally binding.
- Health insurers are legally obligated to provide services prescribed by law and to accept every person as an insured individual. In individual cases, they determine reimbursement amounts and make corresponding payments. Health insurers operate within a narrow, publicly regulated framework. In other countries, this function is reserved for the state or public bodies.
From a US perspective, the mere fact that health insurers are organised under private law, operate independently and compete with each other does not preclude classification as state-regulated prices. This holds true even though reimbursement is determined by the health insurer based but on the detailed provisions of Swiss health insurance legislation.
The fact that prices paid by health insurers are not published does not alter this analysis. They are subject to disclosure to US authorities in the same way as state-set prices. Prices negotiated in confidential price negotiations must also be disclosed to US authorities.
Conclusion
The Federal Council’s assertion that individual case reimbursement offers a sufficient safeguard against the negative effects of US most-favoured-nation pricing is open to serious challenge. Developments in the US will have a significant impact on health care in Switzerland, making it essential to take proactive measures to protect Swiss patients.
A central concern lies in the detailed regulation of individual case reimbursement that has been in force since 1 January 2024 (Art. 71a and 71b para. 3 of the Swiss Healthcare Ordinance of 22 September 2023). While these provisions on therapeutic benefit assessment and reimbursement amounts were designed to enhance legal certainty and ensure consistent implementation across health insurers, they may prove counterproductive.
By formalising reimbursement parameters to a high degree, the framework increases the likelihood that US authorities could characterise individual case reimbursement as a form of state price-setting. Consequently, prices set by private health insurers in Switzerland could feed directly into US pricing calculations. Since pharmaceutical companies must avoid this at all costs, the recent amendment to Swiss health-care legislation threatens to limit the access of Swiss patients to new and innovative medicines.
For more information on the Swiss health-care sector, contact your CMS client partner or the CME experts who wrote this article.
This publication forms part of a broader series examining the implications of US pricing policy for Switzerland. We have published additional contributions addressing complementary legal, regulatory and policy dimensions of this issue in greater depth. Readers are invited to consult these further analyses for a more comprehensive understanding of the challenges and possible responses. For more information contact you CMS client partner or local CMS experts.
