Reimbursement in individual cases (Art. 71a–d HIO) and off-label use

As a fundamental principle, medicinal products may only be dispensed in Switzerland if they have been evaluated for safety, efficacy and quality and subsequently approved by the regulatory authority Swissmedic. Broad and equitable access for patients to a treatment is only achieved once the Federal Office of Public Health has added the treatment to the Specialties List and it is thus covered for obligatory reimbursement by health insurers. To do so, the criteria for the drug’s effectiveness, appropriateness, and economic efficiency must be met. In some cases a medication cannot be reimbursed via the Specialties List. In such cases, Article 71a–d of the Health Insurance Ordinance (HIO) is a success story: If patients require a medicinal product that is not approved by Swissmedic or is not on the Specialties List of the Swiss Federal Office of Public Health, and is therefore not covered by compulsory health insurance, Article 71a–d HIO is the fallback option. It gives Swiss patients access to medically necessary treatments, even if, for example, a specific indication is not approved (commonly referred to as “off-label use”). This is subject to the following conditions: the disease is terminal or has the potential to cause chronic damage to health; a high therapeutic benefit is expected from the use of the drug; there is no effective and approved alternative; and the therapeutic benefit must be proportionate to the cost. The main beneficiaries of this regulation should be individual patients for whom (new) treatment options are a last resort.

For example, off-label use plays a role in clinical research involving children. Particularly complex ethical aspects have to be taken into account in such cases. In addition, in the case of rare diseases, some individual indications will never achieve full approval status, as the number of patients is too small to carry out clinical trials.

Challenges in individual case reimbursement

The last revision in 2024 poses new challenges today. According to a survey conducted by Interpharma and vips, many companies have found solutions that have enabled them to continue providing patients with care despite the drastic deterioration in reimbursement conditions in individual cases. Nevertheless, following the implementation of the HIO revision between April 1 and December 31, 2024, more than 1,500 patients who previously had access lost access to individual case reimbursement. Extrapolated to the year as a whole, this equates to more than 2,000 cases. The problem is the high, fixed price discounts, which are now also combined with a few other discounts. In cases where discounts are too high (e.g. up to 90%), it may simply no longer be sustainable for the marketing authorization holder to provide the product.

Added to this is the continuing unequal treatment of patients by health insurance companies. Against this backdrop, access to and reimbursement of medicines in off-label use are not always equal for all affected parties. This can lead to discrimination depending on the insurer, or as a result of different decisions.

It is therefore all the more important to remedy the underlying problem by modernizing the entirety of the outdated pricing system for standard reimbursement through the Specialties List. Over the years Article 71 has developed into a kind of bridging solution for products that become “stuck in traffic” en route to becoming included in the Specialties List. Statistics from Interpharma show that the availability of new, innovative drugs in Switzerland has been increasingly delayed since 2016. As a result, physicians are increasingly resorting to Article 71 in order to provide their patients with the best possible treatment, and this instrument is consequently overburdened. This is counterproductive, which is why the regular reimbursement process should be improved and the Article 71 process returned to its original purpose as a case-by-case regulation.