Four years after the Nobel Prize for the CRISPR/Cas9 gene-editing tool, Swissmedic has approved the first CRISPR/Cas9-based gene therapy in Switzerland. This therapy offers people with sickle cell disease and beta thalassemia the chance of a cure. A parliamentary interpellation submitted by National Councillor Benjamin Fischer calls on the Federal Council to clarify urgent reimbursement questions so that patients can benefit from this newly approved, innovative therapy as soon as possible.
The benefit is clear—but who should pay?
Sickle cell disease and beta thalassemia are genetic disorders that were previously difficult to treat and burdened patients throughout their lives. Despite approval in September 2024, those affected in Switzerland currently cannot yet access the new gene therapy. The reason is unresolved reimbursement issues: tariff partners have not yet reached an agreement on how the treatment costs should be covered. The medical benefit of the treatment is substantial—potentially lifelong cure, prevention of disability, and return to working life—yet the costs amount to CHF 2 to 2.5 million per patient.
A motion submitted by National Councillor Benjamin Fischer in May asks the Federal Council to state concretely how to ensure that reimbursement decisions for innovative therapies consider not only direct costs but also long-term benefits. The background is the concern that the longer-term positive effects for patients, society, and social insurance systems may receive insufficient consideration.
Federal Council Cites Tariff Autonomy; Interpharma Calls for Pricing Reform
In August, the Federal Council responded to the motion. It refers to the existing WZW criteria (effectiveness, appropriateness, cost-effectiveness) under the Health Insurance Act. These stipulate that only direct costs may be considered. Although aspects such as ability to work or avoided disability are partly reflected in the assessment, they must not be counted twice in the cost–benefit balance. The Federal Council also emphasized that “it is not the task of the Federal Council to evaluate ongoing tariff negotiations of the tariff partners or to intervene in these negotiations. It is the responsibility of all actors to work towards a high-quality and financially sustainable healthcare system.” Interpharma, in its 2024 annual report, has already called for modernization of the pricing system for approved medicines in Switzerland. It also notes that access to innovative medicines has worsened and that the time between Swissmedic approval and actual patient availability has grown problematically.
Could Financing Follow Models from Abroad?
Health insurance premiums must remain affordable for everyone, while innovative therapies demand high prices that may be economically justified in the long term but impose heavy short-term burdens. A look at other countries suggests possible solutions. In the United States, the costs for a one-time gene therapy to treat spinal muscular atrophy (SMA) in children are paid off over several years. This smooths budget impact and makes the therapy more affordable in the short term. In Germany, for the beta thalassemia gene therapy, an outcome-based pricing model was chosen. The full price is paid only in the case of success; otherwise, the manufacturer receives just 40% of the costs. This allows risk-sharing between health insurers and manufacturers.
For such models to be applied in Switzerland, provisional reimbursement should in principle be granted for Swissmedic-approved gene therapies. A national registry could capture treatment outcomes and enable outcome-dependent payments to pharmaceutical companies. In addition, staggered payments over multiple years and a special fund for very expensive individual cases could ease the burden on insurers. Whether this works will depend above all on political will and the willingness of manufacturers to accept outcome-based agreements. The approval of the first CRISPR-based gene therapy is a historic milestone. Whether this scientific breakthrough quickly reaches patients will now be determined less in the lab than in health policy.
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(Image: Google DeepMind / Unsplash)
