OBJECTIVES: Innovative medical technologies such as autologous and allogenic cell therapies and gene therapies can provide new treatment options for conditions with high unmet medical need. The payers may accept high costs associated with these therapies, some exceeding 300,000 USD, for curative, life-saving treatments. The objective of this analysis is to evaluate the readiness of the Swiss regulatory and reimbursement system to cope with the specific requirements of these therapies.

METHODS: Systematic gap analysis of current policies and legislative procedures for regulatory and reimbursement decisions for cell and gene therapies in Switzerland. Comparative analysis of procedures in European countries.

RESULTS: Any policy on cell and gene therapies is caught between the partially diverging interests on attractive framework for biomedical research, regulatory framework, reimbursement decision and ethical safeguarding of human dignity. Cell and ex-vivo gene therapy products are classified as Transplant Products in Switzerland and advanced therapy medicinal products in the EU, respectively. So far, no gene therapy medicinal product has been authorized in Switzerland, and once reimbursed. Reimbursement of these therapies will rely on FOPH's handling for establishing these products within Swiss reimbursement mechanisms Swiss DRG, TARMED and the list of specialties (SL, positive list). In the EU, actual assessment and reimbursement is handled heterogeneously across EU member states despite central EU approval.

CONCLUSIONS: In Switzerland, policy and legislative gaps could, lead to uncertainty among stakeholders. Using reimbursement of classical transplants as price comparator for such highly innovative products seems inappropriate, but relevant legislation is currently missing. Alternative payment models for high-cost treatments, such as “pay for performance”, are difficult to implement under the current legal bases. Moreover, manufacturers have to consider that the contribution of private households (including out of pocket spending) to the per capita health expenditure is already high. Finally, the ongoing debate on future handling of rare diseases increases uncertainty.