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Consultation procedure regarding amendment of the Health Insurance Ordinance (KVV) and the Health Insurance Benefits Ordinance (KLV) to improve the equal treatment of patients in individual case reimbursement as well as pricing and transparency

10. June 2022 – The Health Insurance Ordinance (Verordnung über die Krankenversicherung, KVV) and the Health Insurance Benefits Ordinance (Krankenpflege-Leistungsverordnung, KLV) shall be amended to improve the equal treatment of patients by health insurers in individual case reimbursement as well as pricing and transparency. At its meeting on 3 June 2022, the Federal Council has published an amendment to the KVV and the KLV for consultation procedure (preliminary legislative procedure).

Under the individual case reimbursement system, health insurers decide on the reimbursement of essential medicines based on the medical assessment by their medical experts. The decision on a cost approval is based on the assessment of the therapeutic benefit of a pharmaceutical or a therapy and the determination of an economic price. Because of today’s significant differences in this assessment, health insurers will in future be obliged to use the benefit assessment tool developed by the medical experts (OLUTool) and to involve experts in the benefit assessment. In addition, health insurer can jointly carry out the benefit assessment for frequently requested pharmaceuticals and to publish the results. Pricing will also be regulated more clearly: The higher the benefit of a pharmaceutical, the higher the price that the health insurer sets with the pharmaceutical company. The Federal Council also wants to enable the reimbursement of low-cost therapies that are not authorised by Swissmedic.

The pharmaceuticals reimbursed by the health insurers within the SHI system are listed on the Speciality List (SL). Pharmaceutical companies shall have the possibility of carrying out a preliminary clarification with the Federal Office of Public Health (FOPH) even before submitting an application for acceptance to the SL, in order to accelerate the process.

Further changes are planned in the field of generics and biosimilars. An additional level with a price difference of 80% to the original is to be introduced. In the periodic price review of generics, the applicable price gaps are to be increased. For biosimilars, the planned changes provide for staggered price gaps depending on the market volume and the price of the reference preparation, in analogy to the generics, whereby the price gaps are smaller than for generics. The changes envisaged by the Federal Council also concern the comparison of prices abroad, for which Norway is now to be used as a reference country instead of Finland. Furthermore, an increase in the self-payment from 20% to 50% is planned for originals which do not meet the generic price level. The dispensing of expensive pharmaceuticals without an increased deductible shall be limited to defined exceptional cases. In the case of therapeutic cross-comparison (Therapeutischer Quervergleich, TQV), the term “patent protection” is replaced by the criterion "15 years since Swissmedic approval of the first commercial form of the original preparation or the inclusion of generics or biosimilars". In the area of multi-indication and follow-on preparations, the amendment to the ordinances provides that the pricing for the secondary indications is to be based solely on the TQV. The consultation period runs until 30 September 2022.

For more information, see here.