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Market access for medical technologies in Switzerland

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Switzerland

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Key topics

There are two key themes describing market access for medical technologies in Switzerland: 

  • Reimbursement: payment mechanism via DRG system, add-on reimbursement via ZE in hospital settings; payment via TARMED (soon to be replaced by TARDOC) catalog in out-patient settings
  • Funding: coverage decisions within the statutory health insurance by the Federal Office of Public Health

There is no health technology assessment challenge in Switzerland. HTA is integrated into funding decision-making.

Switzerland has one innovative payment scheme for medical technologies (Provisional reimbursement of medical procedures). 

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Reimbursement

Reimbursement for hospital procedures is made solely via the SwissDRG system. All cases of hospitalization with at least one overnight stay are reimbursed via DRG. Day cases and outpatient care are completely separate from hospital care provisions and currently reimbursed via a fee-for-service model using the TARMED catalog. However, in 2026, the TARMED catalog is expected to be replaced by the TARDOC catalog for outpatient procedures and the outpatient flat-rates system for interventions performed in day case settings).

The DRG system has the following components:

Diagnosis-related groups

  • DRGs are determined by the combination of a procedure code (CHOP) and a diagnosis code (ICD-10-GM). CHOP nomenclature is maintained by the Federal Statistics Office (BFS/UFS) and released annually
  • The base rate is determined nationally, and the Cantons have to approve and adopt it. In case they do not adopt it, the Cantons may set their own base rate (rarely the case) 

Add-on reimbursement (Zusatzentgelt, ZE)

  • Add-on reimbursement is provided for expensive devices, procedures, and drugs
    Tariff is typically determined on the national level by the administrator of the DRG system, SwissDRG

The SwissDRG system is approved annually.

Procedures performed in out-patient and day case settings are reimbursed via a fee-for-service mechanism via the TARMED catalog (soon to be replaced).

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Funding

In the inpatient sector, medical devices/procedures are automatically reimbursed according to the so-called “principle of trust” unless they are questioned by a stakeholder of the system (typically insurance companies). In this case, the Federal Office for Public Health (FOPH) evaluates the questioned device/procedure and develops a coverage decision. 

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Specifics for IVD tests

In-vitro diagnostic tests are reimbursed using a fee-for-service mechanism via the List of Analyses (Annex 3 of the Healthcare Benefit Ordinance, KLV/OPre) in out-patient settings.

MTRC has experience with more than 156 projects in Switzerland

News and insights

New comprehensive outpatient reimbursement system available for review in Switzerland

On September 18, 2024, the Organization for Outpatient Physician Tariffs (OAAT) AG announced that the comprehensive tariff system, including the TARDOC catalog of individual service tariffs and outpatient flat rates, is now available for review by interested parties. As emphasized by the OAAT AG, the new system has not been approved yet. After the partial approval by the Swiss Federal Council in June 2024, the implementation of the new system was postponed until January 2026.

Implementation of new Swiss outpatient reimbursement system postponed until 2026

On June 19, 2024, the Swiss Federal Council granted partial approval to the new outpatient reimbursement system, consisting of the TARDOC catalog of individual service tariffs and the flat-rate system, which were developed independently. Adjustments were requested to ensure better coordination and adherence to cost neutrality. The full implementation of the new system is now postponed until 2026.

Updates in the coverage of medical services in Switzerland in 2024

On June 18, 2024, the Swiss Federal Office of Public Health published the changes that will occur to the Services Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on July 1, 2024, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Equipment (Annex 2), and List of Analyses (Annex 3).

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