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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 out-patient care are completely separate from hospital care provisions and are reimbursed via a fee-for-service model (TARMED catalog, soon to be replaced by TARDOC catalog, within the statutory health insurance).

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 (soon to be replaced by TARDOC) catalog.

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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 145 projects in Switzerland

News and insights

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).

The 2024 application window for changes in the CHOP classification announced

The application window for changes in the Swiss classification of surgical procedures (CHOP) will open on June 3, 2024. The eligible applicants can submit applications until September 15, 2024.

Changes in laboratory analyses tariff setting in Switzerland

On May 1, 2024, the Swiss Federal Council adopted a message to amend the Federal Health Insurance Act (KVG) following a parliamentary mandate, which requires a change in how tariffs for laboratory analyses are determined. Instead of being set by the Federal Department of Home Affairs (FDHA), the tariffs of tests in the List of Analyses will be determined through negotiations between collective bargaining partners, streamlining the inclusion of innovative analyses and slowing down the increase in healthcare costs.

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