Reimbursement of orphan drugs: the specialities list and Art. 71a to 71d KVV
Compulsory health insurance pays for a medicine listed in the specialities list of the Federal Office of Public Health. Outside the list, or outside the product information and the limitation, Art. 71a to 71d KVV govern individual cases.
The two routes to reimbursement
There are two distinct routes. The ordinary one is listing in the specialities list (SL) maintained by the Federal Office of Public Health (FOPH), which makes compulsory health insurance pay within the listing terms. The second is individual-case reimbursement under Art. 71a to 71d KVV, decided by the insurer per patient.
Access and payment are two separate questions in Swiss law. Swissmedic decides whether a medicine may be placed on the market; the reimbursement system decides whether compulsory health insurance pays for it. An authorised orphan drug can therefore be lawfully available and still unpaid until one of the two routes has been opened.
When Art. 71a to 71d KVV applies
Individual-case reimbursement covers three constellations. It is the pathway relied on most heavily for orphan drugs, because many products either are not yet on the specialities list or are needed outside the wording of the authorised indication. Each constellation has its own basis in the ordinance and the same requirement of prior approval by the insurer.
- A medicine listed in the specialities list used outside the approved product information or outside the limitation attached to the listing.
- A medicine not included in the specialities list but authorised by Swissmedic.
- A medicine not authorised by Swissmedic but imported from a country with an authorisation system recognised as equivalent by Swissmedic, and authorised there for the indication concerned.
| Constellation | Swiss authorisation | On the SL | Basis |
|---|---|---|---|
| Use outside the product information or the SL limitation | Yes | Yes | Art. 71a KVV |
| Authorised medicine not listed | Yes | No | Art. 71b KVV |
| Imported from a country with an equivalent authorisation system, authorised there for the indication | No | No | Art. 71c KVV |
| Common procedural rules, including the two-week decision | n/a | n/a | Art. 71d KVV |
The cost approval process step by step
Costs are covered only after special approval by the insurer, which must first consult its medical adviser. The request is therefore a clinical document, not an administrative form. The insurer decides within two weeks of receiving a complete request for cost approval, which puts the burden of completeness on the treating team.
- The treating physician establishes that the case falls into one of the three constellations of Art. 71a to 71c KVV.
- The physician submits a request for cost approval to the patient's insurer with the clinical justification and the evidence relied upon.
- The insurer consults its medical adviser, as prior consultation is a condition of the approval.
- The insurer decides within two weeks of a complete request.
- Treatment is reimbursed only on the basis of that approval; there is no retroactive entitlement without it.
In practice incomplete requests are the main cause of delay, because the two-week clock starts only when the request is complete. Assembling the dossier once, in full, is faster than answering successive queries.
What changed with the 2024 revision
The amendment of the Health Insurance Ordinance and the Health Care Benefits Ordinance of 22 September 2023 entered into force on 1 January 2024, with further changes on 1 September 2024. The stated aims were to strengthen equal treatment of insured persons, quality, efficiency, transparency and a uniform assessment of cost-effectiveness in individual cases.
For orphan drugs the point of the revision is comparability. Individual-case decisions had been taken by many insurers on differing bases, and a uniform assessment of cost-effectiveness is intended to reduce the spread between comparable patients.
The procedural core did not change. Costs are still covered only after special approval by the insurer following prior consultation of its medical adviser, and the insurer still decides within two weeks of a complete request for cost approval.
Why the SL route still matters for orphan drugs
Individual-case reimbursement is a bridge, not a destination. A listing in the specialities list gives predictable access for every insured patient within the terms of the listing, while Art. 71a to 71d KVV requires a fresh approval for each patient and each insurer. For a marketing authorisation holder the SL is therefore the commercial objective.
- SL listing: access within the listing terms, no per-patient approval, a published public price.
- Individual case: approval per patient, prior consultation of the insurer's medical adviser, decision within two weeks of a complete request.
- Individual case is also the route for indications outside the product information, including after an SL listing exists.
For a rare disease the practical difference is measured in patients. Where a handful of people in Switzerland are affected, a listing removes a per-patient approval step from every one of them, which is why a listing remains the objective even where individual-case decisions have been positive.
Who decides what
Responsibilities are split across three actors and confusing them costs time. Swissmedic decides on authorisation, the Federal Office of Public Health decides on listing in the specialities list and its conditions, and the individual health insurer decides on cost approval in an individual case after consulting its medical adviser.
| Actor | Decision | Instrument |
|---|---|---|
| Swissmedic | Authorisation and orphan drug status | TPA, TPLO |
| Federal Office of Public Health | Listing in the specialities list, limitation, price | KVV, KLV |
| Health insurer | Cost approval in an individual case | Art. 71a to 71d KVV |
A negative decision from one of the three does not bind the others. Swissmedic can authorise a product that the Federal Office of Public Health has not listed, and an insurer can approve costs in an individual case for a medicine that is not on the specialities list.
Frequently asked questions
How long does an insurer have to decide on a cost approval request?
Two weeks from receipt of a complete request for cost approval. The insurer must consult its medical adviser before approving. Because the deadline runs only from completeness, an incomplete submission effectively restarts the clock, so the clinical justification and supporting evidence should be filed in full at once.
Can an unauthorised medicine be reimbursed in Switzerland?
Yes, in the third constellation of Art. 71c KVV: a medicine not authorised by Swissmedic but imported from a country with an authorisation system recognised as equivalent by Swissmedic and authorised there for the indication concerned. Costs are covered only after special approval by the insurer.
Does an SL listing end the need for individual approvals?
Not entirely. Use outside the approved product information or outside the limitation attached to the listing still falls under Art. 71a KVV and needs cost approval from the insurer. Within the listing terms, reimbursement follows the listing without a per-patient decision.
Who pays if the insurer refuses cost approval?
Compulsory health insurance does not, because coverage under Art. 71a to 71d KVV exists only after special approval by the insurer. The refusal is an insurance decision that can be contested through the ordinary channels of social insurance law, which is why the initial justification matters.
What did the 2024 changes aim to fix?
The amendment of the KVV and KLV of 22 September 2023, in force from 1 January 2024 with further changes on 1 September 2024, was intended to strengthen equal treatment of insured persons, quality, efficiency, transparency and a uniform assessment of cost-effectiveness in individual cases.