Art. 71a-d KVV: individual case reimbursement

What do Art. 71a-d KVV regulate?

They regulate reimbursement of a medicine in the individual case when the Specialities List does not cover the situation. The insurer decides after consulting its medical adviser. No right to equal treatment follows from a granted case: the assessment always concerns this patient's concrete situation, not the product as such.

The provisions have applied since 2011 and were tightened with effect from 1 January 2024, notably through uniform benefit assessment criteria and a decision deadline for insurers. They do not replace admission to the Specialities List and are meant to stay the exception.

Which article covers which situation?

The product's authorisation and listing status decides. Art. 71a covers listed medicines used outside their limitation or indication, Art. 71b medicines authorised by Swissmedic but not admitted to the SL, Art. 71c the import of a medicine Swissmedic has not authorised. Art. 71d sets the procedure and the price for all three.

Which two conditions must both be met?

First, the medicine must be expected to deliver a large therapeutic benefit against a disease that can be fatal or cause severe and chronic health impairment. Second, either no effective and authorised therapeutic alternative is available, or the high expected benefit is documented by evidence.

• Disease severity: possible fatal course or severe chronic impairment, judged for this patient and not in the abstract.
• Large therapeutic benefit: a clinically relevant effect on a patient relevant endpoint, not only on a surrogate marker.
• No alternative or high benefit: exhausted prior therapies, contraindications and intolerances belong in the request.
• Cost effectiveness: the insurer weighs the cost against the expected benefit and against any alternatives.

The FOPH assesses benefit against a nine point grid: level of evidence, study design and sample size, clinical relevance of the endpoint, effect size, transferability to the individual case, adverse effects, disease course without treatment, prior therapies, and the view of specialist societies or guidelines.

How does the procedure work?

The treating physician files a cost approval request with the health insurer before therapy starts. The insurer's medical adviser reviews it clinically, the insurer decides and issues a ruling. Without prior approval there is no secured entitlement, even if the substantive conditions later appear to be met.

1. Clarify indication and alternatives, document prior therapies and their outcome.
2. File the request with diagnosis, treatment goal, evidence (studies, guidelines), dosage, treatment duration and a monthly cost estimate.
3. The medical adviser assesses benefit and alternatives, and may raise questions or ask for further documents.
4. Under Art. 71d the insurer normally decides within two weeks of receiving the complete dossier.
5. If approved: start therapy, monitor outcomes and file a renewal request before the approval expires.
6. If refused: objection, then appeal to the cantonal insurance court and finally to the Federal Supreme Court.

How much does the insurer pay?

The insurer pays at most the price it or its purchasing group agreed with the authorisation holder. For a listed product the SL public price is the ceiling. If the holder wants more, it must carry the difference through a rebate to the insurer rather than shifting it to the patient.

• Price agreement: a written arrangement between insurer and authorisation holder, usually with a discount or a rebate model.
• Rebate: the holder pays part of the invoiced amount back to the insurer, while the listed or invoiced price stays visible.
• Franchise and co-payment apply to individual case reimbursement exactly as they do to listed medicines.
• With no price agreement in place, the insurer may refuse to pay on that ground alone.

What do we advise prescribers and manufacturers?

Prescribers save weeks with a complete, evidence based first submission, because follow-up questions are the main source of delay. Authorisation holders should have standard price agreements ready with the large insurers and purchasing groups, so that an otherwise justified case does not fail on price.

For the medical practice

• State disease severity and exhausted alternatives explicitly instead of assuming them.
• Attach publications in full text and explain why the data transfers to this patient.
• Give the treatment goal, stopping criteria and follow-up dates, which makes a time limited approval easier to grant.

For the authorisation holder

• Keep one standard dossier for off-label requests, including an evidence table.
• Prepare rebate models that stay compatible with a later SL admission request.
• Keep the scale in mind: insurers handle several thousand requests a year, of which roughly three quarters are approved.