Guides
Guides to the Specialities List and Swiss drug pricing
Ten guides to medicine reimbursement in Switzerland, written from the practice of admission requests and price reviews. They cover the FOPH procedure, price setting through the foreign price comparison and the therapeutic cross comparison, the 1'454 limited preparations and the rules for 1'132 generics.
- 01What is the Swiss Specialities List?The Specialities List is the register kept by the Federal Office of Public Health of the medicines reimbursed by Swiss mandatory health insurance. It sets an ex-factory price and a public price for every pack, reproduces any reimbursement limitation verbatim and is updated monthly.
- 02How does a medicine get onto the Specialities List?Admission to the Specialities List is a separate Swiss federal procedure that begins after Swissmedic authorisation. The authorisation holder files a price and benefit dossier, the Federal Drug Commission assesses it, and the FOPH rules by formal decision on admission, price and any limitation.
- 03Foreign price comparison and therapeutic cross comparisonThe foreign price comparison and the therapeutic cross comparison are the two calculations with which the FOPH assesses whether a medicine is cost effective. One benchmarks the ex-factory price against nine reference countries, the other compares daily treatment costs inside the same IT group.
- 04Art. 71a-d KVV: individual case reimbursementArticles 71a to 71d of the Health Insurance Ordinance let a Swiss health insurer reimburse a medicine even when it is not on the Specialities List, or not for that indication. It takes a large therapeutic benefit against a severe disease, prior cost approval and a price agreement with the authorisation holder.
- 05Differentiated co-payment: 10 or 40 per centOn medicines covered by Swiss basic insurance the co-payment is normally 10 per cent. Anyone choosing an originator although cheaper generics or biosimilars exist in the same active substance group pays 40 per cent under Art. 38a of the Health Care Benefits Ordinance. Medically justified exceptions stay at 10 per cent.
- 06Public price and ex-factory priceEvery Specialities List entry carries two prices. The ex-factory price is what the authorisation holder receives. On top of it the FOPH adds the distribution share under Art. 67 of the Health Insurance Ordinance and 2.6 per cent VAT. The result is the public price, which is also a maximum price.
- 07Understanding SL limitationsA limitation is the binding condition written into a Specialities List entry under which Swiss mandatory health insurance reimburses a medicine at all. It can restrict the indication, the quantity, the duration or the prescriber group, or require prior cost approval. If it is not met, insurers owe nothing.
- 08Biosimilars in SwitzerlandA biosimilar is a biotechnologically produced follow-on version of a reference biologic. Swissmedic authorises it after a comparative review of quality, efficacy and safety, and the FOPH admits it to the Specialities List at an ex-factory price at least 20 per cent below the reference product.
- 09Generic pricing rules on the Specialities ListA generic counts as cost effective only if its ex-factory price undercuts the originator by a staged percentage. The stage depends on the originator's Swiss turnover during the four years before patent expiry. At the same time the FOPH cuts the originator price and sets demand-side incentives.
- 10Market access Switzerland: the process for manufacturersMarket access in Switzerland means winning two separate procedures in sequence: authorisation by Swissmedic and admission to the Specialities List by the FOPH. Companies that only start on pricing after authorisation have usually already lost the Swiss price.
Market access
Do you need your product on the Specialities List?
Questions about SL listing, prices or limitations? Contact Swiss Reimbursement.
- Independent directory
- Official FOPH data
- Website in eight languages
Guides to the Specialities List and Swiss drug pricing: FAQ
Who are these guides written for?
Three audiences: market access and pricing managers in industry preparing an admission request or defending a price review; pharmacies and medical practices applying limitations and cost approvals day to day; and insured patients who want to understand why a medicine is reimbursed and what it costs.
How often are the guides updated?
Every guide carries the date of its last review. We revisit them on each revision of the Health Insurance Ordinance or the Health Care Benefits Ordinance, on each new FOPH handbook version and at least every six months. Federal Council ordinance changes normally take effect on 1 January or 1 July.
Do the guides replace legal advice?
No. They summarise the law and the practice so you can ask the right questions. What binds is the Health Insurance Act, its ordinance, the Health Care Benefits Ordinance and the FOPH handbook on the Specialities List. A concrete request or an appeal needs an individual assessment.
Market access
Do you need your product on the Specialities List?
Questions about SL listing, prices or limitations? Contact Swiss Reimbursement.
- Independent directory
- Official FOPH data
- Website in eight languages