Information and enquiries
Market access Switzerland: getting your product onto the Specialities List
Swiss Reimbursement is an independent information site. Describe your market access question; enquiries go to info@swissreimbursement.com. Specialist advice requires a separate engagement with a qualified professional.
- Independent directory
- Official FOPH data
- Website in eight languages
- Preparations on the SL
- 3'402
- Preparations with a limitation
- 1'454
- Generics
- 1'132
- Median public price
- CHF 48.85
Why a Swiss partner
The foreign price comparison is unforgiving
Launching first in a low-price EU market permanently lowers the Swiss price level. The launch sequence therefore belongs to pricing strategy, not to the distribution plan.
The procedure is formalistic
A missing source, a badly chosen comparator or a missed 60-day window costs months. The FOPH does not correct a dossier, it returns it.
Four languages, one contact
Requests, rulings and negotiations run in German or French. Specialists work in both official languages and report to you in English.
The process in five stages
An admission request is not decided on filing day but six months earlier: when the reference countries, the comparator products and the launch sequence are chosen. Specialists work the five stages in that order and keep the price corridor auditable from the start.
- 12 to 3 weeks
Test admissibility and the price corridor
Specialists read the professional information and the Swissmedic decision, define the admissible indication, pick the comparator products from the IT group and model both the foreign price comparison and the therapeutic cross comparison as a range. You get a defensible price corridor and the list of data gaps before you invest time.
- 23 to 5 weeks
Build the dossier
Specialists assemble the request to the FOPH handbook: admission form, price calculations with a source per reference country, a three-year turnover forecast, the case for an innovation premium, a proposed limitation text and, where needed, a price model.
- 32 to 6 months
File and steer through the commission
Specialists file inside the 60-day window after Swissmedic authorisation, answer the FOPH questions, prepare the case for the Federal Drug Commission and keep you posted on every deadline extension.
- 44 to 8 weeks
Negotiate the price and publish
Specialists negotiate the ex-factory price, check the ruling for calculation errors and for the correct limitation text, and coordinate the publication date with your logistics so the pack is shippable on the first day of the month.
- 5ongoing
Defend the price across the life cycle
Specialists take on the three-yearly review, recalculate both comparisons, justify deviations, run indication extension requests and prepare the post-patent cut rather than absorbing it.
Possible specialist deliverables
Pricing opinion
The foreign price comparison against the nine reference countries and the therapeutic cross comparison, each with source, reference date and exchange rate. Auditable for the FOPH and for your internal sign-off.
Filing-ready FOPH dossier
Every form, calculation and turnover forecast plus the limitation proposal, in German or French, formally aligned with the current FOPH handbook.
Limitation strategy
A limitation text that covers the target population without narrowing reimbursement unnecessarily, plus the argument for the negotiation.
Ruling review
A check of every FOPH ruling for calculation errors, wrong comparator products and a diverging limitation text, with an appeal recommendation inside the deadline.
Review calendar
Your portfolio mapped to the annual block of the three-yearly review, to patent expiries and to deadlines, so no price cut arrives unprepared.
Art. 71 support
Templates and benefit reasoning for individual case requests, including the price agreement with the insurer.
Realistic timelines
These durations are experience values from Swiss admission procedures, not the statutory minima. Art. 31b of the Health Care Benefits Ordinance sets 60 days for the decision from a complete dossier; in practice questions, commission meeting dates and price negotiations stretch it.
| Phase | Duration | Lead | Output |
|---|---|---|---|
| Preparation and pricing strategy | Month -6 to -3 | Manufacturer and specialists | Price corridor, launch sequence |
| Swissmedic authorisation | Month 0 | Manufacturer | Authorisation, professional information |
| Dossier and filing | Month 0 to 2 | specialists | Request filed with the FOPH |
| FOPH review and commission | Month 2 to 8 | FOPH | Recommendation, price proposal |
| Negotiation and ruling | Month 6 to 10 | specialists and FOPH | Ruling, maximum price |
| Publication | Month 7 to 11 | FOPH | SL entry on the first of a month |
| Three-yearly review | Year 3, then every 3 years | specialists and FOPH | Price confirmed or cut |
Market access questions
How long until our product is on the Specialities List?
Plan for seven to eleven months from Swissmedic authorisation. Art. 31b of the Health Care Benefits Ordinance sets 60 days for the FOPH decision from a complete dossier, but questions, the Federal Drug Commission's meeting cadence and the price negotiation regularly extend the procedure.
Do specialists need a Swiss authorisation holder?
Yes. The authorisation holder must be domiciled in Switzerland and appoint a responsible person for technical matters. You can build that role yourself or hand it to a Swiss partner who holds it on a fiduciary basis and transfers it to you later.
What does supporting an admission request cost?
Specialists work to a fixed fee per stage so your budget holds. The admissibility assessment is a small mandate, the dossier a medium one. The FOPH procedural fees are charged separately. You receive the offer after the first call.
Can a price cut that has already been ruled still be averted?
Partly. An appeal deadline to the Federal Administrative Court runs against the ruling, and calculation errors or wrongly chosen comparators are challengeable. What decides the economics is still the submission before the ruling, which is why specialists work portfolios up ahead of the review year.
Do you also work for generic and biosimilar manufacturers?
Yes. There the calendar is everything: filing before patent expiry, correct placement in the price scale of Art. 65c of the Health Insurance Ordinance, and a publication date that matches supply readiness. Specialists align the request, the logistics and the distribution partner on the same first of the month.
Market access
Do you need your product on the Specialities List?
Questions about SL listing, prices or limitations? Contact Swiss Reimbursement.
Request a market access call