Service
Market access & reimbursement (SL / BAG).
To be reimbursed by Swiss compulsory health insurance, a medicine must be listed on the Specialty List (SL) by the Federal Office of Public Health (BAG). The firm provides the legal support for that pathway: SL listing applications and re-evaluations, BAG pricing and economic-evaluation procedures against the WZW criteria, and price-review and re-examination proceedings.
Who this is for
- Pharma marketing-authorisation holders seeking Swiss reimbursement.
- Foreign manufacturers entering the Swiss reimbursed market.
- Companies defending SL price re-evaluations or re-examinations.
What's included
- SL listing applications: the legal elements of the application to the BAG for admission to the Specialty List (Art. 69 KVV), including the admission conditions of a valid Swissmedic authorisation and proof that the medicine is effective, appropriate and economical (Art. 65 KVV).
- WZW evaluation support: supporting the BAG assessment against the WZW criteria of efficacy, appropriateness and economy (Art. 30 KLV), on which listing and pricing turn.
- Pricing and economic evaluation: the price proposal and the economic-evaluation procedure against the economy principle (Art. 65b KVV), through to the binding maximum public prices the Specialty List carries (Art. 67 KVV).
- Re-evaluations and re-examinations: defending an existing listing and price in the three-yearly review of the admission conditions (Art. 65d KVV) and in other price re-examinations.
- Review defence: submissions and, where appropriate, review proceedings where a listing or price decision goes against the marketing-authorisation holder.
- Reimbursement strategy: pathway and evidence-position advice under the KVV and KLV framework, aligned with the product's regulatory timeline.
How it works
- Strategy. The firm assesses the reimbursement pathway and evidence position for the product.
- Application. The firm prepares the legal elements of the SL listing application.
- WZW procedure. The firm supports the BAG evaluation against efficacy, appropriateness and economy.
- Pricing. The firm advises on the price proposal and the economic-evaluation procedure.
- Review defence. The firm acts in price-review and re-examination proceedings.
Indicative pricing
Fixed fee per listing
from CHF 20,000 / listing
Reimbursement and HTA-strategy work as a capped fixed fee, CHF 12,000 to 28,000.
Indicative starting prices, net and exclusive of Swiss MWST (VAT) where applicable; final fee per written engagement letter.
Frequently asked questions
- What is the Specialty List and why does it matter?
- The Specialty List (SL) is the Federal Office of Public Health (BAG)'s list of medicines reimbursed by Swiss compulsory health insurance, and it is binding on insurers. Without SL listing a medicine is generally not reimbursed, so listing is central to commercial access in Switzerland.
- What are the WZW criteria?
- WZW stands for Wirksamkeit, Zweckmässigkeit and Wirtschaftlichkeit: efficacy, appropriateness and economy. The BAG assesses a medicine against these criteria when deciding on SL listing and pricing (Art. 30 KLV); the detailed criteria are confirmed at engagement.
- Can a listing or price decision be challenged?
- Listing and pricing decisions, and periodic re-evaluations, follow a defined procedure in which the marketing-authorisation holder can make submissions and, where appropriate, seek review. The firm supports both the application and the defence of an existing listing or price.
- Does a medicine need Swissmedic authorisation before it can be listed?
- Yes. A medicine can only be admitted to the Specialty List if it holds a valid Swissmedic authorisation (Art. 65 KVV); authorisation and reimbursement are two separate steps before two different authorities, Swissmedic and then the BAG. Listing further requires proof of efficacy, appropriateness and economy, and the prices the Specialty List carries are binding maximum public prices (Art. 67 KVV). The firm aligns the two timelines so the reimbursement application follows the authorisation without losing time.