What is the Specialty List and why does it matter?

The Specialty List (SL) is the list of medicines reimbursed by Swiss compulsory health insurance, kept by the Federal Office of Public Health (BAG), 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).

Can a listing or price decision be challenged?

Yes. Listing and pricing decisions, and the outcome of periodic re-evaluations, follow a defined procedure in which the marketing-authorization holder can make submissions and, where the BAG decides against it, appeal the decision. GAWEL Legal supports both the application and the defense of an existing listing or price.

Does a medicine need Swissmedic authorization before it can be listed?

Yes. A medicine can only be admitted to the Specialty List if it holds a valid Swissmedic authorization (Art. 65 KVV); authorization 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 listing application can as a rule be filed once Swissmedic's preliminary decision has confirmed the indication and dosage (Art. 69 Abs. 4 KVV), and GAWEL Legal advises on aligning the two timetables.

Market access and reimbursement

GAWEL Legal guides marketing-authorization holders through Swiss Specialty List (SL) listing and BAG pricing on a fixed fee per listing. The work covers listing applications and re-evaluations under the KVV and KLV, economic evaluation against the WZW criteria, and price-review and re-examination proceedings.

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The Swiss reimbursement process

Application: Specialty List admission
Evaluation: Efficacy, appropriateness and economy
Pricing and review: Price proposals and re-examinations

Legal advice on SL listing and BAG proceedings

Who this is for

Pharma marketing-authorization holders seeking Swiss reimbursement
Foreign manufacturers entering the Swiss reimbursed market
Companies defending SL price re-evaluations or re-examinations

Scope

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 authorization 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 defense:
submissions and, where appropriate, review proceedings where a listing or price decision goes against the marketing-authorization holder
Reimbursement strategy:
advice on the application process and supporting evidence under the KVV and KLV framework, aligned with the product's regulatory timeline

How the work proceeds

Strategy The assessment covers the reimbursement process and the evidence available for the product.
Application The legal elements of the SL listing application are prepared.
WZW procedure Legal support covers the BAG evaluation against efficacy, appropriateness and economy.
Pricing Advice addresses the price proposal and the economic-evaluation procedure.
Review defense Representation covers price-review and re-examination proceedings.

Fees

Fixed fee per listing

Listing and reimbursement-strategy work runs on a fixed fee per listing.

Questions

What is the Specialty List and why does it matter?: The Specialty List (SL) is the list of medicines reimbursed by Swiss compulsory health insurance, kept by the Federal Office of Public Health (BAG), 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).
Can a listing or price decision be challenged?: Yes. Listing and pricing decisions, and the outcome of periodic re-evaluations, follow a defined procedure in which the marketing-authorization holder can make submissions and, where the BAG decides against it, appeal the decision. GAWEL Legal supports both the application and the defense of an existing listing or price.
Does a medicine need Swissmedic authorization before it can be listed?: Yes. A medicine can only be admitted to the Specialty List if it holds a valid Swissmedic authorization (Art. 65 KVV); authorization 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 listing application can as a rule be filed once Swissmedic's preliminary decision has confirmed the indication and dosage (Art. 69 Abs. 4 KVV), and GAWEL Legal advises on aligning the two timetables.

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Briefly describe the matter and the legal advice you need.

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