Snapshot: medicine and medical device pricing in Switzerland - Lexology

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Pricing and reimbursement

Price regulation

To what grade is the marketplace terms of a medicinal merchandise oregon aesculapian instrumentality governed by instrumentality oregon regulation?

Medicinal products that are reimbursed by the basal wellness security are taxable to authorities terms control. The prices of non-reimbursed products are escaped and are not government-controlled.

A ready-to-use medicinal merchandise (whether prescription-only oregon non-prescription) must, successful principle, beryllium listed connected the speciality database (SL) established by the Federal Office of Public Health to beryllium reimbursed successful the basal wellness security (unless it is paid by hospitals retired of a diagnosis-related radical level rate). When deciding connected the admittance of a medicinal merchandise to the SL, the Federal Office of Public Health determines its database price. This terms is the maximum terms that tin beryllium invoiced by healthcare providers and that volition beryllium reimbursed by wellness security companies. About 80 per cent of the income of pharmaceutical products successful Switzerland subordinate to products listed connected the SL.

If a medicinal merchandise is not listed connected the SL oregon is listed connected the SL but is utilized off-label oregon extracurricular a regulation of reimbursement, it indispensable beryllium taken implicit by the wellness security companies successful basal wellness security if determination is nary effectual and authorised attraction alternate against a fatal oregon terrible and chronic illness, and a precocious therapeutic payment tin beryllium expected from its use, and successful the concern of a 'treatment complex' (ie, erstwhile determination is simply a precise constrictive transportation betwixt aesculapian services that are reimbursed and services that are not oregon are lone partially reimbursed erstwhile the non-reimbursed services are a indispensable information for the treatment, oregon are of sizeable value for the occurrence of the treatment). In these situations, the wellness security companies find the reimbursed magnitude and negociate a outgo information with the pharmaceutical institution concerned.

For aesculapian devices utilized oregon applied by patients themselves oregon persons supporting successful a non-professional capableness oregon by healthcare providers providing nursing services, the wellness security companies wage a definite fixed magnitude per instrumentality that is listed successful the database of immunodeficiency and instrumentality independently of the terms of the circumstantial aesculapian instrumentality successful question. For aesculapian devices applied by medicinal healthcare professionals oregon hospitals that are not for nursing services, the reimbursement is governed by the tariff agreements regulating the reimbursement of their healthcare services.

Negotiations betwixt manufacturers and providers

Must pharmaceutical and aesculapian instrumentality manufacturers negociate the prices of their products with nationalist healthcare providers?

For reimbursed medicinal products, the SL established by the Federal Office of Public Health lists the maximum ex-factory terms and the SL price. Healthcare providers tin negociate a little terms than the ex-factory terms with the pharmaceutical manufacturers. Sometimes rebates are granted, namely to hospitals. Prices of aesculapian devices and non-reimbursed products tin beryllium negotiated among manufacturers and healthcare providers.

Reimbursement

In which circumstances volition the nationalist wellness security strategy reimburse the outgo of medicines?

Under the basal wellness insurance, wellness security companies wage oregon reimburse ready-to-use medicinal products prescribed by physicians for outpatient attraction (or, nether definite circumstances, chiropractors) that are listed connected the SL if they are utilized wrong their indication. The SL listing whitethorn beryllium accompanied by limitations regarding reimbursement.

In 2 exceptional situations, the outgo of a merchandise that is either not listed connected the SL, oregon is listed connected the SL but utilized off-label oregon extracurricular a regulation of reimbursement, is taken implicit by the basal wellness insurance: successful a concern erstwhile determination is nary effectual and authorised attraction alternate against a fatal oregon terrible and chronic unwellness and a precocious therapeutic payment tin beryllium expected from its use, and successful the concern of a ‘treatment complex’ (ie, erstwhile determination is simply a precise constrictive transportation betwixt aesculapian services that are reimbursed and services that are not oregon are lone partially reimbursed erstwhile the non-reimbursed services are a indispensable information for the treatment, oregon are of sizeable value for the occurrence of the treatment). In some situations, the doc of assurance of the respective wellness security institution indispensable beryllium consulted, and the wellness security institution indispensable o.k. reimbursement successful beforehand and find the grade of reimbursement aft having negotiated a cost-contribution with the manufacturer.

In the inpatient sector, the costs of medicines are chiefly paid through, and included in, flat-rate payments per case. For definite medicines, abstracted supplementary fees tin beryllium invoiced by the infirmary to the wellness security companies.

Optional further backstage security whitethorn besides screen definite authorised medicinal products that are not listed successful the SL.

Price adjudication

If applicable, what is the competent assemblage for decisions regarding the pricing and reimbursability of medicinal products?

The competent assemblage is the Swiss Federal Office of Public Health. It decides connected the admittance of finished medicinal products to the SL. A medicinal merchandise is lone admitted to the SL if the applicant tin amusement its efficacy, usefulness and economy. The applicable criteria for fixing the SL terms of an archetypal merchandise are the prices of drugs successful Switzerland with the aforesaid denotation oregon a akin mode of enactment and the mean terms of the merchandise successful different countries. Currently, the prices successful 9 notation countries – Germany, Denmark, England, the Netherlands, France, Austria, Belgium, Finland and Sweden – are utilized for this comparison. To find the SL price, the Federal Office of Public Health adds a organisation borderline to the ex-factory terms determined according to the 2 criteria described above. The fulfilment of the conditions for admittance to the SL is, successful principle, reviewed each 3 years. A reappraisal of the conditions for admittance to the SL besides takes spot instantly aft the expiration of the patent protection, arsenic good arsenic successful the pursuing situations: authorisation of a caller denotation by Swissmedic, regularisation of an denotation by Swissmedic, petition for changing a regulation and petition for a terms increase. The SL prices of generics are determined arsenic a relation of the prices of their notation products. Currently, a revision of immoderate of the provisions connected the terms determination for medicinal products is successful process, including changes successful the notation countries and the information of patent protection.

Discount

Are manufacturers oregon distributors of medicinal products statutorily obliged to springiness a discount to wellness security schemes oregon 3rd parties?

There are nary statutory rules obliging manufacturers oregon distributors of medicinal products to springiness definite discounts. Healthcare providers indispensable walk connected discounts that they person received connected medicinal products oregon successful narration to services reimbursed by the basal wellness security to the debtor of the healthcare merchandise oregon work (insurance oregon patient).

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