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The Swiss government wants to encourage the use of biosimilars
and generics with the aim of decreasing the costs of healthcare.
Recent regulatory and legislative changes will make it easier to
replace reference products by biosimilars and incentivize patients
to choose generics and biosimilars when available.
A. Background
On September 22, 2023, the Swiss Federal Council (Government) published a bill to amend two Federal Ordinances
related to mandatory health insurance, which will enter into
force on January 1, 2024. The bill is part of recent legislative
and regulatory activities that aim at increasing the use of generic
and biosimilar pharmaceutical products in Switzerland.
As per the Federal Council, generic and biosimilar
pharmaceutical products are not used as often in Switzerland as in
comparable developed countries, which results in higher costs for
mandatory health insurance. Among the aims of the changes is to
decrease the costs of health insurance by encouraging the
replacement of original or reference products by generics and
biosimilars.
The latest developments include a change of the relevant
regulatory environment on interchangeability of biosimilars and
more restrictive rules on pricing and reimbursement of both
generics and biosimilars.
The bill also includes measures related to reimbursement of
pharmaceuticals that have not yet received pricing from the Federal
Office of Public Health and the optimization of the process to
obtain such pricing. These issues will not be further addressed in
this Newsflash.
B. Interchangeability of Biosimilars with Reference
Products
On June 22, 2023, the Swiss Agency for Therapeutic Products
(Swissmedic) published an amendment of its Guidance document “Authorisation
biosimilar”(the “Biosimilar
Guidance”). The amendment is based on
Swissmedic’s experience from market surveillance on the safety
and efficacy of biosimilars. Swissmedic’s experience confirms
the results of the European Medicines Agency’s analysis of April 2023, supporting the
interchangeability of biosimilar medicines with corresponding
reference products.
Under the previous version of the Biosimilar Guidance, only the
physician attending the individual patient could decide whether the
reference product or a specific biosimilar be used. A replacement
by another person (in particular the pharmacist or the patient) was
not possible. The new version of the Biosimilar Guidance sets forth
that the “medical professional” (a term that includes,
among others, physicians and pharmacists) can decide to replace the
prescribed reference product by a biosimilar (or the prescribed
biosimilar by another biosimilar), “in consultation with the
patient”.
C. Incentives to Use Generics and Biosimilars
The amended Ordinance on mandatory health insurance
(Krankenversicherungsverordnung / Ordonnance sur
l’assurance-maladie) provides for a more differentiated
computation of minimum price differences between reference products
and biosimilars. While a biosimilar was previously deemed
“economical” if its ex factory price was at least 25%
below the price of the reference product, the minimum difference
now depends on the yearly turnover of the reference product in
Switzerland. For instance, if the yearly turnover is above CHF 25
million, the expected minimum price difference will be 35%.
The amended Ordinance on healthcare benefits
(Krankenpflege-Leistungsverordnung / Ordonnance sur les
prestations de l’assurance des soins) increases the
patient’s deductible when using an original or reference
product in spite of generics or biosimilars being available.
Currently, the patient’s deductible is 10% of all costs above
the patient’s minimum yearly contribution
(“franchise”) and 20% upon purchasing medicinal
products where a cheaper generic product would have been available.
This deductible will be increased to 40% and will also apply when a
cheaper biosimilar would have been available.
D. Comment
These legislative and regulatory changes are designed to address
an acute concern of the Swiss population. According to a recent
survey, the costs of healthcare currently constitute the biggest
concern of Swiss residents (before pensions, migration or energy
supply). Whether these changes will have the intended consequences
(the Federal Council expects a decrease in costs of about CHF 250
million per year) will not be known before several years.
The interchangeability of biosimilars with corresponding
reference products is in line with similar policies in other
European jurisdictions and follows guidance published by the EMA.
The doubling of the health insurance deductible when purchasing
original or reference products may lead to a stronger shift towards
generics and biosimilars, which in turn could lead to increased
litigation activity when original or reference medicinal products
approach the patent cliff.
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guide to the subject matter. Specialist advice should be sought
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