New medicine-pricing rules change how subsidy applications are assessed
Sweden’s medicine-pricing authority begins using new guidelines and application rules on 1 October, bringing together its criteria for judging medicine costs and requests for price increases.
The Dental and Pharmaceutical Benefits Agency, TLV, says the guidelines are intended to make subsidy and pricing decisions more consistent, predictable and transparent. Separate regulations specify the information companies must submit.
The guidelines collect criteria for assessing a reasonable medicine cost that previously appeared across individual decisions and earlier advice. They also include criteria for price increases.
A simplified application procedure can be used for a new medicine or a new formulation containing an established active substance. The regulations clarify what those applications must contain.
Other changes include an adjusted definition of a new medicine and a definition of parallel distribution. Much of the application framework builds on the previous rules.
The October change concerns how applications are assessed. It does not announce a blanket reduction in the prices patients pay.
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