TLV’s new reimbursement and pricing framework is now in force.
From 1 October 2026, Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) has applied the previously announced new regulations affecting pharmaceutical companies’ reimbursement and pricing applications, as well as TLV’s handling of these cases.
The changes include:
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New general guidelines describing TLV’s criteria for reimbursement and pricing decisions.
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Updated application regulations on the content of reimbursement and price applications. TLV states these largely correspond to the previous requirements.
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Separate regulations for pricing interchangeable medicines and for medicine substitution.
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A new ceiling-price framework for interchangeable medicines, with several options to increase prices and ceiling prices, and three levels to which a ceiling price may be reduced.
TLV states that the new rules are intended to support access to effective medicines and reasonable, sustainable societal medicine costs. Generic substitution is not substantively changed.
An updated company handbook reflects the changes, while several previous regulations and general guidelines have been repealed.
