TLV is adjusting how high sales value will be handled in Sweden’s reimbursement and pricing guidelines.
What TLV says is changing
TLV notes that the entry into force of the new general guidelines has been moved to October 2026, and it will already now communicate certain adjustments regarding the method for price reductions linked to high sales value.
TLV states it will:
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Consider whether a medicine has a high expected or actual sales value when assessing what is a reasonable cost of use.
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Allow “exceptionally high” expected sales value to be considered at the initial decision.
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Allow high actual sales value to be considered when amending an existing decision.
At the same time, TLV says it will not currently implement the method described in the December 2025 consultation draft that would systematically and repeatedly lower the price as sales value increases. Instead, TLV says sales value may be considered based on the circumstances in each case, with assessments grounded in section 15 of the Pharmaceutical Benefits Act.
The delay and change of method are motivated by the need to strengthen handling of confidential company prices and by uncertainty from international market developments, notably discussions in the US about linking prices to other countries (MFN).
Timetable
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Decision planned: 11 June 2026
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Entry into force: 1 October 2026
