The Swedish HTA agency TLV has announced changes to the timeline and content of its upcoming guidance on reimbursement and pricing of medicines.
Key points from the update:
📍The previously communicated timeline has been postponed. The revised guidance will enter into force on October 1, 2026
📍The original proposed model for systematic price reductions linked to sales volumes will not be included. Nonetheless, TLV states that sales volumes will be considered in decision-making
📍The decision is motivated by several factors, including uncertainties in international pharmaceutical markets, for instance related to the US Most Favored Nation (MFN) policy
🔗 Full announcement from TLV: Here
The current guidance remains in place until the updated version becomes effective.
For stakeholders in Sweden, this means existing frameworks continue in the near term, although there is likely a shift towards greater consideration of sales volumes.
📊 We will continue to follow developments closely as TLV progresses towards October.
How are you approaching this update in your Swedish market access planning?
