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:

• Consider whether a medicine has a high expected or actual sales value when assessing what is a reasonable cost of use.

• Allow “exceptionally high” expected sales value to be considered at the initial decision.

• 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

• Decision planned: 11 June 2026

• Entry into force: 1 October 2026

Read more at https://www.tlv.se/press/nyheter/arkiv/2026-04-27-justerad-metod-och-tidplan-i-riktlinje-for-subvention-och-prissattning-av-lakemedel.html

Indlægget TLV revises guidelines to price adjustments for high sales value blev først udgivet på NHTA.

TLV has issued an interim update on its government mandate to analyse how Sweden’s pharmaceutical pricing system could be influenced by developments in the international market, with a specific focus on the US “most favoured nation” (MFN) policy.

TLV says it remains unclear how the US’s new pricing models will be implemented and what their consequences could be for medicine prices and availability. According to TLV, the implementation has not yet produced clear effects on the Swedish pharmaceutical market, and it is still too early to say what measures may be needed.

What TLV is doing now

• monitoring and analysing US policy and implementation of MFN, and potential effects on Sweden
• developing methods to assess access to and use of new medicines (subsidised and non-subsidised), including comparisons with other countries
• mapping which medicines are not subsidised via Sweden’s national process
• preparing a mapping of confidential agreements in European countries

TLV will hold four seminars this year and continue interviews and international information exchange. Final reporting is due by 1 december 2026. Read more at https://www.tlv.se/press/nyheter/arkiv/2026-04-01-tlv-foljer-noga-utvecklingen-pa-den-internationella-lakemedelsmarknaden.html

Indlægget TLV updates government on US pricing policy monitoring blev først udgivet på NHTA.