tlv Arkiv - NHTA

TLV publishes new pricing and reimbursement guidelines

NHTA — Tue, 16 Jun 2026 05:17:00 +0000

New general guidelines and regulations on pricing and reimbursement in Sweden.

TLV has announced new general guidelines and regulations for pricing and reimbursement of medicines.

What changes

The guidelines consolidate assessment criteria for what constitutes a reasonable cost
Add criteria for price increases
Introduce a simplified application process for certain new drugs or formulations.
A revised handbook will be published on TLV’s website in late June 2026

Timeline

The new guidelines and regulations take effect from 1 October 2026.
On the same date, the current rules and general advice will cease to apply.
TLV will host a webinar on 2 September 2026 on practical application and the updated handbook.

Indlægget TLV publishes new pricing and reimbursement guidelines blev først udgivet på NHTA.

Nordic HTA cooperation (JNHB) extended for another five years

NHTA — Tue, 02 Jun 2026 11:53:00 +0000

Continuity in Nordic HTA cooperation matters.

In May, the memorandum of understanding for Joint Nordic HTA-bodies (JNHB) was extended by five years.

The extension supports continued Nordic cooperation on joint assessments of new medicines and knowledge sharing.

The participating countries are Denmark, Finland, Iceland, Norway and Sweden.

The article also notes the growing importance of European and regional cooperation, including JSC and JCA activities under the HTA regulation.

TLV Director General Magnus Thyberg said the extension underlines the Nordic authorities’ commitment to strengthening cooperation and provides a stable foundation for future work.

Indlægget Nordic HTA cooperation (JNHB) extended for another five years blev først udgivet på NHTA.

TLV revises guidelines to price adjustments for high sales value

NHTA — Mon, 27 Apr 2026 09:29:00 +0000

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:

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

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

TLV publishes health economic assessment of Blenrep

NHTA — Fri, 10 Apr 2026 11:34:35 +0000

TLV has prepared a health economic assessment for Swedish regions on Blenrep (belantamab mafodotin) used with bortezomib + dexamethasone (BVd) in adults with multiple myeloma who have received at least one prior therapy.

Clinical basis
A phase III study directly compared BVd vs DVd (daratumumab, bortezomib and dexametasone) and showed longer time with disease control and longer overall survival for patients treated with BVd. TLV considers it reasonable to assume the effect advantage also applies versus TLV’s chosen relevant comparator.

Comparator used by TLV
TLV changed the comparator from DVd to a basket of comparators based on learnings from previous assessment of Carvukti. The treatment basket consisting of:

30% DPd (darzalex, pomalidomide and dexametasone) , 40 % PVd (pomalidomide, bortezomib and dexametasone), 30% Kd (carfilzomib and dexametasone)

Cost-effectiveness results

Cost per gained QALY: ~SEK 3.9 million
Sensitivity analyses: ~SEK 3.3–4.9 million per QALY

The assessment is handed to the NT council to support their decision to the regions.

Indlægget TLV publishes health economic assessment of Blenrep blev først udgivet på NHTA.

Sweden’s regions broaden use of tripartite negotiations

NHTA — Wed, 08 Apr 2026 14:05:00 +0000

Sweden’s regions are changing course in how they use tripartite negotiations for reimbursement.

The 21 regions, through the authorisation group (fullmaktsgruppen) working with TLV, have agreed to revise their shared positions and principles for tripartite negotiations with pharmaceutical companies. Previously treated more as an exception, regions now describe these negotiations as an important way to secure access to costly but high-need prescription medicines.

What is changing

More willingness to enter tripartite negotiations, while each request will still be assessed individually.
Medical need (e.g., few treatment alternatives) remains central, alongside equal treatment of comparable medicines and expectations of price competition.
Regions will also weigh TLV’s view on whether a medicine motivates increased willingness to pay.

What 2025 showed
Regions say more negotiations were accepted in 2025, helping several medicines (including for rare diseases) enter the benefits scheme. However, negotiations are not a guarantee: 5 of 12 concluded talks in 2025 ended without an agreement or inclusion.

Indlægget Sweden’s regions broaden use of tripartite negotiations blev først udgivet på NHTA.

TLV updates government on US pricing policy monitoring

NHTA — Wed, 01 Apr 2026 14:08:21 +0000

International pricing policy shifts are on TLV’s radar.

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.