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.

Read more at https://samverkanlakemedel.se/lakemedel—ordnat-inforande/nyheter/nyheter/2026-04-08-regionerna-oppnar-for-fler-trepartsoverlaggningar-for-att-sakra-tillgangen-till-lakemedel

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

NICE and the Medicines and Healthcare products Regulatory Agency (MHRA) have launched a new aligned pathway (from 1 April) designed to move NICE’s decision-making forward so it runs alongside MHRA’s review. The aim is for decisions on licensing and value to be made at the same time, helping patients access new medicines 3 to 6 months faster.

Alongside this, the organisations are introducing an improved integrated scientific advice service:

• Single entry point, one meeting and one payment.

• Advice will be independent yet aligned on topics where conflict can arise, such as endpoints and patient populations.

• Designed to clarify regulations and evidence requirements earlier in development to support the new timelines.

NICE and MHRA announced the changes at the NICE conference in Manchester on 17 March. Companies can join the official webinar at 2pm on Wednesday 25 March.

In October 2025, companies were invited to register as early adopters; 27 companies signed up. The first guidance is expected in June 2026.

Read more at https://www.nice.org.uk/news/articles/patients-to-get-new-medicines-up-to-six-months-sooner-under-new-joint-mhra-nice-approval-process

Indlægget NICE and MHRA align reviews to speed access blev først udgivet på NHTA.

In a visit to Lif, Jesper Fisker (CEO, Danish Cancer Society) warned that the US “most favored nation” (MFN) policy could have consequences for Denmark if Denmark is increasingly used as a reference country for US medicine prices.

Fisker said this could directly affect Danish patients and called for a national Danish solution. In his words, the risk is that Danish patients may not get the best medicines fast enough.

Key points:

• MFN: Fisker calls for a national solution, otherwise it will affect patients.

Read more at https://www.lif.dk/jesper-fisker-most-favored-nation-maa-ikke-gaa-ud-over-danske-patienter/

Indlægget Danish Cancer Society warns MFN could slow access in Denmark blev først udgivet på NHTA.