reimbursement Arkiv - NHTA

Finland adopts most medicines with added value

NHTA — Tue, 16 Jun 2026 07:51:00 +0000

A new report shows a clear pattern in uptake of new medicines in Finland.

Key findings

More than 200 new active substances have been introduced in Finland over the past decade.
Of 330 medicines approved in Europe from 2015 to 2024, 204 were in use in Finland by the end of 2025.
Outpatient medicines are usually adopted in under 1.5 years after marketing authorisation, and hospital medicines in under one year.
Almost all outpatient medicines with at least moderate added therapeutic value are reimbursed if the company applies for reimbursement.
Nearly half of the new medicines were assessed as offering no therapeutic added value, while only one was assessed as offering major added value.

The report is based on public assessments from HAS and on a joint publication from Kela and Fimea.

Indlægget Finland adopts most medicines with added value blev først udgivet på 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.

First medicine receives general reimbursement after confidential price negotiation

NHTA — Wed, 20 May 2026 07:29:00 +0000

The first medicine has now received general reimbursement under Denmark’s pilot scheme for confidential prices.

Anzupgo cream, used for chronic hand eczema, is the first product approved under the scheme. The general reimbursement applies from 25 May 2026.

What happened

LEO Pharma first applied for general reimbursement on standard terms, but the price was assessed as too high versus the treatment value.

LEO Pharma then negotiated a confidential price with Amgros, which was approved by the regions.

On that basis, the Medicines Reimbursement Committee recommended general reimbursement to the Danish Medicines Agency.

What this means in practice

Patients prescribed the medicine will automatically receive reimbursement at the pharmacy.

The scheme is open until 30 June 2028.

The agency also noted the cream’s mild side effect profile compared with other treatments for chronic hand eczema.

Indlægget First medicine receives general reimbursement after confidential price negotiation 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.

Reimbursement can change even when the medicines do not – KELA revise reimbursement status for severe mental health disorders

NHTA — Tue, 07 Apr 2026 20:00:00 +0000

Eligibility rules for full reimbursement can change even when the medicines do not.

Kela, the Social Insurance Institution of Finland, has announced changes effective 1 May 2026 to special reimbursement entitlement 112 (severe psychoses and other severe mental health disorders). Under entitlement 112, several medicines used for these conditions are eligible for 100% special reimbursement.

What changes from 1 May 2026

The update particularly concerns the definition of bipolar disorder, especially mixed episodes.
The statement-issuing body and related terminology will be updated to reflect current practice.

Where to check details
Kela directs readers to its website for the conditions required to be granted entitlement 112.

Indlægget Reimbursement can change even when the medicines do not – KELA revise reimbursement status for severe mental health disorders blev først udgivet på NHTA.

Denmark consults on reimbursement status for cancer medicines

Asger Lindvig — Fri, 27 Mar 2026 13:45:19 +0000

Denmark is reassessing general reimbursement status for several cancer medicines.

The Danish medicines agency (lægemiddelstyrelsen) has launched a public consultation and states it intends to withdraw the general (automatic) subsidy for a number of medicines used in cancer treatment.

The agency explains its rationale as follows:

cancer treatment takes place in hospitals
medicines used in hospitals, or supplied free of charge to non-admitted patients in continued hospital care (per Danish regions’ list of free-of-charge medicine supply), are not considered relevant for general reimbursement
general reimbursement is intended for prescription medicines purchased by patients at community pharmacies

The agency notes that some of the medicines are also used outside cancer (e.g., infertility, endometriosis, reduction of the uterine lining before potential surgical removal, and precocious puberty), but it assesses that these uses also generally take place in hospitals.

Comments can be submitted by email, including input on any patient groups receiving these medicines on prescription, by 6 May 2026. Hearing responses will be published on the agency’s website.

Indlægget Denmark consults on reimbursement status for cancer medicines blev først udgivet på NHTA.