Norway is developing managed-entry agreements for medicines that may be cost-effective for individual patients but create unaffordable or highly uncertain expenditure when used across large eligible populations.
Norway has started work on new contracting models for medicines intended for large patient populations. The initiative addresses a growing affordability problem: a treatment may represent cost-effective use of resources for each patient, yet still create expenditure that the health service cannot readily absorb when large numbers become eligible.
The problem is amplified when uptake, treatment duration or effectiveness in routine practice remain uncertain. A relatively modest difference between expected and actual use can translate into substantial additional expenditure when tens of thousands of patients may receive treatment. Medicines may also shift costs or activity between primary care, specialist services and other parts of the health system.
The Norwegian Medical Products Agency (Direktoratet for medisinske produkter, DMP) is leading the work with the regional health authorities and Norwegian Directorate of Health (Helsedirektoratet). DMP has invited proposals from industry, academia, patient organisations and other stakeholders by 11 September. Its final report is due by 31 December 2026.
Norway already uses alternative pricing agreements to manage uncertainty. The New Methods (Nye metoder) hospital system primarily uses confidential discounts, but can also apply price-volume agreements and more complex arrangements linked to use or outcomes. Blue-prescription reimbursement can likewise include rebates and expenditure controls.
The government considers existing approaches insufficient for some medicines aimed at much larger populations. Earlier policy work has highlighted migraine and obesity treatments as examples where relatively high prices, broad eligibility and uncertain uptake can create substantial aggregate budget exposure even where treatment is considered cost-effective.
The new models could therefore combine price reductions with expenditure caps, price-volume terms, evidence-generation requirements or outcome-linked payments. The objective is to make reimbursement possible where conventional pricing leaves too much financial risk with the health service.
The project extends Norway’s managed-entry approach towards a different access problem: not whether a high-cost medicine provides sufficient value for a small population, but how to fund a potentially valuable treatment when the scale and uncertainty of eligible use could make unrestricted reimbursement financially difficult.
Source: Norwegian Medical Products Agency
Link: Ønsker innspill til avtalemodeller for store pasientgrupper (Seeks input on contract models for large patient groups)
Date: 21 August 2026
Source: Ministry of Health and Care Services
Link: Meld. St. 21 2024–2025 Helse for alle – Rettferdig prioritering i vår felles helsetjeneste (Health for all – Fair prioritisation in our common health service)
Date: 10 April 2025
Please accept {{cookieConsents}} cookies to view this content