The decision timelines for Nordic HTA agencies vary depending on the agency and submission process. In Sweden, Tandvårds- och läkemedelsförmånsverket, TLV—responsible for the reimbursement system of outpatient medicines —has a maximum processing time of 180 days from when a submission is deemed complete.
A recent update, published in January, may affect Sweden’s timelines:
1️⃣ Joint Clinical Assessment(JCA): An application is only deemed complete once the JCA report is published (if applicable).
2️⃣ Crucial material submission: In certain cases, if a company submits crucial material during the assessment, TLV will only consider the application complete once this material is provided.
3️⃣ Three-party negotiations: Accepting the initiation of a process for net price agreements will render the submission incomplete. The processing time then begins from day 0 when the supplementary material is provided following the three-party negotiation (or when TLV is informed that no such information will be provided).
Ensuring an application meets regulatory requirements can be challenging, and the clock for processing time only starts once these are fulfilled. Additional “clock stops” can further delay market access.
The Quantify team stays ahead of the evolving submission landscape to help optimise your launch. We provide strategic guidance to maximise reimbursement success while minimising timelines—both in Sweden and across the Nordic region.
How can we help?
