How Much Does TLV Value Rarity? A Review of Reimbursement

Maria Kinderås, MSc
Senior Associate, Market Access and Outcomes Strategy

Transcript

Orphan drug reimbursement continues to pose significant challenges for Swedish decision-makers – due often to high costs and limited evidence. Historically, the willingness to pay for new treatments appraised by the Swedish Dental and Pharmaceutical Benefits Agency (TLV) has been influenced by disease severity and uncertainty in documentation but not by the rarity of the condition. However, in 2016, TLV for the first time accepted a higher cost per quality-adjusted life-year gained due to rarity. 

Given that, we sought to determine if the rarity of the conditions affected incremental cost-effectiveness ratios, or ICERs, accepted by TLV from 2017 through 2022. We examined data on TLV ICERs, disease severity, uncertainty in health economic analysis, and reimbursement outcomes from TLV decisions during that time.

Although the decision made by TLV in 2016 opened rarity for consideration in determining acceptable ICERs, our current review suggests that there has not been any clear shift in accepting higher ICERs as a function of rarity.

Learn more about this research by viewing the results.

Lanne G, Kinderås M, Ling C, Brodtkorb TH. How much does TLV value rarity? A review of reimbursement decisions on orphan drugs in Sweden from 2017 through 2022. Poster presented at the ISPOR Europe 2023; November 14, 2023. Copenhagen, Denmark.