Discussions on Fair Pricing of Medicines at the Swedish Health Economics Days
The Swedish Health Economics Association (SHEA) held its annual conference, offering valuable insights into key topics in health economics.
Sweden’s TLV Updates Reimbursement Model for Rare Diseases
Sweden has introduced a new reimbursement model for orphan drugs, likely to increase treatment options for rare diseases. At the same time, pharmaceutical companies are now expected to provide local evidence.
The first ISPOR Nordic Chapter Inspirational Meeting brought together Nordic experts in cost-effectiveness, reimbursement, and real-world evidence (RWE) on April 1. Held online, the event featured presentations on current topics from various countries.
Medaffcon’s Country Director Sweden, Lisse-Lotte Hermansson, highlighted the TLV (Dental and Pharmaceutical Benefits Agency) presentation as particularly noteworthy.
Under TLV’s new model, drugs intended for rare diseases may be granted a higher ICER threshold, referring to the cost per quality-adjusted life year (QALY). The ICER threshold reflects the level of cost-effectiveness society considers acceptable and how much it is willing to pay for different treatments. In the case of rare diseases, treatment options are typically limited, and drug development costs are high.
Challenges of Comprehensive Assessment
Under the TLV model, orphan drugs may receive higher reimbursement if they are intended for the treatment of serious conditions. TLV performs a holistic assessment of the drug’s cost-effectiveness, considering factors such as the impact of the disease on quality of life and the lack of treatment alternatives.
According to Hermansson, this comprehensive assessment introduces uncertainty for pharmaceutical companies and requires them to demonstrate benefits more precisely through data.
“If a company plans to bring a rare disease treatment to the Swedish market, it should start early in planning how to collect local data. High-quality data plays a key role in reimbursement decisions. Currently, companies typically rely on phase 3 data in their applications and often do not collect country-specific information in advance to support their evaluation process,” Hermansson emphasizes.
Sweden’s introduction of a higher ICER threshold specifically for rare diseases is unique in Nordic countries. Other Nordic authorities have not officially adopted similar models that raise the threshold based on rarity.
Finland’s New Regulation Facilitates Research on Rare Diseases
During the event, Findata shared updates on the potential for data utilization. As of early April, a new regulation allows Findata to provide cohorts as small as three patients—welcome news for rare disease research. Previously, the minimum cohort size available was five patients.
This change will make rare disease research in Finland more feasible, as small patient groups can now be better reflected in the data.
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