Comparator Misalignment As a Contributor to Negative Reimbursement Decisions for Pharmaceuticals in Sweden
Author(s)
Anna T. Webb, MSc, PhD, Viktória Molnár, Msc, Kajsa Olsson, BA, MSc, Peter Carlqvist, BSc, MSc, PhD.
Nordic Market Access NMA AB, Stockholm, Sweden.
Nordic Market Access NMA AB, Stockholm, Sweden.
OBJECTIVES: The Swedish Dental and Pharmaceutical Benefits Agency (TLV) evaluates health technology assessment (HTA) submissions to determine whether pharmaceutical products should be included in the national reimbursement scheme. The choice of comparator is a critical factor in these assessments. This study aims to assess how often TLV changes the comparator, and whether such changes contribute to the rejection of the reimbursement applications.
METHODS: A search was conducted in the NMAi database to identify all TLV reimbursement rejections issued between 2015-01-01 to 2025-01-01, filtered by category (decisions), and subcategory (rejections and exclusions). For each case, both the final decision and the supporting reimbursement documentation were retrieved and reviewed. Key variables were extracted, including the comparator selected by the company and whether TLV changed the comparator. Missing documentation was requested from TLV using the pharmaceutical name and case number.
RESULTS: A total of 105 hits were identified, which included both the decision and supporting reimbursement documentation with the same case number. From these, 76 unique assessments were identified. TLV recommended a change of comparator in 22 of the 76 rejected assessments (29%). These included various disease areas with no apparent concentration in any particular field, i.e. 1 each in cardiology and infectious diseases, 3 in dermatology, and 4 in neurology. Companies were able to comply with TLV’s suggested comparator in only 3 (13.6%) of these cases.
CONCLUSIONS: The disagreement of the choice of comparator appears to be a contributing factor to the rejection in nearly one-third of rejected TLV assessments. Companies rarely adhere to TLV’s recommendations regarding comparators. This misalignment may reduce the likelihood of reimbursement and underscore the need for alignment on the relevant comparator in HTA assessments. To our knowledge, this is the first study to specifically examine how comparator selection contributes to rejected HTA assessments in Sweden.
METHODS: A search was conducted in the NMAi database to identify all TLV reimbursement rejections issued between 2015-01-01 to 2025-01-01, filtered by category (decisions), and subcategory (rejections and exclusions). For each case, both the final decision and the supporting reimbursement documentation were retrieved and reviewed. Key variables were extracted, including the comparator selected by the company and whether TLV changed the comparator. Missing documentation was requested from TLV using the pharmaceutical name and case number.
RESULTS: A total of 105 hits were identified, which included both the decision and supporting reimbursement documentation with the same case number. From these, 76 unique assessments were identified. TLV recommended a change of comparator in 22 of the 76 rejected assessments (29%). These included various disease areas with no apparent concentration in any particular field, i.e. 1 each in cardiology and infectious diseases, 3 in dermatology, and 4 in neurology. Companies were able to comply with TLV’s suggested comparator in only 3 (13.6%) of these cases.
CONCLUSIONS: The disagreement of the choice of comparator appears to be a contributing factor to the rejection in nearly one-third of rejected TLV assessments. Companies rarely adhere to TLV’s recommendations regarding comparators. This misalignment may reduce the likelihood of reimbursement and underscore the need for alignment on the relevant comparator in HTA assessments. To our knowledge, this is the first study to specifically examine how comparator selection contributes to rejected HTA assessments in Sweden.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA80
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas