EARLY IMPACT OF MOST FAVOURED NATION (MFN) POLICY ON REIMBURSEMENT DECISIONS, LAUNCH ACTIVITY, AND MARKET ACCESS IN SWEDEN
Author(s)
Azad Saei, PhD1, Maisie Ballsdon2.
1WEP Clinical, Stockholm, Sweden, 2WEP Clinical, London, United Kingdom.
1WEP Clinical, Stockholm, Sweden, 2WEP Clinical, London, United Kingdom.
OBJECTIVES: To evaluate the early impact of MFN policy on reimbursement outcomes, launch activity, and cost-effectiveness thresholds in Sweden, based on decisions by the Swedish Dental and Pharmaceutical Benefits Agency (TLV).
METHODS: A retrospective observational pre- and post-analysis of TLV reimbursement decisions for oncology and rare disease medicines was conducted, comparing outcomes one year before and after MFN implementation (May 2025). Outcomes included reimbursement rates, restriction status, launch activity, and accepted incremental cost-effectiveness ratios (ICERs). A sub-analysis excluding cost-minimization studies evaluated decisions supported by full economic assessments. Differences in accepted ICERs pre- and post-MFN were assessed using statistical analysis methods.
RESULTS: The reimbursement rate increased from 68% pre-MFN (13 positive, 6 negative) to 88% post-MFN (28 positive, 4 negative), while the proportion of restricted positive decisions remained stable (54% vs. 57%). However, launch activity declined substantially by 54%. In the sub-analysis, reimbursement rates increased from 64% (7/11) pre-MFN to 75% (9/12) post-MFN. Accepted ICERs rose significantly, with mean ICER increasing from SEK 1.11 Million (M) to SEK 2.17M (p-value <0.05) and median ICER from SEK 1.2M to SEK 2.0M. Post-MFN, median ICERs were higher for rare diseases (SEK 2.5M vs. SEK 1.2M pre-MFN), exceeding historical TLV thresholds (SEK 0.75-1.0M per QALY for high and very high disease severity, respectively).
CONCLUSIONS: MFN implementation was associated with higher reimbursement rates and acceptance of higher ICERs, suggesting increased flexibility in value assessment. However, the decline in launch activity indicates potential unintended consequences for patient access, likely driven by increased uncertainty and more stringent internal decision-making for EU market entry. These findings align with industry-reported concerns, including increased uncertainty and more stringent global launch strategies. While Sweden’s adaptive framework, including special rare disease criteria, may support resilience, these findings highlight the broader impact of external pricing policies on European market entry decisions.
METHODS: A retrospective observational pre- and post-analysis of TLV reimbursement decisions for oncology and rare disease medicines was conducted, comparing outcomes one year before and after MFN implementation (May 2025). Outcomes included reimbursement rates, restriction status, launch activity, and accepted incremental cost-effectiveness ratios (ICERs). A sub-analysis excluding cost-minimization studies evaluated decisions supported by full economic assessments. Differences in accepted ICERs pre- and post-MFN were assessed using statistical analysis methods.
RESULTS: The reimbursement rate increased from 68% pre-MFN (13 positive, 6 negative) to 88% post-MFN (28 positive, 4 negative), while the proportion of restricted positive decisions remained stable (54% vs. 57%). However, launch activity declined substantially by 54%. In the sub-analysis, reimbursement rates increased from 64% (7/11) pre-MFN to 75% (9/12) post-MFN. Accepted ICERs rose significantly, with mean ICER increasing from SEK 1.11 Million (M) to SEK 2.17M (p-value <0.05) and median ICER from SEK 1.2M to SEK 2.0M. Post-MFN, median ICERs were higher for rare diseases (SEK 2.5M vs. SEK 1.2M pre-MFN), exceeding historical TLV thresholds (SEK 0.75-1.0M per QALY for high and very high disease severity, respectively).
CONCLUSIONS: MFN implementation was associated with higher reimbursement rates and acceptance of higher ICERs, suggesting increased flexibility in value assessment. However, the decline in launch activity indicates potential unintended consequences for patient access, likely driven by increased uncertainty and more stringent internal decision-making for EU market entry. These findings align with industry-reported concerns, including increased uncertainty and more stringent global launch strategies. While Sweden’s adaptive framework, including special rare disease criteria, may support resilience, these findings highlight the broader impact of external pricing policies on European market entry decisions.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR236
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Oncology, Rare & Orphan Diseases