GLOBAL VALUE ASSESSMENT FOR BIOLOGICS IN PSORIATIC ARTHRITIS IN THE TIME OF IRA AND MFN: DOES COST PER INCREMENTAL ACR50 RESPONDER ANALYSIS PROVIDE A CLINICALLY MEANINGFUL AND PRACTICAL CROSS-MARKET METRIC?
Author(s)
Chia Yu Yang, MHS1, Ishita Vettiyadan, MS2, Hemant Phatak, PhD3, Emma Anne van Eijndhoven, MSc, MA4, Ambarish J. Ambegaonkar, PhD5.
1Apperture Health LLC, Malrboro, NJ, USA, 2Apperture Health LLC, Marlboro, NJ, USA, 3NA, Needham, MA, USA, 4Apperture Health LLC, Los Angeles, CA, USA, 5Founder and Managing Partner, Apperture Health LLC, Marlboro, NJ, USA.
1Apperture Health LLC, Malrboro, NJ, USA, 2Apperture Health LLC, Marlboro, NJ, USA, 3NA, Needham, MA, USA, 4Apperture Health LLC, Los Angeles, CA, USA, 5Founder and Managing Partner, Apperture Health LLC, Marlboro, NJ, USA.
OBJECTIVES: The treatment landscape for psoriatic arthritis (PsA) has expanded with several advanced therapies measured across multiple endpoints, including ACR20, ACR50, ACR70, PASI90, PASI100 and HAQ‑DI. Value assessment varies across markets, and list price is still the primary metric, leading to perceptions of inequity. This study aims to assess market specific cost required to achieve one additional clinically meaningful responder, using ACR50 at Week 24, across advanced therapies for PsA.
METHODS: Six US FDA (2015-2025) approved advanced therapies: secukinumab, ixekizumab, guselkumab, upadacitinib, risankizumab, and bimekizumab were selected. Placebo-adjusted ACR50 data at 24 weeks from relative clinical trials were extracted for the cost/NNT associated with the responder population. Year 1 costs were computed using Wholesale Acquisition Costs from Analysource™ for the US, the BNF for the UK, BdM_IT for France, and the AOK Nordost for Germany. US costs were also adjusted using a hypothetical Maximum Fair Price (MFP) scenario with a 66.5% discount based on data from recent IPAY cycles.
RESULTS: 24-Week placebo-adjusted ACR50 responder rates, ranged from 18% to 33% across various biologics. UK 2025 prices ranged from £10,501 to £19,957, while German prices ranged from €10,665 to €24,528. Cost per incremental ACR50 responder ranged from $248,966 to $647,397 in the US non‑rebate‑adjusted prices; £31,821 to £100,000 in UK pre-patient access schemes; €28,788 to €79,836 in France; and €38,091 to €118,872 in Germany. Finally, the US MFP adjustment resulted in a cost per incremental ACR50 responder of $83,404 to $216,878.
CONCLUSIONS: Unadjusted annual prices for advanced PsA therapies varied substantially across markets. However, a cost-per-incremental ACR50 responder analysis narrowed this value margin, which diminished even substantially when accounting for blinded rebates. Developing universal multi-dimensional and consistent value metrics acceptable across both sides of the pond will be critical for value preservation given significant changes to policy environments.
METHODS: Six US FDA (2015-2025) approved advanced therapies: secukinumab, ixekizumab, guselkumab, upadacitinib, risankizumab, and bimekizumab were selected. Placebo-adjusted ACR50 data at 24 weeks from relative clinical trials were extracted for the cost/NNT associated with the responder population. Year 1 costs were computed using Wholesale Acquisition Costs from Analysource™ for the US, the BNF for the UK, BdM_IT for France, and the AOK Nordost for Germany. US costs were also adjusted using a hypothetical Maximum Fair Price (MFP) scenario with a 66.5% discount based on data from recent IPAY cycles.
RESULTS: 24-Week placebo-adjusted ACR50 responder rates, ranged from 18% to 33% across various biologics. UK 2025 prices ranged from £10,501 to £19,957, while German prices ranged from €10,665 to €24,528. Cost per incremental ACR50 responder ranged from $248,966 to $647,397 in the US non‑rebate‑adjusted prices; £31,821 to £100,000 in UK pre-patient access schemes; €28,788 to €79,836 in France; and €38,091 to €118,872 in Germany. Finally, the US MFP adjustment resulted in a cost per incremental ACR50 responder of $83,404 to $216,878.
CONCLUSIONS: Unadjusted annual prices for advanced PsA therapies varied substantially across markets. However, a cost-per-incremental ACR50 responder analysis narrowed this value margin, which diminished even substantially when accounting for blinded rebates. Developing universal multi-dimensional and consistent value metrics acceptable across both sides of the pond will be critical for value preservation given significant changes to policy environments.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE51
Topic
Economic Evaluation, Health Policy & Regulatory
Topic Subcategory
Trial-Based Economic Evaluation
Disease
Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)