EMERGING TRENDS IN HEALTH TECHNOLOGY ASSESSMENT, PRICING, AND REIMBURSEMENT: A STRUCTURED REVIEW OF 2025-2026 GLOBAL POLICY DEVELOPMENTS
Author(s)
Saurabh Aggarwal, BS, MS, PhD1, Sushil Kumar, BS2, Ozlem Topaloglu, PhD, MPH3.
1NOVEL Health Strategies, Chevy Chase, MD, USA, 2Institute for Global Policy Research, Washington, DC, USA, 3NOVEL Health Strategies, Bethesda, MD, USA.
1NOVEL Health Strategies, Chevy Chase, MD, USA, 2Institute for Global Policy Research, Washington, DC, USA, 3NOVEL Health Strategies, Bethesda, MD, USA.
OBJECTIVES: Health technology assessment (HTA), pricing, and reimbursement are undergoing rapid, concurrent global reform. We synthesized the most consequential emerging trends shaping market access in 2025-2026.
METHODS: We conducted a structured thematic review of 2025-2026 sources—HEOR congress abstracts, HTA-agency guidance, regulatory and legislative announcements, and policy analyses. Items describing enacted or emerging policy, pricing, or HTA-methodology changes were screened, coded by theme, mechanism, and jurisdiction, triangulated to confirm status, and prioritized by cross-market impact.
RESULTS: RESULTS: Thirty trends were identified across five domains and 12+ jurisdictions. (1) US pricing reform dominated: Inflation Reduction Act Medicare negotiation deepened (rounds 1-2 averaging ~61% reductions; round 3 reaching Part B); the Most-Favored-Nation (MFN) model returned with three new CMS pricing models; the One Big Beautiful Bill Act expanded the orphan-drug exclusion; and Colorado set the first state Upper Payment Limit. (2) In Europe, the EU Joint Clinical Assessment (JCA) became operational (first report June 2026), MFN spillover coincided with a ~35% drop in launches, and AI-enabled "living" evidence synthesis addressed PICO multiplication (up to 67 PICOs). (3) HTA methods evolved: NICE raised its threshold 25% to £25,000-£35,000/QALY, and environmental, caregiver, and societal value entered assessment. (4) Access pathways shifted via FDA's rare-disease "plausible-mechanism" framework, outcomes-based and provisional pricing, and Medicare's GLP-1 bridge. (5) Country reforms included the UK VPAG rebate cut to 14.5%, France's permanent Direct Access, Germany's proposed AMNOG-guardrail repeal, Japan's FY2026 cost-effectiveness reform, Canada's nationwide biosimilar switching, Spain's new Royal Decree (RD 415/2026) establishing an EU-aligned national HTA framework, and Saudi Arabia's mandatory economic evaluations. Cross-cutting signals were convergence on international reference pricing, value beyond cost/QALY, and persistent national divergence despite harmonization.
CONCLUSIONS: HTA, pricing, and reimbursement are shifting simultaneously and interdependently, producing a globally linked pricing system and rising, cross-jurisdictional evidence demands that require proactive, integrated access strategies.
METHODS: We conducted a structured thematic review of 2025-2026 sources—HEOR congress abstracts, HTA-agency guidance, regulatory and legislative announcements, and policy analyses. Items describing enacted or emerging policy, pricing, or HTA-methodology changes were screened, coded by theme, mechanism, and jurisdiction, triangulated to confirm status, and prioritized by cross-market impact.
RESULTS: RESULTS: Thirty trends were identified across five domains and 12+ jurisdictions. (1) US pricing reform dominated: Inflation Reduction Act Medicare negotiation deepened (rounds 1-2 averaging ~61% reductions; round 3 reaching Part B); the Most-Favored-Nation (MFN) model returned with three new CMS pricing models; the One Big Beautiful Bill Act expanded the orphan-drug exclusion; and Colorado set the first state Upper Payment Limit. (2) In Europe, the EU Joint Clinical Assessment (JCA) became operational (first report June 2026), MFN spillover coincided with a ~35% drop in launches, and AI-enabled "living" evidence synthesis addressed PICO multiplication (up to 67 PICOs). (3) HTA methods evolved: NICE raised its threshold 25% to £25,000-£35,000/QALY, and environmental, caregiver, and societal value entered assessment. (4) Access pathways shifted via FDA's rare-disease "plausible-mechanism" framework, outcomes-based and provisional pricing, and Medicare's GLP-1 bridge. (5) Country reforms included the UK VPAG rebate cut to 14.5%, France's permanent Direct Access, Germany's proposed AMNOG-guardrail repeal, Japan's FY2026 cost-effectiveness reform, Canada's nationwide biosimilar switching, Spain's new Royal Decree (RD 415/2026) establishing an EU-aligned national HTA framework, and Saudi Arabia's mandatory economic evaluations. Cross-cutting signals were convergence on international reference pricing, value beyond cost/QALY, and persistent national divergence despite harmonization.
CONCLUSIONS: HTA, pricing, and reimbursement are shifting simultaneously and interdependently, producing a globally linked pricing system and rising, cross-jurisdictional evidence demands that require proactive, integrated access strategies.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR124
Topic
Health Policy & Regulatory, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Reimbursement & Access Policy