Presentation (CTI)

OBJECTIVES: While EU Joint Clinical Assessment (JCA) and US Most-Favoured-Nation (MFN) pricing dominate HEOR attention, lower-profile trends may shape near-term evidence requirements as much. We systematically identified and temporally mapped high-momentum, under-recognised HEOR/market-access trends to support proactive evidence planning.
METHODS: We conducted a retrospective mixed-methods environmental scan (1 Jun 2025-12 Jun 2026), EU/US stratified, across all therapy areas. Four layers were triangulated: a date-stamped policy-event timeline; a targeted grey-literature/whitepaper scan (ISPOR, EFPIA/EUCOPE/PhRMA, NICE, European Commission); anchor-normalised Google Trends (13 terms, Worldwide/US); and a qualitative social layer. Nineteen trends were coded by momentum (emerging/rising/plateauing) and region, then mapped month-by-month. “Under-recognised” trends were defined as those with institutional or academic momentum but limited public mainstream coverage.
RESULTS: While anticipated headline trends (JCA, MFN, IRA, IRP, tariffs, AI, RWE, ATMP) were identified, ten lower-profile trends showed momentum, spanning methodological constraints, early-access reform, evolving value frameworks, equity integration and sustainability. Rising: “PICO multiplicity” as an emerging cross-HTA methodological constraint (~10+ PICOs/product); Joint Scientific Consultation (operationalised via the second 2026 submission window); health equity in HEOR (ISPOR primer; global expansion); novel value frameworks (GRACE applied in neurology; whole-health value); accelerated-approval/evidence-after-launch reform (FDA “plausible mechanism” framework; ICER white paper); and the IRA “pill-penalty” effect on small-molecule portfolios. Emerging: environmental sustainability in HTA (HTAi ESHTA group) and 100% Section-232 pharmaceutical tariffs. Plateauing: the NICE severity modifier. Against the ISPOR 2026-2027 Top-10 (AI #1, RWE #2, value-based healthcare #3), search data captured broad concepts (RWE +859% worldwide) but missed niche policy and methodological shifts, underscoring the value of multi-source scanning.
CONCLUSIONS: Important HEOR and market-access shifts extend beyond headline pricing and HTA reforms. Maintaining focus on high-visibility policies only may carry the risk of underestimating fast-moving methodological, equity and sustainability trends that could shape near-term HTA expectations, highlighting the need for multi-source horizon scanning.