Navigating Change: A Comparative Analysis of Health Technology Assessment Reforms Across Agencies and Their Interdependencies

Author(s)

Cubi-Molla P1, Kumar G2, Radu P3, Garau M1, Bell E4, Pan J5, Gilardino R6, van Bavel J7, Brandtmuller A8, Nelson K9, Goodall M10
1Office of Health Economics, London, LON, UK, 2Office of Health Economics, London, Lon, UK, 3Office of Health Economics, London, UK, 4UKHSA, London, LON, UK, 5Adelphi Values PROVE, Bollington, Cheshire, UK, 6MSD, Dubendorf, ZH, Switzerland, 7MSD, Sydney, NSW, Australia, 8MSD Pharma Hungary Ltd, Budapest, Hungary, 9Drexel University, Philadelphia, PA, USA, 10Goodall HTA Consulting, Manchester, Manchester, UK

OBJECTIVES: Changes in Methods and Processes (M&P) of Health Technology Assessment (HTA) agencies can affect time and degree of patient access to treatments. Our study investigates HTA reforms and explores interdependencies and proactivity in implementing M&P reforms by 14 HTA agencies in Europe, Asia-Pacific, and North America. The study explores how the agencies' positions on modifiers, real-world evidence (RWE), patient involvement, surrogate endpoints and discounting have evolved.

METHODS: We conducted a targeted literature review on M&P guidelines and subsequent changes implemented by 14 HTA agencies from 2010 to 2023. We supplemented and validated initial findings with 29 semi-structured interviews with country-specific experts. We used analytical tools to create interdependency networks and a framework to group HTA agencies based on proactivity and influence.

RESULTS: We classified PBAC(Australia), CADTH(Canada), NICE(England), IQWiG(Germany), and ZIN(the Netherlands) as catalysts of HTA reforms and internationally influential; HAS(France), TLV(Sweden), and KCE(Belgium) as traditionalists; DMC(Denmark), AIFA(Italy), INFARMED(Portugal), ACE(Singapore), AEMPS(Spain), and CDE(Taiwan) as observers.

All HTA agencies appear to use modifiers in their decision-making, whether through an explicit framework or implicitly with an element of discretion. Recent years have seen an increase in guidance or clarification on opportunities for patient involvement in HTA. Most of the HTA agencies consider RWE and use of surrogate endpoints to some extent in decision making, with the caveat that final outcomes are preferred. Base case discount rates have remained mostly unchanged over time, and all agencies have permitted sensitivity analyses on rates for historical or international comparison.

CONCLUSIONS: Our work provides an overview of past HTA M&P reforms internationally. While some HTA agencies have evolved and formalised their positions on certain aspects, others lack an explicit stance. International collaborations represent a valuable route to accelerate changes by encouraging consistency and providing leadership. To be fully successful, collaborations should ensure wide involvement of stakeholders at an early stage.

Conference/Value in Health Info

2024-11, ISPOR Europe 2024, Barcelona, Spain

Value in Health, Volume 27, Issue 12, S2 (December 2024)

Acceptance Code

P55

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Reimbursement & Access Policy, Systems & Structure

Disease

no-additional-disease-conditions-specialized-treatment-areas

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