Evolving HTA and Potential EU HTAR Ripple Effects in the US: Insights From a Stakeholder Survey
Author(s)
Anna-Mari Viita, MASc1, Adam Barrett, BA2, Linda Tirapelle, MASc3, Mina Mehany, BSc4, Vanessa Schaub, PhD5, Elaine Julian, PhD6, Joerg Ruof, Prof Dr. Med., MBA, MPH6, Anouchka Vidal, PharmD5.
1Roche Oy, Espoo, Finland, 2Genentech USA, Inc., San Francisco, CA, USA, 3Roche Diagnostics International Ltd, Rotkreutz, Switzerland, 4Roche Diagnostics Middle East, Dubai, United Arab Emirates, 5F. Hoffmann-La Roche Ltd, Basel, Switzerland, 6Secretariat of the European Access Academy, Basel, Switzerland.
1Roche Oy, Espoo, Finland, 2Genentech USA, Inc., San Francisco, CA, USA, 3Roche Diagnostics International Ltd, Rotkreutz, Switzerland, 4Roche Diagnostics Middle East, Dubai, United Arab Emirates, 5F. Hoffmann-La Roche Ltd, Basel, Switzerland, 6Secretariat of the European Access Academy, Basel, Switzerland.
Presentation Documents
OBJECTIVES: The European Union (EU) health technology assessment regulation (HTAR) applies from January 2025. Based on previous research, it raises attention beyond the EU. Our study aimed to understand the perception of the evolving role of HTA and the level of awareness and potential impact of the EU HTAR in the US.
METHODS: A double-blinded online survey targeting public payers, private payers, and academia was conducted. Results were synthesized using descriptive methods.
RESULTS: The eleven respondents represented well the different respondent groups with academia showing the highest engagement. Seven respondents (64%) anticipated a moderate increase in the use and influence of HTA in the US over the next decade, while three did not anticipate any significant change. Policy and regulatory changes and budget pressures were highlighted as key drivers for the evolving HTA, which based on spontaneous quotes, is anticipated to enhance joint decision-making and evidence-based clinical decisions. Most respondents expect HTA evaluations to have some influence on reimbursement and coverage policies in the future, with cost-effectiveness preferred over additional benefit assessment as a potential HTA framework. The US is currently not expected to intensively engage in international HTA initiatives. There was little knowledge of the EU HTAR outside academia, even among the few respondents with a neutral view on its halo effect, the EU HTAR is not expected to influence drug pricing and negotiations in the US in the short term.
CONCLUSIONS: Despite limited awareness and the perceived impact of the EU HTAR, HTA’s role within the US healthcare system is evolving. Survey insights suggest a growing need for harmonization, streamlined resources, and evidence-based decision-making. They highlight the perception of US healthcare's independence and its preference for domestic solutions over external influences.
METHODS: A double-blinded online survey targeting public payers, private payers, and academia was conducted. Results were synthesized using descriptive methods.
RESULTS: The eleven respondents represented well the different respondent groups with academia showing the highest engagement. Seven respondents (64%) anticipated a moderate increase in the use and influence of HTA in the US over the next decade, while three did not anticipate any significant change. Policy and regulatory changes and budget pressures were highlighted as key drivers for the evolving HTA, which based on spontaneous quotes, is anticipated to enhance joint decision-making and evidence-based clinical decisions. Most respondents expect HTA evaluations to have some influence on reimbursement and coverage policies in the future, with cost-effectiveness preferred over additional benefit assessment as a potential HTA framework. The US is currently not expected to intensively engage in international HTA initiatives. There was little knowledge of the EU HTAR outside academia, even among the few respondents with a neutral view on its halo effect, the EU HTAR is not expected to influence drug pricing and negotiations in the US in the short term.
CONCLUSIONS: Despite limited awareness and the perceived impact of the EU HTAR, HTA’s role within the US healthcare system is evolving. Survey insights suggest a growing need for harmonization, streamlined resources, and evidence-based decision-making. They highlight the perception of US healthcare's independence and its preference for domestic solutions over external influences.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR4
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas