ISPOR engages in health policy issues by convening a wide variety of healthcare stakeholders through its conferences, summits, roundtables, and other events. The Society also helps inform health policy decisions through its public calls-for-comment. ISPOR's members contribute to the Society's responses to calls for comment that are then coordinated and led by its Science Office and Scientific and Health Policy Initiatives teams. PDFs of recent responses include the following.
Health Policy "HEOR by Topic"
Visit ISPOR's Health Policy "HEOR by Topic" webpage. This webpage features the most recent content related to health policy issues from the Society's publications and events.
Health Policy "HEOR by Topic" Page
Public Call-for-Comment Reponses
2024:
- European Commission (EC) - Joint Clinical Assessment (JCA) - Health Technology Assessment: Joint Clinical Assessments of Medicinal Products, April 2024
- US Food and Drug Administration (US FDA) - Use of Real-World Evidence for Medical Devices: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
2023:
- US National Institutes of Health (NIH) - Use of Real-World Data for Biomedical Research: Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) including Electronic Health Records, for NIH Supported Biomedical and Behavioral Research, December 2023
- US Food and Drug Administration (US FDA) - Confirmatory Evidence Use: Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence, December 2023
- European Medicines Agency (EMA)— Single Arm Trials:
Reflection paper on establishing efficacy based on single arm trials submitted as pivotal evidence in a marketing authorization, September 2023 - US Food and Drug Administration (US FDA)—Clinical Outcomes:
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making, July 2023 - Academy of Managed Care Pharmacy (AMCP)—Formulary Submissions:
Format 4.1 Revision: Format for Formulary Submissions, June 2023 - Institute for Clinical and Economic Review (ICER)—Value Assessment:
2023 Value Assessment Framework - Proposed Changes, June 2023 - US Office of Management and Budget (OMB)—Benefit-Cost Analysis:
Regulatory Analysis (Specifically Benefit-Cost Analysis), The US Office of Management and Budget, June 2023 - US Food and Drug Administration (US FDA)—External Control Arms:
External Control Arms, US Food and Drug Administration, May 2023 - US Centers for Medicare & Medicaid Services (CMS)—Medicare Drug Price Negotiation:
Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026, April 2023 - Canadian Agency for Drugs and Technologies in Health (CADTH)—Real-World Evidence:
Real-World Evidence Reporting Guidance, 2023
2022:
- European Medicines Agency (EMA)—Data Quality:
Data Quality Framework for EU Medicines Regulation, November 2022 - European Medicines Agency (EMA)—Real-World Evidence:
Good Practice Guide for the Use of the Metadata Catalogue of Real-World Data Sources, November 2022 - EUnetHTA—Endpoints:
D4.4 Endpoints, November 2022 - US Food and Drug Administration (US FDA)—Patient-Centered Research:
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders, September 2022 - EUnetHTA—Joint Clinical Assessments:
EUnetHTA D4.3.1 and D7.2/7.3 - Practical Guideline Direct and Indirect Comparisons, Patient and Clinical Expert Guidance, and Stakeholder Patient Input Template for Joint Clinical Assessments (JCA), August 2022 - EUnetHTA—Validity:
EUnetHTA D4.5 and D4.6 - Applicability of Evidence and Validity of Clinical Studies, August 2022 - EUnetHTA—Direct and Indirect Comparisons:
EUnetHTA D.4.3.2 Direct and Indirect Comparisons, May 2022 - National Institute for Health and Care Excellence (NICE)—Real-World Evidence:
NICE Real-World Evidence Framework Survey, 2022 - US Food and Drug Administration (US FDA)—Real-World Evidence:
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry, March 2022 - US Food and Drug Administration (US FDA)—Real-World Evidence:
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry, February 2022