ISPOR members reflect the multistakeholder healthcare community and contribute valuable expertise in advancing healthcare decisions through health economics and outcome research (HEOR) methods. The Society facilitates dialogue, deliberation, and consensus building on topics of interest to healthcare decision makers through its conferences, summits, and roundtables. ISPOR also collaborates with decision makers in the development of HEOR guidelines and responses to requests for public comment or consultation.
The Society develops innovative research methods and tools, in collaboration with global thought leaders and members, which provide unbiased resources sought by payers, governments, providers, and other healthcare decision makers. ISPOR monitors the pulse of global, emerging HEOR practices and discussions and is active in the development and review of:
- Pharmacoeconomic guidelines
- Thought-leading papers
- Public calls for comment
- Good Practices for Outcomes Research Reports
- Interactive dialogue with decision makers through special forums and meetings
ISPOR is actively involved in informing health policy decisions by engaging members in public calls-for-comment. Recent dialogue with decision makers involving the Society include:
- Data Quality Framework for EU medicines regulation, EMA Guidance
- Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources, EMA Guidance
- EUnetHTA - 4.4 Endpoints
- Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
- 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)
- EUnetHTA D4.5 and D4.6 - Applicability of Evidence and Validity of Clinical Studies
- EUnetHTA D.4.3.2 Direct and Indirect Comparisons
- NICE real-world evidence framework survey
- 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Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
- Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry
- US Food and Drug Administration Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products (PDF)
- EUnetHTA: A future model of HTA collaboration (PDF)
- The NICE methods of health technology evaluation: the case for change (PDF)
- European Medicines Agency Guidelines on Registry-Based Studies (PDF)
- US Food and Drug Administration Patient-Focused Drug Development: Methods to Identify What Is Important to Patients (PDF)
- INAMI/RIZIV: Real-world evidence to support HTA/payer decisions on highly innovative technologies (PDF)
- ICER Value Assessment Methods for “Single or Short-Term Transformative Therapies” (PDF)
- ICER Update to Value Assessment Framework (PDF)
- ISPOR Survey Response to Public consultation on EMA Regulatory Science to 2025 (PDF)
- ICER Collaborative to Develop New Methods to Guide Value-Based Pricing of Potential Cures (PDF)
- ISPOR final response to HMA_EMA Big Data Summary Report (PDF)
- US Food and Drug Administration Framework for Real-World Evidence Program (PDF)
- US Health and Human Services International Pricing Index Model for Medicare Part B Drugs (PDF)
- US Health and Human Services Regulation to Require Drug Pricing Transparency (PDF)
- US Food and Drug Administration Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (PDF)
- US Health and Human Services Blueprint to Lower Drug Prices and Reduce out-of-Pocket Costs (PDF)
- European Medicines Agency ICH (E9) Estimands and Sensitivity Analysis Consultation (PDF)
ISPOR also maintains active communication with health ministries, regulators, payers, and other decision makers through meetings and ongoing communication by the Society’s executive and science teams.
- ISPOR Health Technology Assessment Roundtables (PDF)
- ISPOR Latin America Regional Health Policy Summit 2019 (PDF)