The Use of Real-World Evidence for Decision-Making: Next Steps to Develop HTA Guidance

In this webinar organized by the RWE4Decisions multi-stakeholder initiative, consideration will be given to methodological recommendations on generation and use of real-world evidence (RWE) in pricing and reimbursement decision-making with a view to identifying what steps need to be taken to align on the way forwards. Guidance can act as a roadmap to generate high-quality RWE, to enable researchers and manufacturers to have a clear understanding of how it will be evaluated and for decision-makers to assess the completeness of their own RWE guidance.

After opening presentations about existing methodological guidance and new initiatives, our panel of national decision-makers will consider the opportunities for collaboration to accelerate progress towards the generation of comprehensive guidance for RWE quality and transparency in HTA/Payer pricing and reimbursement decisions.


A discussion co-moderated by Diane Kleinermans, President of the Commission of Drugs Reimbursement, National Institute for Health and Disability Insurance (INAMI-RIZIV) and Karen Facey, Consultant to RWE4Decisions.

15h00 – 15h05: Welcome

Diane Kleinermans, President of the Commission of Drugs Reimbursement, INAMI-RIZIV

15h05 – 15h20: Presentation: Developing comprehensive guidance to drive the use of RWE for decision-making

Páll Jónsson, Programme Director – Data, National Institute for Health and Care Excellence (NICE) and GetRealInstitute 

15h20 – 15h35: Presentation: Four pillars to share comprehensive RWE guidance for HTA/Payers – building on existing work

Karen Facey, Consultant to RWE4Decisions

15h35 – 15h40: Q&A session 

15h40 – 16h25: Panel discussion: What’s needed to create guidance on high-quality RWE for use in HTA/Payer decision-making 

  • Cláudia Furtado, Head of the HTA, Pricing and Reimbursement Division and Information and Strategic Planning Division, National Authority for Medicines and Health Products (INFARMED) (Portugal)
  • Anja Schiel, Senior Advisor, Norwegian Medicines Agency (NOMA) (Norway) and Chair of the Scientific Advice Working Party, European Medicines Agency (EMA)
  • Aisling O’Leary, Chief Pharmacist, National Centre for Pharmacoeconomic Evaluations (NCPE) (Ireland)
  • Niklas Hedberg, Chief Pharmacist, Swedish Dental and Pharmaceuticals Benefits Agency, (TLV) (Sweden)

16h25 – 16h30: Closing remarks and next steps by Diane Kleinermans, President of the Commission of Drugs Reimbursement, INAMI-RIZIV

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