On this episode, Dr. Anke-Peggy Holtorf joins us to help demystify the complex processes of regulatory affairs and health technology assessment (HTA) and explain the crucial role of patients in these processes.

Anke acts as Secretary of the Board at Health Technology Assessment international and is a Steering Committee member and project coordinator for the Patient and Citizen Involvement in HTA Interest Group. She is co-editor of the 2nd edition of the book on Patient Involvement in HTA, which will be published in 2025. Anke has also taught graduate courses in International Health Policy, HTA, and the role of patient involvement.

Anke's global experience and depth of knowledge spanning decades shine through as she simplifies some highly technical and complex concepts for our listeners.

Chapters:
0:00 - Introductions
1:34 - Overview of regulatory affairs and HTA
6:48 - The regulatory approval process
12:09 - Patient involvement in regulatory affairs
22:19 - Overcoming barriers to patient involvement
27:32 - Regulatory success rates
30:30 - The HTA process
32:32 - Differences in healthcare models
36:46 - Factors evaluated in HTA
43:45 - Patient involvement in HTA
54:32 - Advice for patients and stakeholders
59:08 - Reflections with Caitlin and Clarinda

Resources and definitions:

• HTA - Health Technology Assessment
• Reimbursement: the process by which healthcare providers are compensated/paid back for the medical services they provide, either by the government or through insurance
• Out-of-pocket costs: when patients pay for their own medical costs
• FDA - US Food and Drug Administration
• EMA - European Medicines Agency
• Chinese FDA
• QALY - Quality adjusted life years
• WHO - World Health Organization
• NICE - National Institute for Health and Care Excellence, UK
• CF Trust - Cystic Fibrosis Trust
• EUPATI - European Patients' Academy on Therapeutic Innovation
• EUCAPA - European Capacity Building for Patients
• Anke's report on Patient Involvement in HTA in Europe - full report and short version

Have feedback or suggestions for us? We'd love to hear from you!
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