A Case Study in PICO: What We Might Consider for JCA
Author(s)
Ricci Conesa H1, Leys K2, Budhia S3
1Parexel International, Copenhagen, 84, Denmark, 2Parexel International, London, UK, 3Parexel International, London, LON, UK
Presentation Documents
OBJECTIVES: The development of joint clinical assessments (JCA) often requires the use of multiple population, intervention, comparator, and outcomes (PICO) frameworks. This case-study aims to provide insights for optimizing the adoption processes of new drugs in the European Economic Area (EEA) by comparing country-specific HTA reports for a target product across Scandinavian countries and Finland and analyzing variations in the elements of the PICO framework.
METHODS: HTA reports published by HTA agencies in Denmark, Finland, Norway and Sweden were screened to identify one oncology drug previously assessed for the same disease across all agencies within the last 3 years. Information on the PICO framework relevant fir each HTA agency was extracted and compared across assessments.
RESULTS: The assessment of polatuzumab-vedotin as first-line treatment for patients with diffuse large B-cell lymphoma showed differences in population and outcomes, whereas intervention and comparators elements of the PICO framework remained unchanged. Regarding the population element, agencies in Finland, Norway, and Sweden considered the trial population as relevant, while in Denmark the analysis was restricted to a subgroup that better represented eligible patients according to clinical expert opinion. In terms of outcomes, variations were found in the methods used in economic models for estimating long-term overall survival and in utility weights to estimate health-related quality of life.
CONCLUSIONS: Variations in the population and outcomes elements of the PICO framework were identified, influenced by demographic differences and different economic evaluation methodologies. While JCA focuses on clinical aspects, national HTA agencies still consider both clinical and economic values in their recommendations for the adoption of new drugs. Manufactures should be prepared not only to present multiple PICO frameworks for JCA, but also to demonstrate the full value of a drug in terms of clinical and economic evidence. This comprehensive approach ensures a thorough evaluation and assessment of a drug's overall value.
Conference/Value in Health Info
Value in Health, Volume 27, Issue 12, S2 (December 2024)
Code
HTA30
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Reimbursement & Access Policy, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas