Exploring PICO Variations in Relapsed or Refractory DLBCL in the Context of the European Joint Clinical Assessment
Author(s)
Jindal S1, Saharia P2
1Lumanity, Gurugram, India, 2Lumanity, Gurugram, Haryana, India
Presentation Documents
OBJECTIVES: It is imperative to explore the implications of population, intervention, comparator and outcome (PICO) variations in light of the Joint Clinical Assessment (JCA) since this will become mandatory for oncology drugs in 2025. This review assessed health technology assessment (HTA) submissions in England, Germany, Ireland, Sweden and the Netherlands for variations in the PICO criteria in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) after two or more lines of systemic therapy.
METHODS: HTA reports in DLBCL published between 2020 and 2024 in the NICE (reference HTA) were compared with four other national HTA bodies which are member states implementing the JCA: G-BA (Germany), NCPE (Ireland), TLV (Sweden), and ZIN (the Netherlands). The targeted review examined 30 publicly available HTA reports for six drugs in patients with R/R DLBCL after two or more lines of systemic therapy. PICO information was extracted to identify variations among these countries.
RESULTS: Based on assessments among the countries of interest, anticipated number of PICO combinations for a product in R/R DLBCL after two or more lines of systemic therapy ranges from one to more than 10. More than 10 PICO combinations are also accounted for by NICE, which can be a reflection on PICO combinations possibly anticipated among EUnetHTA 21 countries. Variation in the number of comparators and outcomes emerged as key considerations driving these differences.
CONCLUSIONS: Proposed variation in PICO combinations for R/R DLBCL after two or more lines of systemic therapy highlights challenges in attaining a consolidated approach during the JCA scoping phase. Thus, preparation and awareness of the anticipated scope is the key for success. However, these results should be interpreted with caution, as ‘PICO development process’ may also consider off-label comparators and greater number of countries than that were assessed in this review.
Conference/Value in Health Info
Value in Health, Volume 27, Issue 12, S2 (December 2024)
Code
HTA65
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Value Frameworks & Dossier Format
Disease
Oncology