OBJECTIVES: This review assessed health technology assessment (HTA) submissions in England, Germany, Ireland, and the Netherlands for variations in the population, intervention, comparator, and outcome (PICO) criteria in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. It is particularly important to explore the implications of PICO variations in light of the Joint Clinical Assessment (JCA), which will become mandatory for oncology drugs in 2025.

METHODS: With a large number of molecules being submitted to the UK, HTA reports in DLBCL published between 2020 and 2024 in the NICE were compared with four other national HTA bodies: G-BA (Germany), NCPE (Ireland), ZIN (Netherlands), and TLV (Sweden). The targeted review examined 30 publicly available HTA reports for six drugs in patients with relapsed/refractory DLBCL after two or more lines of systemic therapy. PICO information was extracted to identify variations among these countries.

RESULTS: The review highlights substantial disparities in PICO combinations across European jurisdictions for DLBCL treatments. Based on assessments among the countries of interest, anticipated number of PICO combinations for a product in DLBCL after two or more lines of systemic therapy ranges from four to more than 10. More than 10 PICO combinations are accounted in NICE as well, which can be a reflection on PICO combinations anticipated among EUnetHTA JCA countries. Comparators and outcomes emerged as key considerations driving these differences.

CONCLUSIONS: The proposed variation in PICO combinations for relapsed or refractory DLBCL after two or more lines of systemic therapy highlights a possible challenge. Thus, preparation and being aware of the anticipated scope key is for success. However, these results should be interpreted with caution, as “PICO development process” will also consider off-label comparators and greater number of countries that were assessed in this review.