OBJECTIVES: To assess commonalities between PICOs by EUNETHTA-REA JA3 project, and country assessments in France, Germany and Italy, for POLIVY (polatuzumab in relapse/refractory diffuse-large-B-cell-lymphoma r/r-DLBCL) and STELARA (ustekinumab in ulcerative colitis - UC).

METHODS: Analysis of PICOs identified in EUNEHTA-REA reports; selection of products with >1 assigned PICOs; analysis of published HTA/P&R assessments by HAS-France, G-BA/IQWIG-Germany and AIFA-Italy.

RESULTS: Of 20 REAs published for medicines in the EUNETHTA website, multiple PICOs were assigned to POLIVY and STELARA.

POLIVY in combination with bendamustine and rituximab (BR) was assigned PICO-1a [Adults with r/r-DLBCL who are not candidates for hematopoietic stem cell transplant (HSCT) – after failure of first line therapy] and PICO-1b [Adults with r/r-DLBCL who are not candidates for HSCT – after failure of two or more therapies]; no reimbursement from HAS based on several factors (clinical data, relevance of the comparator and of the primary endpoint chosen, etc.); AIFA approved reimbursement in PICO-1a; no assessment by G-BA but product reimbursed for PICO-1a.

STELARA was assigned PICO-1 [Adults with moderately-severely active UC who have had an inadequate response with, lost response, or were intolerant, or have medical contraindication to conventional therapy and to at least one biologic therapy] and PICO-2 [Adults with moderately-severely active UC who have had an inadequate response with, lost response to, or were intolerant to, or have medical contraindications to conventional therapy]. HAS approved reimbursement in PICO-1 in adults after failure (insufficient response, loss of response, intolerance or contraindication) of conventional treatments (amino-5 salicylates, corticosteroids and immunosuppressants) and at least one anti-TNFα biologic drug and vedolizumab (restriction vs. EMA label). AIFA and G-BA approved reimbursement in PICO-2 (full EMA label).

CONCLUSIONS: For two EUNEHTA-REA drugs appraised for 2 different populations, country authorities in France, Germany and Italy adopted different approaches, an example of discrepancies/misalignments that companies fear in future EU-HTA appraisals.