1628OConsistency of ESMO-MCBS scores with drug access recommendations in Catalonia

• Published in: Annals of oncology Vol. 30; no. Supplement_5
• Main Authors: Salazar, C, Obach, M, Fontanet, J M, Garrido, G, Feliu, A, Riba, M, Umbria, M, Gasol, M, Prat, A, Vallano, A, Pontes, C
• Format: Journal Article
• Language: English
• Published: Oxford University Press 01.10.2019
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdz263.002

Abstract Background The Catalan Healthcare System (CatSalut) runs a specific program for drug evaluation (PHF) aimed to guarantee equity in the access to innovative medications. PHF recommendations determine the degree of priority and mechanism for drug invoicing: clinical criteria with direct invoicing; individualised criteria requiring approval by an ad-hoc committee, and exceptional use with no budget allocation. In 2017, the program incorporated an EVIDEM based matrix for Multiple Criteria Decision Analysis a standard procedure. In 2018, the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) was included in the matrix for oncological drugs. This study retrospectively checked the consistency of recommendations issued by the PHF for oncological drugs with the ESMO-MCBS score. Methods The recommendations of the PHF between 2011 and 2018 for oncological drugs were retrieved from reports and meeting minutes. Pivotal studies were scored using ESMO-MCBS version 1.1 for each drug. Matchings and discrepancies were summarised, and the debate reflected in the minutes of the committees was retrieved. Results Throughout the period 2011 to 2018 a total of 47 decisions were made on 57 oncology drugs evaluated. All PHF recommendations for drugs with ESMO-MCBS scores ≥ 4 were positive. Discrepancies were seen for 2 drugs in the curative setting (A score and exceptional use), 8 drugs in the non-curative (1-2 score and clinical criteria) and 1 in the curative setting (C and clinical criteria). The main criteria supporting the PHF decisions for these products are summarised in the table. Table: 1628OCurativeTrial qualityMifamurtideSafety concernsIpilimumabManaged agreementPembrolizumabNon curativeConsolidated useBevacizumab AfliberceptSubgroupsNintedanib EribulineManaged agreementEverolimus CabazitaxelNoneTrastuzumab Abiraterone Conclusions Factors explaining discrepancies between PHF recommendations and ESMO-MCBS were mostly related to the context of the appraisal. ESMO-MCBS standardises efficacy but does not consider quality of trials, added value to other drugs or other factors. It may not be a single formula to reach decisions, but may be useful to ensure that the size of effect is systematically approached in appraisals, and to complement a multiple criteria based system. Legal entity responsible for the study CatSalut. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.