Proffered Paper - Public policy Proffered Paper session

1628O - Consistency of ESMO-MCBS scores with drug access recommendations in Catalonia (ID 5379)

Presentation Number
Lecture Time
16:54 - 17:06
  • Mercè Obach (Barcelona, Spain)
Salamanca Auditorium (Hall 3), Fira Gran Via, Barcelona, Spain
16:30 - 18:00



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.


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.


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.

Trial qualityMifamurtide
Safety concernsIpilimumab
Managed agreementPembrolizumab
Non curative
Consolidated useBevacizumab Aflibercept
SubgroupsNintedanib Eribuline
Managed agreementEverolimus Cabazitaxel
NoneTrastuzumab Abiraterone


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



Has not received any funding.


All authors have declared no conflicts of interest.