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Proffered Paper - Public policy

5379 - Consistency of ESMO-MCBS scores with drug access recommendations in Catalonia


30 Sep 2019


Proffered Paper - Public policy


Clinical Research

Tumour Site


Mercè Obach


Annals of Oncology (2019) 30 (suppl_5): v671-v682. 10.1093/annonc/mdz263


M. Obach1, J.M. Fontanet1, G. Garrido1, A. Feliu2, M. Riba2, M. Umbria1, M. Gasol1, A. Prat1, A. Vallano1, C. Pontes1

Author affiliations

  • 1 Medicine Service, CatSalut, Barcelona/ES
  • 2 Pharmacy, Hospital de la Santa Creu i Sant Pau, Barcelona/ES


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Abstract 5379


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.Table: 1628O

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.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study



Has not received any funding.


All authors have declared no conflicts of interest.

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