ABSTRACT
Objectives
Our primary objective was to compare the grading of the value of cancer drugs (‘Amélioration du Service Médical Rendu’ [ASMR] level) by the French health technology assessment authority (‘Haute Autorité de santé’ [HAS]) with that by the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Our secondary objective was to study the drivers of the French grading system.
Methods
We included new drugs for solid tumors assessed by the HAS between 2010 and 2016 and compared their ASMR level to scores calculated by the 2016-updated ASCO-VF and 2015 ESMO-MCBS.
Results
We investigated 27 new cancer drugs assessed by the French HAS between 2010 and 2016. Among the 17 drugs eligible for comparison, the correlation between ASMR levels and ASCO and ESMO scores was weak (r = 0.34 and r = 0.27, respectively). The agreement between the HAS and ESMO regarding the level of meaningful additional benefit was moderate (kappa = 0.43). We found no significant association between 12 potential variables and ASMR level of additional benefit of drugs.
Conclusion
Our findings show inconsistencies in cancer drug appraisals among the three appraisers.
Article Highlights
Health technology assessment of cancer drugs in France was weakly correlated with American ASCO-VF (2016 update) and European ESMO-MCBS (2015) scores.
A standardized value framework might not take into account the specific needs of each country.
Health technology assessment of cancer drugs should be fair and reproducible so that the pricing reflects the value delivered.
No single variable can explain the magnitude of the grading given by the French health technology assessment agency, which relies on a voting process.
Acknowledgments
The authors acknowledge Laura Smales from BioMedEditing for her editing services.
Author contribution statement
Conception and design: JL, IDZ, AV
Analysis and interpretation of the data: AV, JL
Drafting of the paper: JL
Revising critically for intellectual content: IA, IDZ, AV
Final approval of the version to be published: JL, AV, LA, IDZ
All authors agree to be accountable for all aspects of the work.
Declaration of interest
L Alter was a former employee of Eli Lilly & Co. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer Disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.