[PRM10] Expected Impact of the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (Esmo-Mcsb) on Health Technology Assessment

[PRM10] Expected Impact of the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (Esmo-Mcsb) on Health Technology Assessment

2016 Value in Health

Rémuzat, C. | Chouaid, C. | Auquier, P. | Borget, I. | Kornfeld, A. | Toumi, M. | Volume: 19, Issue: 7, Pages: A358-A359,

OBJECTIVES: ESMO published in 2015 the Magnitude of Clinical Benefit Scale (MCBS) to support European health authorities’ decisions and recommend therapies with the highest scores in their guidelines. The objective of this research was to analyse how MCBS fits the health technology assessment (HTA) framework in oncology. METHODS: ESMO-MCBS was reviewed to identify dimensions taken into account and compared it to current 3 selected HTA frameworks (clinically driven-France and Germany, and cost-effectiveness driven-United Kingdom). RESULTS: ESMO-MCBS has been developed for solid cancers and is applied to comparative studies. The scale includes 2 parts: form 1 for therapies likely to be curative and form 2 for therapies not likely to be curative, the last one being sub-divided depending on primary endpoints used: overall survival (OS), progression-free survival (PFS) or others. Magnitude of clinical benefit grade is driven by hazard ratio (HR) and minimum observed benefit. This benefit is modulated according to the background risk (OS or PFS in the control arm); lower benefit has higher weight when background risk is higher. Quality of life (QoL) and grade 3-4 toxicities contribute to upgrade or downgrade the benefit score. MCBS does not include any drug-related costs. MCBS will not allow assessing products with single-arm studies. It is not expected to impact countries using health economics evidence for decision making as meaningful benefit is translated in QALY gain. In countries using standardized clinical assessment like Germany, it will conflict with existing methodology driven by confidence interval upper limit. In other countries with less standardised clinical assessment such as in France, it may provide objective guidance. CONCLUSIONS: ESMO-MCBS brings an objective clinical added value scoring method for oncology products. However it might not be adapted to existing HTA analytical framework. Inputs from HTA bodies and payers may prove useful to secure impact on policy decision making.

https://www.doi.org/10.1016/j.jval.2016.09.073