Recognizing the important policy issue of the value of cancer therapies, the European Society of Medical Oncology (ESMO) has developed a validated and reproducible tool to standardize the grading of the relative clinical benefit of new therapies: the magnitude of clinical benefit scale (ESMO-MCBS). The final reimbursement decision about the value of a therapy from a payer’s perspective includes both clinical benefits and costs of new therapies, and relative clinical benefit is assessed with country-specific methods. This study examines the potential of the ESMO-MCBS score to approximate the clinical benefit assessment in HTA decisions in the United Kingdom.
The ESMO-MCBS scoring for 102 advanced oncology drugs, listed in Cherny 2019 and corresponding final HTA documents by UK’s National Institute for Clinical Excellence (NICE) were reviewed and extracted. The relationship between NICE’s final decision (recommended or not; yes, but with restricted indication; with a discount; or only temporarily using the UK’s Cancer Drugs Fund (CDF)), and the relationship between ESMO-MCBS and the main components of the NICE clinical assessment were investigated descriptively and using regression analyses.
76 (74%) of the 102 drugs included in Cherny 2019 were assessed by NICE; 76% of which were recommended by NICE (57% with a discount and 10% with CDF). A mean ESMO-MCBS score > 3.5 was observed for all the different types of positive NICE recommendation. Significantly lower mean ESMO-MCBS score (2.28, SE 0.26) was associated with treatments not recommended. All (100%) of the medications which were recommended, with some condition (discount/CDF) had an ESMO-MCBS ≥ 3 while most (83.3%) of the treatments not recommended were associated with an ESMO-MCBS ≤ 3. The analysis suggests ESMO-MCBS <3 as the optimal threshold to predict positive/negative NICE decision achieving a positive predictive value of 87% and negative predictive value of 71.4%.
An association was found between clinical value for the UK payer and that for physicians using ESMO-MCBS despite the different perspective. Scoring therapies with the ESMO-MCBS can have use beyond clinical guidelines in health policy.
The authors.
Evidera Inc.
All authors have declared no conflicts of interest.