88P - Utilisation of the ESMO-MCBS in prioritising immune-checkpoint inhibitors for a WHO model list of essential medicines application

Background

The WHO Model List of Essential Medicines (EML) serves as guidance for the development of national lists of essential medicines. Since ipilimumab was first approved in 2011, immune checkpoint inhibitors (ICI) have changed the oncologic treatment landscape, leading to significant survival advantages. However, except for malignant melanoma, repeated EML applications of ICIs were unsuccessful and global access remains limited. This study was part of a WHO EML application for the therapeutic class of ICIs in the palliative first-line treatment setting of adult cancers and aims to provide a prioritization framework to select ICIs and indications with the highest potential for EML inclusion.

Methods

After drafting a goal-directed, sequential prioritization plan, the European Medicines Agency’s (EMA) drug database was searched systematically for approved ICI and treatment indications. Next, based on the potential population reach and availability of high-level evidence, ICI-containing treatments approved for the palliative first-line setting were reviewed. Lastly, ESMO-Magnitude of Clinical Benefit Scale (MCBS) scorecards were examined to identify therapeutic indications with a score of 4 or 5, denoting a substantial clinical benefit. ESMO experts will review top-ranked regimens and cancers to complement the evidence about efficacy and harms, judge feasibility and accessibility, and discuss controversial additions.

Results

The EMA drug database search yielded 11 ICIs with 76 different approvals for 21 cancer types and subtypes. Of these, 44 approvals were in the palliative first-line setting. Evaluation against ESMO-MCBS scorecards led to the inclusion of 29 approvals for further evaluation and analysis. Briefing documents for selected cancers and ICIs, with input from ESMO experts, will enhance the transparency and completeness of the EML application to support the WHO Expert committee's selection.

Conclusions

Our research demonstrates the feasibility of using the ESMO-MCBS as part of a framework to identify and prioritise promising ICI-containing treatment regimens for WHO EML application. Therefore, further exploration of the framework as part of the WHO EML application process is warranted.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.