The WHO Expert Committee on the Selection and Use of Essential Medicines is responsible to amend, delete and update the WHO Model List of Essential Medicines (EML) every two years, and to evaluate applications for new medicines proposed to be added to the list. The WHO defines essential medicines as those “that satisfy the priority health care needs of the population”. Essential Medicines are intended to be available within the context of functioning health systems and in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford. Medicines on the WHO EML are identified based on disease prevalence, public health relevance, evidence of clinical efficacy and safety, and comparative costs and cost-effectiveness.
During the 2021 Open Session of the WHO Expert Committee’s meeting, Rosa Giuliani, ESMO Director of Public Policy, presented an update on some of ESMO activities to improve access to medicines. She stated that clinically meaningful cancer medicines are those on the WHO Model List of Essential Medicines and those with a high score on the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS). She noted that the ESMO-MCBS has been acknowledged by the World Health Organisation as “a screening tool to identify cancer treatments that have potential therapeutic value that warrants full evaluation for the Essential Medicines List listing”. [1]
Dr. Giuliani explained that when determining clinically meaningful benefit, the ESMO-MCBS takes into account factors such as, overall survival, progression free survival; quality of life; hazard ratio, long-term survival, response rate; prognosis of the condition; and toxicity, but it does not consider the cost of the medicine. She informed that ESMO realizes that cost is a key component of a sustainable health system model. To tackle issues related to the reimbursement of expensive, innovative medicines, ESMO is working towards the development of a geographically-adapted value-based reimbursement model.
In her presentation, Dr. Giuliani highlighted that many of the cancer medicines on the WHO EML are inexpensive, and also available as generics and biosimilars. They are used to treat the majority of cancers and referenced in the ESMO Clinical Practice Guidelines. She noted that these essential medicines should be on national essential medicines lists and protected against shortages.
Because access to cancer medicines is crucial to the daily practice of medical oncologists, Dr. Giuliani informed that ESMO continues to gather data on their availability worldwide. The ESMO surveys in Europe and internationally on the availability of anti-cancer medicines include medicines on the WHO EML, and have been cited by the WHO as “the most comprehensive assessment on the availability of cancer medicines globally”.[2] To provide an update on the situation, ESMO has launched the second version of the survey and expanded it to collect data on the shortages of inexpensive essential cancer medicines which represent a growing a public health emergency. Given the importance of companion diagnostics, ESMO is also launching a survey on the availability and accessibility of biomolecular technologies in oncology and barriers to their access, as many cancer medicines are for specific cancer subtypes that need to be properly screened for their benefits.