The WHO recently published an updated version of its list of essential medicine and diagnostics. The first WHO essential Medicines List, published in 1977, was a needed revolution in healthcare as it helped establish that medicines fulfilling unmet needs are essential yet remain inaccessible to too many. Since then, the list has been updated every two years with new essential drugs. However, updates to the list of cancer drug specifically can be less frequent, with the last thorough review of cancer medicines conducted in 2015. The current versions are the 21st WHO Essential Medicines List (EML) and the 7th WHO Essential Medicines List for Children (EMLc).
When updating the EML, the WHO Essential Medicines Committee considers input from external partners, including submissions from governments, pharmaceutical companies, medical associations and individuals. In order to merit listing, a medicine must be supported with evidence of its efficacy, safety and cost-effectiveness. This year, the list consists of 450 drugs, with the Expert Committee recommending the addition of 28 new drugs for adults, 23 new drugs for children and new indications for 26 currently listed drugs. The new list includes cancer treatments, antibiotics, anticoagulants, biologics and their respective biosimilars, and diagnostics for noncommunicable and communicable diseases.
Of particular note for the pharmaceutical industry, select higher priced advanced cancer drugs which offer higher survival rates were added to the list in 2019. Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab), two recently developed immunotherapies used to treat melanoma, gained inclusion in the list for the first time given that they offer a 50% improvement in survival rate for a condition that was incurable until only recently. Millennium (the Takeda Oncology Company)’s Velcade (bortezomib), Celgene’s Revlimid (lenalidomide) and Thalomid (thalidomide), and melphalan were also included as the first therapies listed to treat newly diagnosed multiple myeloma in non-transplant as well as transplant eligible settings. Genentech’s Tarceva (erlotinib) along with Boehringer Ingelheim’s Gilotrif (afatinib) and AstraZeneca’s Iressa (gefitinib) for the treatment of non-small cell lung cancer are also now part of the list. Three other treatments known to have better survival rates to treat prostate cancer and leukemia were also added to the list.
The expert committee supported the EML Cancer Medicines Working Group (CMWG) recommendation of using the 4-6-month overall survival interval as a criterion for screening of proposed medicines for EML listing. The committee’s decision was also in favor of using ESMO‒Magnitude of Clinical Benefit Scale (ESMO-MCBS) to screen cancer drugs with potential therapeutic value. Drugs with ESMO-MCBS score A or B in the curative setting and of 4 or 5 in the noncurative setting are good candidates to include in the EML.
Less promisingly, the new edition of the list rejected Keytruda and Opdivo along with Roche’s Tecentriq (atezolizumab) for the treatment of non-small cell lung cancer. The reason for non-inclusion was that provided clinical evidence was deemed insufficient as long-term follow up data were not enough to estimate the magnitude of benefit and that their place in therapy is still evolving. Genentech’s Ocrevus (ocrelizumab) for multiple sclerosis and Novartis’s Ritalin (methylphenidate) for attention-deficit hyperactivity disorder were also rejected. As discussed above, this year the WHO committee focused more on inclusion of cancer drugs in the list; a primary reason for this being the increasing cancer incidence and disease burden across the globe, including 17 million new cancer cases worldwide in 2018. Over the years, selection of essential medicines has moved to an increasingly evidence-based process. Disease burden, public health needs, clinical and cost-effectiveness evidence provided by manufacturers are a few key parameters taken into consideration while including a drug in the list. The WHO mainly considered short-term as well as long-term efficacy and cost-effectiveness of the drugs versus other available alternative treatments while finalizing their model list.
The WHO’s Essential Medicines List is a guide for more than 150 countries to determine which medicines to fund, stock, prescribe and dispense. Each country selects medicines for its essential list according to regional disease burden and unmet needs. It is expected that countries with similar geography, population size, health-care expenditure would have similar essential medicines lists. Country specific needs, WHO regions with varying disease burden and health-care expenditure are the major factors responsible for the difference between country specific lists and the WHO model list. A country’s GDP could also contribute to the number of drugs included in its own list. A market with a lower GDP can usually be expected to have a smaller national list of essential medicines, though there are exceptions to the rule as there could be other factors such as disease burden and healthcare budget deciding country specific lists. For example, Sweden has a smaller list (289 drugs) even though it has a high GDP ($51,200 per capita) while India with a low GDP ($7,200 per capita) offers a relatively long list of essential drugs covered (367 drugs). The other factors responsible for this difference are related to costs, drug effectiveness, morbidity patterns, and rationality of prescribing.
The higher priced essential drugs now listed in the WHO model list could have an improved chance of being subsequently listed in national essential drug lists and thus securing coverage. This provides easy access to patients who cannot afford to buy these life-saving drugs and do not have access to the generic versions. However, countries do not update their lists as frequently as the WHO and listing of drugs in national essential drug lists depends upon the country’s disease burden, priority health concerns and affordability concerns. Year of revision for National Lists of Essential Medicines (NLEM) depends on a country’s specific needs and varies widely from country to country. For instance, Sweden revised its NLEM in 2016 while Brazil revised there’s in 2014. The WHO updates the EML by prioritizing highly effective therapies in order to address health challenges and improve affordable access. The WHO model list emphasizes patient benefits and economical spending with a view to help countries achieve universal health coverage. This year, the EML focuses more on inclusion of advanced cancer treatments with better survival rates so as to make them available to patients at an affordable price. This will result in good quality medical care of patients with life threatening disease like cancer and cost-effective use of health care resources.
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