Three MS therapies listed as WHO essential medicines

by Lindsey Shapiro, PhD | July 27, 2023

For the first time, multiple sclerosis (MS) therapies have been added to the World Health Organization (WHO)’s Model Lists of Essential Medicines (EML), which names those regarded as meeting the most important needs of healthcare systems worldwide.

Glatiramer acetate (sold as Copaxone with generics available), Mavenclad (cladribine) and rituximab made the list because of their ability to safely and cost-effectively slow or delay the disease’s progression.

“Multiple sclerosis is the most common nontraumatic cause of neurological disability in young adults, with approximately 2.8 million people living with multiple sclerosis worldwide,” the WHO Expert Committee on Selection and Use of Essential Medicines wrote in its executive summary. “The Committee considered that the inclusion of effective and safe treatments for multiple sclerosis on the EML would address an important public health need and support global advocacy efforts to reduce the global burden of multiple sclerosis, especially in low- and middle-income countries.”

The list is updated every two years and compiles medications that are of high priority, safe, and cost-effective, and should be available as part of any functioning healthcare system. It’s intended to promote equitable access to medications that address health conditions with a large global burden without negatively affecting the health budgets of low- and middle- income countries.

“The List is an important tool for achieving universal health coverage, providing guidance to governments, health facilities, and procurers on which medicines are the best value in terms of benefits for individuals and communities,” Benedikt Huttner, MD, secretariat of the WHO EML, said in a WHO press release.

The committee — made up of academic, research, medical, and pharmaceutical specialists — met at WHO headquarters in Geneva, Switzerland in April to consider 85 applications covering 100 medications or formulations. Twenty-four new medicines were included on the EML, as well as 12 new ones on the Essential Medicines for Children (EMLc), which is specific for children up to age 12. The committee also cleared some new uses or formulations for already listed medications.

The committee’s choice of glatiramer acetate, Mavenclad, and rituximab as “the most effective, tolerable, and affordable options” for MS was supported by evidence of their favorable safety profile and therapeutic benefit across different settings.

These medications are also suited for different patient populations, such as pregnant women, in the case of glatiramer acetate and rituximab. While injectable glatiramer acetate and oral Mavenclad are both approved for relapsing forms of MS, rituximab hasn’t been cleared by regulatory authorities for the neurodegenerative disease.

Sold under the brand name Rituxan with a number of biosimilars available, rituximab is often used off-label for MS. Like a generic, a biosimilar has a similar safety and efficacy profile to its name brand reference biological medicine, but is typically sold at a lower price.

“The EML includes medicines only on the basis of solid evidence for safety and efficacy,” said Huttner, adding “approved indications within national jurisdictions or the availability of on-label alternatives is not a decision criterion.”

These three therapies’ different routes of administration, different prices (including the availability of more affordable generics and biosimilars), and different recommended indications are expected to facilitate access to MS therapies around the world.

Ocrevus (ocrelizumab) — the only therapy approved for primary progressive MS — was also considered for the list, but wasn’t included because the committee concluded there wasn’t enough evidence that it was better than rituximab, which works in a similar way and is more affordable, despite its benefits.

“Given the evidence base and the increased affordability of rituximab, including the availability of prequalified biosimilars, it has been prioritized over on-label alternatives as an essential medicine to treat relapsing-remitting and progressive MS,” Huttner said.

The EML was launched in 1977. With the recent updates, 502 essential medicines are listed on it and 361 are on the EMLc. This year’s update also included medications for cardiovascular disease, infectious disease, cancer, among others. More than 150 countries use the WHO lists to guide their decisions about the availability and coverage of medications.

“For over 40 years, countries all over world have relied on the WHO Essential Medicines List as a definitive, evidence-based guide the most important medicines for delivering the biggest health impact,” said Tedros Adhanom Ghebreyesus, PhD, WHO director-general. “Rising prices and supply chain disruptions mean that all countries now face increasing problems in ensuring consistent and equitable access to many quality-assured essential medicines. WHO is committed to supporting all countries to overcome these obstacles to increase access with equity.”