WHO asked to add 3 MS treatments to list of ‘essential medicines’ | MS International Federation effort to ensure better therapy access

Aiming to promote equitable access to multiple sclerosis (MS) treatments worldwide, an international MS alliance is asking that three disease-modifying therapies (DMTs) be added to the World Health Organization’s (WHO) list of essential medicines.

Inclusion on the WHO list is considered an important if “initial” step in assuring that helpful treatments are available to people in lower- and middle-income countries, scientists involved in the MS International Federation (MSIF)’s 18-month effort stated.

The three DMTs requested for addition are rituximab (sold as Rituximab), Mavenclad (cladribine), and glatiramer acetate (sold as Copaxone, generics available).

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‘Initial step’ in bringing DMTs to people in low- and middle-income countries

MSIF, a network of national MS organizations, patients, family or friends, and researchers working in the MS space, aims to bring effective MS treatments to people in regions where they are often limited. The WHO’s model list of essential medicines can prod countries to include these medications on their own lists of available and possibly subsidized therapies.

“Access to treatments for neurological disorders is egregiously insufficient, particularly in low-income and middle-income countries,” Jagannadha Avasarala MD, PhD, an MSIF panel member who contributed to the application, and director of the MS care center connected to the University of Kentucky, said in a university press release.

An editorial summarizing the application, titled “Towards equitable access to treatment for multiple sclerosis,” was published in the journal The Lancet Neurology.

MS occurs when the immune system attacks the myelin sheath, a fatty coating around nerve cell fibers that protects nerve cells and helps them to send information. Damage to myelin impairs the proper transmission of electrical signals, leading to a range of disease symptoms.

While more than a dozen DMTs are currently approved for MS, many are only available in wealthier countries.

To close this care gap, the MSIF has been trying to include certain DMTs on the WHO’s essential medicines list. In a previous application filed in 2018, the group asked the World Health Organization to include glatiramer acetate, Gilenya (fingolimod), and Ocrevus (ocrelizumab).

However, a WHO expert committee decided that clear evidence failed to show these treatments were superior to other MS medications in safety, efficacy, and affordability. The committee also stated that the application had not considered commonly used and off-label medications.

MSIF considered 30 on- and off-label MS treatments in current request

Based on this feedback, MSIF, in collaboration with the Cochrane MS group, assessed a total of 30 therapies used in MS both on- and off-label.

An MSIF international panel, composed of patient representatives from low- and middle-income countries and several other stakeholders, considered recommendations from the MSIF Off-Label Treatment and the MSIF Essential Medicines panels. The collected evidence was systematically analyzed to identify the essential medicines.

Treatments were selected using the McMaster GRADE system, which assesses the balance between a therapy’s benefits and harms, the quality of the evidence, cost and cost-effectiveness in poor-resource countries, and availability of biosimilar or generic versions.

Other considered criteria included the potential to reduce health inequities, benefits to health outcomes valued by patients, availability, and whether the medications’ helped address the needs for three special populations (children and adolescents, pregnant, and breastfeeding women).

The group worked for more than a year, holding several virtual meetings during the pandemic, before submitting to WHO its revised application for three DMTs: rituximab, Mavenclad, and glatiramer acetate.

Rituximab is used off-label for MS, meaning it is not approved to treat MS patients. In countries where off-label medications are prohibited or difficult to obtain, the group suggested the inclusion of Ocrevus as an alternative to rituximab.

The WHO expert committee is set to meet April 24-28 to discuss all EML applications, and a decision is expected over the following weeks.

Even if the WHO decided to include these three MS therapies, the “addition of a drug to the EML is still the first hurdle to achieving access to therapies,” the editorial noted. “How access to these medications is implemented … will be the next challenge.”

Some of the proposed DMTs are still under patent or are biologicals, making them expensive, its scientists wrote. Additional measures are required to make these treatments affordable, such as patent owners licensing their patents to third parties for production.

A better diagnosis and management of MS patients in neurological services, as well as adequate infrastructure and training for the safe and effective administration of these therapies, are also necessary.

According to the group, the application is comprehensive and rigorous, has the endorsement of international organizations, and could serve as the basis for future EML applications in other neurological conditions.

2023-03-13 16:31:38