The Multiple Sclerosis International Federation has applied to have Rituxan, Mavenclad and Copaxone added to the World Health Organization’s list of essential medications.
Multiple sclerosis (MS) affects about 2.5 million people worldwide. Although over a dozen disease-modifying treatments (DMTs) are approved to treat MS, access to these therapies in low-and middle-income countries is often limited.
In an effort to expand access to MS treatments worldwide, the Multiple Sclerosis International Federation (MSIF) applied to have three DMTs for MS included in the World Health Organization (WHO) essential medicines list. Inclusion in the WHO list of essential medicines is seen as a first step in assuring equitable access to effective therapies in low- and middle-income countries. The WHO’s list can act as a model for health officials as they draw up lists of medications they will supply.
After an 18-month decision-making process, MSIF sought to have Rituxan (rituximab), Mavenclad (cladribine), and Copaxone (glatiramer acetate) added to the WHO list of essential medicines.
This isn’t the first time the federation has sought to have MS medications added to WHO’s essential medicines list. In 2018, the group applied to have Copaxone (glatiramer acetate), Gilenya (fingolimod), and Ocrevus (ocrelizumab) on the WHO essential medicines list. However, the WHO Expert Committee on Selection and Use of Essential Medicines did not recommend including them on the 2019 list. The committee said was no clear evidence that the treatments were superior to existing MS therapies in terms of efficacy, safety, and affordability and that the application left out off-label and commonly used medications.
Using this feedback, MSIF collaborated with the Cochrane MS group to assess a total of 30 MS therapies (including off-label treatments) for submission of a revised application. An MSIF international panel, consisting of patient representatives and several stakeholders, utilized recommendations from two guidelines to select treatments based on several criteria, such as the trade-off between a treatment’s benefits and harms, cost and cost-effectiveness in low-income and middle-income countries, potential to reduce health inequities, availability of generics or biosimilars, among other factors. The panel also evaluated whether the treatments addressed the needs of children and adolescents, pregnant wome, and lactating women.
The revised application, which included Copaxone, Rituxan, and Mavenclad, was submitted on December 11, 2022. For Copaxone and Rituxan, there are generics and biosimilars available, respectively. Rituxan is used off-label to treat MS. Because some countries may not allow off-label prescribing, MSIF submitted Ocrevus as an alternative.
The WHO Expert Committee is scheduled to meet on April 24-28 to review all essential medicines list applications. A decision is expected within the following weeks.