Everyone with MS should have access to the treatment and care they need to live their lives to the fullest. Yet in 70% of countries, people face huge challenges in accessing the disease modifying therapies (DMTs) they need. (1)
With research consistently demonstrating just how vital it is that people with MS get the right treatment at the right time (2), ECTRIMS is proud to be one of 15 global organisations backing the MSIF’s bid to have MS DMTs added to the World Health Organization’s (WHO) Essential Medicines List (EML).
ECTRIMS President, Mar Tintore, said: “The inequity of access to MS care and treatment is an unacceptable situation and one that we, the global MS community, have a duty to do all we can to rectify. We know that DMTs are able to reduce relapses and slow progression, (3) yet people are still being left behind.
“Adding MS DMTs to the WHO EML would formerly register MS as a global health concern and push the condition up the healthcare priority agenda of WHO and of individual countries. It would move the conversation from whether the therapies should be available, to how we ensure everyone, even those in low-resource settings, can access them.”
Inequitable care
Over the last two decades, 20 DMTs have been approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). These medicines have changed the face of MS care, but progress has been far from equitable. Access remains something of a location lottery, subject to the country’s healthcare system and people’s personal ability to pay.
Data from the Atlas of MS, for example, shows that while 2.8 million people live with MS worldwide, (4) in 70% of countries they face barriers, primarily linked to cost and affordability, in accessing DMTs.
Inclusion on the EML, which was designed to help policy makers and ministries of health decide the medicines needed to meet their population’s minimum healthcare needs, could represent a huge step forward.
The list, which currently contains very few medicines for neurological conditions and none for MS, acts a de facto seal of approval from WHO. This makes it a vital tool for advocacy and awareness raising activities at a national level.
Demonstrating need
MSIF first lobbied for at least one moderate efficacy/high safety DMT, one moderate to high efficacy oral DMT, and one high efficacy monoclonal DMT to be added to the EML in 2018.
The application was rejected by the WHO Expert Committee. However, the panel did recognise the public health need for effective and affordable MS treatments and requested a revised submission.
The updated application is based on a two-year programme of work supported by two independent, multi-disciplinary groups, the MSIF Off-Label Treatments panel (MOLT) and MSIF Essential Medicines Panel (MEMP). Each had international representation, including people affected by MS from Uruguay, Serbia, Namibia, and Morocco.
The MOLT panel systematically reviewed the randomised and non-randomised controlled studies of azathioprine and rituximab, as requested by the WHO Expert Committee following the original application. The MEMP panel carried out a network meta-analysis of the randomized controlled trials for all DMTs currently licenced for MS.
MSIF also partnered with internationally renowned evidence review and decision-making experts the Cochrane MS group and McMaster GRADE Centre.
The work looked at the balance of benefits and harms, the certainty of the evidence base, and cost and cost-effectiveness. They also considered values, equity, acceptability, feasibility, and availability, particularly in low-resource settings, and the needs of special populations, including pregnant and breast-feeding women, and paediatrics.
The result was a short-list of three DMTs, cladribine, glatiramer acetate, and rituximab, for inclusion on the EML application, which was submitted in December 2022.
Next steps
The WHO EML Expert Committee will meet to assess EML applications in April, with the outcome being made public in June.
Tintore added: “If successful, the application would be an important first step in improving the lives and outcomes of thousands of people living with MS around the world.”
For more information on the application, go to the MSIF website.
References:
- Atlas of MS 3rd edition. Part 2 Clinical management of multiple sclerosis around the world: Key findings about the diagnosis and clinical management of MS. (2021). Available at: https://www.msif.org/app/uploads/2021/05/Atlas-3rd-Edition-clinical-management-report-EN-5-5-21.pdf%20Accessed%20February%202023 Accessed February 2023
- Giovannoni, G., Butzkueven, H., Dhib-Jalbut, S., Hobart, J., Kobelt, G., Pepper, G., … & Vollmer, T. (2016). Brain health: time matters in multiple sclerosis. Multiple sclerosis and related disorders, 9, S5-S48.
- Liu, Z., Liao, Q., Wen, H., & Zhang, Y. (2021). Disease modifying therapies in relapsing-remitting multiple sclerosis: a systematic review and network meta-analysis. Autoimmunity Reviews, 20(6), 102826.
- Atlas of MS 3rd edition. Part 1 Mapping multiple sclerosis around the world key epidemiology findings. (2020). Available at: https://www.msif.org/app/uploads/2020/10/Atlas-3rd-Edition-Epidemiology-report-EN-updated-30-9-20.pdf Accessed February 2022