- ECTRIMS has joined the global MS community in endorsing MSIF’s bid to have MS DMTs added to the World Health Organization’s Essential Medicines List.
- Despite the efficacy of DMTs, access is significantly hindered, primarily by affordability in 70% of countries worldwide.
- MSIF’s application could help address these huge disparities in access to MS care.
ECTRIMS is one of 15 global MS organisations to endorse an application by the Multiple Sclerosis International Federation (MSIF) to add three disease modifying therapies (DMTs) to the World Health Organization’s (WHO) Essential Medicines List (EML). If successful, the bid could represent a huge step forward in providing equitable access to MS treatment and 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), changing the face of MS care in many countries. Progress, however, has been far from equitable. In 70% of countries, access is restricted, largely by issues around affordability. (1)
Inclusion on the EML, designed to help policy makers and ministries of health decide which medicines are needed to meet the minimum healthcare needs their populations, would formerly mark MS as a global healthcare concern. It would give MS DMTs a seal of approval from WHO, and act a key tool for advocacy and awareness raising activities at a national level.
“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 rectify. We know that DMTs are able to reduce relapses and slow progression, (2) yet people are still being left behind.
“Adding MS DMTs to the WHO EML would push MS up the healthcare priority agenda of WHO and of individual countries. It would be an important first step in improving the lives and outcomes of thousands of people living with around the world.” ECTRIMS President, Mar Tintoré.
The process
MSIF first lobbied for DMTs to be added to the EML in 2018. While the WHO Expert Committee rejected the application, it 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 evidence for azathioprine and rituximab, as requested by the WHO Expert Committee following the original application, while the MEMP panel carried out a network meta-analysis of 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.
Their work looked at:
- the balance of benefits and harms
- the certainty of the evidence base
- cost and cost-effectiveness in low-resource settings
- values, equity, acceptability, feasibility, and availability, particularly in low-resource settings
- the needs of special populations, including pregnant and breast-feeding women, and paediatrics
As a result of this work MSIF has recommended that, as a minimum, cladribine, glatiramer acetate, and rituximab for the treatment of MS be included in the WHO EML.
“Access to MS treatment is subject to a country’s healthcare system and whether someone can pay for services. The Atlas of MS shows that in 70% of countries people with MS face barriers in accessing DMTs, and around half of countries say a major barrier is the cost to the individual, government, healthcare system or insurance provider.
“It is vital for people with MS to get the right treatment at the right time, which is why MSIF has applied for MS DMTs to be added to the WHO EML.” MSIF CEO Peer Baneke
The application will be assessed in April, with the MSIF being notified of the outcome in June.
For more information on the application, including on how cladribine, glatiramer acetate, and rituximab were selected for inclusion, go to the MSIF website.
Reference:
- 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.