Successful advocacy results in cladribine access for Iran

MS is a condition that should be treated. This was the message from the World Health Organization (WHO) when it added three MS treatments to its list of essential medicines (EML) in 2023. The other key message is that it is important to make a range of treatments available, to meet the diverse needs of people with MS at different stages of their lives.

Why was the Iran MS Society interested in cladribine?

Iran has had access to several disease-modifying treatments (DMTs) for MS for many years, such as interferon beta, dimethyl fumarate, teriflunomide, fingolimod, natalizumab and ocrelizumab – but until 2024 cladribine was missing from this list.

Cladribine offers certain advantages, particularly in low-resource settings. It is an oral medicine, requiring only 16-20 days of total treatment distributed over 2 years, and at this point, many people with MS will not need any further treatment. Therefore, it is low burden for people with MS, and less likely to be influenced by treatment disruptions in settings where medication supplies can be erratic. It also means that family planning and pregnancy can be planned around when people are getting their treatment.

The Iran MS Society takes action

There are many steps that need to happen for a drug to be made available in a country. One of these is getting the treatment registered in the country, so it can be added to that country’s approved list of treatments. Pharmaceutical companies will often apply to a country to have their treatment registered, and the government organisation will have to weigh up all the available evidence.

This is where national patient organisations, such as the Iran MS Society can play a role: by setting out clearly the benefit of having this specific drug made available for people with MS.

1. Support for registration of cladribine

The Iran MS Society, which includes healthcare professionals and people with MS, wrote a letter of support when Merck applied to have cladribine registered in Iran in 2024.

2. Discussion with the Ministry of Health

The formal application process was followed by discussions with the Iranian Ministry of Health. Professor Mohammad Ali Sahraian, the Vice-President of the Iran MS Society is also a member of MSIF’s International Medical and Scientific Expert Group, and is very knowledgeable about the work to get MS treatments listed on the World Health Organization’s Essential Medicines List. Therefore, he could use the WHO EML listing as key evidence for the importance of making cladribine available to people with MS in Iran.

3. Advocacy to get insurance coverage

Although cladribine was successfully registered in Iran in 2024, at first it was only available if covered by private insurance, or at very high out-of-pocket cost. It was not available through the public insurance scheme. The Iranian MS Society therefore wrote another letter setting out the case for why cladribine should be covered by public insurance, requesting the Ministry of Health to provide some co-payment for this treatment. Here again, the evidence of cladribine being listed by the WHO on the EML was used in negotiations with insurance companies. Cladribine is now partly covered by the public insurance scheme, meaning that more people are able to access this treatment.

How did the listing of MS treatments on the WHO EML help?

In countries where several treatments are already available, policy-makers might push back on requests for additional treatments to be licensed, even more so if the treatments will require government reimbursement. So the listing of specific treatments on the WHO EML really helped, by showing that a specific treatment recommended by the WHO as a minimum essential treatment was not available in the country.