Who is eligible for
Disease Modifying Drugs?

Not everyone with MS is eligible for Disease Modifying Drugs, and not everyone would benefit from having them. DMDs are only prescribed on the NHS for people who meet certain criteria.

The criteria are based on the results of clinical trials of the drugs which indicated which patients would benefit. It all depends on which kind of MS you have and which drug is being considered.

Who can be considered for interferon beta and glatiramer acetate?

Interferon beta and glatiramer acetate are self-administered DMDs funded under a special scheme between the NHS and the manufacturers of the drugs known as the Department of Health Risk Sharing Scheme. Under the scheme, patients can only receive the drugs if they meet guidelines, or criteria, agreed by the Association of British Neurologists (ABN). The scheme is based on the 2001 ABN guidelines for the prescribing of beta-interferon and glatiramer acetate in multiple sclerosis. The ABN updated its guidelines in 2007 and a further revision of the guidelines was published at the end of 2009. The revised 2009 guidelines can be accessed through the References page of this site.

Let's look in detail at the criteria used to decide who would benefit from DMDs:

Relapsing remitting MS

The following criteria need to be met before you can be considered for treatment with interferon beta or glatiramer acetate

• You have been diagnosed with MS
• You must be able to walk independently:
• with an EDSS of 6.5 or less for interferon beta, meaning that you must be able to walk at least 10 metres with or without assistance
• with an EDSS of 5.5 or less for glatiramer acetate, meaning that you must be able to walk at least 100m without assistance
• You must have experienced at least two clinically significant relapses in the last 2 years

Clinically Isolated Syndrome (CIS)

Clinically Isolated Syndrome (CIS) is the first episode of MS symptoms lasting at least 24 hours, but before a formal diagnosis of MS has been made. People with CIS who show abnormalities on MRI scans within one year may receive treatment with interferon beta or glatiramer acetate provided local health service commissioners agree. Four of the five self-administered drugs are licensed for CIS. These are: interferon beta 1a (Avonex®), interferon beta 1b (Betaferon® and Extavia®), and glatiramer acetate (Copaxone®).

Secondary progressive MS (interferon beta only)

The following criteria must be met for starting on treatment with interferon beta.

• You must be able to walk (at least 10 metres with or without assistance)
• You must have experienced at least two disabling relapses in the last two years
• You must have experienced minimal increase in disability due to slow progression over the last two years.

Glatiramer acetate is not available for those with secondary progressive MS (it has not been tested in this type of MS).

The next section of the this site; 'Self-administered DMDs' will help those eligible to choose between these four DMDs.

Who can be considered for natalizumab?

Natalizumab was approved for prescription under the NHS by both NICE (for England ,Wales and Northern Ireland) and the Scottish Medicines Consortium (for Scotland) in 2007. Under the guidance, natalizumab is approved only for patients with rapidly evolving severe relapsing-remitting MS (RES). Rapidly evolving severe relapsing remitting MS is defined by:

• Two or more disabling relapses in 1 year AND
• One or more gadolinium-enhancing lesions on brain MRI;
OR
• A significant increase in T2 lesion load compared with a previous MRI

Although some people eligible for natalizumab have never taken disease modifying drugs before, some will have used interferon beta or glatiramer acetate, but still have high levels of disease activity.

The 'Natalizumab' section of this site will help those eligible for the drug, to decide if it may be beneficial for them.