Disease modifying drug therapy Eligibility criteria
Because the disease modifying drugs act in different ways, not every person with MS will benefit from, or even respond to, the drugs in the same way. For this reason guidance has been issued setting out the eligibility criteria for the prescribing of the licensed drugs.
Self-administered drugs
Prescribing guidelines
The Association of British Neurologists (ABN) published guidance for the treatment of multiple sclerosis with interferon beta and glatiramer acetate in 2001. The guidance is subject to ongoing review so people considering disease modifying drugs should discuss all issues relating to eligibility with their consultant or MS nurse.
On the basis of the 2001 ABN guidance for the prescribing of interferon beta and glatiramer acetate, in order to start treatment on any one of the self-administered disease modifying drugs an individual must:
- be able to walk at least 10 metres with or without assistance for interferon beta; and at least 100m without assistance for glatiramer acetate
- have experienced at least two clinically significant relapses in the last two years
- normally be aged 18 or above
Licence indications
The ABN guidelines are more prescriptive in their recommendations than the licensing information for each of these drugs. The following is an overview of the products licensed for use in the respective subtypes, or potential presentation of MS in the case of clinically isolated syndrome:
- Relapsing remitting MS
- Secondary progressive MS
- Clinically isolated syndrome (CIS)
The licensed drugs for relapsing remitting MS are: Avonex, Betaferon, Rebif, Extavia and Copaxone.
The licensed drugs for secondary progressive MS where relapses are still a feature are: Betaferon, Extavia and Rebif.
Four of the five self-administered disease modifying drugs are licensed for use in clinically isolated syndrome. Current evidence supports early treatment with the drugs to delay progression to clinically definite MS.
The licensed drugs for treatment of clinically isolated syndrome are: Avonex, Betaferon, Extavia and Copaxone.
Hospital-administered drug
Prescribing guidelines
The National Institute for Health and Clinical Excellence (NICE) for England and Wales and Northern Ireland; and the Scottish Medicines Consortium (SMC) for Scotland, issued guidance for NHS prescription of natalizumab (Tysabri) in 2007. The guidance recommends natalizumab is used only in the treatment of rapidly evolving severe relapsing remitting multiple sclerosis (RES) as defined by:
- two or more disabling relapses in 1 year, and one or more gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI)
- a significant increase in T2 lesion load compared with a previous MRI
Licence indications
- Rapidly evolving severe relapsing remitting MS
- patients with high disease activity despite treatment with interferon beta
- patients with rapidly evolving severe relapsing remitting MS
Natalizumab is the only disease modifying drug to be licensed for this specific subtype of MS. It is licensed as a single disease modifying drug treatment in highly active relapsing remitting multiple sclerosis for the following groups: