Access to disease modifying drugs
Disease modifying drugs is an umbrella term for drugs that may change the underlying course of MS and are used for those with the relapsing form of the disease.
New disease modifying drug treatments are currently going through licensing and NICE appraisal. These are:
The MS Trust is fighting hard through the consultation process to ensure that NICE rules in favour of each treatment so that they can be prescribed for people with MS where appropriate. We advocate a coherent approach to prescribing all disease modifying drug treatments, both established and new.
None of these potential new treatments yet has a licence for use in MS. Without a licence they cannot be prescribed at all - NICE's role is to judge whether or not the NHS should pay for them.
The EMA (European licensing agency) has made an initial indication in favour of teriflunomide and BG-12, although full licences have yet to be granted. Decisions on laquinimod and alemtuzumab are due later this year. If any of the drugs is delayed during the licensing process, then this will slow down the appraisal process as NICE will only rule on licensed treatments.
So far, NICE has assumed each treatment will be licensed. Their anticipated guidance publication dates are as follows:
- Teriflunomide January 2014
- BG-12 (dimethyl fumarate) January 2014
- Laquinimod February 2014
- Alemtuzumab April 2014
Consequently, the earliest anyone with MS might be prescribed one of these is spring next year. NICE guidance applies to England and Wales. The Department for Health, Social Services and Public Safety in Northern Ireland will make their own assessment, as will the Scottish Medicines Consortium in Scotland. Both tend to wait for NICE's appraisal before embarking on their own processes.