BMJ 2002;324:316 ( 9 February )
Ruth Little, BMJ
Patients with multiple sclerosis will now be able to have "disease modifying" drugs under a new government scheme of "risk sharing" for England and Wales, the Department of Health announced this week. Patients who are assessed as likely to benefit from the drugs will be given them until they are deemed to be no longer effective.
Simultaneously, the National Institute for Clinical Excellence (NICE) released its "guidance on drugs for multiple sclerosis" which recommended against the use of interferon beta or glatiramer acetate by the NHS on the basis of "clinical and cost effectiveness."
NICE recommended in October that the Department of Health, the National Assembly for Wales, and drug manufacturers should explore cost effective ways of making the drugs available to patients with multiple sclerosis (10 November, p 1087). In response the NHS and five pharmaceutical manufacturers have united for a "payment by results" scheme.
Under the new scheme eligible patients will be contacted by a specialist neurologist and assessed. Individuals will be eligible if they have relapsing and remitting multiple sclerosis or secondary progressive multiple sclerosis with prominent relapses. They must also meet the Association of British Neurologists' guidelines and be monitored for treatment efficacy. Eligible patients will undergo a lengthy assessment of their baseline level of disability, against which the disease progression and treatment effect will be compared each year for 10 years. Only their neurologist will be able to prescribe the appropriate medication.
Treatment will be funded by the NHS until it is deemed to be no longer effective. Under the scheme, the cost of drugs per patient has been cut from between £7000 ($9970; 11500) and £12000 to between £6000 and £9000 a year per patient. The expected yearly NHS bill is estimated at £50m.
Groups of patients will be monitored over the lifetime of the scheme, and costs to the NHS will be adjusted according to whether expected benefits to patients are realised. The price will drop further if expected clinical improvement targets are not met.
The government has thrown its backing behind the scheme. The health secretary, Alan Milburn, said: "Consultant neurologists will have a choice of treatments for their patients. We are also introducing statutory obligations to ensure that decisions by neurologists are backed up with funding so that these patients get the drugs they need.
"Patients will be monitored to see whether the drugs are working for them. Prices will be reduced if patients don't benefit as anticipated."
Up to 20 000-30 000 patients of the estimated 60 000-80 000 people with multiple sclerosis will need assessment, of whom about 10000 are expected to be eligible. Neurology centres will need to organise assessment procedures, which should be in place by May 2002. The drug manufacturers will also provide some specialist nurses to assist in the assessment process, which may take up to 18 months.
The scheme will produce data on this cohort of patients for further information and research into the efficacy of this treatment.
NICE has recommended that the 2-3% of patients already taking interferon beta or glatiramer acetate should continue their medication until such time as both patient and doctor decide to stop treatment (according to the Association of British Neurologists' guidelines). This includes individuals taking drugs because of clinical trials and women who stopped their medication owing to pregnancy.
Association of British Neurologists' guidelines for eligibility to treatment for multiple sclerosis
Relapsing and remitting disease - eligibility for interferon beta-1a and beta-1b, and glatiramer acetate
© BMJ 2002