Helen Johnson investigates how successful the government drug 'risk-sharing' scheme has been for patients with multiple sclerosis

in february 2002 the department of Health announced an innovative scheme designed to give patients with multiple sclerosis (MS) wider access to two drug treatments - beta interferon and glatiramer acetate.

The scheme was introduced following a protracted, and often controversial, appraisal process by the National Institute for Clinical Excellence. NICE refused to recommend NHS use of the drugs, concluding that their limited clinical effectiveness did not justify the high treatment cost. It invited the department, National Assembly for Wales and manufacturers to consider other ways in which these drugs could be made available on the NHS in a cost-effective manner.

Under the scheme - positioned as a "payments by results" initiative - the NHS will fund individual courses of treatment as long as patients continue to benefit. Specialist neurologists will determine a patient's eligibility and monitor their response to treatment over an extended period of time. If patients fail to respond to treatment as anticipated, the cost of the drug to the NHS is reduced, thereby transferring some of the financial risk on to the manufacturers. Such was the government's commitment to ensuring effective implementation of the scheme, that ministers issued a declaration placing Health Authorities and Primary Care Trusts (PCTs) under a statutory obligation to fund and implement it.

Patients are eligible for NHS treatment if they suffer from relapsing/remitting, or secondary progressive, MS and meet strict assessment criteria devised by the Association of British Neurologists. It was estimated that 8-10,000 of the 63,000 MS patients in England and Wales could benefit.

Critics have described the "ground-breaking" scheme as nothing more than a compromise deal which allowed ministers to dodge the healthcare rationing debate, whilst heading off a potential legal challenge to the NICE decision by manufacturers. Patient groups warmly welcomed the scheme whilst expressing disappointment that its announcement came too late for those patients whose disease had progressed beyond the point where they might have been eligible to participate.

MS centres that had the necessary resources and infrastructure in place to do so were permitted to write NHS prescriptions for beta-interferon and glatiramer acetate from May 6, 2002. Six months on, have the high expectations been met?

In practice the scheme has taken longer than expected to become fully operational. Issues such as funding, service infrastructure, specialist nursing personnel and - in particular - robust mechanisms for patient assessment and data collection have severely delayed its start in many parts of England and Wales.

Initial hopes that neurology centres would be geared up to administer the scheme by May proved to be wildly optimistic. The NHS is generally expected to meet the costs of the scheme from the general budget, including not just the cost of the drugs - estimated at £12,000 per patient - but also the costs needed to assess and support patients. Nearly half of MS centres have reported difficulties either in funding the total cost of the scheme or in putting in place the necessary systems to assess and monitor patient progress.

Fears about the length of time needed to complete initial patient assessments have been justified. Patient groups warned that a major expansion of neurological services would be required in order to assess some 20-30,000 patients for eligibility without causing undue delay and distress. It is anticipated it will take another 12-18 months to complete the recruitment of sufficient numbers of patients for monitoring purposes.

However positive progress is now being reported on a number of fronts. Groups involved in the practical implementation of the scheme confirm that the majority of PCTs have nominated clinical leads responsible for driving it forward at a local level, whilst 44 centres have specialist MS nurses in post. Patient data collection - initially hampered by the lack of robust monitoring tools - is underway, with consultants reporting that data has been collected from several hundred patients. A consortium of clinicians and health service researchers has been appointed to manage the data collection and monitoring aspects of the scheme nationally. However only eight out of 50 prescribing centres contacted by the consortium were assessing patients and prescribing at the end of September. Frustrated MS patients continue to report what are perceived to be "stalling tactics" by neurological centres and trusts.

After a delayed start to the scheme, there are now encouraging signs of progress, but it is still too early to say whether this initiative will end uncertainty for thousands of MS patients.