The Pharmaceutical Journal
Vol 269 No 7209 p153-154
3 August 2002

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Slow start for MS risk-sharing scheme

Six months ago, the Department of Health announced that people with multiple sclerosis would be able to take part in an innovative risk-sharing scheme for MS drugs financed jointly by the pharmaceutical industry and Government. Monika Polak (member of staff of The Journal) investigates what progress has been made since then

On 4 February, the Department of Health said it would be entering into a revolutionary risk-sharing scheme with the pharmaceutical industry, where the cost of disease-modifying drugs for multiple sclerosis (MS) — beta interferon and glatiramer — would be shared between itself and the manufacturers. If the drugs were found not to be working, the National Health Service would get all of its money back.

At the time, clinicians and patients welcomed the one-off scheme, and hoped the drugs would be quickly supplied the to those who needed them most and who had already endured a substantial wait. However, setting up the scheme is proving to be a long, drawn-out process. This slow start follows a protracted appraisal of the drugs by the National Institute for Clinical Excellence, which instead of taking the usual one year to complete, took more than two.

Recruitment to the scheme should have begun in May, but only a minority of patients have so far been assessed and had treatment started. Indeed, the original Department of Health circular that announced the scheme last February recognised it could take up to 18 months to complete the recruitment phase. In an attempt to maintain momentum, the Department reminded all primary care trusts and strategic health authorities of their obligations, including a statutory obligation to provide funding for beta interferon and glatiramer, in a new health service circular last month. SHAs should have already identified local leads for the scheme and notified the Department and PCTs. Similarly, PCTs are expected to forward the name of a local lead to SHAs by 31 August.

David Harrison, spokesman for the Multiple Sclerosis Society, says the slow start was foreseen by many: "Everybody knew that the process of getting people into the system and getting them assessed was going to be a lengthy one.

"The scheme technically started on 6 May and there is obviously an expectation among people who have been waiting a long time that the drugs will be forthcoming quickly. But it is not quite as simple as that — this is part of a structured, national study, so the baselines and the way to collect and analyse data have to be in place first," he added.

Mr Harrison also hopes the appointment of an overall co-ordinator, announced in last month's circular, will quicken the pace. A consortium led by Professor Jon Nicholl of the School for Health and Related Research (ScHARR) at Sheffield University has been appointed to co-ordinate patient monitoring and oversee the trial at a national level. Although a minimum data set requirement has been issued by the scheme's steering group, allowing established centres to enrol patients as soon as possible, one of the first tasks for Professor Nicholl and his team will be to determine the full data requirements. Initial meetings between specialist centres and co-ordinators are likely to set time scales and identify any difficulties.

According to Mr Harrison, there are a variety of obstacles to be overcome: "There are different reasons for delay in different places — some centres are readier than others. In certain places, there are limited services, for example no MS nurses, or not enough neurologists," he says.

In recognition of this, the MS Society, together with MS drug manufacturers and the NHS are funding 21 specialist MS nursing posts this year. Mr Harrison says recruitment via this fast-track route is going well, and he expects a significant number of posts to be approved imminently. Individual manufacturers are also providing funding for additional consultant sessions and other clinical and administrative posts, as well as for additional MS nurses.

But problems of manpower are not new in the NHS. Perhaps of more concern are reports coming in to the MS Society of neurologists telling patients that these disease-modifying drugs are not available to patients on the NHS, or that funding for treatment is not available.

Mr Harrison says: "There are misunderstandings about what the scheme means, even among health professionals. In one case, the consultant could not work out which PCT the patient fell under and therefore who would fund the treatment — these are the sorts of glitches in the system.

"The Department of Health has asked the MS Society to let it know of any problems that are occurring. We are as keen as anyone to see people on these drugs as soon as possible and with this latest reminder from the Department, we can look to things falling into place," he added.

As well as trying to identify problem spots, the DoH says it will be seeking reassurance from health authorities by mid-September that PCTs have complied with their duties in relation to the scheme. A DoH spokeswoman said details of which specialist centres would be involved in each area were still being finalised, but that the work was likely to be completed "in the next few weeks".

The Association of British Neurologists is helping the DoH ensure that sites are suitable as MS centres. Professor of neurology at Liverpool University, Professor David Chadwick, is chair of the ABN advisory group on MS guidelines, currently advising the Government on this issue. He estimates there may be as many as 50 centres in the United Kingdom eventually involved.

Some of these have already been providing a specialist MS service, working to ABN clinical guidelines on beta interferon and glatiramer acetate in multiple sclerosis, published in 2001. These are being used as a basis for prescribing under the risk-sharing scheme and recommend that treatment is initiated by a consultant neurologist with expertise in MS and that patients are followed up monthly or quarterly for the first year by a consultant neurologist. Patients should subsequently be seen at six-month intervals.

Professor Chadwick says: "One or two centres have collected the minimum data set on patients who have already started treatment. There are some centres where patients were getting treatment all the time. In some regions there is a strong hub and spoke pattern of care that can provide the multidisciplinary care needed. Other areas don't have that sort of strength — individual neurologists may take on prescribing for their own patients, rather than handing that over to a central facility."

According to Professor Chadwick, the United Kingdom has one neurologist per 200,000 of the population — many fewer than in other western European countries. And although more MS nurses are now being trained, he believes "a considerable burden" will still fall on ABN members.

"The difficult bit is ensuring that centres have adequate resources to assess and document what may be quite a large number of patients who are deemed eligible for treatment for the first time," Professor Chadwick says. "Data collection forms will be available by September, but I don't think all the centres will start then, because of the resource implications.

"In some parts of the country, patients will get treatment immediately, others will see delay as the resources come in. I would hope that between 10 and 20 centres will be in a position to be working the scheme by September," he added.

Although the Welsh Assembly has ring-fenced £1.8m for the scheme, Ministers in England and Scotland have been less generous, telling SHAs and health boards they must provide funding from their existing budgets. The DoH justifies this position by saying the MS drugs deal had already been taken into account when baseline funding allocation were made the previous year. The risk-sharing scheme could cost the NHS £50m a year and cash-strapped SHAs and PCTs may find it increasingly difficult to prioritise funding.

Professor Chadwick believes the huge organisational changes currently taking place in the NHS have also impacted on implementation of the scheme, and said some neurologists were reporting problems with funding. "How compliant PCTs in some areas will be with central advice is debatable. There may be costs of around £50m — that's a significant chunk of development money," he said.

However, on a more positive note, Professor Chadwick believes the scheme will help develop neurology services based on multidisciplinary teams, which will improve the management of people with other conditions, such as epilepsy. "That will be an important by-product of this scheme," he concludes.

Clearly all sides are committed to ensuring all eligible patients are treated as quickly as possible. However it seems that variations in the standard of care for MS patients look likely to continue in the short term at least.