Diagnose and adios
“Diagnose and adios”. This was the phrase used to describe the management of multiple sclerosis (MS) up until the mid-1990s.
It’s hard to fathom today, but back then neurologists had little to offer people with MS by way of drugs and treatments and many were left to deal with complex and unpredictable symptoms alone. “Neurologists routinely told people like me ‘You’ve got MS – go home and learn to live with it’,” MS Trust co-founder Chris Jones remembers.
The landscape was bleak. MS specialist nurses were few and far between, research into the condition was limited and, understandably, hope was in short supply.
A changing landscape
But then, in 1996, finally a ray of light. The first disease modifying therapy (DMT) was licensed and, whilst by no means a cure, this drug did significantly reduce the number of relapses suffered by people with relapsing remitting MS. Finally, there was reason to believe the future might be a little brighter.
Unfortunately it wasn’t that simple. At the time, the DMTs were considered to be expensive at an average of £10,000 a year, and many people who had waited so long for any advancement in the treatment of MS were left disappointed when hospitals across the UK refused to fund these DMTs.
In 1999 the Department of Health (DoH) referred the DMTs for assessment by the newly-formed National Institute for Clinical Excellence (NICE, the precursor to the National Institute for Health and Care Excellence). NICE had been set up to provide evidence-based guidance for the NHS to ensure doctors used the most effective and affordable treatments. At the time, fewer than 1,000 people were actually receiving the therapies, as opposed to the 17,000 the Department of Health’s advisors estimated would benefit from the treatments.
A disappointing decision
NICE announced the results of their appraisal in July 2000 and it was not the positive outcome the MS community had hoped for. They announced that the four MS drugs (Avonex, Betaferon, Copaxone and Rebif) were not cost effective and therefore should not be made available on the NHS. The MS Trust, alongside other stakeholders, campaigned tirelessly against the NICE decision, believing people with MS deserved so much more. Two years of consultations and appeals followed, but when NICE issued its final ruling in February 2002, the decision, devastatingly, remained the same.
During the time it took for NICE to reach its decision, a further 6,400 people were diagnosed with MS. Hardly any people were prescribed DMTs, and many of those who would have been eligible for treatment had progressed significantly in terms of disability and were no longer suitable for the drugs anyway. The few lucky enough to have been put on the DMTs lived in constant fear that they would suddenly be taken off them.
In its final guidance, NICE did acknowledge that the evidence showed the four drugs did have numerous benefits for people with MS and invited the Department of Health and the pharmaceutical companies who owned the drugs to find a way to make the treatments available in a more cost-effective way.
The RSS is born
And so, the MS Risk Sharing Scheme (RSS) was born. A unique and innovative scheme, the first of its kind in the UK in fact, the aim was to ensure these treatments could be made available on the NHS in a cost-effective manner whilst the long-term cost efficiency was assessed. It operated under the oversight of a Steering Group, which included the MS Trust, and allowed people from all over the UK who met the 2001 Association of British neurologists (ABN) criteria for treatment, to access the drugs. A percentage of those people were included in a long-term monitoring study to evaluate the cost-effectiveness of the drugs over 10 years and answer some of the concerns NICE had raised in its appraisal.
Data was collected from over 5,000 patients - at the time it was the largest study of MS treatments anywhere in the world - and the final results, published in the BMJ this week, show that the four drugs included within the scheme deliver real benefits to people with MS. The data showed that the treatments are all clinically effective in slowing down disease progression in relapsing remitting MS, meaning that they are cost-effective for the NHS.
A catalyst for change
Looking back, it is clear that the long-term impact of the RSS should not be underestimated. Not only has it ensured 18,000 people with relapsing remitting MS have access to disease modifying treatments and provided the platform for new MS treatments to be approved, it has also been the catalyst for vast development in MS services across the UK. Thanks to the scheme, the number of MS nurses has increased from around 80 to over 240; the number of specialist MS physiotherapists, occupational therapists and neurologists has also risen significantly, over 70 specialist MS centres have been established across the UK and, under the RSS, funding has been made available for MS specialists to access the best training and education.
These improvements mean that the scheme has bought tangible benefits to EVERYONE affected by MS, not just those who are on a drug therapy.
For a charity of our size, it was a bold decision to get involved with the RSS, but we took the risk because we believe people with MS deserve access to the most effective treatments and the best possible MS services. As well as being administrator of the scheme, we played a pivotal role in the education and development of MS nurses throughout the RSS and we are proud to have contributed to what the RSS achieved for people with MS in the UK.
Looking to the future
But we are not resting on our laurels and we know there is still so much more to be done. The RSS was a turning point, and a hugely important turning point, but people with MS still face many challenges. One of the most pressing issues is the lack of treatment options for people with progressive MS. NICE recently rejected Ocrelizumab for early primary progressive MS on the NHS in England and Wales and we know there is a tough fight ahead to ensure this group of people have access to the treatments they deserve. We promise to continue to be in the corner of everyone affected by MS.