More than 100,000 people in the UK have multiple sclerosis (MS), the most common cause of serious physical disability in working age adults, according to the MS guidelines set out by the National Institute for Health and Care Excellence.
Although the condition is regarded as relatively rare and public awareness of it is low, recent innovations in treating and assessing MS are creating a fresh focus on the disease. Research suggests, for example, that MRI scans – already used in diagnosis – may be useful in predicting how MS will progress. In addition, a new drug therapy just approved in the US offers help for symptoms in the most chronic form of the condition. But, given that the drug has yet to be licensed in Europe, can the UK keep up with the latest innovations in the treatment of MS?
This was the backdrop to a recent roundtable discussion, supported by biotech company Sanofi Genzyme. Are the tools for assessing MS fit for purpose? How can early diagnosis and treatment be sped up? What matters to patients? These were among the questions explored by a panel of experts.
What is MS?
MS is a lifelong neurological condition that affects the central nervous system and involves damage to the coating around the nerve fibres. Symptoms, varying in severity from mild or remitting to debilitating, include difficulties with walking, balance, vision and speech. In its most chronic form, MS can cause blindness and severe disabilities.
While there is no known cure, the past 20 years has seen a shift from no available treatments to the creation of drug modifying therapies (DMTs) to help control symptoms in some types of the condition. Dr Klaus Schmierer, reader in clinical neurology at Queen Mary University of London and consultant neurologist at Barts Health NHS Trust, said: “MS treatment has really taken off and been revolutionised. We need to pick up that pace.”
There are three types of MS. About 85% of people diagnosed have relapsing-remitting MS (RRMS), with episodes of new or increasing symptoms that worsen then improve over time. About 65% of people with RRMS may develop secondary progressive MS, involving fewer or no relapses but increased disability. The remaining 10-15% of people are diagnosed with primary progressive MS PPMS, which involves worsening symptoms that build up over years without remission.
Recently, the first licensed drug treatment for people with PPMS was approved in the US. The drug, which can slow the rate of progressive MS, is under review by the European Medicines Agency.
Diagnosis, referral and the problem of delays
GPs are the gatekeepers to diagnosis: they cannot diagnose themselves but can refer patients with suspected MS to a neurologist who confirms or rules out the condition. However, the variable symptoms in all types of MS make it a challenge for GPs to decide on when to refer. Debbie Quinn, policy adviser to the UK MS Specialist Nurse Association, said: “GPs are in a very difficult position – where is that threshold? Because some symptoms will come and go for a few years. A lot of the time symptoms will appear like a trapped nerve.”
George Pepper, who was diagnosed with RRMS at 22 and is co-founder of social network Shift MS, said his diagnosis was relatively fast due to his serious symptoms. “I had some discomfort in my shoulder – I didn’t put it down to neurological symptoms. It persisted and, understandably, the GP put it down to a trapped nerve.”
When Pepper developed eyesight problems a few weeks later, the GP knew he had optic neuritis – inflammation of the optic nerve that is associated with MS. That, said Pepper, “was a red flag to my GP”. Attendees also heard that the shortage of neurologists undermines diagnosis rates. Not all hospitals have neurology departments, or magnetic resonance imaging (MRI), which is one of the main methods of diagnosing MS.
“We are still quite short of neurologists. When you look at the current distribution, it is something like one neurologist in 100,000 of the population,” said Schmierer, adding that the UK compares badly to the rest of Europe, which has one neurologist per 25,000 people.
MS Society research showed that 39% of patients wait more than a year to be diagnosed. Dr Jeremy Hobart, consultant neurologist at Plymouth Hospitals NHS Trust said: “There’s a delay in the condition being recognised; a delay in referral to a neurologist; a delay in seeing a neurologist and in the timing of investigations, and in the reporting of those investigations.”
Dr Ann Robinson, a north London GP, suggested diagnosis might be quicker if GPs used the urgent referral system currently in place for patients suspected of having cancer. This would mean patients being referred to a neurologist within two weeks, rather than waiting, in some cases, more than a year. However, Robinson acknowledged that funding constraints make this difficult: “There are no resources or political will to fund a two-week wait.”
Another challenge in MS treatment is the relatively low takeup of available drug therapies. The UK, according to the Association of British Neurologists, is ranked 25 out of 27 European countries for the number of people with the relapsing form of MS who use DMTs. MS Society interim director of research Susan Kohlhaas said: “When people have access to MS nurses and neurologists and feel informed about the treatment out there, they’re much more likely to be on treatment.”
Hobart suggested lowering the investigation threshold to drive up rates of diagnosis: “We have to lower the threshold for investigation … to pick up those who do have the disease.”
However, lower thresholds would be costly, warned London GP Dr Kate Adams. Referring to the fact that MRI scans can cost upwards of £130, she said that while GPs do not limit referrals, “there’s only so much money in the health system”.
Dr Raju Kapoor, consultant neurologist at the National Hospital for Neurology and Neurosurgery in London, said increased costs caused by speeding up diagnosis could be offset by improved health as people stay in work for longer. He said: “We’re getting into health economics – if you remove the lag, we will save money.”
Another approach to improving diagnosis, said Kapoor, is better contact between GPs and the neurologists to whom they refer patients. Kapoor said: “It’s rare for a GP to contact me directly, but when they do it’s actually quite rewarding because you can solve things very fast.” Adams regularly contacts specialists directly, and in Plymouth, said Hobart, GPs directly contact radiologists specialising in the central nervous system to discuss MRI.
Could testing be simpler?
Future strategies, said Peer Baneke, MS International Federation chief executive, could involve spending on new diagnostic tools, such as blood tests. Blood tests are currently used to rule out conditions similar to MS, but Baneke said: “Is it realistic to expect at some stage you could have a different marker for MS that would give an indication of the diagnosis?”
Attendees discussed off-label prescribing options – using medicines outside the terms of their licence if based on evidence and in patients’ best interests. However, as Kapoor said, “the fact we’ve been so rigid has meant we’ve not exposed our patients to a lot of potentially toxic drugs”.
Might the new NHS online system to manage high-cost drugs, Blueteq, result in drug therapies being rationed? No, according to Kapoor: “It’s about what’s on the label, so if a patient says ‘I want a high-cost, high-potency drug’ but they can’t have it, this isn’t based on it being high cost, it’s because the drug isn’t licensed for that particular situation.”
Attendees agreed that treatment decisions should be made jointly by patients and professionals. Pepper said his severe symptoms drove him to immediately consider “the top shelf” of drug therapy. However, he described the patient experience as “hugely variable”. He raised concerns that members of the social network for MS that he founded, Shift MS, may shun available treatment because they are not adequately informed. “I see a lot in our community talking of opting out of treatment – they just don’t particularly want to have treatment,” he said, adding: “I don’t think the implications of that decision are made clear – it’s hugely important to engage people with MS to empower themselves as early s as possible.”
Many around the table echoed Hobart’s optimism that “in relapsing forms of the condition, we can alter the natural history”. In addition, said Kapoor, new developments on the horizon for the progressive form of MS, mean “we are in a better place to control the disease”. The consensus, Robinson concluded, was that treatment must be more efficient – regardless of the type of MS. “Anything that makes access to neurologists and care of patients better is going to impact on people living with MS.”
At the table
David Brindle (chair) Public services editor, the Guardian
Dr Kate Adams GP and Guardian contributor
Susan Kohlhaas Interim director of research, MS Society
Debbie Quinn Policy adviser, UK MS Specialist Nurse Association
Dr Jeremy Hobart Consultant neurologist Plymouth Hospitals, NHS Trust
Dr Raju Kapoor Consultant neurologist, National Hospital for Neurology and Neurosurgery
Dr Ann Robinson GP and Guardian contributor
Peer Baneke Chief executive, MS International Federation
George Pepper Co-founder, Shift MS
Dr Klaus Schmierer Consultant neurologist, Barts Health NHS Trust