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Multiple sclerosis guideline production takes off
World Report
Multiple sclerosis guideline production takes off John Maurice reviews guidelines for the manangement of multiple sclerosis in high-income countries following a new release from the UK’s National Institute of Health and Clinical Excellence.
Astier/BSIP/Corbis
Multiple sclerosis is well named. Almost everything about the disease is multiple, not just the multiple sclerotic patches in the brain that gave the disease its name. For a start, there are at least 20 possible symptoms the disease can cause, not to mention many life-changing outcomes, such as emotional and psychosocial difficulties, dependency, sexual difficulties, and loss of employment. “Multiple sclerosis has an enormous impact on almost every aspect of life and can appear in such a variety of different forms in different people who each have different needs”, says Kathleen Costello, associate vice president of Advocacy Services and Research at the New York-based US National Multiple Sclerosis Society. “It is clearly one of the most complex diseases to manage.” The complexity of managing multiple sclerosis has, in recent years, expanded the therapeutic arsenal to more than 70 different medicines, not counting the more than 50 complementary and alternative medicines and procedures of doubtful efficacy, ranging from meditation to music therapy, hyperbaric oxygen to horseback riding.
NICE recommends multidisciplinary care teams for patients with multiple sclerosis
1914
The complexity of the disease has also spawned the creation of more than 90 national and international patient and professional organisations. Guidelines, too, are not in short supply.
England’s guidelines In October, England’s National Institute for Health and Care Excellence (NICE) issued new guidelines for managing the disease, that update its previous guidelines published in 2003. The recommendations of the new guidelines pertain only
“‘...the new NICE guidelines should greatly improve multiple sclerosis care and treatment...’” to symptoms of the disease, not the so-called disease-modifying therapies nor the management of the relapses that characterise the disease. Three new recommendations were generally welcomed. One calls for a person with suspected multiple sclerosis to be referred as soon as possible to a consultant neurologist experienced in diagnosing the disease. Paul Cooper, consultant neurologist at the Greater Manchester Neuroscience Centre, who chaired the NICE guideline committee, believes this recommendation could go some way to solving some shortcomings of English multiple sclerosis services. “The quality of our services has up to now been notoriously patchy”, he said, “with patients getting excellent service in some places and poor service in others. The problem has been a traditional shortage of neurologists in large areas of the country. This has resulted in mistaken diagnoses being made on the basis of an MRI scan that has not been looked at by someone who understands the full
range of conditions associated with the disease. It has also resulted in patients with a positive diagnosis not receiving the information and support they and their families need. Giving an experienced neurologist the responsibility of confirming the diagnosis should improve services.” A second NICE recommendation calls for case management to be undertaken by a team embracing a broad range of skills, not only in neurology but also general practice, specialised nursing, social work, physiotherapy, occupational therapy, speech and language therapy, psychology, dietary expertise, and rehabilitation. Such teams are already proving their worth in some UK cities, such as Belfast, Liverpool, and Newcastle. A third NICE recommendation that has also drawn praise is for health-care professionals to review at least once a year how a patient is faring on the prescribed treatment. “This review”, Cooper says, “should be done whether or not the person with multiple sclerosis feels the need. It reflects our wish to make our guidelines proactive”. Not everything about the new NICE guidelines pleased everyone. Several patient organisations voiced criticism over NICE’s rejection of two medicines that it found to be “not cost-effective”: nabiximols (Sativex), a cannabis-based oral spray for people with spasticity problems caused by multiple sclerosis, and fampridine (Fampyra) for people with walking problems caused by the disease. Cooper explains: “We’re not rationing services. We’re saying that the additional funds required to implement our guidelines are better spent on providing proactive multidisciplinary care than on a www.thelancet.com Vol 384 November 29, 2014
World Report
couple of very expensive drugs with modest benefit.” Nick Rijke, director of policy and research with the MS Society, Britain’s largest multiple sclerosis charity, disagrees. “Nabiximols has already been approved and is used by the Wales National Health Service. And fampridine has been prescribed in the UK under a conditional licence agreement, which allows the drug to be used on an experimental basis pending provision of additional evidence.” To which Cooper replies: “If the drugs had been more reasonably priced our recommendation would likely have been positive. The current cost in the UK doesn’t justify its use.” On the whole, though, Rijke believes “the new NICE guidelines should greatly improve multiple sclerosis care and treatment. I don’t think you’ll find a body like NICE anywhere else in the world.”
Other high-income countries The guideline landscape of the USA is certainly different from that of the UK. “We have numerous guidelines for most aspects of multiple sclerosis care and intervention but there is no official obligation for guideline users to implement them”, says Costello. “There’s no consistent cook-book approach that is followed federally or state-wide, or by private institutions. Some would say that it’s a shortcoming but many feel there is insufficient evidence in certain areas of case management, such as disease-modifying therapies or complementary and alternative medicine, to justify having specific guidelines. The Consortium of MS Centers and the American Academy of Neurology have published guidelines that have been helpful in guiding decision making. But essentially treatment decisions are made through collaboration between the individual care provider and the person with multiple sclerosis.” In Australia and New Zealand a team of 24 experienced neurologists published a three-part review www.thelancet.com Vol 384 November 29, 2014
on disease-modifying therapies earlier this year. “The advice given in this paper is intended as a best-practice guideline”, says team leader Simon Broadley, professor of neurology and dean of medicine at the Griffith University School of Medicine, Queensland, Australia. “Unlike many other countries we make no formal distinction between first, second, and third-line treatments. All of the disease-modifying agents can be used first-line if the attending neurologist so judges.” The review paper will be updated every year, he says.
“‘...treatment decisions are made through collaboration between the individual care provider and the person with multiple sclerosis.’” Back in Europe, Italy has 240 government-accredited health centres for the treatment and care of multiple sclerosis patients. It does not have guidelines as such—only a document produced 2 years ago by the Italian Neurological Society that lists the minimum professional skills and equipment that each centre should have to fulfil its mandate. At about the same time, seven of Italy’s 20 regions began compiling official clinical pathways for the management of the disease. One region, Sicily, has already issued its pathway. “These pathway documents give detailed recommendations about drug treatment and rehabilitation. Ultimately we want all our regions to have these tools”, says Mario Battaglia, president of the Italian Multiple Sclerosis Foundation. French guidelines are in many ways similar to the NICE guidelines. Like NICE, they are produced by a governmental body, the Haute Autorité de Santé (HAS, or French National Authority for Health). HAS guidelines also put a neurologist in the driving seat for diagnosis, treatment, and care and give high priority to forming multidisciplinary
teams. France, though, lags somewhat in keeping its formal guidelines up to date. The latest HAS guideline, published in 2007, is based on a 2001 consensus statement by the French Neurology Society. This professional body is currently working with the French Society for Physical and Rehabilitation Medicine to produce updated guidelines. HAS, moreover, publishes documents updated every year about multiple sclerosis procedures and services reimbursed by the social security system. “Pending future publication of official guidelines, these documents keep all the players in the multiple sclerosis community abreast of developments in the treatment of the disease”, says André Morin, project manager in HAS’s Chronic Disease and Patient Care Department. In Germany, multiple sclerosis guidelines are drawn up every 2 years by the so-called Competence Network on Multiple Sclerosis, a network launched in 2009 and funded by the German Ministry of Education and Research. The guidelines have to be cleared by a review board of another entity, the Association of Scientific Medical Societies in Germany, which helps its 168 member societies to produce guidelines. “Unlike many other countries”, says Bernhard Hemmer, who heads the Neurological Clinic at Technical University Munich, Germany, ”German patients have access to all drugs approved by German or European regulatory authorities, whether or not these drugs are recommended by clinical guidelines. We would also like to form multidisciplinary teams but we are hampered by financial constraints on outpatient hospital care.” “When all is said and done”, remarks Paul Cooper, “the test of a good guideline, wherever you work, is in the strength of the evidence on which it rests and the extent to which it is adopted.”
John Maurice 1915
Multiple sclerosis guideline production takes off John Maurice reviews guidelines for the manangement of multiple sclerosis in high-income countries following a new release from the UK’s National Institute of Health and Clinical Excellence.
Astier/BSIP/Corbis
Multiple sclerosis is well named. Almost everything about the disease is multiple, not just the multiple sclerotic patches in the brain that gave the disease its name. For a start, there are at least 20 possible symptoms the disease can cause, not to mention many life-changing outcomes, such as emotional and psychosocial difficulties, dependency, sexual difficulties, and loss of employment. “Multiple sclerosis has an enormous impact on almost every aspect of life and can appear in such a variety of different forms in different people who each have different needs”, says Kathleen Costello, associate vice president of Advocacy Services and Research at the New York-based US National Multiple Sclerosis Society. “It is clearly one of the most complex diseases to manage.” The complexity of managing multiple sclerosis has, in recent years, expanded the therapeutic arsenal to more than 70 different medicines, not counting the more than 50 complementary and alternative medicines and procedures of doubtful efficacy, ranging from meditation to music therapy, hyperbaric oxygen to horseback riding.
NICE recommends multidisciplinary care teams for patients with multiple sclerosis
1914
The complexity of the disease has also spawned the creation of more than 90 national and international patient and professional organisations. Guidelines, too, are not in short supply.
England’s guidelines In October, England’s National Institute for Health and Care Excellence (NICE) issued new guidelines for managing the disease, that update its previous guidelines published in 2003. The recommendations of the new guidelines pertain only
“‘...the new NICE guidelines should greatly improve multiple sclerosis care and treatment...’” to symptoms of the disease, not the so-called disease-modifying therapies nor the management of the relapses that characterise the disease. Three new recommendations were generally welcomed. One calls for a person with suspected multiple sclerosis to be referred as soon as possible to a consultant neurologist experienced in diagnosing the disease. Paul Cooper, consultant neurologist at the Greater Manchester Neuroscience Centre, who chaired the NICE guideline committee, believes this recommendation could go some way to solving some shortcomings of English multiple sclerosis services. “The quality of our services has up to now been notoriously patchy”, he said, “with patients getting excellent service in some places and poor service in others. The problem has been a traditional shortage of neurologists in large areas of the country. This has resulted in mistaken diagnoses being made on the basis of an MRI scan that has not been looked at by someone who understands the full
range of conditions associated with the disease. It has also resulted in patients with a positive diagnosis not receiving the information and support they and their families need. Giving an experienced neurologist the responsibility of confirming the diagnosis should improve services.” A second NICE recommendation calls for case management to be undertaken by a team embracing a broad range of skills, not only in neurology but also general practice, specialised nursing, social work, physiotherapy, occupational therapy, speech and language therapy, psychology, dietary expertise, and rehabilitation. Such teams are already proving their worth in some UK cities, such as Belfast, Liverpool, and Newcastle. A third NICE recommendation that has also drawn praise is for health-care professionals to review at least once a year how a patient is faring on the prescribed treatment. “This review”, Cooper says, “should be done whether or not the person with multiple sclerosis feels the need. It reflects our wish to make our guidelines proactive”. Not everything about the new NICE guidelines pleased everyone. Several patient organisations voiced criticism over NICE’s rejection of two medicines that it found to be “not cost-effective”: nabiximols (Sativex), a cannabis-based oral spray for people with spasticity problems caused by multiple sclerosis, and fampridine (Fampyra) for people with walking problems caused by the disease. Cooper explains: “We’re not rationing services. We’re saying that the additional funds required to implement our guidelines are better spent on providing proactive multidisciplinary care than on a www.thelancet.com Vol 384 November 29, 2014
World Report
couple of very expensive drugs with modest benefit.” Nick Rijke, director of policy and research with the MS Society, Britain’s largest multiple sclerosis charity, disagrees. “Nabiximols has already been approved and is used by the Wales National Health Service. And fampridine has been prescribed in the UK under a conditional licence agreement, which allows the drug to be used on an experimental basis pending provision of additional evidence.” To which Cooper replies: “If the drugs had been more reasonably priced our recommendation would likely have been positive. The current cost in the UK doesn’t justify its use.” On the whole, though, Rijke believes “the new NICE guidelines should greatly improve multiple sclerosis care and treatment. I don’t think you’ll find a body like NICE anywhere else in the world.”
Other high-income countries The guideline landscape of the USA is certainly different from that of the UK. “We have numerous guidelines for most aspects of multiple sclerosis care and intervention but there is no official obligation for guideline users to implement them”, says Costello. “There’s no consistent cook-book approach that is followed federally or state-wide, or by private institutions. Some would say that it’s a shortcoming but many feel there is insufficient evidence in certain areas of case management, such as disease-modifying therapies or complementary and alternative medicine, to justify having specific guidelines. The Consortium of MS Centers and the American Academy of Neurology have published guidelines that have been helpful in guiding decision making. But essentially treatment decisions are made through collaboration between the individual care provider and the person with multiple sclerosis.” In Australia and New Zealand a team of 24 experienced neurologists published a three-part review www.thelancet.com Vol 384 November 29, 2014
on disease-modifying therapies earlier this year. “The advice given in this paper is intended as a best-practice guideline”, says team leader Simon Broadley, professor of neurology and dean of medicine at the Griffith University School of Medicine, Queensland, Australia. “Unlike many other countries we make no formal distinction between first, second, and third-line treatments. All of the disease-modifying agents can be used first-line if the attending neurologist so judges.” The review paper will be updated every year, he says.
“‘...treatment decisions are made through collaboration between the individual care provider and the person with multiple sclerosis.’” Back in Europe, Italy has 240 government-accredited health centres for the treatment and care of multiple sclerosis patients. It does not have guidelines as such—only a document produced 2 years ago by the Italian Neurological Society that lists the minimum professional skills and equipment that each centre should have to fulfil its mandate. At about the same time, seven of Italy’s 20 regions began compiling official clinical pathways for the management of the disease. One region, Sicily, has already issued its pathway. “These pathway documents give detailed recommendations about drug treatment and rehabilitation. Ultimately we want all our regions to have these tools”, says Mario Battaglia, president of the Italian Multiple Sclerosis Foundation. French guidelines are in many ways similar to the NICE guidelines. Like NICE, they are produced by a governmental body, the Haute Autorité de Santé (HAS, or French National Authority for Health). HAS guidelines also put a neurologist in the driving seat for diagnosis, treatment, and care and give high priority to forming multidisciplinary
teams. France, though, lags somewhat in keeping its formal guidelines up to date. The latest HAS guideline, published in 2007, is based on a 2001 consensus statement by the French Neurology Society. This professional body is currently working with the French Society for Physical and Rehabilitation Medicine to produce updated guidelines. HAS, moreover, publishes documents updated every year about multiple sclerosis procedures and services reimbursed by the social security system. “Pending future publication of official guidelines, these documents keep all the players in the multiple sclerosis community abreast of developments in the treatment of the disease”, says André Morin, project manager in HAS’s Chronic Disease and Patient Care Department. In Germany, multiple sclerosis guidelines are drawn up every 2 years by the so-called Competence Network on Multiple Sclerosis, a network launched in 2009 and funded by the German Ministry of Education and Research. The guidelines have to be cleared by a review board of another entity, the Association of Scientific Medical Societies in Germany, which helps its 168 member societies to produce guidelines. “Unlike many other countries”, says Bernhard Hemmer, who heads the Neurological Clinic at Technical University Munich, Germany, ”German patients have access to all drugs approved by German or European regulatory authorities, whether or not these drugs are recommended by clinical guidelines. We would also like to form multidisciplinary teams but we are hampered by financial constraints on outpatient hospital care.” “When all is said and done”, remarks Paul Cooper, “the test of a good guideline, wherever you work, is in the strength of the evidence on which it rests and the extent to which it is adopted.”
John Maurice 1915