NICE Updates Its Guidelines for MS Management

The National Institute for Health and Care Excellence (NICE) in England has updated its guidelines for the diagnosis and management of adults with multiple sclerosis (MS).

Called Multiple sclerosis in adults: management, the new guidelines update and replace the 2014 recommendations and are meant to be followed by healthcare professionals in England and Wales within their National Health Services.

The document is also meant for social care practitioners, commissioners and providers, and people with MS and their families and carers.

It includes new and updated recommendations on diagnosis, information and support, care coordination, symptom management and rehabilitation, modifiable risk factors, comprehensive review, managing relapses and exacerbations, and other treatments.

According to the U.K.’s MS Trust, the new guidelines are enriched with more detailed information throughout and add new, relevant sections in MS management, including pregnancy and advanced disease, the organization noted in a press release.

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NICE has recommended health professionals regularly ask MS patients whether they are thinking about starting or extending their family, either through pregnancy or adoption. It has also expanded the information and advice that health professionals should discuss with patients regarding this subject.

Healthcare professionals, according to the guidelines, should also provide adequate information and support to patients whose disease is becoming more advanced, covering mental health, mobility aids, and legal rights, such as social care, employment rights and benefits, and the right to a carer’s assessment and support.

The guidelines continue to recommend a comprehensive annual review of all aspects of a patient’s care, but have expanded the list of what it should cover and now advises patients to ask for a review if it has not occurred.

People suspected of having MS, but who do not meet standard criteria for a diagnosis, should also undergo regular reviews (for example, annually) and be provided information on whom to contact for advice about any symptom change.

The importance of being followed by a multidisciplinary team is recognized, and the list of professionals in such a team was extended to include hospital pharmacists and consultants in rehabilitation medicine.

NICE also recommends that every person with MS should be given “an appropriate single point of contact with knowledge of MS services to coordinate care and help them access service.”

In addition, the document provides guidance on the assessment of fatigue — one of the most common and disabling MS symptoms — and on its nonpharmacological and pharmacological treatments.

Healthcare professionals should check for causes other than MS, such as sleep problems, treatment side effects, anxiety and depression, and other health conditions.

Personalized discussions are encouraged to help patients self-manage their fatigue, and appropriate physical exercise is recommended, as well as stress management and well-being approaches.

Regarding pharmacological treatments for fatigue, the guidelines expanded the list to include off-label use of modafinil (sold under the brand name Provigil, among others) and selective serotonin reuptake inhibitors (SSRIs), in addition to amantadine.

Modafinil is used for treating narcolepsy (a condition characterized by excessive daytime sleepiness), and SSRIs are a commonly used class of antidepressant medications that includes Prozac (fluoxetine).

Since NICE’s 2014 guidelines clearly stated that there was insufficient evidence to recommend modafinil or SSRIs for treating MS-related fatigue and warned about their potential harms, the MS Trust expressed concerns about their inclusion in the current document.

“The quality of the new evidence presented in the 2022 guideline does not justify a change to this recommendation,” the Trust stated in its release.

The nonprofit group also noted that the current guidelines lack a general guidance on treatment pathways for disease-modifying therapies (DMTs), in contrast to NICE guidelines for other conditions, such as Parkinson’s disease and rheumatoid arthritis.

“As a result, people are given no indication of what they can expect from MS services, in terms of timescales for initial discussions about their treatment options and then for starting a disease modifying drug or a review of their current treatment,” the MS Trust stated.

“We believe that a lack of guidance on treatment pathways has contributed to considerable variation in disease modifying drug prescribing across England and Wales,” the Trust added.

The MS Trust also emphasized its disappointment regarding the noninclusion of Fampyra (fampridine) — sold as Ampyra in the U.S. and with generics also available — in the treatment recommendations for walking difficulties in MS patients.

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While acknowledging that Fampyra is effective in some patients, NICE considered that the therapy remains not cost-effective. This was in line with its December recommendation against the addition of Fampyra to the list of medications available to MS patients through the country’s NHS.

Developed by Acorda Therapeutics, Fampyra is an extended-release oral tablet that aids walking in MS patients by improving electric signal conduction through nerve fibers in the brain and spinal cord.

The therapy was approved in the U.S. in 2010 to improve walking skills in MS patients. It was granted a conditional approval in Europe for the same indication in 2011, followed by a full approval in 2017.

While Fampyra’s cost-effectiveness was also a concern of health authorities in Scotland and Wales, the therapy is now available in these countries at a reduced-price agreement with Biogen, which markets the therapy outside the U.S.

“But the NICE guideline development process does not allow for these discussions to take place,” the Trust stated.

Notably, during the consultation period, from the release of the draft guidance to Jan. 31, the MS Trust and other MS organizations provided responses highlighting the experience of patients treated with Fampyra.

“We will continue to press for a solution which allows fair access to this treatment across all of the devolved nations,” the Trust stated.