The National Institute for Health and Clinical Excellence (NICE), an agency under the UK’s National Health Service (NHS), has recently rejected Zeposia. Zeposia is an oral, multiple sclerosis (MS) treatment created by Bristol-Myers Squibb. While this decision is not final, it has a large impact on the MS community within the UK.
About Multiple Sclerosis (MS)
Multiple sclerosis (MS) is a neurological disorder that affects the sending of signals from the brain to the body. When one has this disorder, their immune systems attack myelin, which is the protective covering of nerve cells. In severe cases, these nerves can be damaged permanently. There are two types of MS, relapsing/remitting or progressive. The former is characterized by long periods without symptoms followed by episodes of intense symptoms. Progressive MS does not include periods without symptoms, instead people constantly feel the effects of the disorder. It can result in the loss of daily function.
There is no known cause for MS. It is an autoimmune disease, which occurs when the immune system attacks parts of the body, in this case myelin. These attacks result in the slowing or blockage of neuro messages. It is suspected that there is a hereditary element, but a combination of genetics and environmental factors are most likely the cause. What is known is that this disorder can occur at any age, but is most common from the ages of 15 to 60, and females are twice as likely to have it.
Symptoms of multiple sclerosis can vary from patient to patient; all parts of the body can be affected. Muscles in the extremities and the eyes are most commonly impacted. The first symptoms often appear between the ages of 20 to 40, which could be weakness, numbness, loss of coordination and balance, or problems with speech, vision, and bladder control. While there is currently no cure for MS, specific symptoms can be treated, and there are FDA approved treatment options.
Why Was Zeposia Rejected?
NICE rejected Zeposia, meaning that it will not receive funding from the NHS. They did so for a number of reasons. The first issue they found involved disease progression; the drug’s effect on the progression of disability is not clear. Secondly, there was no analysis that supported the use of Zeposia as a second-line treatment.
In addition, NICE pointed out that there are already a range of other oral treatment options available to MS patients in the UK: Gilenya and Tecfidera. They also note the highly effective, injected drugs that have already received approval, such as Lemtrada and Ocrevus.
Because of these issues and confidential commercial agreements, NICE is unable to give details in regards to its cost-effectiveness estimate; however, they did announce that it would likely fall outside of the threshold of £30,000 per Quality Adjusted Life Year.
The Rejection’s Effect on Patients
Multiple sclerosis patients are disappointed by NICE’s decision, with the MS Society labeling it as “frustrating.” As oral treatment options are limited, Zeposia would’ve offered an alternative to patients. It also comes without the gastrointestinal side effects of Tecfidera, meaning that it would also bring a benefit.
They acknowledge that the decision is not final, and they are urging NICE to keep the well-being of those with MS in mind when reviewing their choice.
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