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NICE Draft Guidance recommends new treatments for spinal muscular atrophy as part of a managed access agreement | News and Features | News
MAA is a special agreement between the NHS England and NHS Improvement and Roche. This will give people access to treatment with risdiplam while more data is being collected to address the uncertainties identified by the independent NICE Commission. After this, the NICE will decide whether to recommend it for daily use on the NHS and update the guidance. Until then, it is available through MAA.
SMA is a progressive condition that affects the nerves in the spinal cord that control movement. This leads to weakness, progressive lack of exercise, dyspnea and dysphagia.
SMAs can be grouped into five major types (types 0-4). Type 1 SMA is one of the most severe forms of SMA, and people with SMA usually die before the age of two without treatment. This is usually due to respiratory failure.
Risdiplam is licensed to treat people with types 1, 2, and 3 SMAs Some people have symptoms before they begin to appear.
The Commission agreed that risdiplam is innovative because it means that oral administration of risdiplam is an alternative for those who cannot receive other treatments for SMA. It also means that people can have it at home.
Clinical evidence may indicate that risdiplam improves abdominal exercise, standing, or walking ability in people with type 1, type 2, and type 3 SMA and is effective in people before they begin to show symptoms of SMA. Indicates that there is. There is also some evidence to suggest that people with type 1 SMA live longer with risdiplam. However, there is no direct evidence comparing risdiplam with the best supportive care for type 1 SMA. And there is no long-term evidence that risdiplam as a whole is profitable.
The Commission could not recommend Risdiplam for regular test runs at this time, as cost-effectiveness estimates were significantly higher than would normally be considered cost-effective use of NHS resources. In the case of type 1 SMA, this was despite agreeing that risdiplam could be considered a life-prolonging treatment at the end of life.
Meindert Boysen, Deputy Chief Executive Officer and Director of NICE’s Health Technology Evaluation Center, said: “We are pleased to have a convenient oral treatment option for SMA patients that can be administered at home. This is not only less burdensome, but also has a positive impact on the lives of both SMA patients and their caregivers. It also reduces the need for treatment management for the NHS.
“In practice, the availability of oral medications should give access to treatment to those who do not have other currently recommended options, as well as greater adherence to treatment.”
NICE already recommended nuinersen Some people with type 1, 2, 3 SMA and presymptomatic SMA as part of a managed access contract. NICE also publishes recommended guidance Onasemnogene Abe Parbobeck Some infants up to 12 months with type 1 SMA For treatment of SMA before symptomatic treatment.
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