Ozanimod (Zeposia) - NICE says no in final decision

NICE has announced that it does not recommend ozanimod (Zeposia) as an NHS treatment in England and Wales. This confirms NICE’s initial decision published earlier this year.

The NICE appraisal committee reviewed the comments received after the publication of the draft recommendation but did not change their decision. NICE acknowledges that ozanimod reduces the number of relapses and brain lesions compared to beta interferon (Avonex) but is unsure of ozanimod’s ability to slow down disability progression. As a result, ozanimod is not considered to be cost-effective for the NHS.

The MS Trust is very disappointed with NICE’s decision to reject ozanimod. People who don’t want or are unable to self-inject or travel to hospital infusion clinics have limited options. As a once daily tablet with few side effects, ozanimod offers advantages over existing treatments and would have increased choices for people with relapsing remitting MS and their doctors.

- David Martin, Chief Executive Officer, MS Trust

Ozanimod would be welcomed by both people with MS and neurologists as an alternative to the two oral treatments currently used for active relapsing remitting MS; it is taken just once a day which fits in well with daily routines; it is as effective or more effective at reducing relapses; and has a low level of side effects which would suit people unable to tolerate other disease modifying drugs.

As this is a final decision, the NICE appraisal process provides little opportunity to persuade NICE to change their verdict, but the MS Trust will continue to work with the manufacturer, clinicians, people with MS and other stakeholders to improve the choices for everyone living with MS. We remain fully committed to supporting people with MS to get the best and most appropriate treatment for them.

This decision affects England and Wales only; ozanimod has been approved for the NHS in Scotland. Anyone already taking ozanimod will not be affected by this guidance and can continue without change until they and their neurologist consider it appropriate to stop.

About ozanimod

Ozanimod is taken as a tablet, once daily. A low dose is taken initially which is gradually increased over the first week. This reduces the risk of slowing the heart rate.

In a two year clinical trial, ozanimod reduced the risk of relapses by 38% compared to beta interferon (Avonex) and reduced the number of new active lesions seen on MRI. There was no significant difference in disability progression between ozanimod and Avonex.

The most common side effects reported in clinical trials were nasopharyngitis (common cold), reduced white blood cell count, headache, chest infections and urinary tract infections. Ozanimod caused temporary increases in liver enzymes which generally returned to normal levels without the need to stop treatment.

Ozanimod belongs to the same class of drugs as Gilenya (fingolimod). It works by retaining lymphocytes (immune cells) in lymph nodes. The number of lymphocytes reaching the brain is decreased, which reduces the immune attack on nerve cells in the brain and spinal cord.