NICE backs Ocrevus for PPMS in England – but with caveats

Patients with a severe progressive form of multiple sclerosis will get access to the first licensed treatment for the condition after NICE recommended regular NHS funding for Roche’s Ocrevus, although there are still restrictions on who will receive it.

The cost-effectiveness body had initially said that Ocrevus (ocrelizumab) was too expensive in primary progressive multiple sclerosis (PPMS) in first draft guidance issued last summer.

In that guidance NICE said that the NHS would have to pay between £78,000 and £84,000 for each patient to gain one year of quality life at Roche’s current price, more than double the body’s upper limit of £30,000.

But after agreeing a new confidential pricing deal with Roche, NICE has recommended it for PPMS patients in England.

However it will be restricted to those with early inflammatory disease, and with imaging features characteristic of the disease.

Roche reached the deal after negotiating with NHS England and NICE, and is in further talks with representatives of the devolved NHS systems in Wales and Northern Ireland to make the drug available to PPMS patients in those countries.

The company is also in negotiations with the Scottish Medicines Consortium, which conducts health technology assessments on behalf of the NHS in Scotland.

Roche will also begin a study of Ocrevus to understand the significance of maintaining upper-limb function in people with progressive MS, which could open the door for a broader group of PPMS patients to gain access to the drug.

ORATORIO-HAND will be the first study to use a measure of arm, wrist and hand function as a primary endpoint, acknowledging their importance in maintaining quality of life.

This study will recruit adults with PPMS, including those in a wheelchair and up to 65 years old.

It follows a campaign by patients and doctors, who called for the trial to show that Ocrevus could still be useful for patients once they have become wheelchair bound as the MS progresses.

Because of a lack of clinical data showing the importance of disease-modifying drugs once a patient is wheelchair-bound, health systems such as the NHS withdraw access to them once PPMS patients lose mobility in their legs.

MS campaigner Trishna Bharadia said the trial represented a “welcome shift in mindset” about evaluating the needs of people with MS.

“Staying independent for as long as possible is hugely important for people with MS and this trial will offer hope to possibly find ways of being able to do that when people have more advanced disease.”

Following NICE’s rejection of Ocrevus in PPMS, more than 21,000 patients had signed a petition calling for a rethink, and more than 3,000 people raised the issue with their local MP, the MS Society charity said.

Genevieve Edwards, director of external affairs at the MS Society, said: “This is a landmark moment and an incredible victory for the more than 21,000 of us who helped overturn this result. We now want to see everyone who could benefit from ocrelizumab being able to access it, with increased support for MS services to make sure this happens.

“Right now however there isn’t enough evidence to show ocrelizumab can work for everyone, and we know the restrictions will be a massive blow for those who still don’t have any options. We’re driving research to find more and better treatments, and calling for drug trials to more fully address the needs of everyone with MS, until the day we are able to stop it in its tracks.”

Patients with PPMS see their neurological functions steadily worsening, without early relapses or remissions.

Symptoms include muscle weakness, depression, mood swings, paralysis, problems with bowel and bladder control, and sexual dysfunction.

 

 

 

 

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