Roche calls for talks after NICE rejects drug for progressive MS

Roche has said it will continue with talks with UK health officials to bring its multiple sclerosis drug Ocrevus to NHS patients with primary progressive disease, after NICE said it was not cost-effective in final draft guidance.

Primary progressive MS differs from the relapsing form of the disease, as symptoms gradually get worse over time, instead of occurring in sudden flare-ups.

MS affects over 100,000 people in the UK and one in eight people with MS are diagnosed with the primary progressive form, meaning around 625 people a year could benefit from Ocrevus.

Ocrevus is the first drug that has been shown to slow progression of this form of the disease – but NICE has said evidence about the size and duration of the effect was unclear.

The biggest problem for NICE was the cost per Quality Adjusted Life Year gained, compared with standard of care between £62,766 and £67,366 – more than double NICE’s upper threshold of £30,000 per QALY.

But in an interview with pharmaphorum, Roche has said it will continue in talks with NICE, the Department of Health (DH), and NHS England, to get the drug on the UK market.

NICE usually reviews its guidance three years after a final decision, but manufacturers can ask for this to be brought forward.

Roche is also open to managed access agreements, which allow for results-based payment schemes where the NHS only pays while the drug is producing benefits.

Another area where Roche is calling for more flexibility is on indication-specific prices – these are not allowed under DH rules but could break the deadlock, according to Roche’s communications policy and access director, Keith Jordan.

Jordan told pharmaphorum: “It’s very disappointing, but most of all it’s devastating for patients to be denied access for the only treatment for PPMS.”

“We are absolutely committed to working with NICE to find a solution that works with everyone. What we offered is an indication specific price that NICE was not able to accept due to bureaucratic rules. We believe that price would make Ocrevus cost effective in the PPMS.”

“DH rules allow one list price and one net price, we would prefer the opportunity to have indication specific price, but that’s not possible under current rules,” said Jordan who urged all parties to be “flexible”.

The MS Society charity is petitioning NICE, NHS England, and Roche, to make Ocrevus available on the NHS to patients with PPMS.

[caption id="attachment_46755" align="alignleft" width="149"] PPMS patient Holly Ford[/caption]

PPMS patient Holly Ford

Holly Ford, 25, from Milton Keynes, was diagnosed with PPMS in March this year, and had pinned all her hopes on the drug. She said: “Having any treatment would mean an awful lot to me. You can’t imagine what it’s like to get a diagnosis of PPMS and be told there’s nothing for you. I know ocrelizumab won’t make me better but it could stop me from getting worse. I’m already struggling to get around and have to use a wheelchair for longer distances.”

“MS is unpredictable and different for everyone, but the thought of losing my independence is terrifying. Having treatment would put my mind at ease about the future, and things like starting a family. If I get much worse I will struggle to look after myself, never mind a child.”

NICE also published draft guidance earlier this month which recommended ocrelizumab for some adults with relapsing-remitting MS.