Roche's MS drug Ocrevus priced in line with Novartis rival in UK

Roche has said it plans to UK price its latest multiple sclerosis drug Ocrevus in line with its close rival from Novartis - aiming to undercut some established rivals.

Approved in Europe earlier this month, Ocrevus (ocrelizumab) offers a new treatment option for patients with relapsing disease.

It is also the first drug approved for patients with primary progressive MS (PPMS), where symptoms get worse over time.

In an interview with pharmaphorum, Marius Scholtz, country medical lead for Roche UK, said the drug will have around the same yearly cost in relapsing disease as Novartis’ once-daily pill, Gilenya (fingolimod).

He told pharmaphorum: “The price will be similar to other highly effective medicines. It will not be the most expensive but it will not be the cheapest – a very effective drug at the same list price as Gilenya.”

When NICE assessed Gilenya back in 2012, it said the drug costs the NHS £19,169 per person annually, based on a price of £1,470 for 28 capsules.

Although Novartis also offered a commercially confidential discount for Gilenya in order to get it past NICE, this gives a ball-park indication of the cost of Ocrevus.

As Ocrevus is given twice a year once, after two initial infusions two weeks a part, this points to a cost of just under £10,000 per infusion, although Scholtz would not give a precise figure.

It’s highly likely that Roche will also have to offer a discount in order to get Ocrevus reimbursed, as most medicines do not make it through the NICE process at full price.

In the US, Roche has already got a chunk of the market by undercutting German Merck's Rebif (interferon beta 1a) - but prices in the UK could well change as part of a review of MS drug prices by NICE that began late last year.

NICE is threatening to end funding for five established MS drugs because a risk sharing scheme that has been in place since 2001 has come to an end.

Scholtz said it has just begun the process of getting Ocrevus assessed by NICE in relapsing disease, and is preparing a separate dossier for its use in primary progressive disease.

Roche will be meeting with NICE in the coming months to begin the appraisal process for relapsing disease, said Scholtz.

PPMS delays

But he warned that Ocrevus will likely be later to market in PPMS because of its first-to-market status in that indication.

[caption id="attachment_36414" align="alignnone" width="222"] Roche's Marius Scholtz[/caption]

“In PPMS we are still working on our submission – it is slightly more complex and will require more work to get into NICE. It will require a different review because the patient populations are very different,” said Scholtz.

The company hopes to get NICE to approve regular NHS funding for Ocrevus by the end of the year, said Scholtz.

But he added: “In PPMS it will be the first drug to go through the process so we are not sure how long it will take. It might take substantially longer.”

In PPMS, Ocrevus is likely to be assessed using NICE’s standard technology appraisal process, rather than special pathways reserved for rare or very rare diseases.

Ocrevus is already a huge hit in the US, where it has generated revenues of around $500 million in its first six months or so on the market.

In the UK, drugs that cost more than £20 million in any of their first three years or so on the market are subject to a further review by NICE – but Scholtz said it was too early to say whether this restriction will apply to Ocrevus.

“It is very early in the process and it is difficult to know if we are likely to meet that threshold,” said Scholtz.

Crowded market

Ocrevus is competing in a crowded market for MS drugs, but looks likely to have advantages over already marketed rivals.

Along with strong efficacy figures in relapsing disease, trial evidence does not show a link with the rare but deadly brain disease progressive multifocal leukoencephalopathy (PML) – seen in certain patients treated with Biogen’s Tysabri (natalizumab).

Although one patient treated with Ocrevus has reportedly developed PML, Roche blamed this on previous treatment with Tysabri.

And while Biogen’s Tecfidera (dimethyl fumarate) pill is also commonly used, it is associated with unpleasant gastrointestinal side effects.

This did not occur in trials of Ocrevus, which is unlikely to produce these issues as it is infused – itching, rash and difficulty breathing are listed the most common side effects with the Roche drug.

Merck KGaA's recently approved MS pill Mavenclad (cladribine) is also available to NHS patients after the company agreed to only charge for patients that respond to the treatment.