In June, the National Institute for Health and Care Excellence (NICE) endorsed Ocrevus for relapsing-remitting MS - the most common type of the disease - but it has now rejected it for the rarer and more severe primary-progressive form of MS.
Ocrevus is the only available treatment for primary-progressive MS (PPMS), while there are several drugs for relapsing-remitting MS (RRMS), and Roche UK general manager Richard Erwin said Monday's decision was "devastating news" for patients.
It is not the first time the Swiss drugmaker has clashed with NICE, which determines if drugs are cost-effective enough to be used in the National Health Service (NHS) in England and Wales.
Roche has also battled to get a number of its cancer drugs approved by NICE in the past, prompting Chief Executive Severin Schwan to brand Britain's health system as "stupid" three years ago https://uk.reuters.com/article/us-roche-cancer-britain/roche-ceo-attacks-britains-stupid-cancer-drug-system-idUKKCN0R81J620150908.
In the case of Ocrevus, Roche said it had reached a stalemate because the authorities were not allowed to even consider a confidential discounted price for using the drug in PPMS that was different from the RRMS price.
That is a problem because the evidence showing the benefit of Ocrevus in PPMS is not as compelling as in RRMS, so a lower price would be needed to reach NICE cost-effectiveness thresholds.
The restriction meant NICE had to consider the existing RRMS approved price for the PPMS indication and this was deemed too expensive. In a statement, NICE said the size and duration of the drug's benefits in PPMS were uncertain and it could not be considered an acceptable use of NHS resources.
Worldwide, Ocrevus has proved to be a big commercial success for Roche, with sales topping $1 billion in the first half of 2018, and the company said it hoped an agreement could be reached for its use within the NHS.
"Roche is confident that given the flexibility to offer an indication-specific price, we will be able to offer a price that is deemed cost-effective for PPMS," the company said.
(Reporting by Ben Hirschler; Editing by Mark Potter)