NICE issues early 'no' votes on Roche's RoActemra, Novartis' Rydapt

NICE says Roche's RoActemra is too pricey for use in giant cell arteritis.

Two Swiss pharma giants got some news out of England Tuesday that they weren’t too excited about.

The National Institute of Health and Care Excellence (NICE) in draft guidance shot down both Roche’s RoActemra, as a treatment for giant cell arteritis, and Novartis’ Rydapt, as a therapy for a specific type of acute myeloid leukemia.

In Roche’s case, a committee evaluating the drug “concluded that there were substantial uncertainties in the evidence about how long patients would have to take the treatment and what the long-term benefits were,” the cost watchdog said. And the cost-effectiveness estimate NICE came up with for the medat least £65,800 per quality-adjusted life year gainedis “much higher” than the range it normally considers to be a good use of the NHS’ resources.

With Rydapt, the committee concluded that clinical trial evience “did not reflect how the drug would be used in clinical practice,” NICE said, adding that “uncertainty and problems with the economic model” precluded an endorsement. The gatekeeper found that the most likely cost-effectiveness estimate of Rydapt plus chemo, compared with chemo alone, surpassed £62,818 per quality-adjusted life year gained.

RELATED: U.K. cost watchdog nixes pricey biologics for moderate rheumatoid arthritis

Both companies have plenty of experience with negative NICE decisions; Roche’s struggles in particular have been well-documented. With RoActemra specifically, the body last year recommended the med in some rheumatoid arthritis patients, but not those with moderate forms of the conditiona verdict NICE kept intact after multiple unsuccessful appeals from RA drugmakers.

As both phama giants know, though, discounts can go a long way when it comes to changing minds at NICE, and Roche and Novartis now have some time to make their cases. A public consultation period will go through Jan. 4, and NICE will weigh the comments it receives during that span at its next meeting.

RELATED: Novartis wins FDA nod for Rydapt, a new targeted drug for acute myeloid leukemia

A Novartis flip-flop would be needed if it wants to max out Rydapt’s sales potential. The treatment, which won FDA approval in April after securing a breakthrough designation last year, is expected to generate more than $250 million annually in the next few years.