Roche won European approval for its new-age cancer med Polivy just last month, but its launch in the U.K. just hit an early snag.
In draft guidance, the U.K.’s National Institute for Health and Care Excellence (NICE) rejected Roche's new Polivy based on uncertainties in the long-term evidence. The new med, along with Roche’s Rituxan and the chemotherapy bendamustine, scored a conditional nod in Europe last month to treat diffuse large B-cell lymphoma patients who are ineligible for a hematopoietic stem cell transplant.
The patients currently have no standard treatment in the U.K., NICE says, though the combo of Rituxan and bendamustine is one option.
Adding Polivy to those two medicines allows patients "more time before their disease gets worse” than those on Rituxan and bendamustine alone, NICE concluded after reviewing the evidence. The data show it also helps patients live longer, but it isn’t clear by how much.
Citing shortfalls in long-term evidence, NICE said cost-efficacy estimates for the combo are “very uncertain." It didn’t recommend the drug for use on NHS England or the Cancer Drugs Fund.
A Roche spokesman said the decision is “disappointing” as the patients have limited treatment options.
Still, the company “will now have an opportunity to respond to NICE and continue to explore all potential funding options to work towards a positive final decision,” he added. Roche aims to “make Polivy available for all eligible patients as soon as possible.”
Polivy won conditional approval in Europe last month, following a U.S. nod back in June. It’s an important new launch for the drugmaker as a trio of Roche cancer blockbusters—Rituxan, Herceptin and Avastin—all face new biosimilars in the U.S., putting billions in annual sales under threat.
The European Commission approved Polivy in January based on a phase 1b/2 study that showed more patients responding and patients living longer with the addition of the drug to bendamustine and Rituxan.
In the Polivy arm, 40% of patients showed no signs of cancer after treatment. That compared with 17.5% for bendamustine and Rituxan. Patients in the Polivy group lived more than twice as long as those in the bendamustine and Rituxan group. And patients saw their treatment benefits last longer as well, at a median 10.3 months versus 4.1 months for bendamustine and Rituxan.