With its three blockbuster oncology meds under assault from biosimilar rivals, Swiss drugmaker Roche is looking to its next-gen therapies for a boost. New lymphoma launch Polivy faced a setback earlier this year when England's cost-effectiveness body said no go—but fortunately for Roche, they changed their minds.
The National Institute for Health and Care Excellence (NICE) recommended Polivy to treat B-cell lymphoma after Roche offered a confidential discount for the therapy and provided updated survival data.
Roughly 530 patients each year on England's National Health Service would be eligible for Polivy.
NICE previously shot down the Roche launch in February, citing unclear evidence that a combo of Polivy, Roche’s Rituxan and the chemotherapy bendamustine kept patients alive over a longer period of time.
The combo won its European approval in January to treat diffuse large B-cell lymphoma patients who are ineligible for a stem cell transplant. The trio earned its FDA nod back in June 2019.
Despite the early knock, NICE left the door open for Polivy's eventual recommendation.
For one, targeted patients had no standard treatment in the U.K., NICE said in February, though the combo of Rituxan and bendamustine was one option.
Moreover, adding Polivy to those two medicines allows patients "more time before their disease gets worse” than those on Rituxan and bendamustine alone, the watchdog acknowledged in its draft review.
Polivy's start has been small for Roche, but it's still a big deal as the drugmaker faces losing sales of three blockbuster oncology meds—Rituxan, Herceptin and Avastin—to U.S. biosimilars.
Polivy cleared $91.3 million in the first half of 2020, but Roche is hoping to keep boosting the drug's label in the coming years to expand its target market. According to its R&D pipeline, Polivy is currently in a phase 3 trial for first-line B-cell lymphoma patients with a trial readout expected next year. The drug is also in a phase 2 trial in follicular lymphoma.