ZURICH: Novartis's Kymriah cell therapy won the blessing of health authorities in England for adult lymphoma patients, the Swiss drugmaker said on Friday, reversing last year's rejection.
The list price is 282,000 pounds (US$369,000) per patient, given as a single intravenous infusion, but Novartis agreed to offer the therapy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) at a confidential discounted price, the National Institute for Health and Care Excellence (NICE) said.
NICE had turned down a previous proposal from Novartis in September, saying it exceeded the level considered an acceptable use of resources.
"Today's positive announcement regarding access to Kymriah treatment in England and Wales was secured as a result of our close working collaboration with NICE and NHS England, with all parties showing flexibility," Novartis said.
DLBCL patients eligible for Kymriah have life expectancies of just months, after failing previous treatments.
Novartis expects Kymriah to eventually top US$1 billion in annual sales, though the drug has started modestly with US$76 million in 2018. Over 2019, the company expects to increase commercial and clinical capacity for Kymriah four-fold after buying more production facilities and deals with partners.
The Swiss firm hopes expanding its treatment geography will narrow the sales gap with Gilead Sciences' Yescarta, which reaped US$183 million in the first nine months of 2018.
Novartis already has NICE's go-ahead for children and young people with aggressive acute lymphoblastic leukaemia (ALL) when other drugs have failed.
The Basel-based company now has 26 treatment centers in the European Union and Kymriah is now commercially available to patients from 10 countries, it said.
Kymriah belongs to a new class of treatments, like Yescarta, called CAR-T therapies where disease-fighting T cells are removed from a patient and genetically modified to better recognize and attack cancer.
They are then re-infused into the same patient where they can circulate for years to seek out and fight the disease.
Novartis is also working with the U.S. Food and Drug Administration to resolve a snag in which some batches of Kymriah did not meet commercial specifications, forcing the company to give it away for free to some patients.
"We expect resolution ... soon," a spokeswoman said.
(Reporting by John Miller; Editing by Edmund Blair)