CAR-T, Regulatory, UK Biotech

With a deeper discount in place, NICE now ready to endorse use of Novartis’ Kymriah in adult lymphoma patients

Looks like Novartis has made nice with UK’s NICE. The cost-effectiveness watchdog reversed its September position to endorse the Swiss drugmaker’s CAR-T therapy, Kymriah, in adult lymphoma patients, after accepting a deeper discount on a therapy that carries a list price of £282,000 (roughly $368232), it said on Friday.

Kymriah was the first CAR-T drug to win approval in the United States and Europe, but sales have suffered due to manufacturing wobbles. Still, the company expects the drug — which reengineers a patient’s’ immune cells to recognize and attack cancer — to eventually generate blockbuster sales.

NICE, in a draft review in September, said although the treatment has significant clinical benefit, Novartis has not provided any data comparing its use to that of last-resort chemotherapy, the standard of care in the patient population. It also said the immunotherapy was far too expensive to recommend for use in adults with lymphoma, but separately endorsed its use in leukemia patients up to the age of 25. On Thursday, the BBC reported that an 11-year-old boy with leukemia was the first NHS patient to be given Kymriah, after prior treatment failed to keep his cancer at bay.

On Friday, NICE said adult lymphoma patients would be able to gain access to the drug via the Cancer Drugs Fund — a fund that aims to make promising cancer drugs available to patients before they are fully sanctioned for use in the NHS. “CAR T-cell therapy is expensive, however the treatment is specific to each individual and could be a potential cure for some, although it is early days. Our recommendation for…the Cancer Drugs Fund means people can benefit while more data is collected,” the agency said in a statement.

Novartis’ recent engagement with NICE has not been smooth-sailing. Last month, NICE refused to endorse Novartis’ migraine-prevention treatment Aimovig, saying the totality of the data supporting the medicine did not include all “relevant” comparisons against existing drugs and outcomes. The company is working with the agency to see whether that determination can be changed, but more importantly, it will be hoping to stay on good terms with agency ahead of the expected approval of its SMA gene-therapy, Zolgensma. If approved, the drugmaker thinks it would be justified in charging between $4 million to $5 million for the therapy, a price that will all but certain inspire criticism from NICE.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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