Novartis’ new CAR-T Kymriah drug only weeks ago picked up a blessing from England cost watchdogs to treat lymphoma in children. Now, the agency is turning away the drug in adult patients with relapsed or refractory diffuse large B-cell lymphoma after two prior therapies over cost concerns.

In draft guidance published Wednesday, NICE officials said that Kymriah represents a "step change" in treatment for the patients. But NICE said because there’s no data testing Kymriah versus salvage chemotherapy, the "exact size" of the benefit for the drug is unknown. According to clinical experts, there’s no standard treatment for the patient group after two failed therapies.

NICE calculations found that the drug is too expensive to be considered an efficient use of resources, according to the agency. The experts encouraged further discussion as the review process continues.

A Novartis spokeswoman said while the company is "disappointed" with the initial decision, Novartis recognizes "that this one-time therapy is an innovative and radically different treatment approach with curative intent, and it may be challenging to adequately compare Kymriah to current treatments for patients with this type of blood cancer who have limited options."

Further, Novartis "strongly" disagrees with NICE’s decision to not consider Kymriah a life-extending treatment at the end of life. Novartis’ representative said for patients who’ve failed on two prior therapies, "life expectancy can be counted in months rather than years." The company will continue to work with NICE to "support the adoption of this medical innovation for patients," she added. 

The decision comes two weeks after Kymriah scored a NICE recommendation in children and young adults with B-cell acute lymphoblastic leukemia (ALL) who haven’t responded to other treatments. The drug carries a list price of £282,000 ($361,000) in England.

But the guidance also falls in line with a NICE finding for Gilead’s competing Yescarta. That drug in August failed to secure a recommendation from NICE in adults with relapsed large B-cell lymphoma. At the time, a Gilead spokesman said the company's "priority is to make [Yescarta] available to patients in the UK as soon as possible and as such we believe we will soon be able to reach an agreement." 

CAR-T drugs are made of T cells that are collected from each patient, re-engineered and infused back into the patient to attack cancer. Novartis and Gilead scored early U.S. approvals in the field and moved into European countries more recently.

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