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Novartis Cancer Therapy Kymriah Hits Hurdle in Europe

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Novartis AG’s cancer drug Kymriah faced its first setback in Europe as U.K. health authorities made an initial recommendation against paying for the breakthrough therapy to treat a form of lymphoma in adults.

Although the one-time treatment has demonstrated significant benefits, and Novartis had offered an undisclosed discount on the list price of 282,000 pounds ($372,000), Kymriah isn’t adequately cost-effective for routine funding, the National Institute for Health and Care Excellence said in a statement Wednesday. Further discussion is needed, according to the cost adviser.

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Novartis said it’s disappointed with the preliminary decision, and that it may be difficult to assess the value of new treatments like Kymriah that are aimed at curing lethal diseases.

The latest ruling follows an agreement earlier this month that Novartis clinched with England’s state-funded health service to make Kymriah available to children with a type of childhood leukemia. After the first arrangement of its kind in Europe, young patients could begin receiving Kymriah within weeks, the health service said at the time.

Balking at Cost

The agency’s recommendation on treatment of adults with lymphoma is the second time British officials have balked at the cost of CAR-T therapies, which involve extracting immune cells from the body and genetically engineering them to hunt and kill cancer cells after they’re put back into the patient. Gilead Sciences Inc.’s Yescarta, a CAR-T that costs $373,000 in the U.S., was rejected in the U.K. last month.The U.K. adviser cited a lack of data comparing the Novartis treatment to a standard form of chemotherapy, making it hard to determine the new drug’s benefits, as well as the side effects that patients may experience. Novartis said it “strongly” disagrees with the decision, which doesn’t take into account that many patients can expect to live for only months when other therapies fail.

“It may be challenging to adequately compare Kymriah to current treatments for patients with this type of blood cancer who have limited options,” the drugmaker said in an email.

Novartis noted that the recommendation isn’t final and may change. NICE will consider comments on its preliminary decision at a meeting on Oct. 23, according to its statement.

Drugmakers are seeking reimbursement for new one-time therapies that offer potential cures for a range of devastating diseases but come with significant price tags. Governments are trying to rein in health spending while also boosting access to the treatments.

In Germany, Novartis set a price of 320,000 euros ($375,000) that’s now subject to negotiation with authorities, Pascal Touchon, head of the drugmaker’s cell and gene therapy business, said in an interview last week.

— Read `Rigged’ System Blocks Lower-Cost Drugs, Head of FDA Sayson ThinkAdvisor.

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