NICE flip-flops on Takeda's Adcetris—with restrictions

NICE issued negative draft guidance on Takeda's Adcetris last August.

Takeda has scored a victory in its quest to secure reimbursement in England for lymphoma med Adcetris. But it’s only a partial victory.

England’s cost watchdog, the National Institute for Health and Care Excellence, issued new guidance Friday backing the med as a treatment for relapsed or refractory systemic anaplastic large cell lymphoma, a rare form of non-Hodgkin’s lymphoma. Of course, that's assuming the company sticks to a confidential discount agreement it’s struck with the NHS.

But there’s a catch. NICE only recommends Adcetris for patients who have no restriction or minimal restriction in physical activities, as scored by an Eastern Cooperative Oncology Group performance status of 0 or 1.

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Takeda U.K.’s general manager, Adam Zaeske, expressed disappointment that the body had added “a last-minute ECOG restriction that could result in a small number of patients no longer having access to the medicine and being left with limited options.” Overall, though, the company is “pleased” with NICE’s positive decision, he said in a statement.

RELATED: With Adcetris rejection, Takeda feels the sting of NICE's CDF takeover

Takeda felt the heat from NICE just over a year ago as the cost-effectiveness gatekeeper was reviewing meds that had previously been covered on England’s Cancer Drugs Fund. It issued a negative verdict, citing “immature and limited” evidence of the med’s clinical effectiveness and also pointing to Adcetris’ price of between £69,000 and £87,000 per patient per course.

Meanwhile, on the other side of the pond, the Japanese drugmaker’s partner, Seattle Genetics, got its own good Adcetris news earlier this week. The FDA granted the company a priority review for the drug as a therapy for patients with cutaneous T-cell lymphoma.

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