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NICE reverses stance on Takeda’s Adcetris

But firm criticises final draft guidance's new restrictions on the non-Hodgkin’s lymphoma drug

takedaTakeda has claimed a partial win for its non-Hodgkin’s lymphoma drug Adcetris (brentuximab vedotin) after persuading NICE to change its mind and issue new draft guidance.

The firm said its “hard work, flexibility and determination” had successfully overturned previous negative draft guidance from the UK’s cost-effectiveness watchdog.

The antibody-drug conjugate is now set to be backed to treat relapsed or refractory (R/R) systemic anaplastic large cell lymphoma (sALCL), a rare form of non-Hodgkin’s lymphoma that affects less than 100 patients in the UK each year.

But much to the Japanese firm’s dismay NICE’s final appraisal determination only recommends Adcetris as a treatment option if patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which are patients who have no or only minimal restriction in physical activities.

Takeda UK’s general manager Adam Zaeske said: “We are pleased with the positive NICE decision, however, it is disappointing that NICE has 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.”

NICE’s final draft guidance comes on the back of a five-year follow up from a phase II trial concerning 58 patients, which showed an estimated five-year survival rate of 60% compared to previous treatments that reported a median overall survival of three months after relapse.

Professor Tim Illidge, The Christie NHS Foundation trust, said: “R/R sALCL is an aggressive lymphoma that in the past has carried an extremely poor prognosis when initial therapy has failed and patients would succumb to their disease in a short period.

“I am delighted that patients can maintain long term access to Brentuximab vedotin through this NICE decision.”

The drug has previously been available on the NHS via the Cancer Drugs Fund since 2013 but free from the ECOG performance restriction and according to Takeda, they were not “aware of any data that would support this restriction”.

A final decision on the drug’s use to treat relapsed or refractory systemic anaplastic large cell lymphoma is expected on 25 October.

Article by
Gemma Jones

25th August 2017

From: Regulatory

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