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

Cancer drug makers have worried about the future of their products in England since its cost watchdog announced would take the reins of the Cancer Drugs Fund. Now, an appraisal of Takeda’s Adcetris shows they may have had good reason to.

The National Institute for Health and Care Excellence (NICE) said Wednesday in draft guidance that it wouldn’t recommend the med for the treatment of refractory systemic anaplastic lymphoma or relapsed or refractory CD30+ Hodgkin’s lymphoma, citing “immature and limited” evidence of the med’s clinical effectiveness.

It also pointed to the med’s price--Adcetris can cost between £69,000 and £87,000 per patient per course--and noted that the agency didn’t have the evidence needed to show that Adcetris represented a good value for that kind of money.

“We understand that this preliminary decision will be disappointing to patients who could be eligible for treatment,” Carole Longson, director of NICE’s Center for Health Technology Evaluation, said in a statement. "But we need to make sure that the drugs and treatments we look at will benefit patients and be a cost effective use of NHS resources."

While the guidance won’t affect patients who are already on the drug--their treatment can continue without change to the funding arrangements that are already in place--if it holds, it could affect sales of Adcetris moving forward.

Even so, Takeda chose not to put forward a case for the product’s inclusion in the new CDF. That's because of Adcetris’ tiny patient population--it sees about 50 to 60 eligible patients per year. The Japanese pharma was unclear on what further information it could gather on the drug through data collection going forward, it told NICE.

Pharma hasn’t been shy about sharing its opinions on NICE’s move to take over the beleaguered fund, which provided funding for several therapies the watchdogs deemed too pricey for routine NHS use. The head of global oncology for Eisai--whose Lenvima was axed from CDF’s covered list--said the switch creates “an utterly disgraceful situation,” while Roche recently argued that NICE’s methodology perpetuates “ongoing anxiety around the availability of existing and new cancer medicines” for patients.

- see the draft guidance (PDF)

Related Articles:
On day one of cancer fund overhaul, NICE faces new calls for reform
Charities and pharma decry 'disgraceful' changes to England's Cancer Drugs Fund
Look out, drugmakers: NICE is taking the reins of England's Cancer Drugs Fund
Eisai considers legal action over NICE delay of Lenvima
Roche CEO lashes out at U.K.'s 'stupid' move to stop paying for a dozen-plus cancer meds