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www.fdanews.com/articles/169623-nice-declines-dendreons-prostate-cancer-drug-provenge

NICE Declines Dendreon’s Prostate Cancer Drug Provenge

January 20, 2015

Dendreon has not demonstrated that its prostate cancer drug Provenge provides enough benefit over less expensive drugs to justify reimbursement, the UK healthcare cost watchdog said last week.

While the National Institute for Health and Care Excellence acknowledges that patients given Provenge (sipuleucel-T) had higher rates of overall survival in placebo-controlled trials, it still doubts that the drug offers any additional benefit over Janssen’s Zytiga (abiraterone).

A course of Zytiga costs $5,000, while Provenge carries a $71,400 price tag for a course of treatment, well above the range usually considered a cost-effective use of National Health Service resources, NICE says.

Provenge is a cellular immunotherapy meant to identify and attack prostate cancer cells in adults who have asymptomatic or minimally symptomatic metastatic nonvisceral hormone-relapsed prostate cancer but are not yet due for chemotherapy.

Dendreon still has the chance to appeal NICE’s decision before a final guidance is issued, but a negative ruling would most likely force prostate cancer patients seeking Provenge to turn to the Cancer Drugs Fund, which provides access to some cancer drugs that NICE turns down.

However, the fund has also recently been cutting back on the treatment options it will support, dropping drugs that it finds offer little clinical value, and it’s not clear if it would pay for Provenge.

While the fund’s budget is set to grow by some $121 million in 2015/2016, the fund is trying to keep enough money available for non-drug cancer treatments, such as surgical procedures, by refusing to pay for some drugs and negotiating price reductions with drug companies.

By eliminating reimbursement for certain drugs, the fund also makes room to underwrite new drugs such as Amgen’s Vectibix (panitumumab) for bowel cancer and Janssen’s Imbruvica (ibrutinib) for chronic lymphocytic leukemia and mantle cell lymphoma, fund chairman Peter Clark said.

The Association of the British Pharmaceutical Industry CEO Stephen Whitehead continues to call on the government to reform NICE to expand coverage for cancer medications. Dendreon did not respond to a request for comment on whether it will appeal the NICE decision.

View NICE’s final draft guidance at www.fdanews.com/01-13-15-NICEguidance.pdf. — Lena Freund