NICE failure to agree a Zytiga price with Janssen is 'fiasco'

Medical charity Prostate Cancer UK has reacted angrily to the news that NICE has rejected Janssen's Zytiga for broader use in new draft guidance, dubbing it "a kick in the teeth for men with advanced prostate cancer".

The UK's cost-effectiveness watchdog has previously backed the use of Zytiga (abiraterone) for treating advanced prostate cancer after docetaxel-containing chemotherapy, but stopped short of recommending its use in men who have yet to receive chemotherapy but whose disease has spread after hormone-based treatment.

Prostate Cancer UK's chief executive Owen Sharp said the decision was "a fiasco", as for many men in England and Wales use of Zytiga in this setting would provide "a vital opportunity for extra time with loved ones and a chance to delay chemotherapy and the debilitating side effects which come with it".

The charity is urging NICE and Johnson & Johnson (J&J) subsidiary Janssen to return to the negotiating table to try to thrash out an agreement on Zytiga's pricing that would allow the drug to be prescribed more widely. Abiraterone pre-chemotherapy was the second-most requested drug on England's Cancer Drugs Fund - used to provide access to therapies not covered under the National Health Service (NHS) - between April 2013 and March 2014.

NICE chief executive Sir Andrew Dillon said the agency was "disappointed not to be able to recommend abiraterone...to delay chemotherapy and its associate side effects", but said Janssen's "particularly complex" economic models suggested that the drug did not offer enough benefit to justify its price.

Zytiga has a list price of £2,930 for 120 tablets - a month's supply - although Janssen negotiated a patient access scheme with the NHS two years ago which provides an undisclosed discount that has also been offered for both post- and pre-chemotherapy use.

A particular issue is that while trials indicate Zytiga can delay the progression of prostate cancer, its effects on extending survival are not clear. Using the standard Cost per Quality Adjusted Life Year (QALY) model, Zytiga fell outside the £20,000 to £30,000 acceptable range, coming in at £46,700.

"An inflexible NICE process plus the drug company's inability to produce all the requested data has led to this being just the latest in a string of hugely disappointing rulings on prostate cancer drugs," said Sharp.

"Once again men in England will have to take their chances with the Cancer Drugs Fund, with men in Wales and Northern Ireland left with nowhere to turn." The current cash allocated to the Fund will likely come to an end in April 2016, however, as at the moment there is no guarantee more money will be made available by the government.

The charity's position was also backed by the Institute of Cancer Research (ICR), which contributed to the discovery and development of abiraterone.

ICR interim chief executive Professor Paul Workman said it was "illogical" that NICE did not have the flexibility to assess use of abiraterone before chemotherapy under the same end-of-life criteria used in its first appraisal, "simply because men were surviving for longer than the two-year cut-off".

He added that it was a "bizarre consequence of the current rules for appraisals that patients have to wait until their life expectancy drops before they can access beneficial drugs on the NHS."

Meanwhile, Janssen said it was also disappointed by the draft ruling and intends to appeal. The decision "leaves thousands of men in England in the advanced stages of prostate cancer with no option but to accept chemotherapy," said the company's medical director Peter Barnes.

"These men will eventually be able to receive abiraterone on the NHS after chemotherapy anyway," he pointed out.

Zytiga is one of the most important growth products for J&J, with worldwide sales of the drug in the first half of the year growing more than 38 per cent to reach $464m.

Link

NICE says no to early use of prostate cancer drug

Image courtesy of Shutterstock