12:00 AM
Feb 06, 2012
 |  BioCentury  |  Regulation

Small does have a price

Price still drives NICE on end-of-life drugs; J&J's Zytiga latest turndown

Companies looking for clarity on whether their drugs meet the National Institute for Health and Clinical Excellence's patient population criteria for end-of-life treatment won't find it by looking at decisions made so far by the U.K. body. What they will find is that it's still all about price.

The end-of-life criteria were intended to allow NICE appraisal committees to recommend NHS coverage of some drugs for "small" populations of terminally ill patients even if the treatments normally would be considered too expensive.

The reality is reflected in the most recent negative appraisal on Johnson & Johnson's Zytiga abiraterone for prostate cancer.

According to J&J's estimate, Zytiga actually would be used in a smaller patient population - 3,300 patients - than the 4,000 patients the NICE appraisal committee deemed would be eligible under the small population criteria for Pfizer Inc.'s Sutent sunitinib to treat first-line renal cell carcinoma (RCC).

Yet the committee said Zytiga's population was not small enough.

The difference is in the cost. For Zytiga, NICE estimated the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) at £63,200 ($99,050). Its estimate for Sutent is £50,000 ($78,400).

Using its end-of-life criteria, NICE has recommended at least four drugs with ICERs/QALY under £50,000 per year and turned down at least two above that threshold (see "Pounds Over Patients").

The initial end-of-life draft guidance, released in 2008, said a drug could be recommended if it is licensed to treat patients not expected to live for more than 24 months; its ICER exceeds the cost-effective threshold of £30,000, and it extends life substantially compared with current NHS treatment, generally considered to be about a three-month gain in overall survival (OS).

According to the draft, the indicated patient population should...

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