Astellas' Xtandi too expensive for UK's NHS, says NICE

The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has published draft guidance in which Japanese drug major Astellas Pharma’s (TYO: 4503) Xtandi (enzalutamide) is not recommended as a drug to treat advanced prostate cancer.

It says that enzalutamide is not a cost-effective, pre-chemotherapy treatment and that there are too many uncertainties associated with the evidence provided by drug manufacturer.   

The drug is licensed to treat people with prostate cancer that has spread to other parts of the body; who have not yet had chemotherapy; and in whom treatments to lower the amount of male sex hormones – which normally stop the cancer from growing and spreading - no longer work.

NICE chief executive Sir Andrew Dillon said: “The clinical trial results showed enzalutamide can extend life when compared with placebo, but it was not clear for how long. This was because there were uncertainties associated with way the company had carried out adjustments to take account of the effect on length of life of treatments used when enzalutamide is no longer effective. The Appraisal Committee was also concerned that the company had not adequately evaluated the uncertainties in its cost-effectiveness analyses.”

Using its preferred assumptions, the committee concluded that the incremental cost-effectiveness ratio (ICER) for enzalutamide compared with best supportive care was above £40,000 ($60,960) per quality-adjusted life years (QALY) gained.

The company has agreed a patient access scheme with the Department of Health. If enzalutamide had been recommended, this scheme would have provided a simple discount to the list price of enzalutamide with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence, the NICE noted.