NICE, the National Institute for Health and Care Excellence, has issued a new draft guidance recommendation for Astellas Pharma’s Xtandi (enzalutamide), a prostate cancer drug. The newly issued draft guidance follows up on one issued October 2013, tightening the conditions under which the drug is approved for use by the UK’s National Health Service. The new restrictions prompted Astellas to detail its objections and call for looser restrictions. In addition, Prostate Cancer UK, an advocacy group, called the new draft guidance “disheartening.”

NICE plans to recommend enzalutamide as an option for treating hormone-relapsed metastatic prostate cancer in adults, only if their disease has progressed during or after a docetaxel-containing chemotherapy regimen, they have not been treated with abiraterone, and the manufacturer provides enzalutamide with the discount agreed in the patient access scheme.

With respect to the abiraterone-related restriction, NICE explained, “In the trial data provided by the manufacturer of enzalutamide, patients had disease that had progressed during or after a docetaxel-containing chemotherapy regimen, but none of the patients had received previous treatment with abiraterone. Therefore the Committee was not able to draw any conclusions about the effectiveness of enzalutamide after previous abiraterone treatment and considered it important to reflect this in its recommendations.”

Astellas expressed disappointment that patients who would have been eligible to receive enzalutamide under the previous draft guidance recommendation and licensed indication might now be deemed ineligible. Also, the company noted that the Scottish Medicines Consortium (SMC) was not issuing similar restrictions.

Commenting on the NICE recommendation, Owen Sharp, chief executive at Prostate Cancer UK, characterized it as a “blatant U-turn.” Restricting approval of enzalutamide to patients who had not already had the drug abiraterone, he said, “leaves hundreds of men, who have few treatments anyway, with no hope of accessing enzalutamide.”

“The process,” he continued, “has been marked by confusion and a real lack of transparency.”

In a statement, NICE recognized that ezalutamide works differently from other drugs currently available for treating prostate cancer: “Enzalutamide has a different mechanism of action from other antiandrogens; it blocks binding of androgens to androgen receptors, prevents activated androgen receptors from migrating to the nucleus, and blocks the interaction of the activated androgen receptor with DNA in the nucleus.”

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