The National Institute for Health and Care Excellence (NICE) has recommended the use of Astellas’ Xtandi in the treatment of prostate cancer, but with restrictions that were heavily criticised by the pharma company.
NICE, which provides recommendations on the cost-effectiveness of healthcare products for NHS use, issued second draft guidance stating that Xtandi (enzalutamide) was an effective use of NHS resources in England and Wales when used to treat men with hormone-relapsed metastatic prostate cancer.
However, the guidance only covers the use of the drug in this indication in cases where a patient’s disease has progressed during, or after, a chemotherapy regimen with docetaxel and, crucially for Astellas, if they have not already been treated with Janssen’s rival oncology product Zytiga (abiraterone).
This tightens up previous draft guidance that had recommended Xtandi for NHS patients whose disease has progressed during or after one docetaxel-containing chemotherapy regimen.
Both pieces of guidance also only agreed to recommend the drug if provided by Astellas at a discount through a patient access scheme.
NICE explained that the reason for adding in the restriction concerning a patient’s prior use of Zytiga was because Astellas did not provide data from studies involving patients who had received prior treatment with Janssen’s drug, which was recommended by NICE in June 2012.
“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,” said the cost-effectiveness body.
Astellas disputed NICE’s conclusion, claiming it was “surprised” by the decision, which it says limits the decision-making ability of healthcare professionals.
Dr Alan McDougall, medical director at Astellas in the UK, commented: “Today’s announcement from NICE represents a major setback for many prostate cancer patients who would otherwise be eligible for treatment with enzalutamide according to the original draft guidance and licensed indication.”
The Japanese pharma company also cited the guidance issued by the Scottish Medicines Consortium (SMC) recommending Xtandi without restrictions.
The recommendation is now up for consultation before further draft guidance is issued by NICE.