Astellas and Medivation’s prostate cancer drug Xtandi has been given the go-ahead for use within the NHS in England and Wales in new guidance from the National Institute for Health and Care Excellence (NICE).
Final guidance released today by NICE means that Xtandi (enzalutamide) is now approved for use in England and Wales for men with prostate cancer who have already been treated with the chemotherapy drug docetaxel.
A first draft was released last October with no restrictions, but a later version released in January did not recommend use of Xtandi in patients who had already been treated with Janssen’s rival oncology product Zytiga (abiraterone).
Now, the latest, final draft does away with the abiraterone restriction “following the response to consultation,” according to the cost-effectiveness watchdog, bringing England and Wales into parity with Scotland, which approved the drug in November 2013.
News of the volte-face was “cautiously welcomed” by medical charity Prostate Cancer UK, which has been at the forefront of a public campaign to remove the restriction and has accused NICE of “dithering” over the issue.
“By removing the outright ban, NICE has stated that there is no clinical reason for enzalutamide not being prescribed after abiraterone,” commented Owen Sharp, the charity’s chief executive, although he is uncertain at the moment of the real implications of the new draft.
“If it transpires in reality that this is a de facto restriction thinly veiled by complex prose, we will be holding relevant parties to account,” he stressed.
NICE said it changed the draft on the strength of new observational data provided by Astellas which suggested that some patients may benefit from enzalutamide given after abiraterone, but has certainly not endorsed this use.
“There are too many uncertainties in the evidence,” it said in a statement, adding that its committee concluded that it was “that it was not possible at this stage to make a recommendation on the clinical and cost-effectiveness of enzalutamide when given after abiraterone.”
The lack of a recommendation on use after abiraterone puts the decision into the hands of NHS bodies and raises the possibility that there may be regional variations on the use of enzalutamide after abiraterone.
“We know that the manufacturer is currently collecting data on the use of enzalutamide after abiraterone and we look forward to seeing the results of the ongoing trials,” said Professor Carole Longson, centre for health technology evaluation director at NICE.
Xtandi was approved in Europe last year and is predicted to make sales of more than $500m this year, mainly on the back of strong growth in the US.