Abiraterone receives new NICE approval in ‘significant shift’

The prostate cancer drug abiraterone has received new approval from the National Institute for Health and Care Excellence (NICE) for use on the NHS in England and Wales, in what the body says is a “significant shift” from previous recommendations.

In final draft guidance, published on 30 October 2025, NICE approved abiraterone — both the original and generic versions — in combination with androgen deprivation therapy (ADT) and prednisolone or prednisone for men diagnosed with high-risk hormone-sensitive metastatic prostate cancer.

The androgen biosynthesis inhibitor could benefit around 4,000 patients in England and potentially save the NHS millions of pounds annually through greater use of the generic version of abiraterone rather than using enzalutamide and apalutamide, NICE said.

NICE added that although the usual treatment for this type of cancer is enzalutamide plus ADT or apalutamide plus ADT, the abiraterone treatment regimen can now be offered to the same population.

There is now sufficient evidence to show that abiraterone plus ADT, alongside prednisolone or prednisone, benefits patients and provides value for money. However, “prednisone is not currently available in England, but it is included in the recommendation to match the abiraterone marketing authorisation”, the guidance said.

In a press release published alongside the final draft guidance, NICE said that previous guidance, from 2021, did not recommend abiraterone because at that time “it did not represent value for money for the NHS”.

“The availability of lower-cost generic versions prompted a re-evaluation, leading to today’s positive recommendation,” it added.

NICE said that the new recommendation should address geographical variation in availability of the drug.

Commenting on the approval, Ashley Dalton, minister for public health and prevention, said: “By seizing the opportunity of generic medicines that deliver better value, we’re making sure thousands of men with prostate cancer can now access this vital treatment — delivering better care while also driving the smarter spending our NHS desperately needs.”

Diana Matthews, advanced oncology pharmacist and non-medical prescriber in urology at Velindre Cancer Centre at Velindre University NHS Trust in Cardiff, said: “We now officially have a broad choice of drugs for prostate cancer patients, and practice can be standardised across the country, with the same access across the four nations. 

“With the rapid advance of new treatments within cancer, we also need to be mindful of costs. Using generic drugs will help the NHS to save money that can then be spent on new treatments reaching out to more and more patients.”

However, a spokesperson from the charity Prostate Cancer UK said that while it welcomed the news, “this decision will not save or extend lives as these men already had access to equally effective treatments”. Abiraterone must be prescribed earlier, for men with high-risk but non-metastatic disease, it added.

Amy Rylance, assistant director of health improvement at Prostate Cancer UK, said: “While this decision is a positive step for men with advanced cancer who will now have a wider choice of treatments, it also highlights a much bigger problem.

“We have known for years that prescribing abiraterone at an earlier stage would half the number of men who go on to die from the disease. The NHS has so far failed to act to approve this safe, cheap and effective treatment — and for every week this goes on another 13 men will die as a result.

“With this approval, the NHS has shown it can cut through the red tape and make effective, affordable treatments available when it chooses to. It must now do the same to help these men, who simply cannot afford to wait any longer.”

On 24 October 2025, NICE recommended darolutamide for advanced prostate cancer, in a move which the body said could benefit 6,000 men in England.