In a significant policy reversal, the National Institute for Health and Care Excellence (NICE) has recommended abiraterone for adults with newly diagnosed high-risk metastatic prostate cancer, following a reassessment prompted by the availability of lower-cost generic versions. 

NICE’s final draft guidance reverses its 2021 decision, which did not recommend abiraterone on cost-effectiveness grounds.

The updated advice supports the use of abiraterone and its generic equivalents in combination with androgen deprivation therapy (ADT) and prednisolone or prednisone.

Approximately 4000 men in England and Wales are expected to benefit from the decision.

Comparable Efficacy, Broader Access

Abiraterone works by blocking the production of androgens, including testosterone, which fuel prostate cancer growth, effectively starving cancer cells of the hormones they need to multiply and spread. It is administered once daily in combination with standard ADT and a low-dose steroid such as prednisone or prednisolone.

Although prednisone is not routinely available in England, it is included in the recommendation to align with abiraterone’s marketing authorisation.

Clinical trial evidence has shown that abiraterone plus ADT with prednisolone or prednisone is more effective than placebo plus ADT or ADT alone. While no direct head-to-head comparisons have been conducted with enzalutamide or apalutamide, indirect comparisons suggest equivalent efficacy between these treatment combinations.

Cost Considerations and Implementation

The recommendation follows a substantial reduction in price after the patent for branded abiraterone expired in October 2022, allowing generic formulations to enter the market.

Generic medicines contain the same active ingredient, strength, and safety profile as brand-name medications but become available after patent expiration.

NICE’s cost comparisons found that abiraterone-containing regimens offer similar or lower overall costs compared with enzalutamide or apalutamide plus ADT. The agency estimates that wider use of generic abiraterone could save the NHS millions of pounds annually, with savings available for reinvestment in new treatments and service improvements.

England’s Public Health and Prevention Minister Ashley Dalton said that by using “generic medicines that deliver better value,” the NHS is “delivering better care while driving smarter spending.”

The review also applied NICE’s Whole Lifecycle Approach, designed to make guidance more flexible and responsive to changes in evidence, pricing, and clinical practice. The framework supports the aims of the government’s 10-Year Health Plan for England to deliver optimal patient care and smarter NHS spending.

NHS England and integrated care boards have agreed to fund abiraterone within 30 days of final guidance publication, ensuring consistent access for eligible patients across the health service.