NICE’s backing of the prostate cancer drug abiraterone could help thousands and save the NHS millions
Our landmark review demonstrates a new approach to keeping NHS care up-to-date and could benefit thousands of adults with metastatic prostate cancer.
Today we’ve published final draft guidance recommending abiraterone and its generic variants in combination with androgen deprivation therapy and prednisolone or prednisone as an option for adults with newly diagnosed high-risk hormone‑sensitive metastatic prostate cancer.
The decision marks a significant shift from our 2021 guidance, which could not recommend abiraterone because, at the 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.
Generic medicines are versions of brand-name drugs that have the same active ingredient, strength, and safety. They are developed after a brand-name drug's patent expires.
While generic abiraterone is already being used in some areas, its availability has varied. Our positive recommendation addresses this inconsistency, expanding access to a clinically effective medicine with as many as 4,000 people now able to benefit from this additional treatment option.
We estimate the NHS could potentially save £millions annually by greater use of the generic version of abiraterone rather than using enzalutamide and apalutamide, the other treatments we recommend at this stage - funds which can be reinvested in breakthrough treatments and care improvements.
The review also tested a new process as part of our whole life-cycle approach to guidance development. This approach makes our recommendations more responsive to changes in evidence, pricing, and clinical practice - supporting the Government’s 10 Year Plan to keep NHS care up to date and cost-effective.
Helen Knight, Director of Medicines Evaluation at NICE, said: "Assessing the cost-effectiveness of generic medicines is a new departure for NICE, but one that is central to our ambition of getting the best treatments to patients quickly while ensuring the NHS gets the best value for its money.
Our whole life-cycle approach means we can respond dynamically when circumstances change, whether that's new evidence emerging or, as in this case, more affordable versions of effective treatments becoming available. This allows us to widen access where we previously couldn't recommend a treatment.
Minister for Public Health and Prevention, Ashley Dalton, said: "It's brilliant that thousands of men with advanced prostate cancer will now get consistent access to a treatment that can prolong their life.
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.
This is what an NHS fit for the future looks like - making every penny count so we can reinvest savings into the cutting-edge treatments of tomorrow.
Mark Samuels, Chief Executive of Medicines UK, said: "We welcome NICE's recommendation for generic abiraterone and the innovative approach taken to this evaluation. This decision demonstrates how the off-patent medicines sector – which provides four in every five NHS prescriptions – plays a vital role in both improving patient access and creating financial headroom for the NHS.
NICE’s approach shows a commitment to helping make the UK an attractive and supportive environment for generic medicines. By continuously reviewing guidance and streamlining assessment processes, NICE is helping to unlock the full potential of off-patent medicines to deliver better value and wider, earlier access for patients. We look forward to continuing this collaborative approach as more medicines come off patent in the coming years.
We expect to publish final guidance on abiraterone next month. NHS England and integrated care boards have agreed to provide funding to implement this guidance 30 days after publication.