The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending abiraterone and its generic versions, alongside androgen deprivation therapy and prednisolone or prednisone, for adults with newly diagnosed high-risk hormone-sensitive metastatic prostate cancer.
The decision marks a significant shift from its 2021 guidance, which could not recommend abiraterone as it did not represent value for money for the NHS.
The availability of lower-cost generic versions prompted a re-evaluation, leading to the new, positive, recommendation.
While generic abiraterone is already being used in some areas, its availability has varied.
NICE's positive recommendation addresses this inconsistency, expanding access to a clinically effective medicine with as many as 4000 people now able to benefit from this additional treatment option.
The independent UK body estimates the NHS could potentially save millions annually through the use of the generic version of abiraterone, rather than enzalutamide and apalutamide, the other treatments recommended at this stage.
These funds which can be reinvested in breakthrough treatments and care improvements.
The review also tested a new process as part of NICE's whole life-cycle approach to guidance development.
This approach makes the body's recommendations more responsive to changes in evidence, pricing and clinical practice, supporting the Government’s Ten 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, added: "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."
NICE expects 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.