A drug has been recommended for treating some patients with advanced prostate cancer after more than three years of evaluation by the National Institute for Health and Care Excellence.
NICE has approved abiraterone acetate (Zytiga) for the treatment of metastatic hormone-relapsed prostate cancer (mCRPC) before chemotherapy.
“There are few treatments available for patients at this stage of prostate cancer”
The final guidance, published today, represents a change from the previous draft guidance decision made by NICE’s appraisal committee, when the drug had been rejected on grounds of cost-effectiveness.
Initial evidence submitted by the drug’s manufacturer Janssen failed to demonstrate the quality of life and long-term survival for patients receiving abiraterone, according to NICE, meaning it could not previously recommend the drug as indicated.
Janssen then submitted new evidence focusing on a large group of patients treated with abiraterone in the US, which showed that 14% of these patients were still taking abiraterone after 4.4 years.
NICE finally recommends prostate cancer drug
The appraisal committee expressed some concerns about whether the US results could be generalised to the UK, but said they recognised the new data supported the case for some patients taking abiraterone for long periods of time.
As a result, the committee has now concluded that abiraterone is a cost-effective treatment option.
Professor Carole Longson, director of NICE’s Centre for Health Technology Evaluation, said: “I am very pleased that the new evidence submitted has meant we are able to recommend abiraterone.
“There are few treatments available for patients at this stage of prostate cancer so this is very good news,” she said.
Abiraterone has only been available for use before chemotherapy via applications to the Cancer Drugs Fund where it was the second most requested medicine, but the NICE guidance will now make it routinely available.
Where NICE recommends a treatment, the NHS is legally obliged to begin funding the drug within three months of the final publication date.
“The answer today is the right one, but I would urge NICE to implement the planned overhaul of its drug appraisal processes”
It is estimated that 5,900 people with prostate cancer could be eligible for treatment with abiraterone before chemotherapy each year.
The drug is already approved by NICE for routine use in men with metastatic hormone-relapsed prostate cancer after chemotherapy.
Professor Paul Workman, chief executive of the Institute of Cancer Research in London, which first discovered abiraterone, said he was “extremely pleased” with the decision but called on NICE to review its drug appraisal process.
“This is a big victory for men in England with prostate cancer, and means they will finally catch up with the US, Europe and indeed Scotland in being able to access abiraterone earlier in the course of treatment.
“Abiraterone was discovered at the ICR’s laboratories in London, and it’s great that men with advanced cancer who are treated on the NHS will now routinely receive a drug that allows them to live longer and delay chemotherapy,” he said.
However, he added: “The answer today is the right one, but I would urge NICE to implement the planned overhaul of its drug appraisal processes as soon as possible to avoid repeated delays in getting the best, most innovative treatments to patients.
Professor Paul Workman
“It’s been more than three years since NICE first started evaluating use of abiraterone pre chemotherapy, and it’s very frustrating that it has taken that long for NICE and the drug’s manufacturer to find a way of making it available cost-effectively,” said Professor Workman.
Professor Malcolm Mason, Cancer Research UK’s prostate cancer expert, said: “We’re delighted to hear that NICE has approved abiraterone to be used before chemotherapy for men with prostate cancer that has spread and has come back after their first line hormone therapy.
”Cancer Research UK funded the research that led to the discovery and development of this drug, which was only possible thanks to the generosity of our public supporters, making this a true UK success story,” he said. ”This is a great development for prostate cancer patients.”
The current list price of abiraterone is £2,930 for 120 tablets (excluding VAT). It is anticipated that the list price will be reduced to £2,300 for 120 tablets at the time of publication of the final guidance.
The company also agreed a complex patient access scheme with the Department of Health, which involves the NHS paying the new list price for abiraterone for the first 10 months of treatment. After 10 months, the company will rebate the cost of any subsequent tablets prescribed.