Institute of Cancer Research Criticises NICE Rejection of Abiraterone

Dawn O'Shea

July 16, 2021

The Institute of Cancer Research (ICR) has expressed disappointment at the decision by The National Institute for Health and Care Excellence (NICE) not to approve abiraterone as a first-line treatment for newly diagnosed, advanced prostate cancer.

A NICE appraisal committee acknowledged that clinical trial results show that, compared with ADT alone, a combination of abiraterone plus ADT and either prednisone or prednisolone increases progression-free survival (PFS) but not overall survival.

Results also show that, compared with docetaxel plus ADT, abiraterone plus ADT increases PFS. The committee remarked that there is no evidence for abiraterone plus ADT compared with ADT alone for men who cannot receive docetaxel. Abiraterone has also been found to halve the risk of serious complications compared with ADT and docetaxel.

However, the cost-effectiveness estimates of abiraterone compared with ADT alone, or with docetaxel for the whole population, were higher than that which NICE consider cost-effective.

The decision followed a long period of discussions and an appeal.

The first public consultation on this topic was initiated in May 2018. This was subsequently suspended to facilitate price negotiations. A final appraisal determination was published in June 2020.

An appeal followed in September 2020. Some of the appellants included the British Uro-oncology Group (BUG), Prostate Cancer UK, and Tackle Prostate Cancer. Public consultation on the new guidance was initiated at the end of last year.

'Great Shame'

The ICR said the evidence supports the clinical benefits of abiraterone. It says the treatment has been rejected on financial grounds.

Professor Nick James, Professor of Prostate and Bladder Cancer Research at the ICR, and consultant oncologist at the Royal Marsden NHS Foundation Trust, said: "Abiraterone has clear benefits for helping men with prostate cancer to live longer with a better quality of life, so it is a great shame that patients are being denied the drug on the grounds of cost.”

A NICE spokesperson said: "We are disappointed not to be able to recommend abiraterone as a further option for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer.

"However, even with a proposed discount to the price of abiraterone, the cost-effectiveness estimates are higher than what NICE considers an effective use of NHS resources. NICE already recommends enzalutamide for high-risk hormone-sensitive metastatic prostate cancer so most people with this condition already have access to an effective treatment."

This article was adapted from Univadis, part of the Medscape Professional Network.

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