No NICE Approval for Abiraterone for High-risk Metastatic Hormone-naive Prostate Cancer

Dawn O'Shea

July 03, 2020

NICE will not be recommending abiraterone (Zytiga, Janssen-Cilag) with prednisone or prednisolone plus androgen deprivation therapy (ADT) for newly diagnosed high-risk hormone-sensitive metastatic prostate cancer (mPCa).

In a final appraisal document, NICE acknowledges that clinical trial results show abiraterone with prednisone or prednisolone plus ADT increases progression-free survival (PFS) and overall survival (OS) compared with ADT alone. However, NICE expresses concern that the trial data may overestimate the effectiveness of abiraterone because the treatments offered in the trials after disease progresses do not reflect those offered in the NHS.

Two randomised controlled trials have investigated abiraterone in combination in hormone-sensitive mPCa.

LATITUDE was a double-blind trial including 1199 patients with newly diagnosed high-risk hormone-sensitive mPCa. Patients were randomised to either abiraterone plus ADT plus a corticosteroid or ADT alone. Median PFS was 14.8 months with ADT alone and 33.0 months with abiraterone in combination (hazard ratio [HR] 0.47; 95% CI 0.39-0.55). Based on the planned final analysis, median OS with ADT alone was 36.5 months and was 53.3 months with abiraterone in combination (HR 0.66; 95% CI 0.56-0.78).

STAMPEDE was a multi-arm non-blinded trial that included patients with newly diagnosed hormone-sensitive metastatic, node-positive, or high-risk localised disease. Randomised trial arms included, but were not limited to, abiraterone plus ADT plus a corticosteroid, ADT alone, and docetaxel plus ADT plus a corticosteroid. The hazard ratio for PFS in the high-risk metastatic subgroup was 0.46 (95% CI 0.36-0.59), and for overall survival was 0.54 (95% CI 0.41-0.70).

Even with the discounted price offered by the pharmaceutical company, the cost-effectiveness estimates of abiraterone with prednisone or prednisolone plus ADT compared with both ADT alone and docetaxel plus ADT were also higher than the range normally considered a cost-effective use of NHS resources.

'Deeply Disappointed'

The Institute of Cancer Research (ICR) discovered the drug and called on NHS England and the manufacturer to come to an agreement on pricing that would allow men to benefit from abiraterone at the start of treatment.

Professor Nick James from ICR led the STAMPEDE trial. He commented: "I am deeply disappointed that abiraterone has not been approved by NICE as a first-line treatment option for men with advanced prostate cancer. Abiraterone offers men a clear improvement in quality of life compared with chemotherapy or hormone therapy alone, with long-term benefits that can last several years. The quality of life benefits of abiraterone are particularly important for older men who might not be well enough to receive chemotherapy. It is especially frustrating that there will be such stark differences across the UK, with men in Scotland able to access abiraterone first line, but those in England and Wales facing the prospect of missing out."

Appeals against the decision can be up to 10th July 2020.

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

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