NICE set to deny access to UK-discovered prostate cancer drug for mHSPC

British medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued draft guidance not recommending Zytiga (abiraterone acetate) plus androgen deprivation therapy (ADT) within its marketing authorization, for men with untreated high-risk hormone-sensitive metastatic prostate cancer (mHSPC).

Expressing its disappointment with the guidance, US health care giant Johnson & Johnson’s (NYSE: JNJ) local subsidiary Janssen pointed out that, should the NICE Appraisal Consultation Document (ACD) become final, up to 4,400 men with this particularly aggressive form of prostate cancer will be unable to access the treatment until their disease has progressed. Furthermore, around half of these patients who are unable to tolerate conventional chemotherapy (docetaxel), will be left with no life-prolonging treatment option at this early, but crucial stage in the treatment pathway. Abiraterone is the only licensed treatment for mHSPC that can delay chemotherapy and disease progression, prolong overall survival and maintain patients’ quality of life.

Jennifer Lee, director of health economics, market access and reimbursement (HEMAR) and advocacy at Janssen UK, said: “This is extremely disappointing news for men in the UK with mHSPC and their families. Many of these men are already living with the psychological burden of being diagnosed with an aggressive disease that has a poor prognosis and highly debilitating symptoms, which can greatly impact quality of life. Such patients have the right to treatment choice, and the right to experience the life-extending benefits of a novel treatment, before their disease progresses.”