NICE Reverses Stand on Abiraterone After Janssen Submits Additional Data

Based on the review of some additional data submitted by Janssen, the manufacturer of abiraterone (Zytiga), an appraisal committee from the National Institute for Health and Care Excellence (NICE) has finalized a guidance that recommends the drug for use in some prostate cancer patients prior to chemotherapy.

Back in 2014, NICE refused the use of the drug at the early stage—following hormone deprivation therapy and prior to chemotherapy—citing insufficient evidence to prove value. “We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way,” Andrew Dillon, chief executive of NICE, has said in a statement, adding that data submitted by Janssen failed to prove abiraterone’s cost effectiveness when administered to patients at that stage.

Subsequently, Janssen submitted supplementary evidence from a large group of patients treated with abiraterone in the United States, which showed that 14% of the patients were still taking abiraterone after 4.4 years. According to the press release by NICE, Following a review of this new evidence, the appraisal committee recognized that the new data supported the case for some patients taking abiraterone for long periods of time and could be worth the cost of £2300 for 120 tablets of abiraterone.

Carole Longson, PhD, who heads the Centre for Heath Technology Evaluation at NICE, said in a statement, “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.”

The final guidance recommends abiraterone as an option for treating hormone-relapsed prostate cancer in patients with mild to no symptoms, who have relapsed after androgen deprivation, and prior to initiating chemotherapy. This is provided Janssen grants a rebate on the cost of the drug after the 11^th month (for patients who stay on treatment for more than 10 months) and till the end of treatment. The following are some of the features of the recommendation:

• Janssen is expected to reduce the list price of the drug from £2930 to £2300 for 120 tablets, in addition to agreeing on a complex patient access scheme (PAS) with the Department of Health.
• The committee believes abiraterone trumps placebo in extending the time to progression and survival in this patient population.
• The committee agreed that £28,600 and £32,800 would be the ideal range for incremental cost effectiveness ratio per quality-adjusted life year, for abiraterone compared to the best supportive care.
• The committee recognized the value of delaying chemotherapy (and the associated side effects) in these patients, and a cost-effective use of National Health Services resources.