NICE reverses course, endorses expanded use of J&J's Zytiga
- The U.K.'s National Institute of Health and Excellence recommended Johnson and Johnson's prostate cancer drug Zytiga (abireterone) based on new long-term data and some discounts, the cost regulator said this week. NICE had previously rejected neoadjuvant use of Zytiga in October 2014.
- In addition to providing data showing use of the hormonal therapy improved long-term outcomes and was safe, Janssen (a division of J&J) also agreed to cover the cost of tablets prescribed to patients after 10 months. The list price, currently at £2,930 for 120 tablets, will also be reduced to £2,300 for the same amount, NICE said.
- Zytiga was developed by researchers at the the Institute of Cancer Research in London in the mid-1990's. It was approved in the U.S. in 2011.
Originally, Nice rejected Zytiga because its viewed the evidence as insufficient to demonstrate quality of life and long-term survival. However, Janssen submitted new data from the U.S. showing 14% of patients were still taking Zytiga after 4.4 years.
The positive efficacy and safety data, combined with the decrease in cost was key for NICE approval.
“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," said Carole Longson, director of the Centre of Health Technology Evaluation at NICE.
While Paul Workman, chief executive of the Institute of Cancer Research in London, lauded NICE's change of heart, he told Reuters: "“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."
NICE estimates 5,900 people with prostate cancer could be eligible for treatment with Zytiga each year.