Janssen disappointed over NICE no-no

Janssen has expressed “disappointment” that NICE does not recommend the use of Zytiga® (abiraterone acetate).

The NICE Appraisal Consultation Document (ACD) does not recommend abiraterone acetate for the treatment of men with advanced (metastatic) hormone relapsed prostate cancer (mCRPC) who have not previously been treated with chemotherapy. Janssen says that it will now work with NICE to address the current concerns raised.

According to the firm, analyses of clinical trial data for abiraterone acetate consistently confirm the value of this medicine for patients. When compared to the standard treatment approach, abiraterone acetate delays disease progression and provides patients with a better quality of life with reduced pain.

Janssen also says that there is a major ongoing study which shows that there is a continued trend in prolonging the life of patients treated with abiraterone and prednisolone, compared with those who were treated with prednisolone alone.

Regulatory authorities in both Europe and the United States approved abiraterone acetate for this indication in December 2012.3 Since then it has been prescribed to slow the progression of the disease and delay the need for chemo in many thousands of patients across Europe and the United States, and is the second most requested treatment on the NHS Cancer Drugs Fund (CDF).

A spokesperson for Janssen said: “We believe that NICE should have made use of the flexibilities available to them under their ‘end-of-life criteria’ – a special consideration that has traditionally been used in assessing medicines for diseases such as cancer.

“In 2012, the ‘end-of-life’ criteria, alongside a Patient Access Scheme offered by Janssen, saw abiraterone recommended for use after chemotherapy. This PAS has been maintained in this appraisal prior to chemotherapy; however, this current decision from NICE, if it stands, would mean that men are denied the opportunity to delay chemotherapy, and furthermore denies options to those who either do not want chemotherapy, or who are unable to go through chemotherapy.”

The company expressed concerns that such patients will be left without access to any NICE approved additional active treatment options, after failure of androgen deprivation therapy, other than steroids.

Janssen maintains that the evidence presented to NICE demonstrates that abiraterone acetate meets NICE’s end of life criteria, and represents a cost-effective use of NHS resources.