NICE: no early Zytiga use
pharmafile | May 14, 2014 | News story | Sales and Marketing | Cancer, Janssen, NHS, NICE, Zytiga, johnson, prostate
Janssen has criticised NICE’s decision not to recommend Zytiga on the NHS at an earlier stage in the prostate cancer patient pathway.
The Johnson & Johnson company expressed its disappointment that NICE’s draft guidance comes down against using Zytiga (abiraterone acetate) for men with advanced hormone relapsed prostate cancer (mCRPC) who have not previously been treated with chemotherapy.
The manufacturer is supported by the Institute for Cancer Research (ICR), whose deputy chief executive, Professor Paul Workman, says he was ‘very disappointed’.
He argues that Zytiga is now used as standard after chemotherapy, extending the lives of patients with fewer side effects than chemotherapy.
“The decision to refuse use of abiraterone before chemotherapy will deny many thousands of men the opportunity to access the drug earlier in their course of treatment,” he adds, calling it a “particular blow for men who are unable to have chemotherapy because they are too old or too frail”.
Janssen has not given up hope, saying it will “work constructively with NICE to address the concerns they have raised at this stage in the process”. Chief among these concerns is what benefit will be derived by patients at what cost.
NICE already recommends Zytiga as a second-line treatment after docetaxel chemotherapy, but it supposes the picture is cloudier when looking at how well the drug works when people with the disease have had one failed treatment, have few symptoms and when chemotherapy would not yet be given.
NICE chief executive Sir Andrew Dillon explains: “The manufacturer’s own economic model showed that the drug would not be cost-effective at this stage.
“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,” he goes on.
He urges Janssen to use the consultation period to beef-up the information it gives to the appraisal committee. At present, the firm’s clinical evidence comes from one trial, COU-AA-302.
NICE was concerned that while the results suggested Zytiga could extend time to progression compared to placebo – the trial was stopped early so improved survival was not proved.
The committee also felt “there were a number of issues with the way the manufacturer calculated estimated cost-effectiveness”.
Adam Hill
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