NICE says no to early use of prostate cancer drug
Janssen's prostate cancer drug Zytiga should not be used earlier in patients, because it would not be cost effective, says NICE.
Draft guidance from the cost effectiveness watchdog says Zytiga (abiraterone) should not be used in prostate cancer which has spread in men whose first treatment has failed, have no or mild symptoms and for whom chemotherapy is not yet clinically indicated.
NICE's committee concluded that the drug increased time to progression in the disease compared with placebo, but that whether it extended life was uncertain.
Despite these doubts about the clinical benefits of the drug in these patients, Zytiga is already being used extensively in England via the alternative funding route of the Cancer Drugs Fund (CDF).
Charity Prostate Cancer UK has 'implored' NICE and Janssen to find a solution to the problem, which would ensure wider access to the drug.
Established second line use
Zytiga is already as a 'second-line' treatment after a docetaxel containing chemotherapy regimen – the new appraisal looks at using the drug in patients with few symptoms and when chemotherapy would not yet be given.
Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: "Although abiraterone is not a new drug, it is the first treatment to become available at this point in the treatment pathway. 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.
However, NICE concluded that the manufacturer's own economic model showed that the drug would not be cost-effective at this stage, and said for this reason it could not recommend the drug in this preliminary guidance.
Dillon concluded: "We hope that during this consultation, the manufacturer uses this opportunity to look again at its submission and provides the committee with additional information which may enable them to reconsider."
The clinical evidence submitted by the manufacturer came from one trial (COU-AA-302). The results indicated that Zytiga could extend time to progression compared to placebo, the Committee said it was concerned that as the trial was stopped early, the results never reached the level needed to prove whether the drug improved survival.
The committee also felt there were a number of issues with the way the manufacturer calculated estimated cost-effectiveness. NICE says the health economic model was particularly complex, and the committee felt that it was not transparent enough for the Evidence Review Group (ERG) to fully validate and critique. However, the manufacturer's current data showed that abiraterone cannot be considered value for money.
Zytiga costs £2930 for a month's treatment, but Janssen has agreed a patient access scheme with the Department of Health, for which the lower price is confidential.
Patient group implores NICE and Janssen to find solution
The drug is available through the Cancer Drugs Fund (CDF) and has been used in these earlier stage patients for well over a year via the fund.
Mikis Euripides, Director of Policy and Strategy at Prostate Cancer UK said: "This news is a huge blow to those with advanced disease who have long hoped for the chance to delay chemotherapy and the debilitating side effects and incessant hospital visits which come with it.
Euripides says that in the sixteen months since it became available on the CDF in England, pre-chemotherapy abiraterone has become the fund's second most requested drug. He concludes this shows great confidence from clinicians about the drug's benefits at this stage, as well as the value patients put on being able to delay or avoid having chemotherapy, with the advice of their doctor.
"It seems unforgiveable that such a powerful and beneficial treatment should be left tantalisingly out of reach," added Euripides. "We implore Janssen and NICE to work together to do everything in their power to make this vital treatment available as soon as possible for all in England and Wales who need it. This decision has been delayed once before, and it is more than frustrating that still we seem to be no further forward. Men should not be forced to wait a moment longer."
Xtandi gets go-ahead
Last week NICE also released final guidance on the use of another prostate cancer treatment, Astellas' Xtandi (enzalutamide) in England and Wales, recommending its on the NHS for men who have already been treated with the chemotherapy drug docetaxel.
This news was welcomed by Prostate Cancer UK, because NICE had earlier said no to use of the drug after treatment with Zytiga had failed.
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