The National Institute for Health and Clinical Excellence has issued new draft guidance not recommending the use of Janssen's Zytiga (abiraterone) in combination with prednisone or prednisolone for the treatment of castration-resistance metastatic prostate cancer that has progressed on or after docetaxel-containing therapy.
The draft guidance has now been issued for consultation.
Commenting on the draft recommendations, NICE chief executive Sir Andrew Dillon said: "abiraterone is a drug that could potentially extend life by more than three months compared with placebo. For patients, one of the key benefits of this drug is that it can be taken orally at home. We are therefore disappointed not to be able to recommend it for use on the NHS."
However, he added: "it is an expensive drug and the independent advisory committee that made this decision did not feel the drug provided enough benefit to patients to justify the price the NHS is being asked to pay, even with the discount the manufacturer has offered."
The committee had concluded that the most plausible Incremental Cost-Effectiveness Ratio for Zytiga would be at least £63,200 per quality-adjusted life year, after taking into account a discount which has been agreed between Janssen and the Department of Health.
Zytiga costs £2,930 for a 30-day supply of 120 tablets. It is taken as a single dose of 1g per day, taken as four 250mg tablets. Janssen has agreed a patient access scheme with the Department of Health which makes the drug available at a discounted price, the size of which is commercial in confidence.
NICE also reports that the panel additionally felt that Zytiga did not meet the criteria to be considered under the Institute’s special arrangements for drugs treating people at the end of their life, as the population for which it is licensed cannot be considered to be small.
Consultees, including the manufacturer, healthcare professionals and members of the public, are now able to comment on the preliminary recommendations, which are available on NICE's website. "The manufacturer can also consider whether it wishes to further reduce the acquisition cost to the NHS of the drug by proposing a revised patient access scheme," the Institute suggests.
NICE points out that the draft has not been issued to the NHS, and until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once the Institute issues its final guidance on a technology, it replaces local recommendations across the country. The Scottish Medicines Consortium has not yet published guidance on Zytiga for this condition, it adds.