NICE recommends abiraterone for prostate cancer

21 Mar 2016 03:12 PM

NICE has issued final guidance recommending abiraterone (marketed as Zytiga by Janssen) for some prostate cancer patients*. This is a change from the appraisal committee’s previous draft guidance decision.

It is estimated that 5,900 people with prostate cancer could be eligible for treatment with abiraterone each year.1

Initial evidence submitted by the manufacturer to NICE failed to demonstrate the quality of life and long-term survival for patients receiving abiraterone, meaning NICE could not recommend the drug as indicated.

When requested, Janssen submitted new evidence focusing on a large group of patients treated with abiraterone in the USA. The data showed that 14% of the patients were still taking abiraterone after 4.4 years. The appraisal committee expressed some concerns about whether these results could be generalised to the UK, but they recognised that the new data supported the case for some patients taking abiraterone for long periods of time. As such the committee hasnow concluded that abiraterone is a cost-effective treatment option.

Commenting on the final decision, Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: “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.”

Where NICE recommends a treatment, the NHS is legally obliged to begin funding the drug within 3 months of the final publication date.

References

1Office for National Statistics (2013) ‘Cancer Statistics Registrations, England, 2013’. Accessed online.

Notes to Editors

*Abiraterone in combination with prednisone or prednisolone is recommended, within its marketing authorisation, as an option for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated, and only when the company rebates the drug cost of abiraterone from the 11th month until the end of treatment for people who remain on treatment for more than 10 months.

• The current list price of abiraterone is £2,930 for 120 tablets (excluding VAT; British national formulary [BNF], accessed online November 2015). It is anticipated that the list price will be reduced to £2,300 for 120 tablets at the time of publication of the final guidance. The company also agreed a complex patient access scheme (PAS) with the Department of Health, which involves the NHS paying the new list price for abiraterone for the first 10 months of treatment. After 10 months, the company will rebate the cost of any subsequent tablets prescribed. The simple discount PAS for abiraterone, which was agreed as part of the appraisal of abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen, has been replaced by the complex patient access scheme.
• The committee heard from clinical specialists that, when chemotherapy is indicated, most people would have docetaxel. But, when people have no or mild symptoms clinicians may instead offer best supportive care including corticosteroids such as prednisolone to delay chemotherapy and its adverse effects.
• The committee concluded that abiraterone compared with placebo extended the time to progression and survival times, but how much it extended life was uncertain.
• The committee agreed the most plausible incremental cost-effectiveness ratio for abiraterone compared with best supportive care was between £28,600 and £32,800 per quality-adjusted life year gained. This range depended on which assumption was made about how long people took abiraterone for, and therefore the benefit of abiraterone long-term.
• The committee agreed that abiraterone was innovative, and recognized that there were benefits that were not fully captured in the economic model, such as the value to patients in delaying chemotherapy. Taking this into account, the committee agreed that the incremental cost-effectiveness ratio for abiraterone compared with best supportive care would likely fall below £30,000 per quality-adjusted life year gained, and it considered abiraterone to be a cost-effective use of NHS resources.
• The committee noted that abiraterone, which is taken with prednisolone, has a marketing authorisation for use before chemotherapy. It understood that patients can currently get abiraterone at this point in the treatment pathway through the Cancer Drugs Fund.

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