Revised patient access scheme and more information allow NICE to recommend abiraterone for prostate cancer

Revised patient access scheme and more information allow NICE to recommend abiraterone for prostate cancer

NICE, the healthcare guidance body, has issued new draft guidance recommending the use of abiraterone (Zytiga, Janssen) in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed after one docetaxel-containing therapy.

Commenting on the draft recommendations Sir Andrew Dillon, Chief Executive of NICE said: "During the consultation on the draft guidance Janssen, the manufacturer of the drug, submitted further information for the committee to consider. This included a revised patient access scheme which involves providing the drug to the NHS at a discounted price; further information on which patients would benefit most and clarification on how many patients could receive the drug. These factors enabled the committee to revise its preliminary recommendation and now recommend the drug for use on the NHS.

"We are very pleased that Janssen's submission to our consultation means that we are able to produce draft guidance recommending abiraterone - it is an effective treatment, potentially extending life by more than three months, and it also allows patients to be treated at home as it can be taken orally."

During consultation on the first draft guidance, the manufacturer revised their patient access scheme. Further information on a subgroup of patients that may receive the most benefit from the drug was also provided: patients who had previously been treated with one docetaxel-containing chemotherapy regimen. The manufacturer also submitted further information on the number of patients for whom abiraterone is licensed, enabling the drug to be considered under NICE's end of life criteria.

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

For more information, please call the NICE press office on 0845 003 7782 or 07775 583 813.
Notes to Editors

1. Castration-resistant prostate cancer is defined by disease progression despite androgen-deprivation therapy and may present as one or any combination of a continuous rise in serum levels of prostate-specific antigen, progression of pre-existing disease, or appearance of new metastases
About the guidance

2. The draft guidance will be available from 16 May 2012. Embargoed copies of the draft guidance are available from the NICE press office on request.

3. The main treatment options for patients whose disease progresses after first-line docetaxel include mitoxantrone, best supportive care, and re-treatment with docetaxel (which is not recommended by current NICE guidance).

4. Abiraterone could potentially extend life by more than 3 months.

5. The Committee concluded that the ICER (cost per quality-adjusted life year) for the one prior chemotherapy subgroup would be more than the manufacturer's estimate of £46,800 per QALY gained, but less than £50,000 after taking into account the discount agreed between the manufacturer and the Department of Health.

6. The list price of abiraterone is £2,930 for a 30-day supply of 120 tablets. It is taken as a single dose of 1 g per day, taken as four 250-mg tablets. The manufacturer of abiraterone (Janssen) has agreed a revised patient access scheme with the Department of Health which makes abiraterone available at a discounted price. The size of the discount is commercial in confidence at the request of the manufacturer.

7. The SMC published guidance in March 2012 not recommending abiraterone for this condition. They are currently considering a re-submission and are due to publish their decision later this summer -
About NICE

8. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

9. NICE produces guidance in three areas of health:

    Public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
    Health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
    Clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

10. NICE produces standards for patient care:

    Quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
    Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

11. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.