NICE recommends abiraterone and erlotinib
Abiraterone (Zytiga, Janssen) is recommended in combination with prednisone or prednisolone as a treatment option for castration-resistant metastatic prostate cancer1 that has progressed on or after one docetaxel-containing therapy.
Erlotinib (Tarceva, Roche Products) is recommended as an option for the treatment of people with locally advanced or metastatic EGFR mutation-positive2 non-small-cell lung cancer (NSCLC).
Commenting on the guidance, Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "NICE recommends more than 80% of the drugs it appraises and we are very pleased to be able to add these two treatments to the list of options available to patients.
"During the consultation on the draft guidance the manufacturer of abiraterone, submitted a revised patient access scheme providing the drug to the NHS at a discounted price, as well as further information on which patients with prostate cancer would benefit most and clarification on how many patients could receive the drug. These factors enabled the committee to revise its preliminary views and recommend the drug for use on the NHS.
"In the treatment of lung cancer, NICE has already recommended a drug called gefitinib as an option for the first-line treatment of EGFR mutation-positive NSCLC, which is now the treatment that most patients receive. We are pleased to be able to recommend another treatment option for this stage of the disease."
Notes to Editors
Explanation of terms
1. Castration-resistant prostate cancer is defined by disease progression despite traditional 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
2. Patients are required to test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation.
About the abirateroneguidance
3. The final guidance will be available at www.guidance.nice.org.uk/ta259 from 27 June 2012. Embargoed copies of the guidance are available from the NICE press office on request.
4. The main treatment options for patients whose disease progresses after first-line docetaxel therapy include mitoxantrone, best supportive care, and re-treatment with docetaxel (which is not recommended by current NICE guidance).
5. Abiraterone could potentially extend life by more than 3 months.
6. The Committee concluded that the 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.
7. 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.
8. 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 the erlotinibguidance
9. The final guidance will be available at www.guidance.nice.org.uk/ta258 from 27 June 12. Embargoed copies of the guidance are available from the NICE press office on request.
10. Erlotinib is given orally at a recommended dosage of 150 mg/day. The cost of a pack of 30 (150-mg) tablets is £1,631.53. The manufacturer of erlotinib has agreed a revised patient access scheme with the Department of Health in which a confidential discount from the list price is applied to original invoices.
11. The Committee discussed the results from the updated analyses comparing erlotinib and gefitinib, and on balance agreed that the sums of money either saved or spent are small given the uncertainties associated with the analysis. The Committee concluded that at the price agreed under the patient access scheme (as revised in 2012) erlotinib should be recommended as an option for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive NSCLC.
12. Erlotinib does not meet the criteria to be considered under end-of-life.
13. Erlotinib and gefitinib work in a different way to chemotherapy. They are given in tablet form and are known as "targeted agents" because they block certain processes in the cancer cells.
14. Erlotinib has been recommended by the SMC in Scotland for this condition.
15. There are two main types of primary lung cancer. These are classified by the type of cells in which the cancer starts. They are:
a. Non-small cell lung cancer (of which there are three different types, called squamous cell carcinoma, adenocarcinoma and large cell carcinoma) is the most common type of lung cancer, accounting for around 88% of all cases.
b. Small cell lung cancer accounts for around 12% of all cases. Small cell lung cancer is more aggressive than non-small cell lung cancer, and it usually spreads faster.
16. Lung cancer is the second most common cancer (after breast cancer) in England and Wales. An estimated 40,800 new cases are diagnosed every year.
17. Smoking cigarettes, pipes, or cigars is the most common cause of lung cancer. Other risk factors include:
- Smoking cigarettes in the past.
- Being exposed to second-hand smoke.
- Being treated with radiation therapy to the breast or chest.
- Being exposed to asbestos, radon, chromium, nickel, arsenic, soot, or tar.
- Living where there is air pollution.
When smoking is combined with other risk factors, the risk of developing lung cancer is increased.
18. The gefitinib guidance is available at: www.nice.org.uk/guidance/TA192.
19. The manufacturer agreed a patient access scheme with the Department of Health in which gefitinib will be available at a single fixed cost of £12,200 per patient irrespective of the duration of treatment. The manufacturer will not invoice the NHS until the third monthly pack of gefitinib is supplied. This means that for patients who receive only one or two months of treatment, gefitinib will be provided free of charge.
20. Gefitinib showed longer progression-free survival and similar effects in terms of overall survival compared with the current treatment of pemetrexed used in combination with cisplatin.
21. The National Institute for Health and Care 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
22. 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.
23. 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
24. 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.
This page was last updated: 26 June 2012