NICE draft guidance recommends new treatment option for lung cancer
NICE, the healthcare guidance body, has issued final draft guidance recommending erlotinib (Tarceva, Roche Products) as an option for the treatment of people with locally advanced or metastatic EFGR mutation-positive1 non-small-cell lung cancer (NSCLC).
Commenting on the draft guidance, Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "NICE has already recommended a drug called gefitinib for the first-line treatment of EGFR mutation-positive NSCLC, which is now the treatment that most patients receive. There is currently no trial data available which directly compares erlotinib and gefitinib, however, clinical specialists informed the committee that the drugs are very similar and equally as effective.
"During their initial discussion of this topic, the independent advisory committee felt that they did not have enough information to be able to make the decision to recommend it for use in the NHS as an alternative to gefitinib and therefore asked the manufacturer to provide further analyses during consultation on the first draft guidance.
"During this period, the manufacturer of erlotinib provided these further analyses and the committee were able to recommend erlotinib as a cost effective use of NHS recourses. We are pleased to be able to recommend another treatment option for this stage of the disease."
The draft guidance is now with consultees, who have the opportunity to appeal against it.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.
Notes to Editors
Explanation of terms
1. Patients are required to test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation.
About the guidance
2. The final draft guidance will be available from 10 May 2012.
Embargoed copies of the draft guidance are available from the NICE press office on request.
3. 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.
4. 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.
5. Erlotinib does not meet the criteria to be considered under end-of-life.
6. 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.
7. Erlotinib has been recommended by the SMC in Scotland for this condition: http://www.scottishmedicines.org.uk/SMC_Advice/Advice/749_11_erlotinib_Tarceva/erlotinib_Tarceva
8. The gefitinib guidance is available.
9. 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.
10. 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.
About lung cancer
11. 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.
12. 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.
13. 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.
14. 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
15. 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.
16. 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
17. 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: 09 May 2012