NICE asks for more information on lung cancer drug

NICE, the healthcare guidance body, has issued new draft guidance requesting that Roche, the manufacturer of erlotinib (Tarceva), provides further information on the use of their drug for the first-line treatment of locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC).

The draft guidance has been issued for consultation. Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Commenting on the draft guidance, Sir Andrew Dillon, Chief Executive of NICE, said: "NICE has already recommended a drug called gefitinib for the first-line treatment of EGFR mutation-positive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. When it was asked to consider Tarceva, our independent advisory committee concluded that it did not have enough information to be able to make the decision to recommend or not recommend it for routine use in the NHS as an alternative to gefitinib. It has therefore asked the manufacturer provide further analyses. We hope that Roche will be able to provide this additional information so that the Committee can consider it at its next meeting on the topic."


Notes to Editors

About the guidance

1. The draft guidance will be available at from 17 February 2012. Please contact the NICE press office for an embargoed copy of the draft guidance.

2. Erlotinib is given orally at a recommended dosage of 150 mg/day. The cost of a pack of 30 (150-mg) tablets is £1631.53. The manufacturer of erlotinib has agreed a patient access scheme with the Department of Health in which a confidential discount from the list price is applied to original invoices.

3. The Committee concluded that it did not have sufficient information to assess the clinical and cost-effectiveness of erlotinib compared with gefitinib.

4. There was no trial data available which directly compared erlotinib and gefitinib.

5. Erlotinib has recently been recommended by the SMC in Scotland for this condition.

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. The Committee has requested an updated cost effectiveness analysis of erlotinib compared with gefitinib with different progression-free survival and utility assumptions, and further sensitivity analyses that look at how the cost-effectiveness of erlotinib changes depending on how many patients are able to continue taking erlotinib and gefitinib after 60 days of treatment, which is the point at which the NHS currently has to start paying for gefitinib under that drug's agreed patient access scheme.

About gefitinib

8. The gefitinib guidance is available at:

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:

  • 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.
  • 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.

About NICE

14. 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

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: 16 February 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.