NICE unable to recommend erlotinib for the maintenance treatment of non-small-cell lung cancer

NICE unable to recommend erlotinib for the maintenance treatment of non-small-cell lung cancer

In preliminary guidance issued today, NICE has been unable to recommend erlotinib (Tarceva, Roche Products) as a maintenance treatment for people with non small cell lung cancer who have had first line treatment and their disease had remained stable.

Draft guidance has been issued for public consultation and the manufacturer and other consultees now have an opportunity to consider and respond to comments made by the independent Appraisal Committee.

Lung cancer is one of the most common cancers in the UK, with around 38,000 people diagnosed every year. Maintenance treatment is a relatively new concept in lung cancer care. Its goals are to prolong the benefits of treatment and to maximise quality of life for as long as possible.

Sir Andrew Dillon, Chief Executive at NICE said: "In November 2008 we recommended erlotinib as a second line treatment for non small cell lung cancer and we are disappointed not to have been able to recommend the drug as a maintenance treatment as well. Erlotinib has been shown to have some clinical benefit, with the manufacturer estimating it can potentially extend life by approximately 3.3 months. However, our independent advisory committee felt that a number of assumptions in the manufacturer's economic model were not appropriate; for example, the overall cost of erlotinib had been underestimated. These issues led the committee to conclude that, on current evidence, the cost of the drug related to the benefits it brings means that erlotinib would not be a good use of NHS money."

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.


Notes to Editors
About the guidance
1. NICE's preliminary recommendations are available for public consultation from 16 June 2010 at

2. Cost-effectiveness is the additional cost of one year of healthy life (expressed as the cost per quality adjusted life year, or QALY, gained). The Committee considered the best available estimate for the base case ICER to be greater than £59,000 per QALY gained.

3. The manufacturer of erlotinib proposed a patient access scheme in which the acquisition cost of erlotinib is reduced by 14.5% (that is, £1394.96 for a pack of 30 tablets [150 mg]). The normal acquisition cost of a pack of 30 tablets (150 mg) is £1631.53

4. The committee agreed that erlotinib should not be considered under criteria for evaluating life extending, end of life treatments It thought that the total population for whom erlotinib was licensed was not small enough to allow the end-of-life advice to apply.

5. 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
6. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

7. 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 and procedures within the NHS clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS. Download PDF version