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NICE is issuing a second consultation document as part of its appraisal of 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 has remained stable. This second draft of the guidance does not recommend erlotinib.

Sir Andrew Dillon, Chief Executive at NICE said: "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. We have already recommended pemetrexed as a treatment under some of these circumstances. However, where pemetrexed was demonstrated to offer a potential additional 5.2 months of life to patients, it is uncertain how much benefit erlotinib can offer as a maintenance treatment.

"We are disappointed not to have been able to recommend a further treatment option for this cancer, however, there is considerable uncertainty about its clinically effectiveness in this setting and we need to be sure that new and existing treatments offer good value for the NHS."

Erlotinib has been shown to have some clinical benefit, with the manufacturer estimating it can potentially extend life by approximately 3.3 months. However, the independent Appraisal Committee did not feel the evidence was sufficiently robust to demonstrate this extension to life.

Draft guidance has been issued for public consultation and the manufacturer and other consultees now have an opportunity to consider and respond to comments made by the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

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 25 November 2010 at http://guidance.nice.org.uk/TA/Wave19/8.

2. 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.

3. NICE recommended pemetrexed for this indication in June 2010: http://guidance.nice.org.uk/TA190

4. 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 for erlotinib versus best supportive care to be greater than £50,000 per QALY gained.

5. The manufacturer of erlotinib agreed a patient access scheme with the Department of Health 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. The cost of erlotinib varies for each patient depending on what dose they receive and for how long. The manufacturer estimated that the average cost of erlotinib per patient would be approximately £6,400

6. The committee agreed that erlotinib should not fulfil the 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 and the potential of the drug to extend life was uncertain.

7. 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

8. 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.

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