Erlotinib not recommended for maintenance treatment of non-small-cell lung cancer
NICE has been unable to recommend the use of erlotinib (Tarceva, Roche Products) as a maintenance treatment for people with non-small-cell lung cancer who have had first line treatment with platinum-based chemotherapy and their disease has remained stable.
The aim of maintenance treatment is to prolong the benefits of initial treatment and to maximise quality of life for as long as possible. NICE has previously recommended pemetrexed as a maintenance treatment for non-small-cell lung cancer for a specific type of lung cancer.
Although erlotinib has been shown to help some patients live longer, the independent Appraisal Committee felt that there was too much uncertainty about the amount of extra time or overall survival gain expected from the treatment and that based on the evidence available erlotinib was not considered value for money.
Commenting on the guidance Andrew Dillon, Chief Executive of NICE said: "We are disappointed not to have been able to recommend erlotinib. However, where pemetrexed was shown to offer a potential additional 5.2 months of life to patients with a specific type of lung cancer, it is uncertain how much benefit erlotinib can offer as a maintenance treatment."
The Institute received one appeal on its final draft guidance for this appraisal from the manufacturer of erlotinib, Roche Products Ltd. The appeal was heard on 16 May and was dismissed on all points. When an appeal has been held, regardless of the outcome, NICE always publishes guidance as soon as possible. This means that publication doesn't necessarily take place on the regular NICE publication day, which is the fourth Wednesday of the month.
Notes to Editors
About the guidance
1. The guidance will be available from 29 June at www.nice.org.uk/guidance/TA227
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 under certain circumstances 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 considerably 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 manufacturer of erlotinib estimated that maintenance treatment with erlotinib can potentially extend life by approximately 3.3 months in patients with stable disease However, the independent Appraisal Committee did not feel the evidence was sufficiently robust to demonstrate this extension to life.
7. The Committee agreed that erlotinib did 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 very uncertain.
8. 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.
9. 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
10. 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.
11. 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
12. 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: 27 June 2011