NICE consults on pemetrexed for the maintenance treatment of non-small-celllung cancer
NICE, the healthcare guidance body, has issued new draft guidance not recommending pemetrexed (Alimta, Eli Lilly) for the maintenance treatment of non-small-cell lung cancer (NSCLC) following induction therapy with pemetrexed and cisplatin1.
Lung cancer is one of the most common cancers in the UK, with around 38,000 people diagnosed every year. Non-small-cell lung cancer is the most common type of lung cancer, accounting for around 80% of all cases.
The two main goals of maintenance treatment are to prolong the period of remission after first-line chemotherapy and increase the likelihood of being able to receive second-line chemotherapy.
NICE has already recommended pemetrexed as a first line treatment option for NSCLC and as a maintenance treatment option following platinum-based chemotherapy in combination with gemcitabine, paclitaxel or docetaxel. This appraisal is concerned with the extension to the marketing authorisation for pemetrexed as a maintenance treatment following pemetrexed and cisplatin.
Commenting on the draft guidance, Sir Andrew Dillon, Chief Executive of NICE said: “Pemetrexed is already recommended as maintenance treatment following a different first line treatment However, in this case, as maintenance treatment following pemetrexed and cisplatin, although effective, the potential gain for patients are less but the cost to the NHS remains the same.
“It is disappointing not to be able to recommend pemetrexed in our preliminary guidance, but we can only recommend treatments which are both clinically and cost effective.”
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
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.
Notes to Editors
About the guidance
1. The draft recommendation is: Pemetrexed is not recommended for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) other than predominantly squamous cell histology in people whose disease has not progressed immediately following induction therapy with pemetrexed and cisplatin.
2. The draft guidance will be available from the 22 February 2013. Embargoed copies of the draft guidance are available from the NICE press office on request.
3. The results from the PARAMOUNT clinical trial indicated that pemetrexed provides a gain in progression-free survival (1.28 months) and overall survival (2.85 months).
4. The Committee considered that the most plausible incremental cost-effectiveness ratio (ICER) was in excess of £76,300 per Quality Adjusted Life Year (QALY) gained.
5. The average total treatment cost is approximately £11,640.
6. The Committee considered that the total population for whom pemetrexed is licensed was not small enough to allow for the end-of-life advice to apply. It is noted that even if the supplementary advice on end-of-life treatments was taken into account, the most plausible ICER was higher than that normally considered to be cost effective.
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.
8. Pemetrexed for the maintenance treatment of non-small-cell lung cancer
9. Pemetrexed for the first-line treatment of non-small-cell lung cancer
10. Pemetrexed has a marketing authorisation for the following indications:
- in combination with cisplatin for the first-line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology
- as monotherapy for the maintenance treatment of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy
- as monotherapy for the second-line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology.
- in combination with cisplatin for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
1. 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.
2. 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
- social care - the Health and Social Care Act (2012) sets out a new responsibility for NICE to develop guidance and quality standards for social care. To reflect this new role, from 1 April 2013 NICE will be called the National Institute for Health and Care Excellence (NICE) and it will become a Non-Departmental Public Body.
3. NICE produces standards for patient care:
- quality standards - these describe high-priority areas for quality improvement in a defined care or service area
- 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
- CCG Outcomes Indicator Set (formerly known as COF) - NICE develops the potential clinical health improvement indicators to ensure quality of care for patients and communities served by the clinical commissioning groups (CCGs).
4. 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: 21 February 2013