NICE, the healthcare guidance body, has issued final draft guidance not recommending pemetrexed (Alimta, Eli Lilly) for the maintenance treatment of non-small-cell lung cancer (NSCLC)¹ following induction therapy with pemetrexed and cisplatin.

Lung cancer is one of the most common cancers, with around 36,000 people diagnosed every year in England and Wales. Non-small-cell lung cancer is the most common type of lung cancer, accounting for around 80% of all cases.

Commenting on the draft guidance, Sir Andrew Dillon, Chief Executive of NICE said: “The two main goals of maintenance treatment are to prolong the period of remission after first-line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 already recommends pemetrexed as a treatment option for maintenance treatment following a different first line treatment. However, in this case, pemetrexed as maintenance treatment following combination therapy with cisplatin, although effective, the benefits did not justify the costs.

“It is disappointing not to be able to recommend pemetrexed in this draft guidance, but we can only recommend treatments which are both clinically and cost effective.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. This draft guidance does not mean that people currently taking pemetrexed as maintenance treatment following induction therapy with pemetrexed and cisplatin will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.

This appraisal is concerned with an extension to the marketing authorisation for the maintenance indication approved in 2012 which includes pemetrexed as maintenance therapy after first-line platinum-based chemotherapy including a pemetrexed plus platinum combination.

NICE already recommends pemetrexed as a first line treatment option for certain types of locally advanced or metastatic NSCLC and as a maintenance treatment option for locally advanced or metastatic NSCLC other than predominantly squamous cell histology if disease has not progressed immediately following platinum-based chemotherapy in combination with gemcitabine, paclitaxel or docetaxel.

Ends

Notes to Editors

About the draft guidance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 histology for people whose disease has not progressed immediately following induction therapy with pemetrexed and cisplatin.

2. The draft guidance will be available at from 13 June 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 an overall median progression-free survival benefit (1.68 months) and an overall median survival benefit (2.85 months).

4. The Committee considered that the most plausible incremental cost-effectiveness ratio (ICER) was approximately £82,000 per Quality Adjusted Life Year (QALY) gained.

5. Assuming 8 cycles of treatment, the average total treatment cost is approximately £11,520.

6. The Committee considered that the total population for whom pemetrexed is licensed was not small enough for the end-of-life advice to apply. It 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. NICE guidance previously published on pemetrexed:

• Pemetrexed for the maintenance treatment of non-small-cell lung cancer
• Pemetrexed for the first-line treatment of non-small-cell lung cancer

9. 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.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website: www.nice.org.uk and follow us on Twitter: @NICEComms.