Keywords: UK, NICE, Eli Lilly, Alimta, NSCLC, Pemetrexed, Lung cancer

Data uncertainties mean NICE unable to recommend pemetrexed for NSCLC maintenance treatment

Article | 17 December 2009

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Giving an initial negative opinion, the UK’s National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of pemetrexed (brand name Alimta, a chemotherapy drug manufactured and marketed by US drug major Eli Lilly, which is indicated for the treatment of pleural mesothelioma as well as non-small cell lung cancer) for the maintenance treatment of non-small-cell lung cancer.

In its draft guidance, published today, the NICE does not recommend pemetrexed. However, this draft has been issued for consultation and the manufacturer now has an opportunity to consider and respond to comments made by the independent Appraisal Committee

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Lung cancer is one of the most common cancers in the UK, with around 38,000 people diagnosed every year. Maintenance treatment after first-line treatment is a new concept in lung cancer care and is not currently practised in the UK. The 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

Carole Longson, Health Technology Evaluation Centre director at the NICE said: “In September NICE recommended pemetrexed as a first-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. The committee felt that there were many uncertainties in the data and analysis provided by the manufacturer. These uncertainties led the committee to conclude that, on current evidence, the cost of the drug related to the benefits it brings means that pemetrexed would not be a good use of National Health Service money.

Explaining its evaluation process, the NICE notes that 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 £51,000 ($82,788) per QALY gained. However, due to the uncertainties in the manufacturer’s economic model, this may be higher.

The committee agreed that pemetrexed should be considered under criteria for evaluating life-extending, end of life treatments, but, even when applying these considerations the scale of the additional weight that would need to be applied to the original QALY in order for the cost effectiveness of the drug to fall within the current threshold range would be too great, said the agency.

The next step in the NICE process is for the manufacturer to consider the Committee’s comments and respond to its concerns.