| Sumario: | About 2,600 new cases of lung cancer are diagnosed each year in Norway, of which 80% are classified as non-small cell lung cancer (NSCLC). Of these, about 75% have locally advanced or metastatic disease at the time of diagnosis. Palliative chemotherapy is the standard treatment for patients in NSCLC stages IIIB-IV who cannot receive curative treatment and whose performance status is good (PS 0-2). The five-year survival rate for patients in these stages is low at about 1%. Pemetrexed disodium (Alimta(r)) has marketing authorisation in Norway 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. This health technology assessment (HTA) includes a systematic review of the efficacy and safety of pemetrexed given in addition to best supportive care for the maintenance treatment of patients with NSCLC. It also incorporates an economic evaluation of this intervention compared to a strategy of watchful waiting plus best supportive care.1. One clinical trial was included in the systematic review, the quality and risk of bias of which was assessed to be moderate and low, respectively. The rate of adverse events associated with pemetrexed was low.2. In a sub-group analysis of the non-squamous patient population, the pe- metrexed group showed an improved median overall survival compared to the placebo group of 5.2 months (15.5 months vs. 10.3 months, HR 0.70 CI 0.56 to 0.88).3. The economic analysis was based on a Markov model with a time-horizon of six years. The analysis resulted in a cost per quality-adjusted life year and life year gained of approximately NOK 770 000 and NOK 425 000, respectively.4. Whether maintenance treatment with pemetrexed compared to watchful wait- ing is to be considered cost-effective depends on whether the threshold of NOK 500 000 is applied to QALYs gained, in which case it most likely is not, or life years gained, in which case it most likely is.5. The results are associated with uncertainty as they are based on the efficacy data of a sub-population analysis from only one clinical trial.
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