Abstract

The end-of-life consideration introduced by NICE in January 2009 allows extension of the upper limit of the cost-effectiveness thresholds beyond £30,000 per QALY for therapies that are indicated in patients with a short life expectancy and for small patient populations, with survival benefit of at least 3 months. The aim of this study was to assess the impact of the end-of-life considerations on health technology assessment (HTA) recommendations for oncology therapies. NICE single technology appraisals (STAs) for oncology therapies published between 2009 and June 11, 2015 were assessed. End-of-life consideration, HTA recommendations, incremental cost-effectiveness ratio (ICER) values and the availability of patient access schemes were extracted. A total of 53 STAs were identified during the study period and 20 appraisals/therapies met the end-of-life criteria. Maximum end-of-life considerations were granted in the year 2009 and 2012 (4 each), while 2013 to 2015 recorded the minimum (2 each). Of the therapies meeting the end-of-life criteria, 13 received positive recommendations with the ICER values ranging from £31,800 to £58,590. Highest percentage of positive recommendations were reported in the year 2009 (100%), whereas no positive recommendations were recorded in 2013, which could be attributable to the high ICER values of the end-of-life therapies appraised in 2013 (£40,000 to £100,000). In 2014 and 2015 each, 50% therapies (1/2) received positive recommendations. Of the 13 positive recommendations, 11 included patient access schemes by manufacturers. Unacceptably high ICER values followed by economic modelling issues leading to uncertain ICER values were major drivers of negative decisions. The use of end-of-life criteria for maximizing patient access remains suboptimal, as fewer treatments have met the end-of-life criteria in recent years. Also, increasing ICER values in end-of-life cancer appraisals have resulted in negative decisions. Patient access schemes by manufacturers may improve patients’ access to novel end-of-life oncology therapies.

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