The most plausible incremental cost-effectiveness ratio was uncertain, but unlikely to be above what NICE normally considers an acceptable use of NHS resources. Abemaciclib also presented increases in adverse events related to gastrointestinal disorders and increases in severe adverse events, but the safety profile was deemed acceptable to patients given the potential benefits.
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The National Institute for Health and Care Excellence (NICE) recommended abemaciclib with endocrine therapy (ET) as an option for the adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.Ĭohort 1 of the MonarchE trial was considered an adequate representation of this population and generalisable to National Health Service (NHS) clinical practice.Ībemaciclib in combination with ET improved invasive disease-free survival and distant relapse-free survival results compared with ET alone. NICE recommended abemaciclib with ET as an option for the adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence. ICER estimates were £9164 per quality-adjusted life-year gained for the company’s base-case and £17,810 for the ERG’s base-case. Areas of uncertainty included the extrapolation of long-term survival curves, the duration of treatment effect and treatment waning, and the proportion of patients who receive other CDK4/6 treatments for metastatic disease after receiving abemaciclib. The ERG believed that the modelling structure presented in the de novo economic model by the company was appropriate but highlighted several areas of uncertainty that had the potential to have a significant impact on the resulting incremental cost-effectiveness ratio (ICER).
Trial results showed improvements in invasive disease-free survival for the abemaciclib arm, which was considered an appropriate surrogate outcome. The ERG considered Cohort 1 as an adequate representation of this population and the AC concluded that Cohort 1 was generalisable to National Health Service clinical practice. The trial included two cohorts that used different inclusion criteria to define high risk of recurrence. A systematic literature review identified the MonarchE trial, an ongoing, open-label, randomised, double blind trial involving 5637 people comparing abemaciclib in combination with ET versus ET alone. The ERG produced a critical review of the evidence for the clinical and cost-effectiveness evidence in the CS and also independently searched for relevant evidence and modified the manufacturer decision analytic model to examine the impact of altering some of the key assumptions. This paper summarised the Company Submission (CS), presents the ERG’s critical review of the clinical and cost-effectiveness evidence in the CS, highlights the key methodological considerations, and describes the development of the NICE guidance by the Appraisal Committee. Kleijnen Systematic Reviews Ltd, in combination with Newcastle University, was commissioned to act as the independent Evidence Review Group (ERG). The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Eli Lilly) of abemaciclib (Verzenios) to submit evidence for the clinical and cost effectiveness of this drug in combination with endocrine therapy (ET) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence, as part of the Institute’s Single Technology Appraisal (STA) process.
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