mMCC is a rare, aggressive skin cancer with limited response to chemotherapy and a poor prognosis. Avelumab, an anti–PD-L1 IgG1 monoclonal antibody, provides a new treatment option with demonstrated durable responses and promising survival outcomes in the only registrational, prospective study of mMCC, JAVELIN Merkel 200 (JM 200; NCT02155647). This analysis assesses the CE of avelumab vs SC in pts with mMCC.
A 3-state partitioned-survival model was generated to assess the lifetime costs and effects of avelumab and SC from a UK National Health Service (NHS) perspective. Survival and health-related quality-of-life data were taken from JM 200 and observational studies to inform estimates of life-years (LYs) and quality-adjusted LYs (QALYs). Published literature and NHS reference costs were sought to quantify costs within the model, with other parameters sourced from JM 200, literature, or clinical opinion. Overall costs and QALYs were used to calculate the incremental CE ratio (ICER [cost per QALY gained]). Treatment-experienced (TE) pts had a minimum follow-up of 24 months, while data were extrapolated using hazard ratios for treatment-naive (TN) pts due to data immaturity.
When costs and QALYs were discounted at 3.5% per annum, avelumab was associated with ICERs of £32,612 (TE) and £36,635 (TN) per QALY gained. Probabilistic sensitivity analysis demonstrated that avelumab was associated with a 93.3% (TE) and 76.4% (TN) probability of being CE at a willingness-to-pay threshold of £50,000 per QALY gained.Table: 1291P
This CE analysis from JM 200 demonstrates that avelumab is a CE treatment option for pts with mMCC vs SC. The UK National Institute for Health and Care Excellence recommended avelumab for TE and TN pts; hence, an effective treatment is now available to all UK pts with mMCC. A confirmatory analysis will be conducted with more-mature TN data.
Clinical trial identification
Clinical Trial Number: NCT02155647.
Legal entity responsible for the study
Merck KGaA, Darmstadt, Germany.
This trial was sponsored by Merck KGaA, Darmstadt, Germany, and is part of an alliance between Pfizer, Inc. and Merck KGaA, Darmstadt, Germany.
Medical writing support was provided by ClinicalThinking Inc., Hamilton, NJ, USA.
M. Bharmal, C. Pescott: Employee: Merck KGaA, Darmstadt, Germany. A. Amin, C. Stapelkamp: Employee: Merck Serono Ltd. A. Hatswell: Employee: BresMed Health Solutions. C. Lilley, A. Willis, A. Bullement: Employee: BresMed Health Solutions.