Cost Effectiveness of Avelumab for Metastatic Merkel Cell Carcinoma

Bullement, Ash; Nathan, Paul; Willis, Anna; Amin, Amerah; Lilley, C.; Stapelkamp, Ceilidh; Hatswell, Anthony J.; Pescott, Chris; Bharmal, Murtuza

doi:10.1007/s41669-018-0115-y

Cited by 20 publications

(27 citation statements)

References 40 publications

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“…The importance of appropriate survival extrapolation is particularly highlighted within the context of HTA, as noted within NICE TSD 14: "different methods have varying functional forms and are likely to result in different survival estimates, with the differences potentially largeparticularly when a substantial amount of extrapolation is required" [9]. A model under-estimating RMST by approximately 1 month would translate to an under-estimate in life-years gained of 0.08, equivalent to approximately 0.06 (undiscounted) QALYs (assuming a utility value of 0.71 per the published cost-utility analysis of avelumab in mMCC) [43]. Though a seemingly small decrease in QALYs gained, were this decrement applied to the published base-case cost-utility results, the incremental cost-effectiveness ratio (ICER) would increase by approximately £1000.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection

Bullement¹,

Willis

Amin

et al. 2020

BMC Med Res Methodol

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Background: Due to limited duration of follow up in clinical trials of cancer treatments, estimates of lifetime survival benefits are typically derived using statistical extrapolation methods. To justify the method used, a range of approaches have been proposed including statistical goodness-of-fit tests and comparing estimates against a previous data cut (i.e. interim data collected). In this study, we extend these approaches by presenting a range of extrapolations fitted to four pre-planned data cuts from the JAVELIN Merkel 200 (JM200) trial. By comparing different estimates of survival and goodness-of-fit as JM200 data mature, we undertook an iterative process of fitting and re-fitting survival models to retrospectively identify early indications of likely long-term survival. Methods: Standard and spline-based parametric models were fitted to overall survival data from each JM200 data cut. Goodness-of-fit was determined using an assessment of the estimated hazard function, information theorybased methods and objective comparisons of estimation accuracy. Best-fitting extrapolations were compared to establish which one provided the most accurate estimation, and how statistical goodness-of-fit differed. Results: Spline-based models provided the closest fit to the final JM200 data cut, though all extrapolation methods based on the earliest data cut underestimated the 'true' long-term survival (difference in restricted mean survival time [RMST] at 36 months: − 1.1 to − 0.5 months). Goodness-of-fit scores illustrated that an increasingly flexible model was favored as data matured. Given an early data cut, a more flexible model better aligned with clinical expectations could be reasonably justified using a range of metrics, including RMST and goodness-of-fit scores (which were typically within a 2-point range of the statistically 'best-fitting' model). Conclusions: Survival estimates from the spline-based models are more aligned with clinical expectation and provided a better fit to the JM200 data, despite not exhibiting the definitively 'best' statistical goodness-of-fit. Longer-term data are required to further validate extrapolations, though this study illustrates the importance of clinical plausibility when selecting the most appropriate model. In addition, hazard-based plots and goodness-of-fit tests from multiple data cuts present useful approaches to identify when a more flexible model may be advantageous.

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Section: Discussionmentioning

confidence: 99%

Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection

Bullement¹,

Willis

Amin

et al. 2020

BMC Med Res Methodol

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“…The results suggested that avelumab is likely to be a cost-effective treatment option for UK patients with mMCC. 29 To fully assess ICI value in mMCC, additional factors such as clinical efficacy measures, safety, and patient-reported outcomes must be considered. 30–32 Previously published studies examining the costs related to the use of ICIs in patients with mMCC are not fully comparable to the current study due to different study criteria 4 , 19 , 33 or different healthcare systems.…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes, Costs, and Healthcare Resource Utilization in Patients with Metastatic Merkel Cell Carcinoma Treated with Immune Checkpoint Inhibitors vs Chemotherapy

Zheng¹,

Takata²,

Mackey³

et al. 2021

CEOR

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Purpose Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer with poor prognosis. This study compared patient characteristics, comorbidities, adverse events (AEs), treatment persistence, healthcare resource utilization (HRU) and costs in patients with metastatic MCC (mMCC) treated with immune checkpoint inhibitors (ICIs) or recommended chemotherapy per 2018 National Comprehensive Cancer Network (NCCN) Guidelines. Patients and Methods A retrospective, observational study was conducted using data from 3/1/2015 through 12/31/2017 from the Premier Healthcare Database, a US hospital discharge database. The study included patients aged ≥12 years with International Classification of Diseases Codes for MCC and metastasis, categorized by their first treatment (index) during the study period (ICI or NCCN-recommended chemotherapy [chemotherapy]). Patient, hospital, and visit characteristics were assessed at the index date and Charlson Comorbidity Index (CCI) score and comorbidities during a 6-month look-back period. Clinical outcomes, including AEs and treatment persistence were assessed over 90 days and HRU and costs over 180 days post-index. Results Of 75 patients with mMCC receiving ICIs (n=37) or chemotherapy (n=38), mean age was ≈73 years, and 21.3% had a history of immune-related (IR) conditions. Overall, ICI- and chemotherapy-treated patients were similar in most baseline characteristics, IR comorbidities, and CCI score. However, more ICI patients (46%) than chemotherapy patients (26%) persisted on treatment over 90-day follow-up, odds ratio (95% CI): 2.04 (0.93, 4.47), P =0.07. Over 180-day follow-up, 33% of patients had an inpatient admission with mean length of stay (LOS) ≈2 days shorter for ICI vs chemotherapy (not statistically significant). Total costs, primarily driven by pharmacy costs, were higher for ICIs than chemotherapy; other departmental costs were similar between treatment groups. Conclusion In a real-world setting, patients with mMCC receiving ICIs had higher treatment persistence over 90 days, shorter inpatient LOS and similar departmental cost (excluding pharmacy cost) than those receiving chemotherapy.

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“…A recent study compared avelumab with chemotherapy, standard care, and best supportive care for UK metastatic merkel cell carcinoma (mMCC) patients and found out that avelumub was cost-effective as the WTP threshold of £50,000 per QALY (Bullement et al, 2019). There are some reasons why a different conclusion was provided.…”

Section: Discussionmentioning

confidence: 99%

A Cost-Effectiveness Analysis: First-Line Avelumab Plus Axitinib Versus Sunitinib for Advanced Renal-Cell Carcinoma

Liang

et al. 2020

Front. Pharmacol.

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Background: Compared with the standard of care with sunitinib, avelumab plus axitinib can increase progression-free survival in the first-line of advanced renal cell carcinoma (RCC), but the economic effect of the treatment is unknown. The purpose of the research was to evaluate the cost-effectiveness of the avelumab plus axitinib versus sunitinib in firstline treatment for advanced RCC from the US payer perspective. Methods: A Markov model was developed to evaluate the economic and health outcomes of avelumab plus axitinib vs sunitinib in the first-line setting for advanced RCC. The clinical data were obtained from the JAVELIN Renal 101 Clinical Trials. Deterministic and probabilistic sensitivity analyses were performed to assess uncertainty in the model. Health outcomes were measured in quality-adjusted life-years (QALYs).

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Cost Effectiveness of Avelumab for Metastatic Merkel Cell Carcinoma

Cited by 20 publications

References 40 publications

Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection

Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection

Clinical Outcomes, Costs, and Healthcare Resource Utilization in Patients with Metastatic Merkel Cell Carcinoma Treated with Immune Checkpoint Inhibitors vs Chemotherapy

A Cost-Effectiveness Analysis: First-Line Avelumab Plus Axitinib Versus Sunitinib for Advanced Renal-Cell Carcinoma

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