Cost Effectiveness of Pembrolizumab for Advanced Melanoma Treatment in Portugal

Miguel, L Silva; Lopes, Francisca Vargas; Pinheiro, Benedita A.; Wang, Jingshu; Xu, Ruifeng; Pellissier, James M.; Laires, P.A.

doi:10.1016/j.jval.2017.05.009

Cited by 23 publications

(23 citation statements)

References 16 publications

(23 reference statements)

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“…Most studies (n = 8) used a Markov modeling approach. One study used a decision tree model, 27 4 used a partitioned survival model, [28][29][30][31] and the modeling approach was not described in 2 studies. 32,33 Most studies used the conventional 3-health state model of PFS, progressive disease, and death (n = 10).…”

Section: Study Design and Structural Assumptionsmentioning

confidence: 99%

“…41 Six studies included only 1 comparator, using evidence from a single phase III clinical trial. [30][31][32]35,37,40 For the remaining studies, approaches to evidence synthesis were varied and sometimes unclear, 29 and included naïve comparison, 27,33,34,36,39 Bucher indirect comparison, 28 mixed covariate adjusted indirect comparisons using individual patient data, 38 and network metaanalysis. 41 Most commonly, PFS and OS outcomes from clinical trials were the source of treatment effects in the studies (n = 13).…”

Section: Study Design and Structural Assumptionsmentioning

confidence: 99%

“…32 Extrapolation of OS curves used external data sources (eg, cancer registries, long-term follow-up of ipilimumab trials) in a number of the studies to capture the natural history of the disease. 28,30,31,38 Only 1 study reported adjusting the OS data for treatment crossover. 28 With 1 exception, 37 studies did not consider the suitability of parametric modeling or explore alternative options.…”

Section: Study Design and Structural Assumptionsmentioning

confidence: 99%

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Economic Evaluation of Systemic Treatments for Advanced Melanoma: A Systematic Review

2020

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Background: Many high cost treatments for advanced melanoma have become available in recent years. National health technology assessment agencies have raised concerns regarding uncertainty in their clinical and cost-effectiveness. Objective: The aim of this systematic review is to identify economic evaluations of treatments for advanced melanoma and review model assumptions, outcomes, and quality as preparation for a health technology assessment. Methods: A search of Embase, MEDLINE, EconLit, and the Cochrane Database was conducted. Only studies using decisionanalytic models were included. Two authors independently completed full-text review and data extraction. Results: Fifteen studies were identified. There were major differences in the structural assumptions underpinning the models. There was general agreement in study conclusions, although the predicted costs and quality-adjusted life years for each treatment varied. BRAF monotherapy (vemurafenib, dabrafenib) or BRAF/MEK combination therapy (BRAF monotherapy with cobimetinib or trametinib) has not been shown to be cost-effective in any jurisdiction. PD-1 inhibitors (pembrolizumab, nivolumab) are consistently found to be cost-effective compared with ipilimumab, although their costeffectiveness compared with chemotherapy is not established. Combination therapy with nivolumab and ipilimumab is unlikely to be cost-effective in any setting. One study including all agents found that none of the new treatments were cost-effective relative to chemotherapy. Publication of the study in a health economics journal is associated with better reporting of and higher-quality assessment than those published in clinical journals. Conclusion: Despite differences in model structures and assumptions, the conclusions of most included studies were consistent. Health technology assessment has a key role in maximizing value from high-cost innovative treatments. Consideration should be given to divestment from BRAF/MEK inhibitors and ipilimumab in favor of reimbursement of PD-1 inhibitors.

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Section: Study Design and Structural Assumptionsmentioning

confidence: 99%

Section: Study Design and Structural Assumptionsmentioning

confidence: 99%

Section: Study Design and Structural Assumptionsmentioning

confidence: 99%

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Economic Evaluation of Systemic Treatments for Advanced Melanoma: A Systematic Review

2020

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“…With the advent of pembrolizumab as a new adjuvant treatment option, it will be important for payers and decision-makers to understand whether this immunotherapy represents good value for resources relative to standard of care in this indication. While studies have examined the costeffectiveness of pembrolizumab as a treatment for advanced melanoma in the US 27 and European settings 28,29 , there have been no published economic evaluations of pembrolizumab or any other novel immunotherapy as adjuvant treatment for melanoma. Prior economic evaluations in this setting have been limited to interferon-based regimens [30][31][32][33][34] .…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness of pembrolizumab for the adjuvant treatment of resected high-risk stage III melanoma in the United States

Bensimon

Zhou

Jenkins

et al. 2019

Journal of Medical Economics

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Aims: To evaluate the cost-effectiveness of adjuvant pembrolizumab relative to observation alone following complete resection of high-risk stage III melanoma with lymph node involvement, from a US health system perspective. Materials and methods: A Markov cohort model with four health states (recurrence-free, locoregional recurrence, distant metastases, and death) was developed to estimate costs, life-years, and qualityadjusted life-years (QALYs) associated with pembrolizumab vs observation over a lifetime (46-year) horizon. Using a parametric multi-state modeling approach, transition probabilities starting from recurrence-free were estimated based on patient-level data from KEYNOTE-054 (NCT02362594), a direct head-to-head phase 3 trial. Post-recurrence transition probabilities were informed by real-world retrospective data and clinical trials in advanced melanoma. Health state utilities and adverse eventrelated disutility were derived from KEYNOTE-054 trial data and published literature. Costs of drug acquisition and administration, adverse events, disease management, and terminal care were estimated in 2018 US dollars. Deterministic and probabilistic sensitivity analyses were conducted to assess robustness. Results: Over a lifetime horizon, adjuvant pembrolizumab and observation were associated with total QALYs of 9.24 and 5.95, total life-years of 10.54 and 7.15, and total costs of $489,820 and $440,431, respectively. The resulting incremental cost-effectiveness ratios (ICERs) for pembrolizumab vs observation were $15,009/QALY and $14,550/life-year. Across the range of input values and assumptions tested in deterministic sensitivity analyses, pembrolizumab ranged from being a dominant strategy to having an ICER of $57,449/QALY vs observation. The ICER was below a willingness-to-pay threshold of $100,000/QALY in 90.2% of probabilistic simulations. Limitations: Long-term extrapolation of outcomes was based on interim results from KEYNOTE-054, with a median follow-up of 15 months. Conclusions: Based on common willingness-to-pay benchmarks, pembrolizumab is highly cost-effective compared with observation alone for the adjuvant treatment of completely resected stage III melanoma in the US. ARTICLE HISTORY

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“…Cost-effectiveness analysis has been carried out in numerous indications for ICIs yielding cost-effectiveness in some indications with a high willingness-to-pay (WTP) threshold [141]. With a WTP threshold of $100,000/QALY, the first line monotherapy studies have shown the cost-effectiveness of the therapy in melanoma (nivolumab/pembrolizumab vs. dacarbazine/ipilimumab [142][143][144][145]) and in NSCLC PD-L1 ≥50% (pembrolizumab vs. chemotherapy [146]). Conversely, none of the combinations tested in NSCLC (pembrolizumab+chemotherapy vs. chemotherapy [147] or atezolizumab+bevazicumab+chemotherapy vs. bevazicumab+chemotherapy [148]) or melanoma (nivolumab-ipilimumab vs. nivolumab [149]) were cost-effective with ICER of $147,366-454,092/QALY.…”

Section: Economic Sustainabilitymentioning

confidence: 99%

Possibilities of Improving the Clinical Value of Immune Checkpoint Inhibitor Therapies in Cancer Care by Optimizing Patient Selection

Iivanainen

Koivunen

2020

IJMS

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Immune checkpoint inhibitor (ICI) therapies have become the most important medical therapies in many malignancies, such as melanoma, non-small-cell lung cancer, and urogenital cancers. However, due to generally low response rates of PD-(L)1 monotherapy, both PD-(L)1 combination therapies and novel therapeutics are under large-scale clinical evaluation. Thus far, clinical trials have rather suboptimally defined the patient population most likely to benefit from ICI therapy, and there is an unmet need for negative predictive markers aiming to reduce the number of non-responding patients in clinical practice. Furthermore, there is a strong need for basic tumor immunology research and innovative clinical trials to fully unleash the potential of ICI combinations for the benefit of patients.

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Cost Effectiveness of Pembrolizumab for Advanced Melanoma Treatment in Portugal

Abstract: Considering the usually accepted thresholds in oncology, pembrolizumab is a cost-effective alternative for treating patients with advanced melanoma in Portugal.

Cited by 23 publications

References 16 publications

Economic Evaluation of Systemic Treatments for Advanced Melanoma: A Systematic Review

Economic Evaluation of Systemic Treatments for Advanced Melanoma: A Systematic Review

Cost-effectiveness of pembrolizumab for the adjuvant treatment of resected high-risk stage III melanoma in the United States

Possibilities of Improving the Clinical Value of Immune Checkpoint Inhibitor Therapies in Cancer Care by Optimizing Patient Selection

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