Economic Burden of Toxicities Associated with Advanced Melanoma Treatments in the United States

Bilir, S. Pinar; Zhao, Zhongyun; Wehler, Elizabeth; Munakata, Julie; Barber, Beth

doi:10.1016/j.jval.2013.08.479

Cited by 17 publications

(38 citation statements)

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“…Additionally, the cost on the healthcare system is substantial with one study estimating the cost to be over $20,000 and 5 hospital days for inpatient hospitalization for severe episodes of colitis and diarrhea in the United States. 50 With the increasing use of immune checkpoint inhibitors (ICI) in oncology, there will be a concomitant rise in the incidence of immune-related colitis. This systematic review provides a basis to increase clinician awareness.…”

Section: Discussionmentioning

confidence: 99%

Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: A systematic review and meta-analysis

et al. 2017

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With the rising use of immune checkpoint inhibitors (ICI) across varying tumors types, immune-related colitis is an increasingly encountered, serious adverse event requiring appropriate management. The incidence across ICI treatment regimens and tumor types is unclear. To characterize the incidence of immune-related colitis among various ICI regimens and tumor types. Thirty-four original studies of prospective ICI trials were identified based on a PubMed search completed on November 1st, 2016. Seventeen studies compared incidences across tumor types. The incidences of all-grade, grade 3-4 (severe) colitis, and grade 3-4 (severe) diarrhea were collected. Thirty-four studies containing 8863 patients were included in the meta-analysis. The overall incidence during ipilimumab monotherapy was 9.1% for all-grade colitis, 6.8% for severe colitis, and 7.9% for severe diarrhea. The incidence was lowest during PD-1/PD-L1 inhibitor monotherapy with 1.3% for all-grade colitis, 0.9% for severe colitis and 1.2% for severe diarrhea, while combination ipilimumab and nivolumab resulted in the highest incidences of all-grade colitis (13.6%), severe colitis (9.4%) and severe diarrhea (9.2%) among ICIs. Among melanoma, NSCLC, RCC patients, incidences of colitis and diarrhea with PD-1/PD-L1 inhibitor monotherapy did not significantly differ. Severe colitis incidence was similar with ipilimumab monotherapy at 3 mg/kg and 10 mg/kg (7.1% vs 5.1%, respectively), but significantly higher for severe diarrhea with 10mg/kg (11.5% vs 5.2%). The incidence of immune-related colitis and severe diarrhea was higher with ipilimumab-containing regimens compared with PD-1/PD-L1 inhibitors. There was no significant difference in immune-related colitis between different tumor types with PD-1/L1 inhibitors.

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Section: Discussionmentioning

confidence: 99%

Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: A systematic review and meta-analysis

et al. 2017

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“…Comparing PEMBRO with IPI in controlled trials, PEMBRO as a single agent demonstrated prolonged progression-free and overall survival with fewer high-grade adverse events 6 , and NIVO administered in combination with IPI has better progression free survival and higher rates of objective response than with IPI alone 7 . Costs related to toxicity can be substantial, particularly with respect to inpatient management of AEs [11][12][13] . In clinical trials, reported grade 3 or 4 treatment-related adverse events (AEs) are 59% with IPI þ NIVO in combination and 17% with PEMBRO as a single agent 6,7 .…”

Section: Introductionmentioning

confidence: 99%

Hospitalization and emergency department utilization in patients with advanced melanoma receiving pembrolizumab versus ipilimumab plus nivolumab in US academic centers

Joseph

Shillington

Lee

et al. 2019

Journal of Medical Economics

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Background: Both pembrolizumab (PEMBRO) and ipilimumab þ nivolumab (IPI þ NIVO) are FDAapproved immunotherapy regimens for advanced melanoma (AM). Each regimen has different toxicity profiles potentially impacting healthcare resource utilization (HCRU). This study compared real-world hospitalization and emergency department (ED) utilization within 12 months of therapy initiation of each regimen. Methods: A retrospective cohort study was conducted in AM patients 18 years old initiating PEMBRO or IPI þ NIVO between January 1, 2016-December 30, 2017. Patients were identified from 12 US-based academic and satellite centers. All-cause hospitalization ED visits were identified. These events were used to calculate rates per 1,000 patient months. Utilization between groups was compared using multivariate logistic regression. Results: In total, 400 patients were included (200 PEMBRO, 200 IPI þ NIVO). PEMBRO vs IPI þ NIVO patients had poorer Eastern Cooperative Group (ECOG) performance status, 29% 2-4, vs 12% (p < .001); more diabetes, 21% vs 13% (p ¼ .045); were more often PD-L1 expression positive, 77% vs 63% (p ¼ .011); and less likely BRAF mutant, 35% vs 50% (p ¼ .003). The proportion with more than one hospitalization over 12 months was 17% PEMBRO vs 24% IPI þ NIVO. Less than 2% had more than one admission and none had more than two. Unadjusted mean (SD) hospitalizations per 1,000 patient-months were 16 (37) and 20 (38), PEMBRO and IPI þ NIVO, respectively. Adjusted odds ratio for hospitalization was 0.6 (95% CI ¼ 0.3-0.9; p ¼ .027) for PEMBRO vs IPI þ NIVO. ED visits occurred in 18% vs 21%, PEMBRO and IPI þ NIVO, respectively, 0.7 (p ¼ .186). Conclusions: PEMBRO patients had a significantly lower probability of hospitalization through 12 months vs IPI þ NIVO. The probability of ED visits did not differ.

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“…The importance of clearly-defined treatment algorithms is highlighted by the high incidence of hospitalization and complications from prolonged steroid tapers, which contribute to the financial toxicity of checkpoint inhibitor therapy. 26 Given its retrospective nature, the study has several limitations. First, while general guidelines are available to treat immune-related colitis, there are likely differences in practice patterns at each institution which may have affected treatment outcomes (e.g.…”

Section: Discussionmentioning

confidence: 99%

Clinical characterization of colitis arising from anti-PD-1 based therapy

et al. 2018

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Colitis is a frequent, clinically-significant immune-related adverse event caused by anti-programmed death-1 (PD-1). The clinical features, timing, and management of colitis with anti-PD-1-based regimens are not wellcharacterized. Patients with advanced melanoma that received either anti-PD-1 monotherapy ("monotherapy") or combined with ipilimumab ("combination therapy") were screened from 8 academic medical centers, to identify those with clinically-relevant colitis (colitis requiring systemic steroids). Of 1261 patients who received anti-PD-1-based therapy, 109 experienced colitis. The incidence was 3.2% (30/937) and 24.4% (79/324) in the monotherapy and combination therapy cohorts, respectively. Patients with colitis from combination therapy had significantly earlier symptom onset (7.2 weeks vs 25.4 weeks, p < 0.0001), received higher steroid doses (median prednisone equivalent 1.5 mg/kg vs 1.0 mg/kg, p = 0.0015) and experienced longer steroid tapers (median 6.0 vs 4.0 weeks, p = 0.0065) compared to monotherapy. Infliximab use and steroid-dose escalation occurred more frequently in the combination therapy cohort compared to monotherapy. Nearly all patients had resolution of their symptoms although one patient died from complications. Anti-PD-1 associated colitis has a variable clinical presentation, and is more frequent and severe when associated with combination therapy. This variability in checkpoint-inhibitor associated colitis suggests that further optimization of treatment algorithms is needed.

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Economic Burden of Toxicities Associated with Advanced Melanoma Treatments in the United States

Cited by 17 publications

References 0 publications

Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: A systematic review and meta-analysis

Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: A systematic review and meta-analysis

Hospitalization and emergency department utilization in patients with advanced melanoma receiving pembrolizumab versus ipilimumab plus nivolumab in US academic centers

Clinical characterization of colitis arising from anti-PD-1 based therapy

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