Economic burden in patients with ALK + non-small cell lung cancer,with or without brain metastases,receiving second-line anaplastic lymphoma kinase (ALK) inhibitors

Abstract

Aims: To describe the real-world economic burden of patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) treated with post-crizotinib, second-line ALK inhibitor therapy.

Materials and methods: Retrospective analysis using data from US Optum: Clinformatics Data Mart administrative claims database. Adult patients with ALK?+?NSCLC treated with ceritinib or alectinib as second-line ALK inhibitors between 1 January 2011 and 30 September 2017 were included. Healthcare costs and resource utilization for up to 1?year of therapy were calculated on a per-patient-per-month (PPPM) basis and stratified by presence or absence of brain metastases (BM). Multivariate regression analysis was performed to identify factors associated with costs. Top ten cost drivers of non-inpatient procedure costs were recorded.

Results: One hundred and twelve patients received second-line ALK inhibitors. Total mean PPPM healthcare costs were $23,984 for all patients receiving up to 1?year of post-crizotinib, second-line ALK inhibitor therapy. Total mean PPPM costs for patients with BM on or prior to post-crizotinib, second-line ALK inhibitor therapy were 1.37-times as high as those for patients without BM (p?=?0.0406). Mean PPPM outpatient visits and inpatient hospitalization stays were higher for patients with BM versus no BM. The main cost drivers for non-inpatient procedures were radiation therapy, medications, and diagnostic radiology.

Limitations: Analyses did not include newer ALK-directed therapies. BM development after the index date (defined as the date of the first claim for a second-line ALK inhibitor) may have been misclassified as non-BM. Findings may not be generalizable to patients with no health insurance coverage.

Conclusions: Treatment of patients with ALK?+?NSCLC with ceritinib or alectinib as post-crizotinib, second-line ALK inhibitor therapy represents a high economic burden. Healthcare costs and resource utilization were significantly higher for patients with ALK?+?NSCLC with BM versus no BM.     

Infusion administration billing for vedolizumab and infliximab in inflammatory bowel disease

Abstract

Aims: Increasing use of biologics has led to interest in treatment components with potential for cost savings. This study was aimed at comparing administration times and associated costs of infliximab and vedolizumab infusions for inflammatory bowel disease (IBD).

Materials and methods: This study used claims data from the Symphony Health Integrated Dataverse to identify IBD patients using infliximab or vedolizumab between 20 May 2014 and 29 February 2016. Use of Current Procedural Terminology administration codes was evaluated and costs calculated using the 2016 Center for Medicare and Medicaid Services Physician Fee Schedule. Assessments included infusion times, associated costs, productivity loss using average wage estimates from the United States Bureau of Labor Statistics, and home infusion adoption.

Results: A total of 10,051 infliximab and 3114 vedolizumab patients with first-hour claims were identified; 52.0% were female and 64.5% had Crohn’s disease. There were 48,377 infliximab first-hour claims (mean 4.8 infusions per patient); 46,462 (96.0%) had a second-hour claim. In comparison, there were 14,717 vedolizumab claims (mean 4.7 infusions per patient), with only 411 (2.8%) second-hour claims, resulting in vedolizumab cost savings of approximately $1.27 million. The difference in second-hour infusions resulted in 46,051 additional hours of productivity loss with infliximab, and lost wages averaging $1.18 million (range $0.68–$1.77 million).

Limitations: Administration costs were inferred as charge costs and not directly assessed. Productivity loss assessed time spent on infusion only, and included a small proportion of patients beyond working age.

Conclusions: Second-hour infusion billing was significantly lower with vedolizumab than with infliximab, corresponding to cost savings and reduced productivity loss.     

Annual costs of tumor necrosis factor inhibitors using real-world data in a commercially insured population in the United States

Abstract

Objective:

To calculate annual cost per treated patient of tumor necrosis factor (TNF) inhibitors etanercept, adalimumab, and infliximab for common approved indications, based on actual TNF-inhibitor use in clinical practice.

Methods:

Adults with ≥1 claim for etanercept, adalimumab, or infliximab between January 2005 and March 2009 were identified from the IMS LifeLink? Health Plan Claims Database. Patients new to therapy or continuing therapy (i.e., a prior claim for a TNF-inhibitor) were analyzed separately. Included patients had been enrolled from 180 days before the first TNF-inhibitor claim (index date) through 360 days after the index date and had a diagnosis during the pre-index period for rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis. Patients with Crohn’s disease, ulcerative colitis, or juvenile idiopathic arthritis were excluded. Annual costs were calculated using wholesale acquisition costs for the TNF-inhibitor and Medicare Physician Fee Schedule for drug administration. Costs from restarting or switching TNF-inhibitor therapy during the first year were included.

Results:

A total of 27,704 patients (11,528 new, 16,176 continuing) had claims for etanercept, adalimumab, or infliximab, most commonly (65%) for treatment of rheumatoid arthritis. The most commonly used agent was etanercept (14,777 patients; 53%), followed by adalimumab (6862 patients; 25%) and infliximab (6065 patients; 22%). Annual cost per treated patient was etanercept $14,873, adalimumab $17,766, and infliximab $21,256 across all indications. Annual cost per treated patient by disease was (etanercept/adalimumab/infliximab): rheumatoid arthritis ($14,314/$17,700/$20,390), psoriasis ($17,182/$17,682/$23,935), psoriatic arthritis ($15,030/$18,483/$24,974), and ankylosing spondylitis ($14,254/$16,925/$23,056). New and continuing patients showed similar results, with etanercept having the lowest costs.

Limitations:

This analysis is limited to three TNF-inhibitors and a US managed-care population.

Conclusions:

Based on this analysis of real-world use of TNF-inhibitors among patients in nationwide clinical practice settings, the annual TNF-inhibitor cost per treated patient was lowest for etanercept across all indications.     

Healthcare costs associated with nephrology care in pre-dialysis chronic kidney disease patients

Abstract

Objective:

To compare the healthcare costs of pre-dialysis chronic kidney disease (CKD) patients cared for in a nephrology clinic setting versus other care settings.

Methods:

An analysis of health claims between 01/2002 and 09/2007 from the Ingenix Impact Database was conducted. Inclusion criteria were ≥18 years of age, ≥1 ICD-9 claim for CKD, and ≥1 estimated glomerular filtration rate (eGFR) value of <60?mL/min/1.73?m². Patients were classified in the nephrology care cohort if they were treated in a nephrology clinic setting at least once during the study period. Univariate and multivariate analyses were conducted to compare average annualized healthcare costs of patients in nephrology care versus other care settings.

Results:

Among the 20,135 patients identified for analysis, 1,547 patients were cared for in a nephrology clinic setting. Nephrology care was associated with lower healthcare costs with an unadjusted cost savings of $3,049 ($11,303 vs. $14,352, p?=?0.0014) and a cost ratio of 0.8:1 relative to other care settings. After adjusting for covariates, nephrology care remained associated with lower costs (adjusted cost savings: $2,742, p?=?0.006).

Limitations:

Key limitations included potential inaccuracies of claims data, the lack of control for patients’ ethnicity in the calculation of eGFR values, and the presence of potential biases due to the observational design of the study.

Conclusions:

The current study demonstrated that pre-dialysis CKD patients treated in nephrology clinics were associated with significantly lower healthcare costs compared with patients treated in other healthcare settings.     

Lifetime cost of everolimus vs axitinib in patients with advanced renal cell carcinoma who failed prior sunitinib therapy in the US

Abstract

Objective:

Everolimus and axitinib are approved in the US to treat patients with advanced renal cell carcinoma (RCC) after failure on sunitinib or sorafenib, and one prior systemic therapy (e.g., sunitinib), respectively. Two indirect comparisons performed to evaluate progression-free survival in patients treated with everolimus vs axitinib suggested similar efficacy between the two treatments. Therefore, this analysis compares the lifetime costs of these two therapies among sunitinib-refractory advanced RCC patients from a US payer perspective.

Research design and methods:

A Markov model was developed to simulate a cohort of sunitinib-refractory advanced RCC patients and estimate the cost of treating patients with everolimus vs axitinib. The following health states were included: stable disease without adverse events (AEs), stable disease with AEs, disease progression (PD), and death. The model included the following resources: active treatments, post-progression treatments, adverse events, physician and nurse visits, scans and tests, and palliative care. Resource utilization inputs were derived from a US claims database analysis. Additionally, a 3% annual discount rate was applied to costs, and the robustness of the model results was tested by conducting sensitivity analyses, including those on dosing scheme and post-progression treatment costs.

Results:

Base case results demonstrated that patients treated with everolimus cost an average of $12,985 (11%) less over their lifetimes than patients treated with axitinib. The primary difference in costs was related to active treatment, which was largely driven by axitinib’s higher dose intensity. Results remained consistent across sensitivity analyses for AE and PD treatment costs, as well as dose intensity and discount rates.

Conclusion:

The results suggest that everolimus likely leads to lower lifetime costs than axitinib for sunitinib-refractory advanced RCC patients in the US.     

The cost-effectiveness of alectinib in anaplastic lymphoma kinase-positive (ALK+) advanced NSCLC previously treated with crizotinib

Introduction Anaplastic lymphoma kinase (ALK) targeting drugs provide an important option for advanced non-small cell lung cancer patients with this distinct tumor type; however, there is considerable uncertainty as to which drug provides the optimal value after crizotinib treatment. This study estimated the cost-utility of alectinib vs ceritinib from a US payer perspective.

Methods A cost-utility model was developed using partition survival methods and three health states: progression-free (PF), post-progression (PP), and death. Survival data were derived from the key clinical trials (alectinib: NP28761 &; NP28673, ceritinib: ASCEND I and II). Costs included drugs, adverse events, and supportive care. Utilities were based on trial data and the literature. One-way and probabilistic sensitivity analyses (PSA) were performed to assess parameter uncertainty.

Results Treatment with alectinib vs ceritinib resulted in increases of 2.55 months in the PF state, 0.44 quality adjusted life-years (QALYs), and $13,868, yielding a mean cost/QALY of $31,180. In the PSA, alectinib had a 96% probability of being cost-effective at a willingness-to-pay of $100,000/QALY. Drivers of model results were drug costs and utilities in the PF health state. The ICER ranged from $10,600–$65,000 per QALY in scenario analyses, including a sub-group analysis limited to patients with prior chemotherapy and crizotinib treatment.

Conclusions Treatment with alectinib in ALK?+?crizotinib-treated patients increased time progression-free and QALYs vs ceritinib. The marginal cost increase was driven by longer treatment durations with alectinib. This model demonstrates that alectinib may be considered a cost-effective treatment after progression on crizotinib.     

Incremental third-party costs associated with COPD exacerbations: a retrospective claims analysis

Abstract

Background:

Exacerbations are a major contributor to the large burden of treating chronic obstructive pulmonary disease (COPD). Estimates of exacerbation costs in the United States are limited.

Objective:

To estimate incremental costs associated with COPD exacerbation, particularly severe exacerbation, in the United States.

Methods:

COPD patients with at least one exacerbation were identified in the Thomson Reuters MarketScan administrative claims database. A COPD exacerbation was defined as patient use of oral or parenteral corticosteroids on the same day or within 7 days following a claim with a COPD diagnosis. Severe exacerbation was further defined if the exacerbation was associated with hospitalization or death. Healthcare costs and exacerbations were evaluated at quarterly intervals starting from patients’ first observed claim with COPD diagnostic code in the database. Incremental costs associated with exacerbation were estimated as cost differences between quarters with exacerbation and quarters without exacerbation.

Results:

A total of 2644,174 patient-quarters, derived from 228,978 COPD patients, were included in the analysis. The average patient was followed an average of 2.9 years. The mean total cost was $17,016 per patient-quarter with severe exacerbation, $6628 per patient-quarter with non-severe exacerbation, an average of $8726 per patient-quarters with any exacerbation compared to $4762 per patient-quarter with no exacerbation. After adjusting for patient demographics, the mean incremental total cost was $11,261 per patient-quarter with severe exacerbation, $1509 per patient-quarter for non-severe exacerbation, and $3439 per patient-quarter with any exacerbation compared with patient-quarters with no exacerbation.

Limitations:

The method used for defining exacerbations does not capture mild exacerbations. Additional limitations exist due to the nature of claims data.

Conclusions:

Exacerbations, especially severe ones, result in a significant economic burden for third-party payers. Effective management of COPD and prevention of exacerbations may lead to improved patient outcomes and reduction in total healthcare costs for long-term management of COPD.     

Adherence,persistence, healthcare utilization,and cost benefits of guideline-recommended hepatitis B pharmacotherapy

Abstract

Objective:

To compare pharmacotherapy adherence, persistence, and healthcare utilization/costs among US patients with chronic hepatitis B (CHB) initiated on an oral antiviral monotherapy recommended as first-line treatment by current national (US) guidelines vs an oral antiviral not recommended as first-line monotherapy.

Research design and methods:

In this retrospective cohort study, patients aged 18–64 with medical claims for CHB who initiated an oral antiviral monotherapy for CHB between 07/01/05 and 01/31/10 were identified from a large US commercial health insurance claims database. Patients were continuously enrolled for a 6-month baseline period and ≥ 90 days follow-up. They were assigned to ‘currently recommended first-line therapy’ (RT: entecavir or tenofovir) or ‘not currently recommended first-line therapy’ (NRT: lamivudine, telbivudine, or adefovir) cohorts.

Main outcome measures:

Multivariate analyses were conducted to compare treatment adherence, persistence, healthcare utilization, and costs for RT vs NRT cohorts.

Results:

Baseline characteristics were similar between RT (n?=?825) and NRT (n?=?916) cohorts. In multivariate analyses, RT patients were twice as likely as NRT patients to be adherent (OR?=?2.09; p?<?0.01) and persistent (mean: RT?=?361 days, NRT?=?298 days; p?<?0.01) and half as likely to have an inpatient stay (OR?=?0.527; p?<?0.01). Between the two oral antivirals recommended as first-line treatment, even though pharmacy cost was higher for entecavir, mean total healthcare costs for entecavir and tenofovir were similar ($1214 and $1332 per patient per month, respectively). Similar results were also observed with regard to adherence, persistence, and healthcare use for entecavir and tenofovir.

Conclusions:

A limitation associated with analysis of administrative claims data is that coding errors can be mitigated but are typically not fully eradicated by careful study design. Nevertheless, the current findings clearly indicate the benefits of initiating CHB treatment with an oral antiviral monotherapy recommended as first-line treatment by current guidelines.     

Pharmacoeconomic analysis for pemetrexed as a maintenance therapy for NSCLC patients with patient assistance program in China

Objective: This study is to evaluate the costs, clinical efficacy, and social benefits of a patient assistance program (PAP) implemented by the China Primary Healthcare Foundation for the use of pemetrexed as a first-line non-squamous non-small cell lung cancer (NSCLC) maintenance therapy in China.

Methods: A survival analysis was conducted on the clinical data of 1,366 patients who participated in the PAP. The progression-free survival (PFS) and median maintenance treatment cycle of pemetrexed were analyzed. A 36-month Markov model from a payer’s perspective was constructed to analyze the cost and effectiveness associated with the PAP for pemetrexed. The inputs of the model were sourced from the PAP clinical database and published literature. The study estimated the incremental quality adjusted life-years (QALYs) (pemetrexed plus best supportive care [BSC] vs BSC only), the cost saving of the PAP, the impact on the percentage of catastrophic health expenditures (CHE), and poverty headcount ratio (HCR).

Results: The median of PFS and maintenance treatment cycles were 187 days and five cycles (total nine cycles, which included four cycles of induction therapy), respectively. The pemetrexed plus BSC treatment with PAP resulted in an additional 0.12 QALYs over BSC only. The total cost was $48,034.46 and $96,191.57 for the patients who had or had not joined the PAP in 3 years, respectively. Compared to the patients without PAP, the percentage of CHE and HCR with PAP was reduced from 98.39% to 19.91% and 66.98% to 4.89%, respectively, indicating that the PAP substantially decreased the number of patients who had CHE and fallen into poverty.

Conclusion: The study concluded that the pemetrexed PAP generated noticeable clinical and economic benefits to society and to patients. The program also increased patients’ compliance with chemotherapy by allowing patients, for whom the pemetrexed treatment was unaffordable, to continue to receive it.     

Healthcare costs for Crohn’s disease patients treated with infliximab: a propensity weighted comparison of the effects of treatment adherence

Objective:

The objective for the research was to evaluate the direct healthcare costs for Crohn’s disease (CD) patients categorized by adherence status.

Methods:

Adult patients with ≥1 claim for infliximab and ≥2 claims for CD who were continuously insured for 12 months before and after their first infliximab infusion (index date) were identified in a 2006–2009 US managed care database. Patients were excluded if they had rheumatoid arthritis claims, received infliximab billed as a pharmacy benefit, or received another biologic drug. Patients were categorized as being either adherent or intermittently adherent to infliximab using a pre-defined algorithm. Total and component direct costs, CD-related costs, rates of surgery, and days of hospitalization were estimated for the 360-day post-index period. Propensity weighted generalized linear models were used to adjust the cost estimates for potential confounding variables.

Results:

The total propensity weighted cost for infliximab adherent patients was $40,425 (95% CI?=?[$38,686, $42,242]), compared to $41,082 (95% CI?=?[$38,163, $44,223]) for the intermittently adherent (p?=?0.71). However, adherent patients had lower total direct medical costs, exclusive of infliximab, that were $13,097 (95% CI?=?[$12,141, $14,127]) compared with $20,068 (95% CI?=?[$17,676, $22,784]) for intermittently adherent patients as a result of substantially lower hospital and outpatient costs (p?Conclusions:

Greater drug-related costs for infliximab adherent patients were offset by lower costs from hospitalization and outpatient visits. These findings indicate that adherent patients have improved clinical outcomes, at a similar aggregate cost, than patients who are only intermittently adherent to therapy.     

Cost-analysis model of colonoscopy preparation using split-dose reduced-volume oral sulfate solution (OSS) and polyethylene glycol with electrolytes solution (PEG-ELS)

Objective:

The study aimed to (1) develop a cost model for colonoscopy preparation among patients referred for colonoscopy using split-dose reduced-volume oral sulfate solution (OSS) and generic polyethylene glycol with electrolytes solution (PEG-ELS), (2) examine cost savings associated with OSS vs PEG-ELS, and (3) assess the robustness of the cost model.

Methods:

Efficacy of each agent was based on the results of a 541-patient clinical trial comparing OSS to PEG-ELS. Cleansing agent and colonoscopy procedure costs were calculated from OptumHealth Reporting & Insights claims data for 2010–Q12013. In the model, patients’ colonoscopies were tracked over a 25 or 35 year time period until the patients reached age 75. The difference per patient per year (PPPY) in total cleansing agent and colonoscopy procedure costs over the time horizon between the OSS and PEG-ELS cohort was calculated. One-way sensitivity analyses were conducted to test the robustness of the cost model.

Results:

The model showed lower cost for OSS patients over the time horizon. Total PPPY costs were $280.34 for the OSS cohort and $296.36 for the PEG-ELS cohort, resulting in a cost saving of $16.01 PPPY for the OSS cohort. This was due primarily to OSS patients having fewer colonoscopies (OSS: 0.158 vs PEG-ELS: 0.170 PPPY). Over the time horizon, cost savings of $4 763 335 were observed among 10, 000 OSS patients. Cost savings switched from OSS to PEG-ELS cohort in four cases: (1) base-case cost of a completed colonoscopy decreased by 75%, (2) base-case cost of OSS increased to over $143 per usage, (3) all non-completers were lost to follow-up, and (4) OSS bowel preparation quality dropped below PEG-ELS to 70%.

Conclusions:

From a payer’s perspective, the model showed that the use of OSS as the cleansing agent resulted in potential cost savings compared with PEG-ELS. Cost savings under OSS remained under various sensitivity analyses.