Tumor treating fields and maintenance temozolomide for newly-diagnosed glioblastoma: a cost-effectiveness study

Abstract

Purpose: The EF-14 trial demonstrated that adding tumor treating fields (TTFields) to maintenance temozolomide (TMZ) significantly extends progression-free survival (PFS) and overall survival (OS) for newly-diagnosed glioblastoma (GBM) patients. This study assessed the cost-effectiveness of TTFields and TMZ for newly-diagnosed GBM from the US healthcare system perspective.

Methods and materials: Outcomes for newly-diagnosed GBM patients were estimated over a lifetime horizon using an area under the curve model with three states: stable disease, progressive disease, or death. The survival model integrated the 5-year EF-14 trial results with long-term GBM epidemiology data and US background mortality rates. Adverse event rates were derived from the EF-14 trial data. Utility values to determine quality-adjusted life-years, adverse event costs, and supportive care costs were obtained from published literature. A 3% discount rate was applied to future costs and outcomes. One-way and probabilistic sensitivity analyses were performed to assess result uncertainty due to parameter variability.

Results: Treatment with TTFields and TMZ was estimated to result in a mean increase in survival of 1.25 life years (95% credible range [CR]?=?0.89–1.67) and 0.96 quality-adjusted life years (QALYs) (95% CR = 0.67–1.30) compared to treatment with TMZ alone. The incremental total cost was $188,637 (95% CR = $145,324–$225,330). The incremental cost-effectiveness ratio (ICER) was $150,452 per life year gained and $197,336 per QALY gained. The model was most sensitive to changes in the cost of TTFields treatment.

Conclusions: Adding TTFields to maintenance TMZ resulted in a substantial increase in the estimated mean lifetime survival and quality-adjusted survival for newly-diagnosed GBM patients. Treatment with TTFields can be considered cost-effective within the reported range of willingness-to-pay thresholds in the US.     

Cost-effectiveness of 3-year vs 1-year adjuvant therapy with imatinib in patients with high risk of gastrointestinal stromal tumour recurrence in the Netherlands; a modelling study alongside the SSGXVIII/AIO trial

Abstract

Background:

Surgical resection of gastrointestinal stromal tumour (GIST) is rarely curative in patients at high risk of tumour recurrence and therefore 1 year of post-surgery adjuvant imatinib therapy has been recommended in this sub-group. Recently, adjuvant imatinib therapy administered for 3 years has been demonstrated to further increase recurrence-free survival and overall survival. The goal of this study was to assess the economic value of extending the duration of adjuvant imatinib therapy in high-risk patients in the Netherlands.

Methods:

A multistate Markov model was developed to simulate how patients’ clinical status after GIST excision evolves over time until death. The model structure encompassed four primary health states: free of recurrence, first GIST recurrence, second GIST recurrence, and death. Transition probabilities between the health states, data on medical care costs, and quality-of-life were obtained from published sources and from expert opinion.

Results:

The expected number of life years (or quality-adjusted life years, QALYs) was higher in the 3-year group than in the 1-year group, 8.91 (6.55) and 7.04 (5.18) years, respectively. In the 3-year and 1-year group, the expected total costs amounted to €120,195 and €79,361, of which, €74,631 (62%) and €27,619 (35%) were adjuvant therapy drug costs, respectively. The difference in health benefits, that is 1.87 life years or 1.37 QALYs, and costs, €40,835, resulted in incremental cost-effectiveness ratios (ICER) of €21,865 per life year gained, and €29,872 per QALY gained.

Limitations:

A limitation of the study was inherently related to the uncertainty around the predictions of RFS. Scenario analyses were conducted to test the sensitivity of different RFS predictions on the results.

Conclusions:

Delayed recurrence due to treatment with longer-term adjuvant imatinib therapy represents a cost-effective treatment option with an ICER below the generally accepted threshold in the Netherlands.     

Clinical outcomes and economic impact of transcatheter mitral leaflet repair in heart failure patients

Background: Mitral regurgitation (MR) is a common valvular heart disorder requiring intervention once it becomes severe. Transcatheter mitral repair with the MitraClip device is a safe and effective therapy for selected patients denied surgery. The authors sought to evaluate the clinical outcomes and economic impact of this therapy compared to medical management in heart-failure patients with symptomatic mitral regurgitation.

Methods and results: The study was comprised of two phases; an observational study of patients with heart failure and mitral regurgitation treated with either medical therapy or the MitraClip, and an economic model. Results of the observational study were used to estimate parameters for the decision model, which estimated costs, and benefits in a hypothetical cohort of patients with heart failure and moderate-to-severe mitral regurgitation treated with either standard medical therapy or MitraClip. The cohort of patients treated with the MitraClip was propensity matched to a population of heart failure patients, and their outcomes compared. At a mean follow-up of 22 months, all-cause mortality was 21% in the MitraClip cohort and 42% in the medical management cohort (p?=?.007). The decision model demonstrated that MitraClip increased life expectancy from 1.87–3.60 years and quality-adjusted life years (QALY) from 1.13–2.76 years. The incremental cost was $52,500 Canadian dollars, corresponding to an incremental cost-effectiveness ratio (ICER) of $32,300.00 per QALY gained. Results were sensitive to the survival benefit.

Conclusion: In heart failure patients with symptomatic moderate–severe mitral regurgitation, therapy with the MitraClip is associated with superior survival and is cost-effective compared to medical therapy.     

Cost-effectiveness of six months versus 1-year adjuvant trastuzumab in HER2 positive early breast cancer in Egypt

Abstract

Introduction: Breast cancer is the most prevalent cancer among women in Egypt. Trastuzumab is administered with chemotherapy for patients with HER2-positive advanced breast cancer (HER2?+?ve ABC) in the metastatic and adjuvant settings resulting in improved treatment outcomes, and long-term follow-up. Some studies have evaluated whether equivalent outcomes can be achieved with reduced treatment duration. This study evaluates the cost-effectiveness of 6-month versus 1-year trastuzumab treatments from payer perspective over a 10 year time horizon.

Methods: A half-cycle corrected Markov model was developed with five mutually exclusive health states; patient with HER2?+ve ABC, disease-free survival (DFS), local or regional relapse, metastatic relapse, and death. A cycle length of 6 months was applied, direct medical costs including cost of treatments, day-care, surgery, health states and follow-up visits were collected, and indirect costs such as lost productivity were not estimated. The transition probabilities and utilities were extracted from published literature, and deterministic sensitivity analyses were conducted.

Results: Among the HER2?+ve ABC patient population in Egypt, the total QALYs of the 6-month trastuzumab were estimated to be 2.99 compared with 2.93 for the 1-year trastuzumab which resulted in a difference of 0.06 QALYs. The total costs were EGP 271,647 ($106,947) and EGP 381,248 ($150,097), respectively. These costs yielded an ICER of –109,600 EGP/QALY (–43,149 $/QALY) for the 6-month trastuzumab. The 6-month trastuzumab is a dominant strategy when compared to 1-year trastuzumab, resulting in improved effectiveness at a reduced cost. All analyses results confirmed the dominance of 6-month trastuzumab and our model robustness.

Conclusions: This study concluded that 6-month trastuzumab is a cost-effective option when compared to 1-year trastuzumab in patients with HER2?+ve ABC in Egypt. Our findings provide health care decision makers with additional insights to best allocate available resources concurrently with the improvement of the Egyptian patient’s outcomes.     

Direct medical costs of treatment in newly-diagnosed high-grade glioma among commercially insured US patients

Aim: This analysis assessed the direct medical costs of newly-diagnosed, temozolomide (TMZ)-treated glioblastoma (GBM) from the perspective of a US commercial setting.

Materials and methods: The analysis included subjects identified from the IMS PharMetrics LifeLink Plus? claims database from January 1, 2008 to August 31, 2014 who were ≥18 years of age, had ≥1 malignant brain cancer diagnosis, had brain surgery ≤90 days prior to TMZ initiation, had TMZ treatment, and were continuously enrolled for ≥12 months pre-diagnosis and ≥1 month post-diagnosis. Per-patient per-month (PPPM) and cumulative costs from 3 months pre-diagnosis to various post-diagnosis follow-up time points were calculated. Multivariable analyses were used to estimate adjusted mean cost and identify contributors of cost.

Results: The study included 2,921 subjects (median age?=?56 years; 60% male). After diagnosis, the median (interquartile range, IQR) number of inpatient, emergency department, and outpatient visits were 2 (1–4), 1 (1–3), and 19 (13–27); median (IQR) length of stay per hospitalization was 5 (3–9) days. Mean total cumulative costs per patient from 3 months pre-diagnosis to 12 months and to 5 years post-diagnosis were $201,749 (197,490–206,024) and $268,031 (262,877–274,416). Mean (SD) PPPM costs were $818 (1,128) and $7,394 (8,676) pre- and post-GBM diagnosis, respectively. The variables most predictive of cumulative costs included radiation therapy (+$81,732), ≥2 weeks of hospitalization (+$49,629), and ≥7 MRI scans (+$40,105).

Conclusions: The direct medical costs of newly-diagnosed, TMZ-treated GBM in commercially insured patients are substantial, with estimated total cumulative costs of $268,031.     

Real-world utilization of molecular diagnostic testing and matched drug therapies in the treatment of metastatic cancers

Aims: To assess the frequency of biopsies and molecular diagnostic testing (human DNA/RNA analysis), anti-cancer drug use (genomically-matched targeted therapy [GMTT], unmatched targeted therapy [UTT], endocrine therapy [ET], and chemotherapy [CT]), and medical service costs among adults with metastatic cancer.

Methods: Adults diagnosed with metastatic breast, non-small cell lung (NSCLC), colorectal, head and neck, ovarian, and uterine cancer (2010Q1–2015Q1) were identified in the OptumHealth Care Solutions claims database and followed from first metastatic diagnosis for ≥1 month and until the end of data availability. Utilization was assessed for each cancer cohort (all and patients aged ≥65 years); per-patient-per-month (PPPM) medical service costs were assessed for all patients. Testing frequency estimates were applied to Surveillance, Epidemiology, and End Results Program data to estimate the number of untested patients (2010–2014).

Results: Patients with metastatic cancer (n?=?8,193; breast [n?=?3,414], NSCLC [n?=?2,231], colorectal [n?=?1,611], head and neck [n?=?511], ovarian [n?=?275], and uterine [n?=?151]) were 63 years old (mean), with 11.1–22.2 months of observation. Biopsy and molecular diagnostic testing frequencies ranged from 7% (uterine) to 73% (ovarian), and from 34% (head and neck) to 52% (breast), respectively. Few were treated with GMTT (breast, 11%; NSCLC, 9%; colorectal, 6%). Treatment with UTT ranged from 0.7% (uterine) to 21% (colorectal). Biopsy, diagnostic testing, and anti-cancer drug therapy were less frequent for those ≥65 years. Medical service costs (PPPM, mean) ranged from $6,618 (head and neck) to $9,940 (ovarian). The estimated number of untested new patients with metastatic cancer was 636,369 (all) and 341,397 (≥65).

Limitations: In addition to the limitations of claims analyses, diagnostic testing frequency may be under-estimated if patients underwent testing prior to study inclusion.

Conclusions: The low frequency of molecular diagnostic testing suggests there are opportunities to better inform management of patients with advanced cancer, particularly decisions to treat with GMTT.     

Budget impact analysis of everolimus for the treatment of hormone receptor positive,human epidermal growth factor receptor-2 negative (HER2−) advanced breast cancer in Kazakhstan

Abstract

Objective:

The aim of this study was to determine the budget impact of everolimus (in combination with letrozole/anastrozole) as a second-line treatment for ER+ HER2? negative advanced and metastatic breast cancer in post-menopausal women.

Research design and methods:

A cumulative cohort model was developed to estimate the 5-year costs associated with introducing everolimus to the Kazakh healthcare system. Two alternative market share scenarios were compared: with everolimus and without everolimus. PFS and OS data were taken from the trial and extrapolated. The background costs of the pre-progressed and post-progressed health states, drug costs and costs associated with adverse events were included in the model.

Results:

The 5-year results from the budget impact analysis demonstrate that the introduction of everolimus leads to a 12% increase in drug costs, a 2% reduction in pre-progression health state costs, a 1% increase in post-progression health state costs, and a 2% reduction in adverse event costs. The net result is only a modest increase in total costs; a 2.69% increase of T201 million, from T7.5 billion to T7.7 billion over a period of 5 years.

Conclusions:

The analysis estimated that, if everolimus were to be introduced to the Kazakh healthcare market for the treatment of ER+ HER2? advanced breast cancer, there would be minimal impact upon overall healthcare expenditure. An increase in drug acquisitions costs was almost exactly offset by a reduction in other healthcare costs, due to improved management of the disease.     

Cost-effectiveness model of abiraterone plus prednisone,cabazitaxel plus prednisone and enzalutamide for visceral metastatic castration resistant prostate cancer therapy after docetaxel therapy resistance

Abstract

Aims: Among patients diagnosed with prostate cancer, 10–20% will develop castration-resistant prostate cancer (CRPC) within 5?years; for 70%, CRPC will metastasize, mostly to the lungs and/or liver. We performed a cost-effectiveness model comparing abiraterone plus prednisone (ABI?+?PRD), cabazitaxel plus prednisone (CAB?+?PRD) and enzalutamide (ENZ) for visceral metastatic CRPC post-docetaxel therapy resistance.

Methods: A three-state (Progression-Free, Progression, Death) lifetime Markov model was constructed to compare ABI?+?PRD, CAB?+?PRD, and ENZ from a United States healthcare payer perspective (2019?US$; discount rate 3%/yr.). Effectiveness was measured in life-years (LYs) and quality-adjusted life years (QALYs). Inputs included treatment costs, grade III/IV adverse events with incidence ≥5%, physician follow-up, lab and imaging tests. Phase III trial Kaplan-Meier curves were extrapolated to estimate overall survival and Progression-Free transition probabilities. Incremental cost-effectiveness ratios (ICERs) and utility ratios (ICURs), probabilistic sensitivity analyses (PSAs) and cost-effectiveness acceptability curves at willingness-to-pay (WTP) thresholds were estimated.

Results: Models estimated 3-year overall survival rates of 1.3% for patients treated with ABI?+?PRD, 16.2% for CAB?+?PRD, and 13.2% for ENZ. Estimated Progression-Free rates at 1.5?years were 0.51% for ABI?+?PRD, 0.27% for CAB?+?PRD, and 14.47% for ENZ. LYs and QALYs were 1.20 and 0.58 respectively for ABI?+?PRD, 1.48 and 0.56 for CAB?+?PRD, and 1.58 and 0.79 for ENZ. Total treatment costs were: $115,433 for ABI?+?PRD, $85,337 for CAB?+?PRD and $109,213 for ENZ. CAB?+?PRD and ENZ dominated ABI?+?PRD due to higher LYs gained. Incremental QALYs for ENZ vs. CAB?+?PRD were larger than incremental LYs. The ICUR for ENZ was $103,674/QALY compared to CAB?+?PRD.

Conclusions: This analysis found ENZ provided greater LYs and QALYs than both ABI?+?PRD and CAB?+?PRD, at a lower cost than ABI?+?PRD, but at a higher cost compared to CAB?+?PRD. For patients with visceral mCRPC after docetaxel therapy resistance, ENZ was cost-effective 92% of the time with a WTP threshold of $100,000/QALY.     

Cost-effectiveness of percutaneous closure of a patent foramen ovale compared with medical management in patients with a cryptogenic stroke: from the US payer perspective

Abstract

Aims: To evaluate the cost-effectiveness of percutaneous patent foramen ovale (PFO) closure, from a US payer perspective. Lower rates of recurrent ischemic stroke have been documented following percutaneous PFO closure in properly selected patients. Stroke in patients aged <60?years is particularly interesting because this population is typically at peak economic productivity and vulnerable to prolonged disability.

Materials and methods: A Markov model comprising six health states (Stable after index stroke, Transient ischemic attack, Post-Transient Ischemic Attack, Clinical ischemic stroke, Post-clinical ischemic stroke, and Death) was constructed to evaluate the cost-effectiveness of PFO closure in combination with medical management versus medical management alone. The base-case model employed a 5-year time-horizon, with transition probabilities, clinical inputs, costs, and utility values ascertained from published and national costing sources. Incremental cost-effectiveness ratio (ICER) was evaluated per US guidelines, utilizing a discount rate of 3.0%.

Results: At 5?years, overall costs and quality-adjusted life-years (QALYs) obtained from PFO closure compared with medical management were $16,323 vs $7,670 and 4.18 vs 3.77, respectively. At 5?years, PFO closure achieved an ICER of $21,049, beneficially lower than the conventional threshold of $50,000. PFO closure reached cost-effectiveness at 2.3?years (ICER = $47,145). Applying discount rates of 0% and 6% had a negligible impact on base-case model findings. Furthermore, PFO closure was 95.4% likely to be cost-effective, with a willingness-to-pay (WTP) threshold of $50,000 and a 5-year time horizon.

Limitations: From a cost perspective, our economic model employed a US patient sub-population, so cost data may not extrapolate to other non-US stroke populations.

Conclusion: Percutaneous PFO closure plus medical management represents a cost-effective approach for lowering the risk of recurrent stroke compared with medical management alone.     

Will a special tax on tobacco reduce lung cancer mortality? Evidence for EU countries

This article carrys out a quantitative evaluation of the effects on the health of smokers of increasing a special tobacco tax, using the mortality rate from lung cancer as an indicator. To that end, it estimates two models that relate tobacco consumption, the mortality rate and this special tax, employing data drawn from a sample made-up of 12 EU countries and covering the years 1983–1993. The results show that increasing the special tax is a useful tool for reducing lung cancer mortality. Specifically, it finds that a 10% increase will reduce the lung cancer mortality rate by 1.21% in the first year, with such a reduction implying the avoidance of 1707 deaths in the sample countries.     

Updated trends in US brand-name and generic drug competition

Objective: To provide updated evidence on US trends in: market exclusivity periods (MEPs, time between brand-name drug launch and first generic competitors) for new molecular entities (NMEs); likelihood, timing and number of Hatch-Waxman Act Paragraph IV patent challenges; and generic drug penetration.

Methods: This study used IMS Health National Sales Perspectives^TM US data to calculate MEPs for the 288 NMEs experiencing initial generic entry between January 1995 and December 2014, the number of generic competitors for 12 months afterward (by level of annual sales prior to generic entry), and generic penetration rates. The likelihood, timing and number of Paragraph IV challengers were calculated using data from Abbreviated New Drug Approval (ANDA) letters, the FDA website, public information searches, and ParagraphFour.com.

Results: For drugs experiencing initial generic entry in 2013–2014, the MEP was 12.5 years for drugs with sales greater than $250 million (in 2008 dollars) in the year prior to generic entry ($250 million?+?NMEs), 13.6 years overall. After generic entry, brands rapidly lost sales, with their average unit share being 7% at 1 year for $250 million?+?NMEs, 12% overall. Ninety-four percent of $250 million?+?NMEs experiencing initial generic entry in 2013–2014 had faced at least one Paragraph IV challenge, an average of 5.2 years after brand launch (76% and 5.9 years for all NMEs). NMEs faced an average of 5.1 and 6.2 Paragraph IV challenges per NME, for all and $250 million?+?NMEs, respectively.

Limitations: Analyses, including Paragraph IV calculations, were restricted to NMEs where generic entry had occurred.

Conclusion: The average 2013–2014 MEP of 12.5 years for $250 million?+?NMEs, 13.6 overall remains consistent with prior research. MEPs are lower, and Paragraph IV challenges are more frequent and occur earlier for $250 million?+?drugs. Generic share erosion is also greater, and continues to intensify for both NME types.     

The economic burden of kidney disorders in Korea

Aims: To estimate the economic burden of kidney disorders in Korea.

Materials and methods: The economic burden of kidney disorders was estimated using a prevalence-based approach. Related kidney diseases in patients with kidney disorders (RPWKD) were defined using codes from the tenth International Classification of Disease (E70–E90, F30–F48, F60–F69, F90–F99, K65–K67, N00–N08, N17–N19, and N30–N39). All diseases in patients with kidney disorders (APWKD) were defined as kidney disorders that involved all disease codes. Economic costs were divided into direct costs (medical costs and non-medical costs) and indirect costs (productivity loss because of morbidity and premature mortality).

Results: The prevalence of kidney disorders increased from 0.08% (2008) to 0.11% (2011). The total economic burden of RPWKD also substantially increased from $898.9 million (2008) to $1.43 billion (2011). This ～59.4% increase in the economic burden was equal to 0.12% of the Korean gross domestic product. The economic burden of APWKD also increased during the study period: $1.06 billion (2008), $1.23 billion (2009), $1.44 billion (2010), and $1.46 billion (2011).

Conclusions: The present study provides the first data regarding the economic burden of kidney disorders in Korea. The findings support the need for early intervention services and prevention programs to prevent, identify, and manage kidney disorders.     

Economic evaluation of nivolumab for the treatment of second-line advanced squamous NSCLC in Canada: a comparison of modeling approaches to estimate and extrapolate survival outcomes

Background Lung cancer is the most common type of cancer in the world and is associated with significant mortality. Nivolumab demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients with advanced squamous non-small cell lung cancer (NSCLC) who were previously treated. The cost-effectiveness of nivolumab has not been assessed in Canada. A contentious component of projecting long-term cost and outcomes in cancer relates to the modeling approach adopted, with the two most common approaches being partitioned survival (PS) and Markov models. The objectives of this analysis were to estimate the cost-utility of nivolumab and to compare the results using these alternative modeling approaches.

Methods Both PS and Markov models were developed using docetaxel and erlotinib as comparators. A three-health state model was used consisting of progression-free, progressed disease, and death. Disease progression and time to progression were estimated by identifying best-fitting survival curves from the clinical trial data for PFS and OS. Expected costs and health outcomes were calculated by combining health-state occupancy with medical resource use and quality-of-life assigned to each of the three health states. The health outcomes included in the model were survival and quality-adjusted-life-years (QALYs).

Results Nivolumab was found to have the highest expected per-patient cost, but also improved per-patient life years (LYs) and QALYs. Nivolumab cost an additional $151,560 and $140,601 per QALY gained compared to docetaxel and erlotinib, respectively, using a PS model approach. The cost-utility estimates using a Markov model were very similar ($152,229 and $141,838, respectively, per QALY gained).

Conclusions Nivolumab was found to involve a trade-off between improved patient survival and QALYs, and increased cost. It was found that the use of a PS or Markov model produced very similar estimates of expected cost, outcomes, and incremental cost-utility.     

The cost effectiveness of a quadrivalent human papillomavirus vaccine (6/11/16/18) in Hungary

Abstract

Objective: A transmission dynamic model was used to assess the epidemiological and economic impact of a quadrivalent human papillomavirus (HPV) (6/11/16/18) vaccine in preventing cervical cancer, cervical intraepithelial neoplasia grades 2 and 3 (CIN 2/3), CIN 1 and genital warts in Hungary.

Methods: The routine vaccination of 12-year-old girls and the routine vaccination of 12-year-old girls plus a temporary catch-up programme for girls and women aged 12–24 years was evaluated.

Results: The model projected that at year 100, both strategies could reduce the incidence of HPV 6/11/16/18-related cervical cancer, CIN 2/3, CIN 1 and genital warts cases among Hungarian women by 90%, 90%, 85% and 93%, respectively. Twenty-five years after the introduction of HPV vaccination in the population, routine vaccination of girls by the age of 12 reduced the cumulative number of cases of cervical cancer, CIN 2/3, CIN 1 and genital warts by 685, 13,473, 3,423 and 163,987, respectively. The incremental cost-effectiveness ratios of the two vaccination strategies were €9,577 and €10,646 per quality-adjusted life-year (QALY) gained over a time horizon of 100 years.

Key limitations: The model did not account for the health and economic impact of other HPV diseases which may result from HPV 16, 18, 6, and 11 infections such as vaginal, vulvar, penile, anal and head-neck cancers, and recurrent respiratory papillomatosis. Epidemiological data from Hungary on these other HPV diseases as well genital warts are needed.

Conclusion: A quadrivalent HPV vaccination programme can reduce the incidence of cervical cancer, CIN and genital warts in Hungary at a cost-per-QALY ratio within the range defined as cost effective.     

Disease-related expenditures and revision rates in chronic rhinosinusitis patients after endoscopic sinus surgery

Aims: The objective of this study was to quantify the treatment costs and revision surgery rates in chronic rhinosinusitis (CRS) patients, with and without nasal polyposis (CRSwNP and CRSsNP), who require treatment with endoscopic sinus surgery (ESS). The additive contributions of nasal polyposis (NP) and revision surgery to 1-year costs were a primary focus.

Materials and methods: Adults (aged 18–64 years) undergoing ESS for CRS in 2012–2015 were identified within the Blue Health Intelligence database and used to estimate revision rates. Patients with ±1 year of enrollment around the index ESS were used to estimate 1-year healthcare expenditures. Revision ESS rates were evaluated via Kaplan-Meier and Cox regression models. Disease-related healthcare and pharmacy expenditures were modeled with generalized linear regression to assess the impact of baseline patient characteristics.

Results: A total of 86,052 patients underwent ESS for CRS (43.5?±?12.4 years; 49.3% male), and a sub-set of 23,542 patients were available for 1-year healthcare expenditure analysis (44.0?±?12.1 years; 50.0% male). Revision ESS rates within 1 year were 3.5% in the CRSwNP cohort and 1.6% in the CRSsNP cohort. NP, deviated septum, gender, and region were statistically significant predictors of revision surgery. Mean 1-year treatment expenditures, including the index ESS, were $8,824 for CRSsNP and $11,166 for CRSwNP patients without revision ESS. CRSwNP doubled the risk of revision surgery in the first year after ESS compared with CRSsNP and cost 24% more in the absence of a second procedure. Revision ESS within the first year increased mean 1-year expenditures by $11,150 and $13,139 for CRSsNP and CRSwNP, respectively.

Limitations: The primary limitation was the limited length of follow-up available for estimating revision ESS rates.

Conclusions: In a large commercially insured US population, disease-related expenditures for patients having ESS for CRS are substantial, as are the additive impacts of NP and revision surgery.     

Budget impact model of tobramycin inhalation solution for treatment of Pseudomonas aeruginosa in cystic fibrosis patients

Abstract

Background:

Pseudomonas aeruginosa (PA) is the most common airway pathogen in cystic fibrosis (CF) patients. The objective of this analysis was to determine the costs of managing PA infection in CF patients with a chronic regimen of tobramycin inhalation solution (TIS).

Methods:

A budget impact model of CF patients was developed to evaluate the costs of TIS from a US managed-care organization (MCO) perspective. The Microsoft Excel model compared TIS treatment plus standard care with standard care alone over a 4-year time horizon and included the cost of drugs, medical care, and annual probabilities of hospitalization and IV anti-pseudomonal (anti-PA) antibiotics administration.

Results:

For an MCO with 5,000,000 members, 389 members 6 years of age or older were estimated to have CF, and 218 (56%) had PA infection. Assuming that use of TIS increased from 20% to 25%, the 1-year budget increased $231,251 or from $0.049 to $0.053 per member per month (PMPM). The net drug budget increase was $243,919, while medical costs associated with exacerbation management decreased $12,669 over the first year. Increasing utilization of TIS, from 20% to 40% over 4 years resulted in an incremental overall budget increase of $925,002, a 3% decrease in hospitalizations, and a 4% decrease in administrations of IV anti-PA antibiotics. These reductions translated to a medical care cost saving of $50,676 over 4 years. Limitations of this study include that the clinical data for the model are from clinical trials conducted in 1996 and the estimation of TIS use for CF patients with chronic PA infections can be impacted by TIS adherence.

Conclusion:

Model results suggest that increasing the use of TIS decreases medical care costs due to decreased hospital admissions and the use of IV anti-PA antibiotics at the expense of higher drug costs.     

The association between smoking cessation outpatient visits and total medical costs: a retrospective,observational analysis of Japanese employee-based public health insurance data

Aims: The short-term effects of smoking cessation (SC) on overall healthcare costs are unclear. This study aimed to compare the short-term medical costs between patients with SC outpatient visits (SCOVs) and those without SCOVs, consisting of SCOV itself and overall medical costs.

Materials and methods: This study is a retrospective, observational study using a Japanese employee-based health insurance claims database (January 1, 2005–December 31, 2013). It analyzed individuals who were registered as smokers based on their medical checkup details. It compared the per-patient-per-year (PPPY) medical costs for male smokers who made ≥1 claim for SCOVs with those who made no claims. We also assessed whether the number of SCOVs by male and female smokers impacted medical costs. The Index Year was the year after the first SCOV claim and that after the first registration as a smoker (non-SCOV group). Medical costs were calculated using regression analysis and adjusted for baseline costs.

Results: In Index Year ?1, PPPY medical costs for male smokers were ～USD 323.01 (JPY 36,500, as of November 2017) higher in the SCOV (n?=?5,608) vs the non-SCOV (n?=?81,721) group; however, by Year 6 the costs were similar. From Year 4–6, PPPY medical costs for SCOVs were lower than those in the adjusted non-SCOV group. For 2,576 male and female smokers in the SCOV group, the average rates of increasing medical costs before and after the SCOV for 1, 2, 3, 4, and 5 SCOVs made were 58%, 44%, 50%, 41%, and 34%, respectively.

Limitations: The database includes limited data on individuals >65 years. Only SCOVs based on claims data and not on other outcomes were assessed.

Conclusions: Medical costs declined in the short-term following the first SCOV. Attendance at a greater number of SCOVs was associated with a lower increase ratio of medical costs.     

Retrospective database analysis of the effect of zoledronic acid on skeletal-related events and mortality in women with breast cancer and bone metastasis in a managed care plan

Abstract

Background:

Bone metastases are common in patients with advanced breast cancer, and place patients at risk for skeletal-related events (SREs) including pathologic fracture, spinal cord compression, hypercalcemia of malignancy, and the need for radiotherapy and/or surgery to bone. These SREs are associated with reduced survival and quality-of-life. The nitrogen-containing bisphosphonates Zometa (zoledronic acid, ZOL) and Aredia (pamidronate disodium, PAM) reduce SRE risk in patients with bone metastases from breast cancer. This database analysis compared SRE and mortality rates in a real-life setting in women with breast cancer receiving ZOL and PAM, and assessed long-term ZOL benefit.

Methods:

A retrospective, claims-based analysis was conducted using commercial and Medicare Advantage data from >45 US managed-care plans. Eligible adult patients had diagnoses for breast cancer and bone metastasis between 01/01/01 and 12/31/06, continuous enrollment in the health plan, and no evidence of bone metastasis or intravenous bisphosphonate (IV-BP) use for 6 months before their first ZOL or PAM infusion. Patients were followed until disenrollment (including mortality) or end of the analysis period (12/31/07). Persistency was defined as absence of a >45-day gap between IV-BP treatments.

Results:

Of 8757 patients (mean age, 58.1 [SD 12.4] years), ～ 30% were treated with ZOL, 15% with PAM, and 55% with no IV-BP. Patients treated with ZOL had a moderately lower incidence of SREs (mean, 36.2 vs 40.0 SREs/100 person-years; p?=?0.0707) and significantly lower mortality (mean, 6.5 vs 11.2 deaths/100 person-years; p?<?0.001) compared with PAM-treated patients. Longer persistency with ZOL was associated with lower risk of fracture and all SREs (trend-test p?=?0.0076 and p?=?0.0200, respectively).

Limitations:

Interpretation of this claims-based analysis must be tempered by the inherent limitations of observational data, such as imbalances in patient populations and the potential for bias in treatment selection.

Conclusions:

This analysis suggests that fewer than half of breast cancer patients with bone metastases receive IV-BPs. Longer persistence with ZOL was associated with lower SRE risk, and ZOL-treated patients had longer survival and a non-significant trend toward fewer SREs compared with PAM.