US Health Plan Research Articles

Neutropenia related hospitalization risk in lung cancer patients with chemotherapy.

e18290 Background: We sought to describe outcomes following granulocyte-colony stimulating factor (G-CSF) prophylaxis in patients with lung cancer receiving chemotherapy regimens with low to intermediate risk for inducing neutropenia related hospitalization. Methods: We identified 11,233 lung cancer (all histologies) patients ≥ 18 years from 14 commercial US health plans. All patients received first cycle chemotherapy during 2008–2013. 5,423 patients received one of the 3 regimens: carboplatin and paclitaxel, cisplatin and etoposide, carboplatin and etoposide. Primary prophylaxis (PP) was defined as G-CSF administration within 5 days of chemotherapy. Outcome was neutropenia, fever, or infection-related hospitalization within 21 days. Regression and number-needed-to-treat (NNT) analyses were used. Results: A total of 11,233 patients received any chemotherapy (21.2% PP), were older (median years 64 PP; 64 no PP) and had at least 1 non-cancer comorbidity (79.8% PP; 77.9% no PP). About 2,776 patients received Carbo/Paclitaxel (13.9% PP), 1,356 patients received Cisp/Etop (23% PP) and 1,291 patients received Carbo/Etop (45.8% PP) regimens. PP was associated with lower risk of neutropenia related hospitalization for any chemotherapy (4.7% PP; 7.5% no PP; odds ratio [OR] 0.61; 95% CI 0.49 – 0.74), for Cisp/Etop (5.1% PP; 8.8% no PP; OR 0.56; 95% CI 0.32 – 0.97) and Carbo/Etop (5.6% PP; 11% no PP; OR 0.48; 95% CI 0.31 – 0.73), but not Carbo/Paclitaxel (5.7% PP; 6.7% no PP; OR 0.84; 95% CI 0.53 – 1.32) regimens. Based on NNT, the total cost of PP for 36 patients with any chemotherapy regimen to avoid one hospitalization would be $128,952 (mean hospitalization cost = $11,900, Standard Deviation [SD] = $9,541). For 28 patients with Cisp/Etop, it would be $101,920 (mean hospitalization cost = $16,957, SD = $16,135). For 19 patients with Carbo/Etop, it would be $63,270 (mean hospitalization cost = $11,356, SD = $6,949). Conclusions: Primary G-CSF prophylaxis was associated with some benefit in lowering neutropenia-related hospitalization in patients with lung cancer receiving Cisp/Etop and Carbo/Etop regimens, although the cost to treat patients remains high. Future studies need to examine the value of continued G-CSF use in subsequent cycles.

Initiation Patterns of Statins in the 2Years After Release of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) Cholesterol Management Guideline in a Large US Health Plan.

BackgroundThe purpose of this study was to characterize changes in statin utilization patterns in patients newly initiated on therapy in the 2 years following the release of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol management guideline in a large US health plan population.Methods and ResultsThis retrospective, observational study used administrative medical and pharmacy claims data to identify patients newly initiated on statin therapy over 4 quarters prior to and 8 quarters following the release of the guideline (average N/quarter=3596). Patients were divided into the 4 statin benefit groups (SBGs) based on risk factors and laboratory lipid levels as defined in the guideline: SBG1 (with atherosclerotic cardiovascular disease [ASCVD]; N=1046/quarter), SBG2 (without ASCVD, with low‐density lipoprotein cholesterol ≥190 mg/dL; N=454/quarter), SBG3 (without ASCVD, aged 40–75 years, with diabetes mellitus, low‐density lipoprotein cholesterol 70–189 mg/dL; N=1391/quarter), SBG4 (no ASCVD or diabetes mellitus, age 40–75 years, low‐density lipoprotein cholesterol 70–189 mg/dL, estimated 10‐year ASCVD risk of ≥7.5%; N=705/quarter). Demographic variables, statin utilization patterns, lipid levels, and comorbidities were analyzed for pre‐ and postguideline periods. Postguideline, gradually increased high‐intensity statin initiation occurred in SBG1, SBG2, and in SBG3 patients with 10‐year ASCVD risk ≥7.5%. Moderate‐ to high‐intensity statin initiation gradually increased among SBG4 patients. Recommended‐intensity statin choice changed to a greater degree among patients treated by specialty care physicians. Regarding sex, target‐intensity statin initiation was lower in women in all groups before and after guideline release.ConclusionsPrescriber implementation of the guideline recommendations has gradually increased, with the most marked change in the increased initiation of high‐intensity statins in patients with ASCVD and in those treated by a specialist.

Disease Burden, Early Discontinuation, and Healthcare Costs in Hepatitis C Patients with and without Chronic Kidney Disease Treated with Interferon-Free Direct-Acting Antiviral Regimens.

BackgroundHepatitis C virus (HCV) is a risk factor for chronic kidney disease (CKD) and end-stage renal disease (ESRD). Direct-acting antiviral agents (DAAs) have improved HCV management in CKD patients, however real-world clinical practice data are limited.ObjectiveThis study examined the prevalence of CKD among HCV patients receiving oral DAAs in a real-world setting. Comorbidities, early discontinuation rates, and healthcare costs were compared between patients with and without CKD.MethodsPatients with HCV who were treated with oral DAAs between November 2013 and June 2015, and who were enrolled in a US health plan, were identified. Early discontinuation was calculated based on observed versus expected treatment duration, and expected treatment duration was based on genotype, initial treatment regimen, baseline cirrhosis, and prior treatments. Healthcare costs were calculated during the baseline, treatment, and post-treatment periods.ResultsThis study included 3438 patients receiving oral DAAs, of whom 6.9% had a CKD diagnosis. CKD patients were more often male (70.8 vs. 62.9%, p = 0.02) and older (mean age 62.0 vs. 58.8 years, p < 0.001) than non-CKD patients, and had a higher prevalence of most comorbidities. Among early discontinuers, CKD patients were more likely to experience anemia (19.4 vs. 7.7%, p = 0.028).ConclusionsFew patients with CKD receive DAA treatment for HCV infections. HCV patients with CKD had significantly more comorbidities and higher baseline healthcare costs than patients without CKD. Compared with non-CKD patients, CKD patients were equally likely to discontinue DAA treatment early but had higher rates of anemia. This study highlights the need for more renal-friendly HCV therapies.

Trajectories of Depressive Symptoms Among Web-Based Health Risk Assessment Participants

BackgroundHealth risk assessments (HRAs), which often screen for depressive symptoms, are administered to millions of employees and health plan members each year. HRA data provide an opportunity to examine longitudinal trends in depressive symptomatology, as researchers have done previously with other populations.ObjectiveThe primary research questions were: (1) Can we observe longitudinal trajectories in HRA populations like those observed in other study samples? (2) Do HRA variables, which primarily reflect modifiable health risks, help us to identify predictors associated with these trajectories? (3) Can we make meaningful recommendations for population health management, applicable to HRA participants, based on predictors we identify?MethodsThis study used growth mixture modeling (GMM) to examine longitudinal trends in depressive symptomatology among 22,963 participants in a Web-based HRA used by US employers and health plans. The HRA assessed modifiable health risks and variables such as stress, sleep, and quality of life.ResultsFive classes were identified: A “minimal depression” class (63.91%, 14,676/22,963) whose scores were consistently low across time, a “low risk” class (19.89%, 4568/22,963) whose condition remained subthreshold, a “deteriorating” class (3.15%, 705/22,963) who began at subthreshold but approached severe depression by the end of the study, a “chronic” class (4.71%, 1081/22,963) who remained highly depressed over time, and a “remitting” class (8.42%, 1933/22,963) who had moderate depression to start, but crossed into minimal depression by the end. Among those with subthreshold symptoms, individuals who were male (P<.001) and older (P=.01) were less likely to show symptom deterioration, whereas current depression treatment (P<.001) and surprisingly, higher sleep quality (P<.001) were associated with increased probability of membership in the “deteriorating” class as compared with “low risk.” Among participants with greater symptomatology to start, those in the “severe” class tended to be younger than the “remitting” class (P<.001). Lower baseline sleep quality (P<.001), quality of life (P<.001), stress level (P<.001), and current treatment involvement (P<.001) were all predictive of membership in the “severe” class.ConclusionsThe trajectories identified were consistent with trends in previous research. The results identified some key predictors: we discuss those that mirror prior studies and offer some hypotheses as to why others did not. The finding that 1 in 5 HRA participants with subthreshold symptoms deteriorated to the point of clinical distress during succeeding years underscores the need to learn more about such individuals. We offer additional recommendations for follow-up research, which should be designed to reflect changes in health plan demographics and HRA delivery platforms. In addition to utilizing additional variables such as cognitive style to refine predictive models, future research could also begin to test the impact of more aggressive outreach strategies aimed at participants who are likely to deteriorate or remain significantly depressed over time.

Rethinking costs of psoriasis: 10% of patients account for nearly 40% of healthcare expenditures among enrollees with psoriasis in a U.S. health plan

Objective: To examine characteristics, healthcare utilization and costs among patients with psoriasis who have high medical costs.Methods: This is a retrospective study of patients with psoriasis with continuous enrollment from 1 January 2011 to 31 December 2013 in a large US health plan. Total paid 2012 healthcare costs excluding biologics (to identify costliest not due to biologic costs) were used to create cohorts representing the top 10% (T10) and bottom 90% (B90) of expenditures. Demographics, comorbidities, prescriptions, all-cause and psoriasis-related healthcare utilization and costs were compared between cohorts. Logistic regression identified demographic and clinical characteristics associated with the 2012 T10 cohort status.Results: 18,653 patients (mean age 48 years; 49% female) were included. Patients in the T10 group accounted for 26% (2011), 39% (2012) and 26% (2013) of all-cause costs including biologics and 13% (2011), 18% (2012) and 11% (2013) of psoriasis-related costs. Mean 2012 total costs were $58,030 for T10 vs. $10,295 for B90 (all-cause) and $10,475 vs. $5301 (psoriasis-related). T10 patients in 2012 filled more prescriptions and were more likely to use corticosteroids (57% vs. 31%); however, biologic use and costs were similar (any use: 23% vs. 24%; prescriptions: 1.5 vs. 1.7, biologic costs: $4959 vs. $5095). Compared with B90 patients, T10 patients were more likely to have hospitalizations (all-cause: 45% vs. 3%; psoriasis-related: 14% vs. 1%) and ER visits (all-cause: 53% vs. 21%; psoriasis-related: 3% vs. 1%), and more likely to have renal disease (odds ratio (OR) = 2.05), depression (OR =1.96), cardiovascular disease (OR =1.88), psoriatic arthritis (OR =1.57) and diabetes (OR =1.50) (all p < .05).Conclusions: The T10 patient cohort in 2012 accounted for nearly 40% of overall healthcare expenditures. However, cost differences between the T10 and B90 patients were not attributable to psoriasis-related biologic treatment utilization and costs. The T10 patients had significantly more inpatient and emergency utilization, and comorbid medical conditions.

Cubital Tunnel Syndrome: Incidence and Demographics in a National Administrative Database.

Compressive neuropathy of the ulnar nerve at the elbow, or cubital tunnel syndrome (CuTS), is the second most common entrapment neuropathy of the upper extremity after carpal tunnel syndrome. While several studies have reported risk factors and outcomes for select populations (mostly surgical), it is difficult to interpret these data without an accurate measure of CuTS disease burden in the general population. To estimate the incidence of CuTS among US health plan enrollees, using a large administrative health care claims database comprised of individuals from all 50 states. An administrative database of commercial insurance beneficiaries was queried for diagnosis and treatment of CuTS over a 6-yr period. We examined subsequent claims to determine frequency of subsequent surgical treatment. Descriptive statistics were used to determine the association of incident cases and surgical treatment with age and gender. The estimated adjusted incidence rate of CuTS is 30.0 per 100 000 person-years. Of the 53 401 identified new cases within this cohort from 2006 to 2012, 41.3% were treated surgically. Incident cases were identified more frequently in men than in women (31.2 vs 28.8 cases per 100 000 person-years), though we observed more cases in women than in men below 50 yr of age (20.9 vs 19.5 cases per 100 000 person-years). Overall, incident cases increase with age in both men and women. In addition to incident cases being more common with increasing age, the percentage of cases treated surgically also increases with age (surgery in 34.4% of cases in the 18-30 yr group vs 48.8% of cases in the 60-65 yr group). The purpose of this study was to estimate the incidence of CuTS among US health plan enrollees. This is the largest published study on the incidence of CuTS, and the first to look at a US population. The overall adjusted incidence of CuTS was 30.0 per 100 000 person-years. Of patients who developed CuTS, 41.3% were treated surgically during the study period. Our results corroborate previously reported literature suggesting incidence increases significantly with age, with a slightly higher incidence in males. A high percentage of people who were diagnosed with CuTS and ended up receiving surgical intervention (41.3%) were older males. These results may aid practitioners in providing some basic prognostic information to patients who develop CuTS.

Abstract P5-08-15: Real-world treatment patterns and survival among triple negative breast cancer patients versus patients with other breast cancer subtypes in early stage breast cancer

Abstract Background: It is generally accepted that outcomes of breast cancer (BC) patients (pts) differ by tumor characteristics, but relatively few studies have examined treatment patterns and outcomes in early stage disease by hormone receptor (HR) and HER2 status. Methods: This retrospective study used physician-reported clinical information (date and stage at diagnosis, HER2 and HR status) for commercially insured BC pts from the Optum Oncology Management Registry linked with the Optum Research Database (medical and pharmacy claims from a national US health plan) and death data from Social Security Administration files from 01/2008 to 6/2014. Pts diagnosed with early stage breast cancer (ESBC) were examined. The index date was diagnosis of BC. Adult pts (≥18 yrs old) had to have known HR and HER2 status, continuous enrollment in the health plan from initial diagnosis for ≥6 months, surgery and systemic cancer therapy. Neo-adjuvant and adjuvant therapy (initial phase of care) based on timing of claims for NCCN-recommended therapy were examined, as well as survival and development of metastasis (based on claims with ICD-9 codes 196.0x, 196.2x, 196.5x-199.0x) after initial phase of care during the study period. Differences across the HR/HER2 subtypes were examined using t-test for continuous variables and chi-square test for categorical variables. Results: Among 6,881 ESBC pts identified, 15% (n=1038) were TNBC pts, 65% HR+/HER2-, 14% HR+/HER2+ and 6% HR-/HER2+. Mean (median) age was 52 (53) years. Treatment patterns and outcomes vary by tumor subtype (Table). HR-/HER2-HR+/HER2-HR-/HER2+HR+/HER2+ N=1038N=4452N=401N=990Length of follow-up, mths, mean(SD)*, median27 (16), 2328 (16), 2529 (16), 2527 (15), 24Length of initial phase of care – mths, mean(SD)*, media10 (7), 922 (15), 1915 (9), 1423 (14), 19Pts with systemic neo-adjuvant therapy N (%)*303 (29)531 (12)140 (35)216 (22)Most common neo-adjuvant regimens (%)Paclitaxel, cyclophosphamide, doxorubicin (45%)Paclitaxel, cyclophosphamide, doxorubicin (31%)Docetaxel, carboplatin, trastuzumab (44%)Docetaxel, carboplatin, trastuzumab (31%)Pts with systemic adjuvant therapy N (%)*740 (71)4065 (91)366 (91)935 (94)Most common adjuvant regimens (%)Paclitaxel, cyclophosphamide, doxorubicin (30%)Tamoxifen (19%)Docetaxel, carboplatin, trastuzumab (30%)Docetaxel, carboplatin, trastuzumab, tamoxifen (9%)Evidence of distant metastasis N (%)*78 (7.5)76 (1.7)17 (4.2)15 (1.5)Mortality N (%)*23(2.2)23 (0.5)1 (0.3)3 (0.3)*p&amp;lt;0.05 Conclusions: The most common neo-adjuvant and adjuvant chemotherapy agents received were similar across HER2 subtypes and regimens for HR+ and HER2+ patients also included hormonal or HER2 targeted agents. TNBC pts had the shortest length of initial phase of care (mean 10 mths), though this cohort had the second highest percentage of patients receiving systemic neo-adjuvant therapy. Development of distant metastasis and mortality during the study period were highest for the HR-/HER2- patients, at 7.5% and 2.2% respectively. Development of novel targets and therapies for TNBC may significantly benefit patients with this BC subtype, in both neo-adjuvant and adjuvant setting to improve outcomes. Citation Format: DaCosta Byfield S, Abushamaa AM, Becker LK, Shepherd SP, Ricker JL, Bonnet P. Real-world treatment patterns and survival among triple negative breast cancer patients versus patients with other breast cancer subtypes in early stage breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-08-15.

Clinical characteristics, healthcare costs, and resource utilization in hepatitis C vary by genotype

Background: In the United States, approximately 3 million people are infected with hepatitis C virus (HCV). Genotypes of HCV variably affect disease progression and treatment response. However, the relationships between HCV genotypes and liver disease progression, healthcare resource utilization, and healthcare costs have not been fully explored.Research design and methods: In this retrospective study of patients with chronic hepatitis C (CHC), healthcare claims from a large US health plan were used to collect data on patient demographic and clinical characteristics.Main outcome measures: Main outcome measures include healthcare resource utilization (HCRU) and healthcare costs. Linked laboratory data provided genotype and select measures to determine liver disease severity.Results: The sample (mean age 50.6 years, 63.5% male) included 10,331 patients, of whom 79.1% had genotype (GT)1, 12.8% had GT2, and 8.1% had GT3. Descriptive analyses demonstrated variation by HCV genotype in liver and non-liver related comorbidities, liver disease severity, and healthcare costs. The highest percentage of patients with liver-related comorbidities and advanced liver disease was found among those with GT3. Meanwhile, patients with GT2 had lower HCRU and the lowest costs, and patients with GT1 had the highest total all-cause costs. These differences may reflect differing rates of non-liver-related comorbidities and all-cause care. Multivariable analyses showed that genotype was a significant predictor of costs and liver disease severity: compared with patients having GT1, those with GT3 were significantly more likely to have advanced liver disease. Patients with GT2 were significantly less likely to have advanced disease and more likely to have lower all-cause costs.Limitations: Results may not be generalizable to patients outside the represented commercial insurance plans, and analysis of a prevalent population may underestimate HCRU and costs relative to a sample of treated patients.Conclusions: These results suggest that liver disease progression varies by genotype and that CHC patients with GT3 appear to have more severe liver disease. These findings highlight the importance of effective HCV treatment for all patients and support guidelines for treatment of high-risk patients, including those with GT3.

Budget impact of everolimus for the treatment of progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin that are advanced or metastatic

Background: Advanced neuroendocrine tumors (NETs) are a rare malignancy with considerable need for effective therapies. Everolimus is a mammalian target of rapamycin (mTOR) inhibitor approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2016 for treatment of adults with progressive, well-differentiated, non-functional NETs of gastrointestinal (GI) or lung origin that are unresectable, locally advanced, or metastatic.Objective: To assess the 3-year budget impact for a typical US health plan following availability of everolimus for treatment of GI and lung NETs.Methods An economic model was developed that considered two perspectives: an entire health plan and a pharmacy budget. The total budget impact included costs of drug therapies, administration, hospitalizations, physician visits, monitoring, and adverse events (AEs). The pharmacy model only considered drug costs.Results: In a US health plan with 1 million members, the model estimated 66 patients with well-differentiated, non-functional, and advanced or metastatic GI NETs and 20 with lung NETs undergoing treatment each year. Total budget impact in the first through third year after FDA approval ranged from $0.0568–$0.1443 per member per month (PMPM) for GI NETs and from $0.0181–$0.0355 PMPM for lung NETs. The total budget impact was lower than the pharmacy budget impact because it included cost offsets from administration and AE management for everolimus compared with alternative therapies (e.g. chemotherapies).Limitations: Because GI and lung NETs are rare diseases with limited published data, several assumptions were made that may influence interpretation of results.Conclusions: The budget impact for everolimus was minimal in this rare disease area with a high unmet need, largely due to low disease prevalence. These results should be considered in the context of significant clinical benefits potentially provided by everolimus, including significantly longer progression-free survival (PFS) for advanced GI and lung NET patients.

P3.07-002 Complications and Costs of Diagnostic and Post-Progression Biopsies among Patients with Non-Small Cell Lung Cancer (NSCLC): Topic: Therapy and Economics

With an increase in biomarker-directed therapies, tissue biopsy to identify targetable mutation status will become a mainstay of managing patients with NSCLC. The current study assessed the frequency, complications and costs of initial diagnostic biopsy (IDP) and post-progression biopsy (PPB) given the current limited information. This retrospective, observational study was conducted using administrative claims data from over 30 million commercially insured individuals in the US (2006-2014). Patients with continuous health-plan enrollment ≥12-months prior and ≥3-months post-index (first-observed) NSCLC diagnosis date were included and followed until health-plan disenrollment, study endpoint (December 2014) or death (whichever occurred earlier). Patients with NSCLC (n=20,013) were categorized into 4 groups (IDB only (58%); IDB+PPB (9%); PPB only (1%); and no biopsy (32%)) based on presence or absence of claim(s) for IDB and/or PPB. Biopsy procedures, post-biopsy complications and costs were assessed during the follow-up period. Identification of claims was based on ICD-9-CM diagnosis/procedure and/or HCPCS codes. All analyses were descriptive in nature. Study included 20,013 patients (median age: 69 years) with 52% being females, 73% enrolled in a preferred provider organization and 35% managed in Midwest. 10% of the patients had a PPB. Bronchoscopy (IDB 53%; PPB 71%) and percutaneous needle biopsy (IDB 42%; PPB 21%) were the commonly employed biopsy procedures. 63% patients had a medical claim for at least 1-complication within 30-days post IDB for difficulty breathing (41%), severe chest pain (23%) or pneumothorax (14%). 30-day complication rate (61%) was similar among patients with a PPB. Among patients undergoing bronchoscopy higher proportion had medical claim for complications including difficulty breathing (IDB: 44% vs. 37%; PPB: 46% vs. 26%) and hemoptysis (IDB: 14% vs. 4%; PPB: 15% vs. 3%) compared with patients undergoing percutaneous needle biopsy. Average IDB episode costs were significantly higher among patients with a complication compared with patients without a complication (day of biopsy: $12,030 vs. $6,508; within 7-days: $13,657 vs. $7,765; p-value<0.001). In this large cohort of NSCLC patients the rate of PPB was 10%. Importantly, for the first time we determined that the rates of complications were similar for the IDB and PPB among patients enrolled in a large national US health plan. With likely increased demands by patients, providers and payers for diagnostics confirmation for biomarker-directed therapies, data from this study will be of value in comparing complications rate and determining budget-impact of newer less-invasive molecular testing methods.

Healthcare Costs Among Patients with Heart Failure: A Comparison of Costs between Matched Decedent and Survivor Cohorts.

Prior research suggests increased costs during the final months of life, yet little is known about healthcare cost differences between patients with heart failure (HF) who die or survive. A retrospective claims study from a large US health plan [commercial and Medicare Advantage with Part D (MAPD)] was conducted. Patients were ≥18years old with two non-inpatient or one inpatient claim(s) with HF diagnosis code(s). The earliest HF claim date during 1 January 2010-31 December 2011 was the index date. Cohort assignment was based on evidence of death within 1year (decedents) or survival for >1year (survivors) post-index. Per-patient-per-month (PPPM) and 1-year (variable decedent follow-up) costs (all-cause and HF-related) were calculated up to 1year post-index. Cohorts were matched on demographic and clinical characteristics. Independent samples t tests and Pearson's chi-square tests were used to examine cohort differences. Among patients with HF, 8344 survivors were 1:1 matched to decedents [mean age 75years, 50% female, 88% MAPD; mean time to decedents' death: 150 (SD 105) days]. Compared to survivors, more decedents had no pharmacy claims for HF-related outpatient pharmacotherapy within 60days post-index (42.1% vs. 27.1%; p<0.001). Decedents also incurred higher all-cause medical costs (PPPM: $21,400 vs. $2663; 1 year: $60,048 vs. $32,394; both p<0.001) and higher HF-related medical costs (PPPM: $16,477 vs. $1358; 1 year: $39,052 vs. $16,519; both p<0.001). Hospitalizations accounted for more than half of all-cause PPPM medical costs (54.6% for survivors, 84.3% for decedents). Patients with HF who died within 1year after an index HF encounter incurred markedly higher costs within 1year (despite the much shorter post-index period) and PPPM costs than those who survived, with the majority of costs attributable to hospitalizations for both patient cohorts. There may be opportunities for improving outcomes in HF, considering higher use of pharmacotherapy and lower costs were seen among survivors.

Budget Impact Analysis of Treating Chemotherapy Patients with Health Care Provider-Administered Tbo-Filgrastim, Filgrastim-Sndz, and Filgrastim in the United States

Introduction: Granulocyte colony-stimulating factors (G-CSFs) are often administered to reduce the incidence, severity, and duration of febrile neutropenia in chemotherapy patients. Tbo-filgrastim and filgrastim-sndz are short-acting G-CSFs with comparable efficacy and safety to that of filgrastim. The present analysis estimated the budget impact of increasing utilization of health care provider (HCP)-administered tbo-filgrastim and filgrastim-sndz on patients with nonmyeloid malignancies treated with myelosuppressive chemotherapy from a US payer perspective.Methods: An interactive budget impact model was developed to estimate the changes in drug and administration costs for a 1 million member health plan. Administration by an HCP (within a clinic or other outpatient setting) was assumed for 80% of patients receiving short-acting G-CSF treatment, with the majority (85%) of products adjudicated through the patient’s medical benefit/provided by the HCP and the remaining 15% purchased through the patient’s pharmacy benefit. For medical benefit adjudication, the model projected increases in the market share of tbo-filgrastim from 37% to 42% and filgrastim-sndz from 2% to 4% (with a decrease in filgrastim market share from 61% to 54%). For pharmacy benefit adjudication, the model projected increases in the market share of tbo-filgrastim from <1% to 2% and filgrastim-sndz from 5% to 7% (with a decrease in filgrastim market share from 95% to 91%). Base case data were derived from publicly available resources. The overall plan budget impact was calculated using a 1-year time horizon, along with the difference in per-member per-year (PMPY) cost between the current and future scenarios; one-way sensitivity analyses were conducted.Results: The effective annual plan per-patient drug cost totaled between $11,904 and $27,199, depending on dose, presentation, and benefit adjudication, for tbo-filgrastim, between $15,418 and $26,015 for filgrastim-sndz, and between $15,573 and $30,663 for filgrastim. The estimated overall annual plan cost associated with HCP-administered short-acting G-CSFs was $177,151,918 (PMPY = $177.15) in the current scenario and $175,230,445 (PMPY = $175.23) in the future scenario. Cost savings totaled $1,921,473 (PMPY = $1.92). The model was most sensitive to changes in the overall proportion of patients with HCP-administered G-CSFs and to HCP filgrastim acquisition cost.Conclusions: Budget impact analyses examine the financial impact associated with the introduction of new treatments or shifting existing treatment patterns in order to help decision makers determine how best to allocate resources. The majority of HCP-administered G-CSF is adjudicated through the medical benefit, where the effective annual plan per-patient drug cost was lowest for tbo-filgrastim (24% lower cost than filgrastim). For the remainder of HCP-administered G-CSF adjudicated through the pharmacy benefit, the effective annual plan per-patient drug cost was lowest for filgrastim-sndz (15% lower cost than filgrastim). The present analysis estimated an annual US health plan cost savings approaching $2 million overall or almost $2.00 PMPY following an increase of market share by approximately 5% for tbo-filgrastim and 2% for filgrastim-sndz. DisclosuresTrautman:Teva Pharmaceuticals, Inc.: Consultancy. Szabo:Patient Centered Outcomes Research (PCORI): Consultancy; Teva Pharmaceuticals, Inc.: Employment; Eli Lilly & Company; Zoetis: Equity Ownership. Lo-Coco:Teva, Novartis, Baxalta, Pfizer: Consultancy; Teva, Lundbeck: Honoraria, Speakers Bureau. James:Teva Pharmaceuticals, Inc.: Consultancy. Gabriel:Teva Pharmaceuticals, Inc.: Employment. Pathak:Teva Pharmaceuticals: Employment, Equity Ownership. Tang:Teva Pharmaceuticals, Inc.: Employment.

Budget Impact Analysis of Treating Chemotherapy Patients with Patient-Administered Tbo-Filgrastim, Filgrastim-Sndz, and Filgrastim in the United States

Introduction: Neutropenia is a common complication in patients receiving myelosuppressive chemotherapy for nonmyeloid malignancies. Severe and febrile neutropenia are associated with prolonged hospitalization, serious infections and the use of broad-spectrum antibiotics, increased medical costs, and increased mortality. Granulocyte colony-stimulating factors (G-CSFs) are often administered to reduce the incidence, severity, and duration of febrile neutropenia in chemotherapy patients. The present analysis estimated the budget impact of increasing utilization of patient (home)-administered tbo-filgrastim and filgrastim-sndz in patients with nonmyeloid malignancies treated with myelosuppressive chemotherapy from a US payer perspective.Methods: An interactive budget impact model was developed to estimate the changes in drug costs associated with projected increases in the market share of tbo-filgrastim from 5% to 10% and filgrastim-sndz from 10% to 12% (with a corresponding decrease in filgrastim market share from 85% to 78%) for a 1 million-member health plan. Patient self-administration at home was assumed for 20% of patients receiving short-acting G-CSF treatment; all products were purchased through the patient's pharmacy benefit and were assumed to have Tier 3 formulary status with a patient co-pay of $54 per prescription. Base-case data were derived from publicly available resources. The overall plan budget impact was calculated using a 1-year time horizon, along with the difference in per-member per-year (PMPY) cost between the current and future scenarios; one-way sensitivity analyses were conducted.Results: The effective annual plan per-patient drug cost totaled between $16,961 and $27,199, depending on dose and presentation, for tbo-filgrastim, between $16,216 and $26,015 for filgrastim-sndz, and between $19,134 and $30,663 for filgrastim. The estimated overall annual plan cost associated with short-acting G-CSFs was $53,298,217 (PMPY = $53.30) in the current scenario and $52,828,832 (PMPY = $52.82) in the future scenario. Estimated cost savings totaled $469,385 (PMPY = $0.48). The model was most sensitive to changes in the overall proportion of patients self-administering G-CSFs at home and to the wholesale acquisition cost for filgrastim.Conclusions: The effective annual plan per-patient drug cost for tbo-filgrastim and filgrastim-sndz was lower by 11% and 15%, respectively, as compared with filgrastim. The present analysis estimated an annual US health plan cost savings approaching $0.5 million overall or $0.50 PMPY following an increase of market share by approximately 5% for tbo-filgrastim and 2% for filgrastim-sndz. DisclosuresTrautman:Teva Pharmaceuticals, Inc.: Consultancy. Szabo:Eli Lilly & Company; Zoetis: Equity Ownership; Teva Pharmaceuticals, Inc.: Employment; Patient Centered Outcomes Research (PCORI): Consultancy. Lo-Coco:Teva, Lundbeck: Honoraria, Speakers Bureau; Teva, Novartis, Baxalta, Pfizer: Consultancy. James:Teva Pharmaceuticals, Inc.: Consultancy. Gabriel:Teva Pharmaceuticals, Inc.: Employment. Pathak:Teva Pharmaceuticals: Employment, Equity Ownership. Tang:Teva Pharmaceuticals, Inc.: Employment.

Real-World Health Care Utilization and Costs Among Patients Newly Initiating Systemic Therapy for Chronic Lymphocytic Leukemia (CLL) in the United States

Background: Chronic lymphocytic leukemia (CLL) is an indolent B-cell malignancy with approximately 18,960 patients expected to be newly diagnosed in 2016 in the United States. CLL is a heterogeneous disease and some patients can be managed with a 'watch-and-wait' strategy, but those with symptomatic or advanced disease may be candidates for active therapy. However, few studies have examined real-world treatment patterns, health care utilization, and costs. This study examined initial therapy received among CLL patients in the US, the associated health care utilization, and total healthcare costs, including patient out-of-pocket costs.Methods: This retrospective studyused the Optum Research Database which includes medical and pharmacy claims from a large national US health plan to identify adults (≥18 years old) insured either commercially or through Medicare Advantage from 5/2013 - 6/2015, with ≥2 medical claims for CLL (ICD-9-CM code 204.1x). Pts required ≥1 claim for systemic cancer therapy; the first observed claim defined the index date. Continuous enrollment in the health plan for 6 months prior to index date (baseline period) and at least 1 month after index date (variable follow-up period) was also required. Pts with additional primary malignancies or who received systemic cancer therapy during the baseline period, and those who underwent stem cell transplant during the study period, were excluded. Therapeutic agents with a NCCN compendium listing for the treatment of CLL were assessed. Patient characteristics, initial regimen received, and duration of the first line of therapy were examined. Healthcare utilization and cost analyses for the entire cohort were descriptive in nature. Patient-per-month (PPM) counts of healthcare utilization and PPM costs were calculated. Costs included both health plan paid and patient out-of-pocket (OOP). Components of healthcare costs included inpatient (IP), non-IP medical, and drugs through the pharmacy benefit.Results: There were 707 CLL pts who met all study criteria during the study period; 40% were commercially insured and 60% were Medicare Advantage enrollees. The most common regimens received as first line of therapy at the time of the analyses included Bendamustine and Rituximab (26%), Rituximab monotherapy (20%), Ibrutinib (14%), Fludarabine+Cyclophosphamide+Rituximab (FCR) (9%), Chlorambucil (7%), and Chlorambucil with Obinutuzumab (6%). The mean duration of first line therapy during the study period was 4.4 months (standard deviation [SD]=3.4). Among the study population, the mean baseline Charlson comorbidity index was 2.87 (SD=1.38) and most were male (65%). The mean age was 70 years (SD=11), but varied by regimen (overall p-value <0.01); the Chlorambucil cohort was the oldest (mean 80 years, SD=8) and the FCR cohort was the youngest (mean 60 years, SD=9). Overall, during first line of therapy, CLL patients visited physician offices and hospital outpatient facilities 3 and 2 times per month, respectively. In addition, 33% and 24% of patients had a least one ER visit or IP stay during the first line of therapy, respectively. The average total PPM healthcare costs for the entire cohort was $17,442 (SD=$15,715) (Table 1). Six percent of the average total PPM was patient OOP costs (mean $1,012). The majority of PPM costs were due to non-IP care (approximately 74% or $12,928), approximately 14% were due to IP care (mean $2,454), and 12% were due to pharmacy costs (mean $2,061).Conclusion:The majority of PPM costs among patients receiving frontline CLL treatment are attributable to visits in the outpatient and hospital outpatient settings followed by inpatient visits and pharmacy costs. Approximately 6% of the PPM healthcare costs are paid OOP by the patient. Total healthcare costs to the system and to the patient will depend on several factors, including adherence to drug regimens, time to progression, and whether regimens are prescribed for a fixed number of cycles or given until disease progression. [Display omitted] DisclosuresDacosta Byfield:Optum: Employment; UnitedHealth Group: Equity Ownership. Blauer-Peterson:Optum: Employment; UnitedHealth Group: Equity Ownership. Montez:Genentech, Inc: Employment; Roche: Equity Ownership. Reyes:Roche: Equity Ownership; Genentech: Employment. Masaquel:Roche: Equity Ownership; Genentech, Inc: Employment.

What Is the Cost of Disease Progression Among Patients with Indolent or Aggressive Non-Hodgkin Lymphoma (NHL)?

Background: The natural histories of aggressive and indolent NHL vary in terms of the timing and pattern of disease progression. However, little is known about the impact of progression of disease (PD) on costs, and in particular how this differs between aggressive and indolent subtypes of NHL. This study examined patterns of care and outcomes for patients with aggressive and indolent NHL, and the impact of PD on health care costs.Methods: To identify cases of NHL, this retrospective studyused medical and pharmacy claims from a large national US health plan to identify commercially insured and Medicare Advantage (MA) patients age ≥18 years from 1/2007 - 8/2014 with ≥2 medical claims for NHL based on ICD-9-CM diagnosis codes. Patients were divided into cohorts of aggressive (AGG) NHL and indolent (IND) and based on diagnosis codes. Patients were required to have ≥1 claim for systemic anti-cancer therapy, with the index date being defined as the first observed claim for such therapy. Continuous enrollment in the health plan for 6 months prior to (baseline period), and ≥6 months after, the index date (variable follow-up period) was required; patients with <6 months of follow-up due to death were included. An algorithm to identify line of therapy (LOT) periods was implemented. PD was defined as: start of a second LOT, receipt of hospice care (based on procedure or revenue codes) or death (based on Social Security Administration death data). Health care costs were calculated over 6-month periods of follow-up (6, 12, 18, 24 months), with costs calculated for pharmacy, inpatient hospital, ambulatory, and other sites of service.Results: A total of 1,197 AGG and 2,454 IND patients met study criteria. Progression was experienced by 40.6% of AGG and 49.4% of IND patients respectively during the entire study period; 6-month progression was 18.9% (AGG) and 18.5% (IND). Compared to patients without PD during the study period, patients who progressed had higher average costs over each time period: in the first 6-months, costs were $138,957 PD vs. $108,607 for non-PD among AGG, and $114,644 PD vs. $80,873 for non-PD among IND (Figure, Table). Similarly, total costs for PD were higher than non-PD over 12, 18, and 24 months (Figure). Costs by site of service were higher for PD patients compared to non-PD patients among both the AGG and IND groups, particularly for inpatients costs; the table shows costs by site of service for the first 6 months, and results were similar over 12, 18, and 24 months. A higher proportion of AGG patients died compared with IND patients. Approximately one third of patients who died used hospice services among AGG and IND, and of these, 90.1% of AGG and 91.3% of IND used 3 or more days of hospice care.Conclusion: Among both aggressive and indolent NHL populations, costs were higher for patients with progressive versus without progressive disease, and increased over longer follow-up time. Patients with aggressive NHL had higher costs compared with patients with indolent NHL for both progressive and non-progressive disease. This study is the first to quantify systematically the cost of progression in NHL, both indolent and aggressive, and can inform efforts to improve value-based care, taking into account costs not just of therapy, but of subsequent progression. [Display omitted] [Display omitted] DisclosuresEngel-Nitz:Optum: Employment, Other: UnitedHealth Group stock. Dacosta Byfield:UnitedHealth Group: Equity Ownership; Optum: Employment. Bancroft:Optum: Employment, Other: UnitedHealth Group stock. Amy:Optum: Employment, Other: UnitedHealth Group stock. Reyes:Genentech: Employment; Roche: Equity Ownership.

Under-Treatment of Patients with Moderate to Severe Psoriasis in the United States: Analysis of Medication Usage with Health Plan Data.

IntroductionPsoriasis is a chronic inflammatory disorder with significant morbidity and mortality, but a persistent gap appears to exist for the adequate treatment of patients with moderate to severe disease. As the extent of under-treatment is unknown, we attempted to determine overall treatment patterns and estimate under-treatment using a large database.MethodsData from the US National Health and Wellness Survey was used to estimate the proportion of patients with mild, moderate or severe psoriasis. The proportion with moderate to severe disease was estimated by excluding those with mild disease, and projecting this to the total insured US population, weighted by age and gender. Using US health plan claims data, patient totals by treatment type were determined between October 1, 2007 and September 30, 2012. Patients had to be continuously enrolled in a health plan and be ≥18 years at the end of the analysis window. Psoriasis was confirmed if patients had at least one claim of any type of psoriasis except psoriatic arthropathy (ICD-9 code 696.1). A monthly treatment history, classified by biologic, traditional oral systemic, phototherapy and topical therapy, was recorded for each patient.ResultsThere were an estimated 1.7 million insured US patients with moderate to severe psoriasis. Of these, 1 million (59%) were not treated for their condition in the preceding year. Among 695,488 patients who were treated for psoriasis in the preceding year, 346,201 were currently receiving treatment and 349,287 had lapsed treatment. Of the patients lapsed and currently treated in this period, the numbers who received each treatment type were 156,409 (biologic), 222,657 (traditional oral systemic), 22,911 (phototherapy), and 293,511 (topical). A limitation of the study was that only insurance claims were analyzed.ConclusionModerate to severe psoriasis remains persistently untreated or under-treated. We suggest that potential barriers preventing access to care be explored.FundingThis study was sponsored by Pfizer Inc.

Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine

Objective: To quantify the annual budget impact if all US commercially insured type 1 diabetes mellitus patients on basal–bolus therapy (T1DMBBT), type 2 diabetes mellitus patients on basal–oral therapy (T2DMBOT), and type 2 diabetes mellitus patients on basal–bolus therapy (T2DMBBT) switched from insulin glargine (IGlar) to insulin degludec (IDeg).Methods: A short-term (1 year) budget impact model was developed to evaluate the costs of IDeg vs. IGlar in three treatment groups (T1DMBBT, insulin-naïve T2DMBOT, and T2DMBBT) through a simulation for a potential US health plan population of 35 million. The analysis captured direct medical costs associated with insulin treatment (insulin, needles, and self-monitored glucose testing) and costs related to managing hypoglycemic episodes. There were a total of 59,780 T1DMBBT patients, 383,145 T2DMBOT patients, and 171,325 T2DMBBT patients expected to be using long-acting insulin. A sensitivity analysis on the entire US population was also conducted.Results: Among T1DMBBT patients, IDeg was associated with an annual cost savings of −$357.13 per patient per year (PPPY), driven primarily by reduced insulin utilization. IDeg was also found to be cost saving among T2DMBOT patients (−$1206.61 PPPY), driven primarily by reductions in the cost of treating severe hypoglycemic episodes. Among T2DMBBT patients, IDeg was associated with an additional cost to the plan of $1420.04 PPPY; however, this result was driven by a higher insulin dose for IDeg compared to IGlar. Overall, IDeg demonstrated cost savings of $240 million per year, which accounted for total cost savings of 3.5% vs. IGlar.Conclusions: The results of this analysis suggest that the reduced insulin utilization and fewer hypoglycemic episodes associated with IDeg may translate into reduced costs for payers. The model is limited by simplification of a complex disease state and assumptions surrounding disease state, treatment patterns, and costs. Therefore, results may not accurately reflect actual health plans or real-world practice patterns.

PHS142 - Multiple Sclerosis: Real-World Healthcare Costs In A Large US Health Plan

PHS142 - Multiple Sclerosis: Real-World Healthcare Costs In A Large US Health Plan

PHP92 - The 2016 US Payor Landscape: Results from a Survey of Medical and Pharmacy Directors on Formulary Management

To determine the types of approaches preferred by Medical and Pharmacy Directors (MDs+PDs) of US health plans, insurers, and pharmacy-benefit managers to enhance the P&T decision-making process and understand formulary reviews/coverage and changes from prior surveys. Online survey of US MDs+PDs from public/private plans with multiple member-types on: advisor+plan information; formulary coverage and restrictions. Fifty-nine percent of respondents were MDs from National=41.1%; local=38.6%; and regional=30.4%. Clinician-administered products (CAPS, including office-administered infusions/injections) always covered under the medical-benefit (64.3%), 5.4% exclusively under the pharmacy-benefit, the remaining 32.7% benefit coverage was threshold/plan-design based, changes were: not anticipated (70.9%); being implemented (5.4%), expected by 12/16 (14.5%) or by 12/18 (3.6%). Mental health [MH] products were carved-out by 25.9%, conditions with multiple MH-therapies required: generics-first (50%), step-therapy (31.5%) or psychiatrist/specialist care (18.5%). Respondents involved in decisions for: prescription-drugs (All=66.5%,Some=22.4%,None=12.1%) and medical-devices (All=53.7%,threshold-dependent=5.6%,None=40.7%). Parity policies were in place for: All=31.2%;None=20.8%;Mandated-states=20.8%; Commercial-plans=14.6%;Select-plans=10.4%;Medicaid-plans=4.2%; Never heard of=18.7. Affordable-Care-Act (ACA) plans are being eliminated by 21.3% (6.4%=Currently,8.5% Before 12/17) and current ACA family-deductibles were: <$1000(7.9%);$1000-$2499(26.3%);$2500-$4999(28.9%);$5000-$9999(15.8%);>$10000(5.3%). Most were happy with their pharmacy-benefit design, the most requested changes were: Formulary changes (17.1%):Tiering(17.1%);Benefit-alignment (11.4%);and tied at 8.6% Biosimilars, Clinician-involvement; and Evidence-based Medicine (EBM). Cost-Effectiveness Research (CER) results will be used: Care Value=34.6%; Care appropriateness=17.3%; Guideline optimization/improvement=11.5%; Pharmaceutical R&D=1.9%; Medical/pharmacy-benefit management=23.1%; Other=0%; Unsure/None of the above=11.5%. The most common desired P&T process change was tied between no-change and better EBM data (both 31.6%). Most were happy with their medical-benefit, the most request change was moving all drugs to the pharmacy-benefit. Top concerns today and in the future included Oncology; Diabetes and Cardiovascular diseases. The managed care P&T Committee decision-making process is undergoing a series of changes. Medical and pharmacy directors, who commonly serve as P&T Committee members, have distinct opinions as to how to alter the process to adapt to these influences.

Serum uric acid levels and the risk of flares among gout patients in a US managed care setting

Objective: Serum uric acid (sUA) levels are causally associated with the risk of gout flares. Our aim was to assess the magnitude of the association and time to first flare among patients in a managed care setting.Research design and methods: We conducted a retrospective cohort study using administrative claims data from a large US health plan. Patients were required to have evidence of gout based on medical and pharmacy claims between January 2009 and April 2012. The 12 months prior to the index gout claim were used to assess baseline sUA levels; risk of gout flares, stratified by baseline sUA levels, was examined for 2 years post-index. Risk of flare was modeled with Cox proportional hazards; time to first flare was assessed by Kaplan–Meier.Results: We identified 18,008 patients with gout and available baseline SUA levels (mg/dL). The hazard ratios for the risk of gout flares compared with sUA <5.0 were: 1.17 for sUA 5.0 to <6.0; 1.69 for sUA 6.0 to <7.0; 2.16 for sUA 7.0 to <8.0; 2.87 for sUA 8.0 to <9.0; and 3.85 for sUA ≥9.0 (all p < .001 except for sUA 5.0 to <6.0 cohort). The time to first flare was shorter for cohorts with higher baseline sUA levels.Conclusion: These findings confirm that higher sUA levels are associated with an increased risk of gout flares in a dose–response manner over 2 years. This data supports the need to treat to sUA target levels as recommended by recent gout care guidelines. Claims-based algorithms were used to identify gout flares; although this would not be expected to influence estimates of risk by sUA level, there may have been over- or under-estimation of the incidence of flares.