Clinical comorbidities,treatment patterns,and healthcare costs among patients with fibromyalgia newly prescribed pregabalin or duloxetine in usual care

Abstract

Objective:

To assess comorbidities, pain-related pharmacotherapy, and healthcare resource use among patients with fibromyalgia (FM) newly prescribed pregabalin or duloxetine (index event) in usual care settings.

Methods:

Using the LifeLink? Health Plan Claims Database, patients with FM (International Classification of Diseases, Ninth Revision, Clinical Modification code 729.1X) were identified. Patients initiated on duloxetine were propensity score-matched with patients initiated on pregabalin (n?=?826; mean age [standard deviation] of 48.3 [9.3] years for both groups). Prevalence of comorbidities, pain-related pharmacotherapy, and healthcare resource use/costs were examined during the 12-month pre-index and follow-up periods.

Results:

Both patient groups had multiple comorbidities and a substantial pain-related and adjuvant medication burden. In the pregabalin group, use of other anticonvulsants decreased significantly (31.6% vs 24.9%), whereas use of serotonin-norepinephrine reuptake inhibitors (SNRIs; 16.5% vs 22.5%) and topical agents (10.1% vs 13.2%) increased in the follow-up period (p?<?0.01). In the duloxetine group, there were significant decreases in the use of other SNRIs (13.0% vs 5.7%), selective serotonin reuptake inhibitors (41.3% vs 21.7%), and tricyclic antidepressants (18.8% vs 13.2%), and an increase in the use of anticonvulsants (28.6% vs 40.1%; p?<?0.0001). There were significant increases (p?<?0.0001) in pharmacy and total healthcare costs in both cohorts, and a significant increase in outpatient costs (p?=?0.0084) in the duloxetine cohort from pre-index to follow-up. There were no significant differences in median total healthcare costs between the pregabalin and duloxetine groups in both the pre-index ($10,159 vs $9,556) and follow-up ($11,390 vs $11,746) periods.

Limitations:

Limitations of this study are typical of those associated with retrospective database analyses.

Conclusions:

Patients with FM prescribed pregabalin or duloxetine were characterized by a significant comorbidity and pain/adjuvant medication burden. Although healthcare costs increased in both groups, there were no statistically significant differences in direct healthcare costs between the two groups.     

Clinical comorbidities,treatment patterns,and direct medical costs of patients with osteoarthritis in usual care: a retrospective claims database analysis

Abstract

Objective:

Comorbidities and resource utilization among patients with osteoarthritis (OA) in clinical practice have been infrequently characterized. The purpose of this study was to examine comorbidities, pain-related pharmacotherapy, and direct medical costs of patients with OA in clinical practice.

Method:

This retrospective cohort analysis used medical and pharmacy claims data from the LifeLink? Database. OA patients (ICD-9-CM codes 715.XX) were matched (age, gender, and region) with individuals without OA. Comorbidities, pain-related pharmacotherapy, and direct medical costs (pharmacy, outpatient, inpatient, total) were examined for the calendar year 2008.

Results:

The sample consisted of 112,951 OA patients and 112,951 controls (mean age: 56.9 [SD?=?9.5] years; 62% female). Relative to controls, OA patients were significantly more likely (p?<?0.0001) to have comorbidities, including musculoskeletal (84.3 vs. 37.1%) and neuropathic pain (22.0 vs. 6.1%) conditions, depression (12.4 vs. 6.4%), anxiety (6.6 vs. 3.5%), and sleep disorders (11.9 vs. 4.2%). OA patients were significantly more likely (p?<?0.0001) to receive pain-related medications, including opioids (40.7 vs. 17.1%), NSAIDs (37.1 vs. 11.5%), tramadol (9.8 vs. 1.8%), and adjunctive medications for treating depression, anxiety, and insomnia. Mean [SD] total direct medical costs were more than two times higher among OA patients ($12,905 [$21,884] vs. $5099 [$13,855]; p?<?0.001) and median costs were more than three times higher ($6188 vs. $1879; p?<?0.0001). Study limitations include potential errors in coding and recording; overestimation of the comorbidity burden; inability to link condition of interest, OA, with prescribed medications; and possible underestimation of the true costs of OA, because indirect costs were not considered and the direct costs were from a third party payer (commercial insurance) perspective.

Conclusion:

The patient burden of OA was characterized by a high prevalence of comorbidities. The payer burden was also substantial, with significantly greater use of pain-related and adjunctive medications, and higher direct medical costs.     

Economic outcomes of exenatide vs liraglutide in type 2 diabetes patients in the United States: results from a retrospective claims database analysis

Abstract

Objective:

The safety and efficacy of the GLP-1 receptor agonists exenatide BID (exenatide) and liraglutide for treating type 2 diabetes mellitus (T2DM) have been established in clinical trials. Effective treatments may lower overall treatment costs. This study examined cost offsets and medication adherence for exenatide vs liraglutide in a large, managed care population in the US.

Methods:

This was a retrospective cohort analysis comprising adult patients with T2DM who initiated exenatide or liraglutide between 1/1/2010 and 6/30/2010 and had 6 months pre-index and post-index continuous eligibility. Patients were propensity score-matched to controls for baseline differences. Medication adherence was measured by proportion of days covered (PDC). Paired t-test and McNemar’s test were used to compare outcomes.

Results:

Matched exenatide and liraglutide cohorts (n?=?1347 pairs) had similar average total 6-month follow-up costs ($6688 vs $7346). However, exenatide patients had significantly lower mean pharmacy costs ($2925 vs $3272, p?<?0.001). Among liraglutide patients, patients receiving the 1.8?mg dose had significantly higher average total costs compared to those receiving the 1.2?mg dose ($8031 vs $6536, p?=?0.026), with higher mean pharmacy costs in the 1.8?mg cohort ($3935 vs $3146, p?<?0.001). There were no significant differences in inpatient or outpatient costs or medication adherence between groups (mean PDC: exenatide 56% vs liraglutide 57%, p?=?0.088).

Limitations:

The study assumed that all information needed for case classification and matching of cohorts was present and not differential across cohorts. The study did not control for covariates that were unavailable, such as HbA1c and duration of diabetes.

Conclusions:

Patients initiating exenatide vs liraglutide for T2DM had similar medication adherence and total healthcare costs; however, exenatide patients had significantly lower total pharmacy costs. Patients prescribed 1.8?mg liraglutide had significantly higher costs compared to those on 1.2?mg.     

Impact of a step-therapy protocol for pregabalin on healthcare utilization and expenditures in a commercial population

Abstract

Objective:

To compare changes in healthcare resource utilization and costs among members with painful diabetic peripheral neuropathy (pDPN), postherpetic neuralgia (PHN), or fibromyalgia (FM) in a commercial health plan implementing pregabalin step-therapy with members in unrestricted plans.

Methods:

Retrospective study of outcomes associated with implementation of a pregabalin step-therapy protocol using claims data from Humana (‘restricted’ cohort) and Thomson Reuters MarketScan (‘unrestricted’ cohort). Members aged 18–65 years receiving treatment for pDPN, PHN, or FM during 2008 or 2009 were identified; cohorts were matched on diagnosis and geographic region. Baseline to follow-up changes in healthcare resource utilization and costs were determined using difference-in-differences (DID) analysis. Statistical models adjusting for covariates explored relationships between restricted access and outcomes.

Results:

A total of 3876 restricted cohort members were identified and matched to 3876 unrestricted cohort members. FM was the predominant diagnosis (84.7%). The unrestricted cohort was older (mean?=?49.0 (SD?=?10.4) years vs 47.6 (SD?=?10.5) years; p?<?0.001), and had greater comorbidity (RxRisk-V score?=?5.4 (SD?=?3.2) vs 4.4 (SD?=?2.9), p?<?0.001) than the restricted cohort. Compared with the unrestricted cohort, the restricted cohort demonstrated a greater year-over-year decrease in pregabalin utilization (?2.6%, p?=?0.008), and greater increases in physical therapy and disease-related outpatient utilization (3.7%, p?=?0.010 and 3.6%, p?=?0.022, respectively). There were no statistically significant net differences in all-cause or disease-related total healthcare, medical, or pharmacy costs between cohorts. After adjusting for baseline compositional differences between cohorts, restricted plan membership was associated with a net increase in all-cause medical ($1222; p?=?0.016) and disease-related healthcare costs ($859; p?=?0.002). Limitations include use of a combined analysis for pDPN, PHN, and FM, especially since the observed results were likely driven by FM; an inability to link the prescribing of a medication with the condition of interest, which is common to claims analyses; and lack of pain severity information.

Conclusions:

Implementation of a pregabalin step-therapy protocol resulted in lower pregabalin utilization, but this restriction was not associated with reductions in total healthcare costs, medical costs, or pharmacy costs.     

The economic burden of psoriasis with high comorbidity among privately insured patients in the United States

Objective: To evaluate the impact of comorbidities on healthcare resource use (HRU), and direct and indirect work-loss-related costs in psoriasis patients.

Methods: Adults with psoriasis (≥2 diagnoses, the first designated as the index date) and non-psoriasis controls (no psoriasis diagnoses, randomly generated index date) were identified in a US healthcare claims database of privately-insured patients (data between January 2010 and March 2017 were used). Psoriasis patients were stratified based on the number of psoriasis-related comorbidities (0, 1–2, or ≥3) developed during the 12?months post-index. All outcomes were evaluated during the follow-up period, spanning the index date until the end of continuous health plan eligibility or data cut-off. HRU and costs per-patient-per-year (PPPY) were compared in psoriasis and non-psoriasis patients with ≥12?months of follow-up.

Results: A total of 9,078 psoriasis (mean age?=?44?years, 51% female) and 48,704 non-psoriasis (mean age?=?41?years, 50% female) patients were selected. During the 12?months post-index, among psoriasis vs non-psoriasis patients, 71.0% vs 83.0% developed no psoriasis-related comorbidities, 26.3% vs 16.0% developed 1–2, and 2.6% vs 1.0% developed ≥3 psoriasis-related comorbidities. Compared to non-psoriasis patients, psoriasis patients had more HRU including outpatient visits (incidence rate ratios [IRRs]?=?1.52, 2.03, and 2.66 for 0, 1–2, and ≥3 comorbidities, respectively [all p?p?p?p?Conclusions: HRU and cost burden of psoriasis are substantial, and increase with the development of psoriasis-related comorbidities.     

Resource utilization and healthcare costs for acute coronary syndrome patients with and without diabetes mellitus

Abstract

Objective:

This study compared differences in healthcare costs and resource utilization for acute coronary syndrome (ACS) patients with and without diabetes mellitus (DM).

Methods:

A retrospective cohort study of a large, US employer-based claims database identified adults hospitalized for ACS between 01/01/2005 and 12/31/2006 and categorized them based on DM status. Resource utilization and costs during the index hospitalization and in the 12-month follow-up period were compared for ACS patients with and without DM using the propensity score stratification bootstrapping method, adjusting for differences in demographic and clinical characteristics.

Results:

Of 12,502 patients who met selection criteria, 3,040 (24%) had a history of DM and 9,462 (76%) did not. Patients with DM were older, female, and had higher rates of previous cardiovascular and renal diseases. After the propensity score stratification, patients with DM incurred higher index hospitalization costs ($32,577 vs. $29,150, p?<?0.01) as well as higher total follow-up healthcare costs ($35,400 vs. $24,080, p?<?0.01), including higher inpatient ($17,278 vs. $11,247, p?<?0.01), outpatient ($12,357 vs. $8,853, p?<?0.01), and pharmacy costs ($5,765 vs. $3,980, p?<?0.01).

Limitations:

General limitations exist with any retrospective claims database analysis including potential diagnostic or procedural coding inaccuracies. Additionally, the patient population was representative of a working-age population with employer-sponsored health insurance and results may not be generalizable to other patient populations.

Conclusions:

DM is significantly associated with increased healthcare resource utilization and costs for ACS patients.     

One-year follow-up healthcare costs of patients hospitalized for transient ischemic attack or ischemic stroke and discharged with aspirin plus extended-release dipyridamole or clopidogrel

Abstract

Objective:

To examine healthcare costs among patients hospitalized for transient ischemic attack or ischemic stroke (TIA/stroke) and prescribed aspirin plus extended-release dipyridamole (ASA-ERDP) or clopidogrel (CLOPID) within 30 days post-discharge using a retrospective claims database from a large US managed care organization.

Methods:

Adult patients with ≥1 hospitalizations for TIA/stroke between January 2007–July 2009 and ≥1 claims for an oral anti-platelet (OAP) were observed for 1 year before and after the first TIA/stroke hospitalization or until death, whichever came first. Cohorts were defined by the first claim for ASA-ERDP or CLOPID within 30 days post-discharge. A generalized linear model, adjusting for demographics, baseline comorbidities and costs, compared total follow-up costs (medical?+?pharmacy) between ASA-ERDP and CLOPID patients.

Results:

Of 6377 patients (2085 ASA-ERDP; 4292 CLOPID) who met the selection criteria, mean (SD) age was 69 (13) years and 50% were male. Unadjusted mean total follow-up costs were lower for ASA-ERDP than CLOPID ($26,201 vs $30,349; p?=?0.002), of which average unadjusted medical and pharmacy costs were $22,094 vs $26,062 (p?=?0.003) and $4107 vs $4288 (p?=?0.119), respectively. Multivariate modeling indicated that the following were associated with higher total costs (all p?<?0.05): higher baseline Quan-Charlson comorbidity score, history of atrial fibrillation and myocardial infarction, index stroke hospitalization, death post-discharge, and index CLOPID use. Adjusted mean total follow-up costs for CLOPID were 9% higher than ASA-ERDP (cost ratio: 1.09; p?=?0.038).

Conclusion:

In this study, compared to CLOPID patients, ASA-ERDP patients were observed to have lower total costs 1 year post-discharge TIA/stroke hospitalization, driven primarily by lower medical costs. Further research into the real-world impact of OAP therapies on clinical and economic outcomes of patients with stroke/TIA is warranted. The findings of this study should be considered within the limitations of an administrative claims analysis, as claims data are collected for the purpose of payment.     

Indirect costs associated with metastatic breast cancer

Abstract

Objective:

To compare the indirect costs of productivity loss between metastatic breast cancer (MBC) and early stage breast cancer (EBC) patients, as well as their respective family members.

Methods:

The MarketScan® Health and Productivity Management database (2005–2009) was used. Adult BC patients eligible for employee benefits of sick leave and/or short-term disability were identified with ICD-9 codes. Difference in sick leave and short-term disability days was calculated between MBC patients and their propensity score matched EBC cohort and general population (controls) during a 12-month follow-up period. Generalized linear models were used to examine the impact of MBC on indirect costs to patients and their families.

Results:

A total of 139 MBC, 432 EBC, and 820 controls were eligible for sick leave and 432 MBC, 1552 EBC, and 4682 controls were eligible for short-term disability (not mutually exclusive). After matching, no statistical difference was found in sick leave days and the associated costs between MBC and EBC cohorts. However, MBC patients had significantly higher short-term disability costs than EBC patients and controls (MBC: $6166?±?$9194 vs EBC: $3690?±?$6673 vs Controls: $558?±?$2487, both p?<?0.001). MBC patients had more sick leave cost than controls ($2383?±?$5539 vs $1282?±?$2083, p?<?0.05). Controlling for covariates, MBC patients incurred 47% more short-term disability costs vs EBC patients (p?=?0.009). Older patients (p?=?0.002), non-HMO payers (p?<?0.05), or patients not receiving chemotherapy during follow-up (p?<?0.001) were associated with lower short-term disability costs. MBC patients’ families incurred 39.7% (p?=?0.06) higher indirect costs compared to EBC patients’ families after controlling for key covariates.

Conclusion:

Productivity loss and associated costs in MBC patients are substantially higher than EBC patients or the general population. These findings underscore the economic burden of MBC from a US societal perspective. Various treatment regimens should be evaluated to identify opportunities to reduce the disease burden from the societal perspective.     

Comorbidity and economic burden among moderate-to-severe psoriasis and/or psoriatic arthritis patients in the US Department of Defense population

Aims: To examine the comorbidity and economic burden among moderate-to-severe psoriasis (PsO) and/or psoriatic arthritis (PsA) patients in the US Department of Defense (DoD) population.

Materials and methods: This retrospective cohort claims analysis was conducted using DoD data from November 2010 to October 2015. Adult patients with ≥2 diagnoses of PsO and/or PsA (cases) were identified, and the first diagnosis date from November 2011 to October 2014 was defined as the index date. Patients were considered moderate-to-severe if they had ≥1 non-topical systemic therapy or phototherapy during the 12 months pre- or 1 month post-index date. Patients without a PsO/PsA diagnosis during the study period (controls) were matched to cases on a 10:1 ratio based on age, sex, region, and index year; the index date was randomly selected. One-to-one propensity score matching (PSM) was conducted to compare study outcomes in the first year post-index date, including healthcare resource utilization (HRU), costs, and comorbidity incidence.

Results: A total of 7,249 cases and 72,490 controls were identified. The mean age was 48.1 years. After PSM, comorbidity incidence was higher among cases, namely dyslipidemia (18.3% vs 13.5%, p?<?.001), hypertension (13.8% vs 8.7%, p?<?.001), and obesity (8.8% vs 6.1%, p?<?.001). Case patients had significantly higher HRU and costs, including inpatient ($2,196 vs $1,642; p?<?.0016), ambulatory ($8,804 vs 4,642; p?<?.001), emergency room ($432 vs $350; p?<?.001), pharmacy ($6,878 vs $1,160; p?<?.001), and total healthcare costs ($18,311 vs $7,795; p?<?.001).

Limitations: Claims data are collected for payment purposes; therefore, such data may have limitations for clinical research.

Conclusions: During follow-up, DoD patients with moderate-to-severe PsO and/or PsA experienced significantly higher HRU, cost, and comorbidity burden.     

Burden of venous leg ulcers in the United States

Objective:

To estimate the annual incremental per-patient and overall payer burden (2012USD) of venous leg ulcers (VLU) in the US.

Methods:

Beneficiaries with and without VLU were identified using two de-identified insurance claims databases: aged 65+ from a 5% random sample of Medicare beneficiaries (2007–2010: n?～?2.3 million); and aged 18–64 from a privately-insured population (2007–2011: n?～?8.4 million). The index date was selected as the date of a VLU claim with no other VLU diagnoses in the preceding 12 months for the VLU cohort and as the date of a random medical claim for the non-VLU patients. These groups were matched using propensity scores to account for differences in demographics, comorbidities, resource utilization, and costs in the 12 month pre-index period. Medical resource use and costs incurred during the 12 month follow-up period were calculated for both payers. Drug costs and indirect work-loss due to disability and medically-related absenteeism were estimated for the privately-insured sample only. Annual VLU incidence rates were also estimated for both payers.

Results:

Data for 58,672 matched VLU/non-VLU pairs of Medicare and 22,476 matched pairs of privately-insured patients were analyzed. Relative to matched non-VLU patients, VLU patients used more medical resources and incurred annual incremental medical costs of $6391 in Medicare ($18,986 vs $12,595), and $7030 ($13,653 vs $6623) in private insurance ($7086 including drug costs). Compared with non-VLU patients, privately-insured VLU patients had more days missed from work (14.0 vs 10.0), resulting in 29% higher work-loss costs (comparisons significant at p?Limitations:

Findings did not account for out-of-pocket payments or other indirect costs (e.g., lost productivity), and relied on accuracy of diagnosis and procedure codes contained in claims data.

Conclusion:

These findings suggest an annual US payer burden of $14.9 billion.     

Medical resource utilisation and healthcare costs in patients with chronic hepatitis C viral infection and thrombocytopenia

Abstract

Background:

Thrombocytopenia is a significant risk for patients with chronic HCV infection and a common side-effect of treatment with pegylated (PEG) interferon (IFN). Thrombocytopenia predisposes patients to bleeding and requirements for platelet transfusions, and may thus place an increased burden on patients and on medical resource utilisation.

Scope:

In a retrospective analysis of an integrated, longitudinal database of medical and pharmacy claims and laboratory results in a US commercial health (insurance) plan, patients with chronic hepatitis C viral (HCV) infection were identified by reviewing ICD-9-CM HCV-, chronic liver disease-, and cirrhosis-related diagnoses. Medical resource utilisation and laboratory results were evaluated during the year following the HCV diagnosis index date as well as during the baseline year prior to that index date. Medical resource utilisation was determined by comparing outpatient visits, emergency department (ER) visits, and inpatient hospital stays for HCV patients with or without thrombocytopenia.

Findings:

HCV patients diagnosed with thrombocytopenia had a greater incidence of bleeding events (27.3 vs. 9.9%), platelet transfusions (8.5 vs. <1%), liver disease-related ambulatory visits (10.4 vs. 4.4; odds ratio [OR]?=?2.3; p?<?0.001), ER visits (OR?=?8.6; p?<?0.01), and inpatient hospital stays (OR?=?17.7; p?<?0.01) during the study period compared with HCV patients without a thrombocytopenia diagnosis. HCV patients with thrombocytopenia had significantly higher overall healthcare costs ($37,924 vs. $12,174; p?<?0.001) and liver disease-related costs ($14,569 vs. $4107; p?<?0.001) than patients without thrombocytopenia.

Limitations:

Administrative claims data are subject to coding errors; additionally, the patient population may not be completely representative of the general chronic HCV population.

Conclusions:

Diagnosis of thrombocytopenia in patients with HCV is associated with increased incidence of certain comorbidities, complications, and medical interventions, and significantly increased medical resource utilisation.     

Medical resource use and costs associated with chylomicronemia

Abstract

Background:

The prevalence of severe hypertriglyceridemia (TG?>?1000?mg/dl) is estimated at 150–400 per 100,000 individuals in North America. Severe hypertriglyceridemia in the fasting state is associated with increased acute pancreatitis risk and is a sign of chylomicronemia which reflects the accumulation in the bloodstream of chylomicrons, the large lipoprotein particles produced in the gut after a meal.

Objective:

To assess medical resource use and costs associated with chylomicronemia.

Methods:

Patients with chylomicronemia of different causes (≥2 diagnoses with ICD-9 code 272.3) were identified from a large US claims database (years 2000 to 2009) and matched 1:1 to controls free of chylomicronemia based on age, gender, demographics, comorbidities, and use of lipid lowering drugs. During a 1-year study period, medical resource use and costs associated with chylomicronemia or acute pancreatitis were compared between matched cases and controls.

Results:

Among 6472 matched pairs, annual per-patient medical costs, calculated independently of the occurrence of acute pancreatitis, were significantly greater by $808 for chylomicronemia cases vs controls ($8029 vs $7220, p?<?0.01), half of which was attributable to chylomicronemia-related services (p?<?0.01). Chylomicronemia cases with a history of acute pancreatitis (n?=?46) had greater rates of inpatient visits (p?<?0.05) and greater average costs for subsequent acute pancreatitis or abdominal pain (p?<?0.01) as well as greater total medical costs ($33,587 vs $4402, p?<?0.01) vs matched controls. The average episode of acute pancreatitis (n?=?104 episodes) generated medical costs of $31,820, almost entirely due to inpatient stays.

Limitations:

Triglyceride levels were not available to characterize disease severity.

Conclusions:

Patients with chylomicronemia, and especially those with a history of acute pancreatitis, incurred significantly greater total medical costs compared with individuals without chylomicronemia but with an otherwise comparable health profile.