Adherence, health care utilization, and costs between long-acting injectable and oral antipsychotic medications in South Carolina Medicaid beneficiaries with schizophrenia.

BACKGROUND: Schizophrenia and schizoaffective disorder require long-term antipsychotic treatment with antipsychotic medications, but poor medication adherence can lead to increased health care utilization and costs. Long-acting injectable antipsychotics (LAIs) offer potential therapeutic advantages in that they require less frequent dosing and improved medication adherence. South Carolina has the highest adoption of LAIs among US states, making it an ideal population for comparing the effectiveness of LAIs vs oral antipsychotics (OAPs) in treating schizophrenia or schizoaffective disorder. OBJECTIVE: To evaluate the effect of LAIs compared with OAPs on medication adherence, health care resource utilization, and costs among South Carolina Medicaid beneficiaries with schizophrenia or schizoaffective disorder. METHODS: South Carolina Medicaid beneficiaries with at least 1 claim for an LAI or OAP between January 1, 2015, and December 31, 2018, aged 18 to 65, with at least 2 claims with diagnoses of schizophrenia or schizoaffective disorder were included. Propensity scores (PSs) were calculated using logistic regression adjusting for confounders and predictors of the outcome. We estimated the "average treatment effect on the treated" by employing PS-weighted t-tests and chi-square tests. RESULTS: A total of 3,531 patients met the inclusion criteria, with 1,537 (44.5%) treated with LAIs and 1,994 (56.5%) treated with OAPs. In PS-weighted analyses, the LAI cohort had a greater proportion of days covered than the OAP cohort with a 365-day fixed denominator (69% vs 64%; P < 0.0001), higher medication possession ratio with a variable denominator while on therapy (85% vs 80%; P < 0.0001), and higher persistence (82% vs 64%; P < 0.0001). The average number of inpatient visits and emergency department visits did not significantly differ between cohorts (0.28 hospitalizations, P = 0.90; 3.68 vs 2.96 emergency department visits, P = 0.19). The number of outpatient visits, including visits for medication administration, were greater in the LAI cohort (23.1 [SD 24.2]) vs OAP (16.9 [SD 21.2]; P < 0.0001); however, including the costs for medication administration visits, outpatient costs (per member) were approximately $2,500 lower in the LAI cohort (P < 0.0001). The number of pharmacy visits was greater in the OAP cohort (LAI 21.0 [SD 17.0] vs OAP 23.0 [SD 15.0]; P = 0.006). All-cause total costs were greater in the LAI cohort ($26,025 [SD $29,909]) vs the OAP cohort ($17,291 [SD $25,261]; P < 0.0001) and were driven by the difference in pharmaceutical costs (LAI $15,273 [SD $16,183] vs OAP $4,696 [SD $10,371]; P < 0.0001). CONCLUSIONS: Among South Carolina Medicaid beneficiaries, treatment with LAIs for schizophrenia or schizoaffective disorder was associated with greater medication adherence rates. Patients using LAIs had higher drug costs and total costs, but lower outpatient and total nondrug costs compared with those using OAPs.

Characteristics of Patients Initiating Guselkumab for Plaque Psoriasis in the Symphony Health Claims Database.

Guselkumab is approved by the Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis. However, characteristics of patients initiating guselkumab in a real-world setting are not well characterized. The present study described baseline characteristics of patients with psoriasis initiating guselkumab in the first year after approval using data from the Symphony Health Claims database. Adult patients with psoriasis with ≥1 claim for guselkumab between 7/13/2017 and 7/2/2018 were included. The index date was defined as the date of the first pharmacy claim for guselkumab. Outcomes of interest included demographics, frequency of prior biologic and non-biologic psoriasis treatments, and frequency of diagnoses or procedures during the year before guselkumab initiation (baseline period). A total of 1,520 patients were included. Mean age was 51.2 (SD 13.4) years and 53.7% of patients were female. During the baseline period, 63.9% of patients had ≥1 biologic drug claim and 66.9% were prescribed topical corticosteroids/combinations. The most common non-psoriasis diagnoses among patients with ≥1 medical claim were hypertension (25.1%), type 2 diabetes (13.4%), and hyperlipidemia (13.4%). The most common procedures reflected routine medical care. These findings describing the baseline characteristics of patients initiating guselkumab provide insights regarding variables that may impact observed treatment outcomes and may ultimately help with treatment decision making. J Drugs Dermatol. 2021;20(10):1127-1131. doi:10.36849/JDD.6024.

Real-World Persistence, Maintenance Dosing, and Pre-Post Corticosteroid and Opioid Use Among Crohn's Disease Patients with Prescription Claims for Ustekinumab in the USA.

BACKGROUND: Real-world evidence for how US Crohn's disease (CD) patients use ustekinumab is limited. OBJECTIVES: The aim of this study was to describe the persistence, maintenance dosing, and pre-post corticosteroid and opioid use for CD patients in the USA treated with ustekinumab and those treated with adalimumab as a commonly used descriptive reference product. METHODS: CD patients aged ≥ 18 years with ≥2 CD diagnoses between 1 October 2012 and 31 May 2018 and ≥ 1 new (i.e., no claim for at least 1 year) outpatient pharmacy claim for ustekinumab or adalimumab (first claim date = index date) on or after 26 September 2016 were selected from Symphony Health database. McNemar's tests were used to derive the p-values for pre-post changes in corticosteroid and opioid use within each treatment cohort. RESULTS: A total of 1073 ustekinumab and 2904 adalimumab patients met analysis criteria. Using a 90-day rule for discontinuation, persistence at 1 year post-index was 69.8% for ustekinumab and 65.1% for adalimumab. The majority received doses within ±30% of the approved labeling (ustekinumab 81.1%; adalimumab 78.8%). Doses higher than US package insert (PI) recommended maintenance dose were 7.0% for ustekinumab and 13.6% for adalimumab for 30% above PI, respectively; and 4.0% versus 9.4% for 50% above PI, respectively. Rates of pre-index biologic use suggest that patients treated with ustekinumab may have greater CD severity based on a greater percentage being biologic-experienced (ustekinumab 51.5% and adalimumab 8.4%). From pre- to post-index, the relative proportion of ustekinumab patients with ≥ 1 pharmacy claim for corticosteroids decreased by 25.5% (p < 0.0001) and opioids decreased by 8.4% (p = 0.0030). Results for adalimumab (a commonly used descriptive reference product in CD) showed generally similar trends. CONCLUSIONS: In this real-world study, persistence for ustekinumab remained high at 1 year. The majority of the patients in the ustekinumab cohort followed US PI recommended dosing. The percentage of patients with average dose above PI recommendations over 1 year were low for ustekinumab. Reductions in the proportion of patients with claims for corticosteroids or opioids were observed in patients using ustekinumab.

Policy Change for Deep Vein Thrombosis: Effects on Length of Stay and Hospitalization Costs of Moving From Warfarin to Direct Oral Anticoagulants.

PURPOSE: Renown Health (Reno, Nevada), a large, locally owned, not-for-profit integrated health care network, has developed an institution-wide policy to shift the treatment of deep vein thrombosis (DVT) from a short-acting anticoagulant and vitamin K antagonist to the direct oral anticoagulant rivaroxaban combined with pharmacy-directed follow-up at an outpatient anticoagulation clinic. We examined data on hospitalizations and costs pre-/post-policy change. METHODS: Data were obtained from the electronic health records of adults with newly diagnosed DVT treated at Renown Health. A quasi-experimental design was used to evaluate patients who received a DVT diagnosis before versus after the policy change. Primary outcomes were number of all-cause inpatient nights at 30 and 60 days post-DVT index date. Secondary outcomes were costs of all-cause overnight stays at 30 and 60 days post-DVT index. Outcomes were evaluated in propensity-weighted logistic regression and generalized linear models. FINDINGS: There were 343 patients pre-policy change and 266 post-policy change. In the first 30 days postindex, the mean (95% CI) numbers of propensity-weighted all-cause inpatient nights were 1.27 (0.83-1.95) prechange and 0.66 (0.42-1.02) postchange (P = 0.038). Mean propensity-weighted estimated all-cause hospital costs in patients diagnosed as outpatients were $7848 ($4990-$12,344) prechange and $2466 ($1553-$3915) postchange (P <0.001). Mean costs of all-cause overnight stays in inpatient-diagnosed DVT patients were $8907 prechange and $7449 postchange (P = 0.600). In the first 60 days postindex, the mean number of all-cause inpatient nights (P = 0.219) and mean costs of all-cause overnight stays (P = 0.275) were not significantly different before and after the policy change. IMPLICATIONS: Changing institutional policy to increase the utilization of a direct oral anticoagulant and pharmacist-led outpatient anticoagulation clinics may reduce length of hospital stay and decrease health care expenditures in the treatment of DVT.

A real-world comparison of relapse rates, healthcare costs and resource use among patients with multiple sclerosis newly initiating subcutaneous interferon beta-1a versus oral disease-modifying drugs.

BACKGROUND: Administrative-claims data enable comparative effectiveness assessment using large numbers of patients treated in real-world settings. OBJECTIVE: To evaluate real-world relapses, healthcare costs and resource use in patients with MS newly initiating subcutaneous interferon beta-1a (sc IFNß-1a) v. oral disease-modifying drugs (DMDs: dimethyl fumarate, fingolimod, teriflunomide). METHODS: Patients from an administrative claims database (1 Jan 2012-31 Dec 2015) were selected if they: were 18-63 years old; had an MS diagnosis; had newly initiated sc IFNß-1a, dimethyl fumarate, fingolimod, or teriflunomide (first claim = index); had no evidence of DMD 12-months pre-index; and had 12-month eligibility pre- and post-index. Relapse was defined as an MS-related inpatient stay, emergency room visit, or outpatient visit with a corticosteroid prescription ± 7 days. Outcomes were evaluated using logistic regression and generalized linear models. RESULTS: A total of 4475 patients met inclusion criteria: 21.9% sc IFNß-1a, 51.0% dimethyl fumarate, 19.7% fingolimod, 7.4% teriflunomide. Teriflunomide patients had 1.357 (95% CI 1.000, 1.831; p = 0.0477) greater odds of 1-year relapse than sc IFNß-1a patients. Estimated mean all-cause 1-year costs were higher after fingolimod (US$72,376) v. sc IFNß-1a initiation (US$65,408; p < 0.0001). Non-DMD costs were not significantly different. CONCLUSION: Patients initiating sc IFNß-1a had better relapse outcomes v. teriflunomide, and lower all-cause costs v. fingolimod.

A retrospective analysis to identify predictors of COPD-related rehospitalization.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is often associated with recurrent hospitalizations. This study aimed to identify factors related to COPD rehospitalization. METHODS: A national US claims database was used to identify patients, aged ≥40 years, hospitalized for COPD. Their first COPD-related hospital admission date in 2009 was set as the index date, with post-discharge COPD-related rehospitalization assessed for 180 days post-index date. Data were analyzed for: 1) all eligible patients in whom early COPD-related rehospitalization was evaluated (1-30 days post discharge; all-patient cohort) and 2) a patient subset not rehospitalized early in whom late COPD-related rehospitalization was evaluated (>30 days post discharge to 180 days post-index date; late cohort). Logistic regressions controlling for age and sex assessed potential COPD-related rehospitalization predictors. Variables from the 360-day pre-index period and index hospitalization were evaluated for each cohort, and 30-day post-discharge variables evaluated for the late cohort. RESULTS: Of 3612 patients with an index hospitalization, 4.8 % (174) had an early COPD-related rehospitalization, and of the remaining 3438 patients, 13.7 % (471) had a late COPD-related rehospitalization. Several pre-index variables were predictive of early COPD-related rehospitalization including: pneumonia; comorbidities; COPD-related drug therapies; and prior hospitalizations. In patients not rehospitalized early, the strongest predictor of late COPD-related rehospitalization was pre-index COPD-related hospitalization (OR = 3.64 [P < 0.001]). The strongest index hospitalization factors predictive of late COPD-related rehospitalization were use of steroids (any route: OR = 1.62 [P = 0.007]) and nebulizers (OR = 1.65 [P = 0.007]); neither predicted early COPD-related rehospitalization. Generally, factors predicting COPD-related rehospitalization were similar in both cohorts. CONCLUSIONS: Several pre-index variables were associated with COPD-related rehospitalization. A strong predictor of COPD-related rehospitalization was prior hospitalization during the pre-index period, particularly with a primary COPD diagnosis, whilst other predictive factors related to increased COPD severity; these may be useful indicators for COPD-related rehospitalization risk assessment. Some factors, e.g., recurrent pneumonia and exacerbations, may be modifiable.

Cost effectiveness of paliperidone palmitate versus oral antipsychotics in patients with schizophrenia and a history of criminal justice involvement.

OBJECTIVE: Conduct a cost effectiveness analysis for the Paliperidone palmitate Research In Demonstrating Effectiveness (PRIDE) trial. RESEARCH DESIGN AND METHODS: PRIDE was a 15 month, prospective, randomized, open-label study in which once monthly paliperidone palmitate significantly delayed the time to first treatment failure (healthcare or criminal justice system [HC/CJS] events) versus oral antipsychotics in recently incarcerated adults with schizophrenia. The present analysis used a state government perspective and HC/CJS event data that were collected on a resource use questionnaire (RUQ) every 3 months. MAIN OUTCOME MEASURES: Since cost information was not collected in the trial, cost estimates from published literature and an analysis of multistate Medicaid data for CJS and HC events, respectively, were applied to RUQ event data. Effectiveness and costs were adjusted to 456 days (trial duration). Incremental cost effectiveness was calculated as the adjusted cost difference divided by the adjusted effectiveness difference. RESULTS: Adjusted costs (in US dollars) in the paliperidone palmitate group (n = 198) and the oral antipsychotic group (n = 193), respectively, were: non-drug costs $22,331 and $25,027; drug costs $18,592 and $7833; and total costs $40,923 and $32,860. Adjusted effectiveness differences and corresponding incremental cost effectiveness per event avoided (in parentheses) for paliperidone palmitate versus oral antipsychotics were as follows: 0.33 fewer CJS events ($24,409), 0.13 fewer psychiatric hospitalizations ($60,484), 0.46 fewer psychiatric hospitalizations or CJS events combined ($17,391), and 0.30 fewer incarcerations ($26,754). CONCLUSIONS: Costs for HC/CJS events avoided offset 25% of the greater drug cost for the paliperidone palmitate versus oral antipsychotic treatment group in this vulnerable population. Use of a recall-dependent RUQ for event rates and cost estimates instead of actual costs are potential limitations and may make the results conservative from a state government perspective. Indirect costs are likely to be substantial for this population, but were not considered in the analysis.

Effectiveness of step therapy policies for specialty pharmaceuticals in immune disorders.

OBJECTIVE: To assess the effectiveness of managed care plans that limited access to infusion biologics via a step therapy policy. STUDY DESIGN: This was a retrospective cohort study using Symphony Health Solutions claims databases that included payer, prescription (Rx), diagnosis (Dx) and procedure (Px) information with unique anonymized patient identifiers. METHODS: The percentage of patients with claims for infusion and subcutaneous (SQ) biologics were evaluated across three increasingly restrictive cohorts: (1) patients in step therapy plans versus all others in the database (population), (2) patients in step therapy plans versus patients that were members of plans that were roughly matched (matched) and (3) a subsample of patients that were members of step therapy plans that had sufficient data for a pre/post analysis (pre/post). RESULTS: The population analysis comparison showed 5.1% fewer patients (p < 0.0001) with claims for infusion biologics among step therapy plans than among the overall plans. The more controlled matched and pre/post analyses showed a greater percentage of patients with claims for intravenous products in the plans with step therapy policies versus plans without step therapy policies, differences of +7.0% (p < 0.0001) and +2.8% (p = 0.0522), respectively. CONCLUSIONS: Policies designed to limit utilization of infusion biologics showed equivocal results. In the near term, the intended effects of implementing step therapy policies may be limited by relatively small numbers of patients that are affected relative to the total number of users.

Medicaid Eligibility and Time to Re-incarceration Among Previously Incarcerated Subjects With Schizophrenia.

Background: Many persons with severe mental illness qualify for Medicaid coverage. However, under federal law, states must either suspend or terminate eligibility once they are incarcerated. We hypothesize that prompt re-acquisition of Medicaid eligibility following release from incarceration lowers the risk of re-incarceration. Objective: To assess the relationship between Medicaid eligibility and risk of re-incarceration among previously incarcerated schizophrenia diagnosed subjects. Methods: Study subjects were selected between January 1, 2006 and September 30, 2011 from a single state Medicaid database that was combined with department of corrections data. Subjects were included if they had a schizophrenia diagnosis (International Classification of Diseases, 9th Revision, Clinical Modification [ICD- 9-CM] code 295.xx), were between the ages of 18 and 62, and had been released from incarceration. Covariates included age, race, gender, marital status, and reason for incarceration. Time to Medicaid eligibility after release from incarceration, cumulative days of eligibility, and whether they were eligible on the re-incarceration date were evaluated in independent models. One and three-year Cox Regression models analyses (p<0.05) were used to evaluate the hazard for re-incarceration. Results: The 932 subjects were 26.5% white, 73.7% male and were, on average, 37.6 years old on their index date (i.e., incarceration release date). They were 73.5% single or divorced and 12.7% were incarcerated for a substance abuse violation. In the 1-year follow-up period, 110 subjects (11.8%) were re-incarcerated. In the 3-year follow-up period 209 (22.4%) were re-incarcerated. Age (in years) was the only significant predictor of re-incarceration for the 1-year models (hazard ratio [HR]=0.976; confidence interval [CI]=0.957, 0.994). Eligibility was a significant predictor in the 3-year follow-up models. A longer 'time to first eligibility' (HR=1.046; CI=1.017, 1.075 was associated with a greater hazard for re-incarceration. Being eligible at the time of re-incarceration (HR=0.659; CI=0.498, 0.870) was associated with a lower hazard, and the cumulative number of months of eligibility (HR=0.978; CI=0.958, 0.997) and age were associated with a lower hazard for re-incarceration (HR=0.986; CI=0.973, 0.999). Conclusions: Access to Medicaid health services post-release may reduce the risk of re-incarceration.

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

OBJECTIVE: The objective for the research was to evaluate the direct healthcare costs for Crohn's disease (CD) patients categorized by adherence status. METHODS: Adult patients with ≥1 claim for infliximab and ≥2 claims for CD who were continuously insured for 12 months before and after their first infliximab infusion (index date) were identified in a 2006-2009 US managed care database. Patients were excluded if they had rheumatoid arthritis claims, received infliximab billed as a pharmacy benefit, or received another biologic drug. Patients were categorized as being either adherent or intermittently adherent to infliximab using a pre-defined algorithm. Total and component direct costs, CD-related costs, rates of surgery, and days of hospitalization were estimated for the 360-day post-index period. Propensity weighted generalized linear models were used to adjust the cost estimates for potential confounding variables. RESULTS: The total propensity weighted cost for infliximab adherent patients was $40,425 (95% CI = [$38,686, $42,242]), compared to $41,082 (95% CI = [$38,163, $44,223]) for the intermittently adherent (p = 0.71). However, adherent patients had lower total direct medical costs, exclusive of infliximab, that were $13,097 (95% CI = [$12,141, $14,127]) compared with $20,068 (95% CI = [$17,676, $22,784]) for intermittently adherent patients as a result of substantially lower hospital and outpatient costs (p < 0.0001). CONCLUSIONS: Greater drug-related costs for infliximab adherent patients were offset by lower costs from hospitalization and outpatient visits. These findings indicate that adherent patients have improved clinical outcomes, at a similar aggregate cost, than patients who are only intermittently adherent to therapy.

Use of an early disease-modifying drug adherence measure to predict future adherence in patients with multiple sclerosis.

BACKGROUND: Patients with multiple sclerosis (MS) who are adherent to their treatment regimens are less likely to experience relapses and the cost associated with relapse. Pharmacists whose practice involves these specialty pharmaceuticals used to treat MS are striving for ways to improve outcomes by achieving treatment adherence in their patients. Specialty pharmacies have reported higher adherence rates than traditional pharmacies, which may translate to improved outcomes. Identifying patients who warrant increased adherence intervention is critical. Models using administrative health care claims to predict adherence have typically included demographic characteristics, comorbidities, and/or previous consumption of health care resources. Addition of a measure of early adherence may improve the ability to predict future adherence outcomes.  OBJECTIVE: To evaluate early adherence with disease-modifying drugs (DMDs) as a predictor of future adherence in patients with MS.  METHODS: The first DMD claim (i.e., index event) for adult MS patients (aged ≥18 years and aged ≤ 65 years) who received self-injected DMDs between January 1, 2006, and May 31, 2010, was identified in a national U.S. managed care database. Patients were required to have continuous eligibility for 12 months pre- and 24 months post-index. Multiple regression models were used to predict future adherence as measured by the proportion of days covered (PDC). The base model included age, gender, a medication intensity measure, presence of a non-MS-related hospitalization pre-index, and markers for physical difficulty, forgetfulness, or depression/stress. Models adding early DMD adherence as a covariate were analyzed using incrementing 30-day periods predicting the subsequent 360 days.  RESULTS: There were 4,606 patients included with an average age of 46.0 (SD 9.4) years, and 78.7% were female. Average PDC in the first 360 days post-index was 80.0% (SD 26.0). Using the first 60 days of early adherence as the only predictor in the model showed an R2 of 20.6%. The base model (i.e., no early adherence measure but other covariates included) yielded an adjusted R2 of only 2.3%. As the time period of early adherence is increased (from 60 to 360 days), the explained variance as measured by adjusted R2 values increased from 20.6% to 53.5% (early adherence-only models). Addition of the covariates, other than early adherence, increased the R2 by 1% to 2%.  CONCLUSIONS: Statistical predictive models that include early adherence with DMDs were able to explain the variance in future adherence outcomes to a greater extent than models based solely on baseline characteristics. The efficiency of an adherence intervention in reaching its intended target can be improved by using models such as these with enhanced specificity and selectivity.

Complexity of pain management among patients with nociceptive or neuropathic neck, back, or osteoarthritis diagnoses.

BACKGROUND: Approaches to pain management are diverse, requiring prescribers to evaluate an array of clinical issues and potential solutions. In addition to the difficult task of selecting a treatment option, pain treatment may be further complicated by multiple prescribers, multiple medications, and multiple mechanisms of pain origination. OBJECTIVE: To describe patient demographics (e.g., age, gender); comorbidities; office visits (e.g., physician, chiropractor, physical therapy, psychiatry, allergist); number of different prescribers overall prescription use; pain medications as classified by the World Health Organization's (WHO) pain ladder; adjuvant medications; nonpharmacologic procedures; and potential drug interactions in a broad sample of patients with nociceptive or neuropathic neck or back diagnoses, or osteoarthritis diagnoses, in a commercial population. METHODS: This claims-data analysis used a cross-sectional cohort comparison with a fixed 2-year observation period from September 1, 2006, to August 31, 2008, for patients in the PharMetrics national managed care database. The assigned cohorts were neuropathic-related neck/back diagnoses (NEURO); neuropathic and nociceptive neck/back diagnoses (NEURO/NOCI); nociceptive neck/back diagnoses without a neuropathic-related diagnosis (NOCI); and only osteoarthritis (OA) diagnoses. All analyses were conducted by cohort. The analysis included the following patient-descriptive variables: patient demographics, comorbidities, office visits, most frequent medical providers and number of different prescribers, all medications, pain medications as classified by the WHO pain ladder, adjuvant medications, adjuvant procedures and potential drug interactions. The goal for selecting these variables was to describe a range of data that might provide insight into the complexity of pain management decisions faced by clinicians. RESULTS: The study included 85,014 patients, classified as NEURO (n = 2,375), NEURO/NOCI (n = 37,019), NOCI (n = 39,496), and OA (n = 6,124). The most frequently occurring comorbidities (observed in > 40% of patients) included cardiovascular and neuropathic pain conditions. Considering all types of medication claims observed among all cohorts, the overall mean prescription claim count for the 2-year observation period was 57.9 claims (standard deviation 56.2). Weak opioids (WHO pain relief ladder rung 2) accounted for the majority of pain medication claims across all cohorts. Across cohorts, 25.7% of patients had 10 or more days of overlapping drug availability (for inducers or inhibitors of the cytochrome P450 system concomitantly), a measure of potential for drug interactions. CONCLUSIONS: Choosing the appropriate pain treatment involves assessing currently used medications for existing illnesses and deciding on the appropriate types of pain medications. However, potentially serious drug-drug interactions are a consequence of multiple drug use, and such a potential requires thoughtful consideration by those involved in patient care.

Adherence patterns for abiraterone acetate and concomitant prednisone use in patients with prostate cancer.

BACKGROUND: With the growing use of oral anticancer medications, understanding adherence patterns has become increasingly important. Abiraterone acetate (AA) is a prodrug of abiraterone, a novel androgen biosynthesis inhibitor. AA is approved for use in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer. OBJECTIVE: To evaluate AA and concomitant prednisone utilization and adherence patterns for patients with prostate cancer in the United States. METHODS: This study used data from 2 administrative health care claims databases--Dataset 1: Truven Health Analytics MarketScan (December 2010 to August 2012) and Dataset 2: Symphony Health Solutions' ProMetis Lx (June 2009 to March 2013). To evaluate the consistency of medication-taking behavior, adherence was measured using medication possession ratio (MPR), which was calculated as the sum of days of supply divided by the days on therapy in patients with at least 2 AA prescriptions. Additional outcomes included the proportion of patients taking prednisone, mean and median daily dose of AA, and concomitant prednisone use. Adherence was also studied by age, health care plan type, or previous recent chemotherapy subgroups. RESULTS: 515 patients (mean age: 72.2) and 3,228 patients (mean age: 72.2) with at least 1 AA claim were selected from Dataset 1 and Dataset 2, respectively. The mean (median) daily AA dose per person per prescription was 998.8 (1,000) mg for Dataset 1 and 994.2 (1,000) mg for Dataset 2, which is within 1% of the recommended daily dose (1,000 mg). Mean (median) MPR was 93% (98%; n = 492) in Study Population 1 and 93% (100%; n = 2,449) in Study Population 2. The mean (median) daily prednisone dose per person per prescription was similar in both datasets with 10.1 (10.0; n = 488) mg and 10.6 (10.0; n = 2,425) mg in Dataset 1 and 2, respectively. Similar adherence patterns were observed for patients in different age groups, for patients with commercial health care plans versus patients with Medicare coverage, and for patients with recent chemotherapy compared with patients without. CONCLUSIONS: Results from 2 observational studies reported high levels of adherence to AA dosing and administration patterns consistent with prescribing information. These findings provide useful insights into the treatment patterns in patients with prostate cancer treated with AA and can contribute to the current discussion in oncologic research and practice.

Inflammatory bowel disease: healthcare costs for patients who are adherent or non-adherent with infliximab therapy.

OBJECTIVE: Healthcare costs of inflammatory bowel disease are substantial. This study examined the effect of adherence versus non-adherence on healthcare costs in patients with inflammatory bowel disease. METHODS: Adults who started infliximab treatment between 2006 and 2009 and had a diagnosis of inflammatory bowel disease were identified from MarketScan Databases. Medication adherence was defined as an infliximab medication possession ratio of 80% or greater in the first year. Mean treatment effects (adherence versus non-adherence) on costs in adherent patients were estimated with propensity-weighted generalized linear models. RESULTS: A total of 1646 patients were identified. Significant variables in the model used to develop propensity weights were age, year of infliximab initiation, having Medicare coverage, presence of supplementary diagnoses, office as the place of service for infliximab initiation, prior aminosalicylate use, prior outpatient costs, number of prior outpatient visits, and number of prior colonoscopies. Mean total costs in adherent (n = 674) and propensity-weighted non-adherent (n = 972) patients were $41,713 versus $47,411 overall (p < 0.001), including $28,289 versus $14,889 for infliximab drug costs (p < 0.001), $2458 versus $17,634 for hospitalizations (p < 0.001), $7357 versus $10,909 for outpatient visits (p < 0.001), $236 versus $458 for emergency room visits (p < 0.001), and $3373 versus $3521 for other pharmaceuticals costs (p = 0.460). LIMITATIONS: Costs associated with infliximab administration (infusions, adverse events) were captured in healthcare costs (inpatient, outpatient, and emergency room), not in infliximab costs. The influence of adherence on indirect costs (e.g., time lost from work) could not be determined. Reasons for non-adherence were not available in the database. CONCLUSIONS: In patients who were adherent to infliximab treatment (a medication possession ratio of 80% or greater in the first year), adherence versus non-adherence was associated with lower total healthcare costs, supporting the overall value of infliximab adherence in patients with inflammatory bowel disease.

Medication possession ratio: implications of using fixed and variable observation periods in assessing adherence with disease-modifying drugs in patients with multiple sclerosis.

BACKGROUND: The purpose of this study was to compare two methods of adherence calculation using administrative data for patients with multiple sclerosis (MS) who are prescribed disease-modifying drugs. METHODS: Pharmacy-billed disease-modifying drug prescription claims were selected from the 2007-2008 LifeLink™ Health Plan Claims Database. The index date was the first disease-modifying drug prescription claim. Two cohorts were created: all patients with a disease-modifying drug claim in 2007 and a subset with continuous eligibility for 12 months post-index. Adherence was calculated across all disease-modifying drugs for 12 months post-index. Medication possession ratios (MPRs) with variable (start to end of therapy) and fixed (365 days) duration denominators were calculated. Variable MPR was calculated by summing days supply from the first to the last prescription (inclusive) divided by time between the last prescription date plus days supply and the first prescription date. Variable MPR was evaluated for all patients and the continuously eligible cohort. Fixed MPR used the same numerator but divided by 365 days of follow-up and evaluated only for the continuously eligible cohort. RESULTS: There were 3405 patients with MS and a disease-modifying drug claim in 2007 and 2145 in the continuously eligible cohort. Means for variable MPR ranged from 87.5% ± 16.6% for the continuously eligible cohort to 90.5% ± 16.0% for the 2007 cohort. The comparable value for fixed MPR was 78.0% ± 28.2% for the continuously eligible cohort. Fixed MPR gave a consistently lower rate of adherence than variable MPR at an 80% adherence threshold. CONCLUSION: Different adherence measures can yield different outcomes, especially when using different eligibility criteria. These results demonstrate the importance of full disclosure of methods used for calculations and specification of the study population.

Cost and utilization of healthcare services for hip and knee replacement.

OBJECTIVE: Describe resource utilization and costs for total hip replacement (THR) and total knee replacement (TKR) for the 90 days before hospitalization for surgery, the hospital event, and the 90 and 360 days after hospitalization for surgery with emphasis on 90 days after hospitalization. METHODS: A large insurance database was used to identify outpatient and summarized hospital resource use and payments (insurer perspective) for THR and TKR. A second large US database provided hospital details (charge description master level) of inpatient services, costs, and charges (hospital perspective) for a different sample of THR and TKR patients. Included patients were ≥45 years old, had no hospitalization record within 1 year before surgery, and THR length of stay (LOS) of 2-8 days or TKR LOS 2-6 days. RESULTS: There were 22 618 THR and 50 686 TKR patients in the insurance database and 81 635 THR and 158 990 TKR in the hospital database. Average age was ∼66 years for THR and TKR patients. Median LOS was 4 days (both surgeries). Hospital costs (hospital perspective) were $17 588 in US dollars (USD) and $16 267 (USD) for THR and TKR, respectively. Reimbursement for hospital services (insurer perspective) were $22 967 (USD) and $21 583 (USD) for THR and TKR, respectively. In 90 days post-surgery, THR and TKR total payments were $3827 (USD) and $4237 (USD), respectively. Payments for the first 90 days post-surgery were 57.5% of the 360-day post-period for THR-related payments and 59.9% for TKR-related payments. CONCLUSION: Payers considering use of episode-of-care payment models for THR and TKR may wish to concentrate efforts on the 90 days post-discharge. LIMITATIONS: While this study used large samples of subjects, generalisability of the results may be limited since the samples were not randomized samples of THR and TKR patients. It is noteworthy that patients in the hospital sample are not the same as those in the insurer sample. Selection of hip-related and knee-related procedures and associated costs was based on qualitative review. Payers may use different billing codes or aggregate costs differently.

Modeling the Frequency and Costs Associated with Postsurgical Gastrointestinal Adverse Events for Tapentadol IR versus Oxycodone IR.

BACKGROUND: Few studies have estimated the economic effect of using an opioid that is associated with lower rates of gastrointestinal (GI) adverse events (AEs) than another opioid for postsurgical pain. OBJECTIVE: To estimate the number of postsurgical GI events and incremental hospital costs, including potential savings, associated with lower GI AE rates, for tapentadol immediate release (IR) versus oxycodone IR, using a literature-based calculator. METHODS: An electronic spreadsheet-based cost calculator was developed to estimate the total number of GI AEs (ie, nausea, vomiting, or constipation) and incremental costs to a hospital when using tapentadol IR 100 mg versus oxycodone IR 15 mg, in a hypothetical cohort of 1500 hospitalized patients requiring short-acting opioids for postsurgical pain. Data inputs were chosen from recently published, well-designed studies, including GI AE rates from a previously published phase 3 clinical trial of postsurgical patients who received these 2 opioids; GI event-related incremental length of stay from a large US hospital database; drug costs using wholesale acquisition costs in 2011 US dollars; and average hospitalization cost from the 2009 Healthcare Cost and Utilization Project database. The base case assumed that 5% (chosen as a conservative estimate) of patients admitted to the hospital would shift from oxycodone IR to tapentadol IR. RESULTS: In this hypothetical cohort of 1500 hospitalized patients, replacing 5% of oxycodone IR 15-mg use with tapentadol IR 100-mg use predicted reductions in the total number of GI events from 1095 to 1085, and in the total cost of GI AEs from $2,978,400 to $2,949,840. This cost reduction translates to a net savings of $22,922 after factoring in drug cost. For individual GI events, the net savings were $26,491 for nausea; $12,212 for vomiting; and $7187 for constipation. CONCLUSION: Using tapentadol IR in place of a traditional µ-opioid shows the potential for reduced GI events and subsequent cost-savings in the postsurgical hospital setting. In the absence of sufficient real-world data, this literature-based cost calculator may assist hospital Pharmacy & Therapeutics committees in their evaluation of the costs of opioid-related GI events.

Trends in neutropenia-related inpatient events.

PURPOSE: Neutropenic complications (NCs) after myelosuppressive chemotherapy are associated with significant morbidity and mortality. We described NC rates by using US hospital discharge data. MATERIALS AND METHODS: This cross-sectional analysis used data from the US National Inpatient Sample database. Hospital discharges with cancer diagnoses (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code) from 1989 to 2007 were analyzed for the ICD-9-CM neutropenia code. NC rates per 10,000 discharges were calculated for all adult discharges without radiation therapy (study population, all cancers); lung cancer, breast cancer, and non-Hodgkin's lymphoma (NHL); and all three combined. The use of growth factors and myelosuppressive chemotherapy from 1994 to 2008 was estimated by using the IMS Health Drug Distribution Database. RESULTS: Estimated lung cancer and breast cancer discharges remained relatively steady, whereas NHL discharges increased. NC rates for each study cancer increased two-fold until the late 1990s before stabilizing and/or declining. The average hospital stay for all three cancers decreased from 10.4 days to 7.1 days. The mortality rates for NCs for the three cancers combined decreased at a fairly constant rate from 10% in 1989 to 5.4% in 2007. Estimated discharges for NCs from 1989 to 2007 ranged from 111,000 to 169,000 for the study population, from 57,000 to 103,000 for all cancers, and from 21,000 to 40,000 for the three study cancers. The use of growth factors and myelosuppressive chemotherapy increased from 1994 to 2008. CONCLUSION: Whereas the number of hospitalizations with cancer diagnoses has remained steady since 1989, hospitalizations for NCs increased approximately two-fold from 1989 to 1997 and then stabilized.

Opioids before and after initiation of pregabalin in patients with diabetic peripheral neuropathy.

OBJECTIVES: To examine opioid prescription claims before and after initiation of pregabalin in patients with a diagnosis of diabetic peripheral neuropathy (DPN). METHODS: This retrospective analysis used a national commercial database of integrated inpatient, outpatient, and prescription claims to identify adults with a DPN diagnosis code within 360 days prior to the first claim for pregabalin between January 1, 2006 and March 31, 2008. Prescription claims for pregabalin or opioids were analyzed in nine consecutive 60-day periods from 180 days before through 360 days after the first pregabalin claim. It was not possible to establish drug administration dates, compliance rates, indications for opioid use, or reasons for treatment discontinuation. RESULTS: Of the 8004 adults who met eligibility criteria, 6080 (76%) received an opioid within the 180 days before and/or 360 days after their first prescription for pregabalin, including 3956 (49%) both before and after, 1580 (20%) after only, and 544 (7%) before only. The percentage of patients with pregabalin claims covering ≥20 of 60 days (within 60-day periods) was 99% (day 1-60), 63% (day 61-120), 50% (day 121-180), 45% (day 181-240), 42% (day 241-300), and 39% (day 301-360). The percentage of patients with opioid claims covering ≥20 of 60 days within the 60-day periods remained stable (range, 25-30%). Among patients with opioid claims, 73-76% received only short-acting opioids, 6-7% received only long-acting opioids, and 18-20% received both short- and long-acting opioids. In the first year, 982 (12%) patients had opioid claims covering ≥20 of 60 days in every 60-day period (i.e., persistent use of opioids). Coexisting musculoskeletal (95%) or neuropathic (61%) pain conditions were frequent. CONCLUSION: A majority of patients with DPN receive an opioid before and/or after their first pregabalin claim. Pregabalin neither interferes with nor replaces opioid use for pain management in patients with DPN. Although nearly 1 in 8 patients received opioids throughout the study period, most claims were for short-acting opioids. The majority of this DPN sample had other pain conditions, including musculoskeletal and neuropathic pain conditions. These results highlight the frequency of opioid use with pregabalin, particularly short-acting opioids.

The association of self-monitoring of blood glucose use with medication adherence and glycemic control in patients with type 2 diabetes initiating non-insulin treatment.

BACKGROUND: The value of self-monitoring of blood glucose (SMBG) for persons with type 2 diabetes who do not use insulin remains controversial. This observational study compares the likelihood of medication adherence and change in glycated hemoglobin (A1C) for non-insulin-using patients using SMBG versus those not using SMBG. The study also assessed the association between diabetes medication adherence and SMBG use. PATIENTS AND METHODS: Data were extracted on 5,172 patients who began non-insulin diabetes medication between October 1, 2006, and March 31, 2009. The study assessed change in A1C associated with SMBG use and testing frequency at different categorical levels of baseline A1C. The likelihood of medication adherence for SMBG users was compared with that for non-SMBG users at different categorical levels of baseline A1C. The study further explored the interactions between SMBG use and medication adherence on change in A1C. RESULTS: SMBG users had greater reductions in A1C compared with nonusers when the baseline A1C was ≥ 7%. Increasing SMBG frequency was associated with greater reductions in A1C. The study also examined the associations among SMBG use, medication adherence, and change in A1C. SMBG users had greater decreases in A1C for both medication-adherent and -nonadherent patients. As expected, medication adherence was associated with greater reductions in A1C for both SMBG nonusers and users. It is interesting that medication-nonadherent SMBG users had similar reductions in A1C compared with medication-adherent non-SMBG users. CONCLUSIONS: Both SMBG use and medication adherence were associated with similar degrees of A1C reduction after controlling for baseline A1C, suggesting that both factors may be important for attaining glycemic control.