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.

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.

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.

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.

Association between sitagliptin adherence and self-monitoring of blood glucose.

BACKGROUND: We evaluated the association between self-monitoring of blood glucose (SMBG) use and sitagliptin or sitagliptin/metformin (SSMT) adherence. SSMT was chosen as these medications have little risk of hypoglycemia and are believed to not require SMBG data for titration. METHODS: This was an observational study using data extracted from a large United States insurance claims database (i3 InVision™ Data Mart, Ingenix, Inc.). Data were extracted on noninsulin-using patients initiating SSMT for each 12-month period pre- and post-SSMT initiation. Logistic regression was used to assess the relationship between SMBG use and the likelihood of being medication adherent (defined as a medication possession ratio of ≥75%) while controlling for covariates. RESULTS: This analysis included 7,306 patients (57.6% male; mean age 54.2 years). Mean pre-SSMT hemoglobin A1c (HbA1c) was 8.0%. In the post-SSMT initiation period, 58% of patients were adherent with SSMT. Older age, male gender, prior use of oral diabetes medication, and lower HbA1c were associated with improved SSMT adherence. SMBG use was associated with improved adherence [odds ratio (OR) ranged from 1.198 to 1.338; p < .05] compared with patients with no SMBG use pre- or post-SSMT initiation. For patients who began SMBG after starting SSMT, greater SMBG use was associated with better adherence (OR 1.449 for higher vs 1.246 for lower strip use; p < .05). CONCLUSIONS: This study demonstrated that SMBG is associated with improved SSMT adherence. This relationship is strengthened with greater SMBG use.

Comparison of resource use by COPD patients on inhaled therapies with long-acting bronchodilators: a database study.

BACKGROUND: The purpose of this analysis was to compare health care costs and utilization among COPD patients who had long-acting beta-2 agonist (LABA) OR long-acting muscarinic antagonist (LAMA); LABA AND LAMA; or LABA, LAMA, AND inhaled corticosteroid (ICS) prescription claims. METHODS: This was a 12 month pre-post, retrospective analysis using COPD patients in a national administrative insurance database. Propensity score and exact matching were used to match patients 1:1:1 between the LABA or LAMA (formoterol, salmeterol, or tiotropium), LABA and LAMA (tiotropium/formoterol or tiotropium/salmeterol), and LABA, LAMA and ICS (bronchodilators plus steroid) groups. Post-period comparisons were evaluated with analysis of covariance. Costs were evaluated from a commercial payer perspective. RESULTS: A total of 523 patients were matched using 29 pre-period variables (e.g., demographics, medication exposure). Post-match assessments indicated balance among the cohorts. COPD-related costs differed among groups (LABA or LAMA $2,051 SE = 91; LABA and LAMA $2,823 SE = 62; LABA, LAMA and ICS $3,546 SE = 89; all p < .0001) with the differences driven by study medication costs. However, non-study COPD medication costs were higher for the LABA or LAMA therapy group ($911 SE = 91) compared to the LABA and LAMA therapy group ($668 SE = 58; p = 0.0238) and non-study respiratory medications were approximately $100 greater for the LABA or LAMA therapy group relative to both LABA and LAMA (p = .0018) and LABA, LAMA, and ICS (p = .0071) therapy groups. While there was no observed difference in outpatient costs, there was a slightly higher number of outpatient visits per patient in the LABA and LAMA (25.5 SE = 0.9, p = 0.0070) relative to the LABA or LAMA therapy group (22.3 SE = 0.8) and higher utilization (89.7% of patients) with COPD visits in the LABA and LAMA therapy group relative to both the LABA or LAMA (73.8%; p < .0001) and LABA, LAMA and ICS therapy groups (85.3; p = 0.0305). CONCLUSIONS: Significant cost differences driven mainly by pharmaceuticals were observed among LABA or LAMA, LABA and LAMA and LABA, LAMA and ICS therapies. A COPD-related cost offset was observed from single bronchodilator to two bronchodilators. Addition of an ICS with two bronchodilators resulted in higher treatment costs without reduction in other COPD-related costs compared with two bronchodilators.

Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results.

BACKGROUND: To evaluate effectiveness outcomes in a real-world setting in patients with schizophrenia initiating risperidone long-acting therapy (RLAT). METHODS: This was a 24-month, multicenter, prospective, longitudinal, observational study in patients with schizophrenia who were initiated on RLAT. Physicians could change treatment during the study as clinically warranted. Data were collected at baseline and subsequently every 3 months up to 24 months. Effectiveness outcomes included changes in illness severity as measured by Clinical Global Impression-Severity (CGI-S) scale; functional scores as measured by Personal and Social Performance (PSP) scale, Global Assessment of Functioning (GAF), and Strauss-Carpenter Levels of Functioning (LOF); and health status (Medical Outcomes Survey Short Form-36 [SF-36]). Life-table methodology was used to estimate the cumulative probability of relapse over time. Adverse events were evaluated for safety. RESULTS: 532 patients were enrolled in the study; 209 (39.3%) completed the 24-month study and 305 (57.3%) had at least 12 months of follow-up data. The mean (SD) age of patients was 42.3 (12.8) years. Most patients were male (66.4%) and either Caucasian (60.3%) or African American (23.7%). All changes in CGI-S from baseline at each subsequent 3-month follow-up visit were statistically significant (p < .0001), indicating improvement in disease severity. Improvements were also noted for the PSP, GAF, and total LOF, indicating improvement in daily functioning and health outcome. CONCLUSIONS: Patients with schizophrenia who were initiated on RLAT demonstrated improvements in measures of effectiveness within 3 months, which persisted over 24 months. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00246194.

Resource utilization in patients with schizophrenia who initiated risperidone long-acting therapy: results from the Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE).

BACKGROUND: Schizophrenia is a chronic mental health disorder associated with increased hospital admissions and excessive utilization of outpatient services and long-term care. This analysis examined health care resource utilization from a 24-month observational study of patients with schizophrenia initiated on risperidone long-acting therapy (RLAT). METHODS: Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE) was a 24-month observational study designed to examine real-world treatment outcomes by prospectively following patients with schizophrenia initiated on RLAT. At baseline visit, prior hospitalization and ER visit dates were obtained for the previous 12 months and subsequent hospitalization visit dates were obtained at 3-month visits, if available. The health care resource utilization outcomes measures observed in this analysis were hospitalizations for any reason, psychiatric-related hospitalizations, and emergency room (ER) visits. Incidence density analysis was used to assess pre-event and postevent rates per person-year (PY). RESULTS: The primary medical resource utilization analysis included 435 patients who had a baseline visit, ≥1 postbaseline visits after RLAT initiation, and valid hospitalization dates. The number of hospitalizations and ER visits per PY declined significantly (p < .0001) after initiation with RLAT. A 41% decrease (difference of -0.29 hospitalizations per PY [95% CI: -0.39 to -0.18] from baseline) in hospitalizations for any reason, a 56% decrease (a difference of -0.35 hospitalizations per PY [95% CI: -0.44 to -0.26] from baseline) in psychiatric-related hospitalizations, and a 40% decrease (-0.26 hospitalizations per PY [95% CI: -0.44 to -0.10] from baseline) in ER visits were observed after the baseline period. The percentage of psychiatric-related hospitalizations decreased significantly after RLAT initiation, and patients had fewer inpatient hospitalizations and ER visits (all p < .0001). CONCLUSION: The results suggest that treatment with RLAT may result in decreased hospitalizations for patients with schizophrenia. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00246194.

Changes in schizophrenia-related hospitalization and ER use among patients receiving paliperidone palmitate: results from a clinical trial with a 52-week open-label extension (OLE).

BACKGROUND: Schizophrenia affects ∼1.1% of the United States population, resulting in substantial direct, indirect and societal costs. OBJECTIVE: To evaluate hospitalization rates associated with use of paliperidone palmitate (PP). METHODS: Data were from a variable-duration double-blind (DB), randomized, relapse-prevention comparison (NCT00111189) of PP vs. placebo (Pbo), followed by a 1-year open-label extension (OLE). Between-phase change in schizophrenia-related hospitalizations was evaluated using data from an investigator-completed questionnaire. Change in hospitalizations using patients before enrollment who participated in the OLE phase was also analyzed. Poisson regression was used to evaluate changes in incidence density within exposure category and by schizophrenia duration. RESULTS: A total of 160 patients in the PP-PP group and 153 in the Pbo-PP group from the DB to the OLE phase were included. Mean age (standard deviation [SD]), gender, and duration of schizophrenia were similar at the start of the DB phase (Pbo: 38.5 years [10.6], 51.0% male, 68.0% ≥5 years' duration; PP: 37.3 years [11.4] (p = 0.342); 51.9% male (p = 0.874); 70.0% ≥5 years' duration (p = 0.698), respectively. From the DB to the end of the OLE phase, the number of hospitalizations per person-year for patients treated during the DB phase with Pbo significantly declined from 0.27 to 0.06 (78% reduction; p = 0.005). A statistically nonsignificant difference was observed for PP patients treated during the DB phase with PP (0.11-0.04; 63.6% reduction; p = 0.076), compared with the OLE phase. Change from before enrollment to the end of the OLE phase (n = 381) produced similar results (0.35-0.04; 88.6% reduction; p < 0.001). Patients who enroll in a clinical trial may be different from the general population and this may affect the generalizability of results. CONCLUSION: From the double-blind to the open-label phase and from prior to the trial until the end of the open-label phase, hospitalizations significantly decreased for patients with schizophrenia treated with PP.