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.

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.

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.

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.

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.

Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium.

BACKGROUND: Because wide variations in mental health care utilization exist throughout the world, determining long-term effectiveness of psychotropic medications in a real-world setting would be beneficial to physicians and patients. The purpose of this analysis was to describe the effectiveness of injectable risperidone long-acting therapy (RLAT) for schizophrenia across countries. METHODS: This was a pragmatic analysis of data from two prospective observational studies conducted in the US (Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation [SOURCE]; ClinicalTrials.gov registration number for the SOURCE study: NCT00246194) and Spain, Australia, and Belgium (electronic Schizophrenia Treatment Adherence Registry [eSTAR]). Two separate analyses were performed to assess clinical improvement during the study and estimate psychiatric hospitalization rates before and after RLAT initiation. Clinical improvement was evaluated using the Clinical Global Impressions-Severity (CGI-S) and Global Assessment of Functioning (GAF) scales, and change from baseline was evaluated using paired t tests. Psychiatric hospitalization rates were analyzed using incidence densities, and the bootstrap resampling method was used to examine differences between the pre-baseline and post-baseline periods. RESULTS: The initial sample comprised 3,069 patients (US, n = 532; Spain, n = 1,345; Australia, n = 784; and Belgium, n = 408). In all, 24 months of study participation, completed by 39.3% (n = 209), 62.7% (n = 843), 45.8% (n = 359), and 64.2% (n = 262) of patients from the US, Spain, Australia, and Belgium, respectively, were included in the clinical analysis. Improvements compared with baseline were observed on both clinical assessments across countries (P < 0.001 at all post-baseline visits). The mean improvement was approximately 1 point on the CGI-S and 15 points on the GAF. A total of 435 (81.8%), 1,339 (99.6%), 734 (93.6%), and 393 (96.3%) patients from the US, Spain, Australia, and Belgium, respectively, had ≥1 post-baseline visit and were included in the analysis of psychiatric hospitalization rates. Hospitalization rates decreased significantly in all countries regardless of hospitalization status at RLAT initiation (P < 0.0001) and decreased significantly in the US and Spain (P < 0.0001) when the analysis was limited to outpatients only. CONCLUSIONS: RLAT in patients with schizophrenia was associated with improvements in clinical and functional outcomes and decreased hospitalization rates in the US, Spain, Australia, and Belgium, despite differences in health care delivery systems.

Predicting hospital admission and discharge with symptom or function scores in patients with schizophrenia: pooled analysis of a clinical trial extension.

BACKGROUND: The purpose of this analysis was to evaluate relationships between hospital admission or discharge and scores for symptom or functioning in patients with schizophrenia. METHODS: Data were from three 52-week open-label extensions of the double-blind pivotal trials of paliperidone extended-release (ER). Symptoms and patient function were measured every 4 weeks using the Personal and Social Performance (PSP) scale and the Positive and Negative Syndrome Scale (PANSS). The intent-to-treat analysis set was defined as open-label patients who had at least one post-baseline PSP and PANSS measurement. Time until first hospitalization was evaluated using the Cox proportional hazard model with categorical time-dependent measures for the PSP (1 to 30, 31 to 70, 71 to 100) or PANSS (< 75, >/= 75 to < 95, >/= 95), as well as age, gender, schizophrenia duration, and country. Similar analyses were performed for time to discharge. RESULTS: Of the 1,077 enrolled patients, 1,028 (95.5%) met study criteria; of these, 382 (37.2%) were hospitalized at open-label baseline. Compared with patients with PSP >/= 71 group, the hazard for new hospitalization was 8.351 times greater (P = 0.0001) for patients with the poorest functioning (PSP 1 to 30) and 1.977 times greater (P = 0.0295) for patients with PSP of 31-70 compared to the >/= 71 group. The hazard for new hospitalization was 5.457 times greater (P < 0.0001) for patients PANSS >/= 95 and 2.316 times greater (P = 0.0027) for the >/= 75 to < 95 group compared with the < 75 group. For patients hospitalized at baseline, the PANSS >/= 95 patients had a discharge hazard that was 0.456 times lower than for the < 75 patients (P < 0.0001). The hazard for discharge was 0.646 times lower (P = 0.0012) for the PANSS >/= 75 to < 95 group compared with the < 75 group. A patient's country was a significant predictor variable, with US patients being admitted and discharged faster. CONCLUSIONS: Better functioning or being less symptomatic is associated with reduced risk for hospitalization and greater chance for early discharge. Treatments or programs that reduce symptoms or improve function decrease the risk of hospitalization in community patients or increase the chance of discharge for hospitalized patients.

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.

Chronic anemia and fatigue in elderly patients: results of a randomized, double-blind, placebo-controlled, crossover exploratory study with epoetin alfa.

OBJECTIVES: To evaluate the effect of epoetin alfa treatment on hemoglobin (Hb), fatigue, quality of life (QOL), and mobility in elderly patients with chronic anemia. DESIGN: An exploratory, 32 week, randomized, double-blind, crossover treatment trial. PARTICIPANTS: Sixty-two community-dwelling individuals aged 65 and older with chronic anemia (Hb < or =11.5 g/dL). INTERVENTION: Subcutaneous epoetin alfa or placebo weekly for 16 weeks (Phase I) with crossover to the opposite treatment (Phase II). MEASUREMENTS: Hb and QOL scores from the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Mobility was assessed as a secondary outcome using the Timed Up and Go (TUG) test. RESULTS: Of the 62 subjects enrolled, complete data were analyzed for 58 in Phase I and 54 participants in Phase II. Of those enrolled, most were African American (95%) and female (85%) and had multiple comorbidities and a mean age+/-standard deviation of 76.1+/-7.2. Mean baseline Hb was 10.5+/-0.9 g/dL (7.3-11.5). In Phase I, 67% of those taking epoetin alfa, and in Phase II, 69% of those taking epoetin alfa had an increase in Hb of more than 2 g/dL, significantly more than those taking placebo (P<.001). Similarly, elderly participants significantly improved on the fatigue and anemia subscales of the FACIT across phases (all P<.05). No significant differences were found between treatment and placebo on TUG scores. Epoetin alfa was well tolerated. CONCLUSION: In this trial involving predominantly older African-American women with anemia, a direct relationship existed between increases in Hb during epoetin alfa therapy and improvements in fatigue and QOL.

Risk of diabetic ketoacidosis after exposure to risperidone or olanzapine.

BACKGROUND: Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE: To assess diabetic ketoacidosis risk in patients receiving risperidone or olanzapine. METHODS: California Medicaid data were evaluated for the presence of a diabetic ketoacidosis hospital claim (9th Edition of the International Classification of Diseases code 2501x) for patients receiving an atypical antipsychotic agent between July 1997 and September 2000. Initial prescription claims were identified for risperidone, olanzapine, clozapine, quetiapine and multiple atypical medications; however, the final analysis was restricted to risperidone and olanzapine owing to sample size challenges in the clozapine and quetiapine groups. Cases were specified if a claim occurred within 45 days after antipsychotic dispensation. Potential confounding variables and duration of antipsychotic exposure were included. RESULTS: Initial users of risperidone (n = 51,330; 31 diabetic ketoacidosis) and olanzapine (n = 51,302; 55 diabetic ketoacidosis) were identified between July 1997 and September 2000. The adjusted risk of diabetic ketoacidosis for olanzapine versus risperidone was 1.62 (p = 0.033). The risk of diabetic ketoacidosis was associated with a longer duration of drug exposure. A progressive and statistically significant divergence in risk was observed between the two treatment groups after the first 30 days of therapy. For risperidone patients, diabetic ketoacidosis risk stabilised after the first 90 days; for olanzapine patients, diabetic ketoacidosis risk continued to increase until 360 days (study duration). For exposures of >30 days, >90 days and >180 days, diabetic ketoacidosis risk was 1.7 (p = 0.026), 2.4 (p = 0.004) and 3.5 (p = 0.001) times greater for olanzapine than risperidone. Treatment group, age, African American race and the presence of schizophrenia or diabetes were significant predictors of diabetic ketoacidosis. CONCLUSION: The risk of diabetic ketoacidosis appears to be greater for patients exposed to olanzapine compared with risperidone after adjusting for confounding factors. This risk appears to increase with longer duration of exposure to olanzapine.

Development and validation of a patient satisfaction and preference questionnaire for inhalation devices.

INTRODUCTION: The Patient Satisfaction and Preference Questionnaire (PASAPQ) is a multi-item measure of respiratory inhalation device satisfaction and preference designed to be easily understood and administered to patients with asthma and COPD. This study assessed its validity, reliability and responsiveness and explored the between-group difference in PASAPQ scores that is meaningful. METHODS: The field test version was developed using literature, focus groups and expert opinion. Item reduction followed. The assessment of the validity, reliability and responsiveness of the PASAPQ utilized data from two clinical studies comparing devices delivering the same medication, and was performed with pre-specified criteria. A minimally important difference (MID) was estimated using both anchor- and distribution-based approaches. RESULTS: Two factors of the PASAPQ, 'performance' and 'convenience', were consistent across studies. Missing and out-of-range data were minimal (<1%) and respondents used a full range of response options. All items correlated most highly with their hypothesized scale and all exceeded the minimum correlation criteria of 0.40. Cronbach's alfa was high (0.87-0.94), providing support for internal reliability for the PASAPQ. Correlations of the overall satisfaction item with the performance domain ranged from 0.78 to 0.91, the convenience domain ranged from 0.54 to 0.71, and the total score ranged from 0.78 to 0.90. These moderate-to-strong correlations provide substantial support for the validity of the PASAPQ domains and total score. Discriminate validity was assessed by calculating PASAPQ scores for patients' ratings of the device that they preferred compared with the other, non-preferred device. The preferred device was rated higher on all satisfaction measures, supporting the ability of the PASAPQ to discriminate between preferred and non-preferred devices. Although a difference of 3 or 4 points may be sufficient to observe a small effect difference between groups, most of the MID estimates were in the 8-10 point range. DISCUSSION AND CONCLUSION: Our analyses across asthma, COPD and patients with mixed respiratory disease (with features of both COPD and asthma), study designs and data sets lead us to conclude that the PASAPQ is a practical, valid, reliable and responsive instrument for measuring respiratory device satisfaction. Furthermore, a difference in satisfaction scores between treatment groups of 10 points is, conservatively, a difference that is meaningful to patients.

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.

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.

Almotriptan versus sumatriptan in migraine treatment: direct medical costs of managing adverse chest symptoms.

OBJECTIVE: Triptans, a popular class of drugs for treatment of migraine headaches, can cause adverse events including chest symptoms. This study estimated the direct medical costs of managing chest symptoms in patients treated for acute migraine with almotriptan or sumatriptan using an economic model. METHODS: The economic model of this study combined data from a randomized clinical trial that compared almotriptan with sumatriptan and data from a practice pattern survey of physicians. The pertinent clinical evaluation period was the time immediately after administration of the first medication dose. The model was developed from the perspective of a managed care payer. RESULTS: The average direct medical cost of managing chest symptoms that appeared after the first dose of an oral triptan was $0.22 for patients treated with almotriptan and $1.64 for patients treated with sumatriptan, a difference of $1.42 per patient. CONCLUSION: Relative to sumatriptan, treatment with almotriptan is likely to reduce patient care costs associated with chest symptom adverse events.

Can smallpox response teams use the experience of disease management programs?

Any attempt to widely disperse smallpox vaccinations will necessitate educating people about the risks and benefits of vaccination. Most disease management programs have extensive experience in distributing educational materials and programs to health care workers and patients as well as in tracking response to interventions. Can this experience lend a hand in the event of widespread vaccination?

A comparison of office-based physician visits for irritable bowel syndrome and for migraine and asthma.

Three years of data from the National Ambulatory Medical Care Survey were analyzed to assess resource utilization for patients with irritable bowel syndrome (IBS), asthma, and migraine. Adjusted for prevalence, IBS-related physician visits occurred at approximately the same rate as those for asthma and 2.6 times the rate of visits for migraine. Specialist consultations for IBS were of similar frequency to those for migraine and more frequent than those for asthma. Diagnostic and screening tests were ordered more often during IBS-related visits than during migraine- or asthma-related visits. Prescription rates were similar for all three conditions. In terms of resource consumption, this chronic disorder places a burden on patients that is comparable with that of such costly conditions as asthma and migraine.

Clinical and economic implications of topical cyclosporin A for the treatment of dry eye.

The purpose of this study was to investigate clinical, economic, and patient-reported outcomes related to topical cyclosporin A for the treatment of dry eye. The medical records of 181 patients with dry eye were reviewed (mean age, 67.6 yr; 72% women) for up to two years (average follow-up, 1.34 yr) before and after treatment with cyclosporin A 0.05% ophthalmic solution administered topically twice daily. Corneal staining, average discomfort scores, and patient satisfaction markedly improved, whereas the number of prescriptions for ancillary medications and dry eye-related visits to the ophthalmologist declined significantly during the treatment period. In a naturalistic clinical setting, topical cyclosporin A therapy improved the signs and symptoms of dry eye disease, resulting in high patient satisfaction, fewer patients with chronic dry eye visiting the ophthalmologist, and less ancillary drug use.

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.

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.