Evaluating the Effect of Treatment Persistence on the Economic Burden of Moderate to Severe Psoriasis and/or Psoriatic Arthritis Patients in the U.S. Department of Defense Population.

BACKGROUND: Psoriasis is a chronic, hyper-proliferative dermatological condition associated with joint symptoms known as psoriatic arthritis (PsA). In a 2013 review, the total economic burden of PsA was estimated at $51.7-$63.2 billion. The economic burden of moderate to severe psoriasis patients has reduced significantly with the advent of biologics, but there remains a dearth of real-world evidence of the impact of treatment persistence on the economic burden of moderate to severe psoriasis and/or PsA patients. OBJECTIVE: To evaluate the overall and psoriasis and/or PsA-related health care utilization and costs among patients who were persistent versus those nonpersistent on index biologic among the moderate to severe psoriasis and/or PsA population. METHODS: Adult patients with ≥ 2 claims with diagnosis of psoriasis and/or PsA during the period of November 2010-October 2015 were identified from the U.S. Department of Defense database; the first diagnosis date during November 2011-October 2014 was defined as the index date. As of the index date, patients were considered to have moderate to severe psoriasis or PsA if they had ≥ 1 nontopical systemic therapy or phototherapy during the 1-year pre- or 1-month post-index date. Persistence to index therapy, defined as the first biologic used (etanercept, adalimumab, ustekinumab, infliximab) on or within 30 days post-index date, was determined based on the biologic dosing schedule and a 90-day gap. Generalized linear models were used to compare the health care utilization and costs between persistent and nonpersistent patients during the 1-year post-index period. RESULTS: A total of 2,945 moderate to severe psoriasis and/or PsA patients were identified. Of those, 1,899 (64.5%) were persistent and 1,046 (35.5%) were nonpersistent. Compared with nonpersistent patients, persistent patients were older (49.2 vs. 45.5 years; P < 0.001) and more likely to be male (52% vs. 45%; P < 0.001). More persistent patients were diagnosed with dyslipidemia (40% vs. 35%; P = 0.002), had lower antidepressant use (23.4% vs. 27.4%; P < 0.001), and had lower anxiolytic use (30% vs. 37%; P < 0.001) compared with nonpersistent patients. After adjusting for demographic and clinical characteristics, nonpersistent patients had higher total medical costs ($12,457 vs. $8,964; P < 0.001) compared with persistent patients, and ambulatory visits (23.9 vs. 21.4; P = 0.007) were a major contributor. Approximately 40% of the total overall medical costs were attributed to psoriasis and PsA. Although persistent patients incurred higher pharmacy costs ($10,684 vs. $7,849; P < 0.001) due to higher biologic use and the potentially high per-unit cost of biologics, their psoriasis- and/or PsA-related medical costs were significantly lower than those of nonpersistent patients ($3,395 vs. $5,041; P < 0.001). Total overall costs combining medical and pharmacy costs were similar between the cohorts ($22,678 vs. $21,477; P = 0.122). CONCLUSIONS: Moderate to severe psoriasis and/or PsA patients who were persistent on index biologic treatment had higher pharmacy utilization and costs, albeit with lower medical costs and similar total costs, compared with nonpersistent patients. DISCLOSURES: This study was funded by Janssen Scientific Affairs. Lee is a paid employee of Janssen Scientific Affairs. Xie, Wang, Vaidya, and Baser are paid employees of STATinMED Research, which is a paid consultant to Janssen Scientific Affairs. This study was presented as an abstract at the Academy of Managed Care Pharmacy 2017 Annual Meeting, March 27-30, 2017, in Denver, CO.

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

AIMS: To examine the comorbidity and economic burden among moderate-to-severe psoriasis (PsO) and/or psoriatic arthritis (PsA) patients in the US Department of Defense (DoD) population. MATERIALS AND METHODS: This retrospective cohort claims analysis was conducted using DoD data from November 2010 to October 2015. Adult patients with ≥2 diagnoses of PsO and/or PsA (cases) were identified, and the first diagnosis date from November 2011 to October 2014 was defined as the index date. Patients were considered moderate-to-severe if they had ≥1 non-topical systemic therapy or phototherapy during the 12 months pre- or 1 month post-index date. Patients without a PsO/PsA diagnosis during the study period (controls) were matched to cases on a 10:1 ratio based on age, sex, region, and index year; the index date was randomly selected. One-to-one propensity score matching (PSM) was conducted to compare study outcomes in the first year post-index date, including healthcare resource utilization (HRU), costs, and comorbidity incidence. RESULTS: A total of 7,249 cases and 72,490 controls were identified. The mean age was 48.1 years. After PSM, comorbidity incidence was higher among cases, namely dyslipidemia (18.3% vs 13.5%, p < .001), hypertension (13.8% vs 8.7%, p < .001), and obesity (8.8% vs 6.1%, p < .001). Case patients had significantly higher HRU and costs, including inpatient ($2,196 vs $1,642; p < .0016), ambulatory ($8,804 vs 4,642; p < .001), emergency room ($432 vs $350; p < .001), pharmacy ($6,878 vs $1,160; p < .001), and total healthcare costs ($18,311 vs $7,795; p < .001). LIMITATIONS: Claims data are collected for payment purposes; therefore, such data may have limitations for clinical research. CONCLUSIONS: During follow-up, DoD patients with moderate-to-severe PsO and/or PsA experienced significantly higher HRU, cost, and comorbidity burden.

Dermatologist and Patient Preferences in Choosing Treatments for Moderate to Severe Psoriasis.

INTRODUCTION: The objective of the study was to determine the relative importance (RI) of treatment attributes psoriasis patients and physicians consider when choosing between biologic therapies based on psoriasis severity. METHODS: A discrete choice experiment (DCE) weighting preference for eight sets of hypothetical treatments for moderate or severe psoriasis was conducted. DCE hypothetical treatments were defined and varied on combinations of efficacy, safety, and dosing attributes [frequency/setting/route of administration (ROA)]. RESULTS: When assuming moderate psoriasis in the patient DCE, ROA (RI 29%) and efficacy (RI 27%) drive treatment choices. When assuming severe disease in the DCE, patients preferred treatments with higher efficacy (RI 36%); ROA was relatively less important (RI 15%). From the physician perspective, ROA (RI 32%) and efficacy (RI 26%) were most important for moderate psoriasis patients. In the physician model for severe psoriasis, efficacy (RI 42%) was the predominant driver followed by ROA (RI 22%). Regardless of severity, probability of loss of response within 1 year was the least important factor. CONCLUSIONS: The severity of disease is a critical element in psoriasis treatment selection. There are high levels of alignment between physician- and patient-derived preferences in biologic treatment choice selection for psoriasis. FUNDING: Janssen Pharmaceuticals.

Patient Preference for Dosing Frequency Based on Prior Biologic Experience.

BACKGROUND: There is limited research exploring patient preferences regarding dosing frequency of biologic treatment of psoriasis. METHODS: Patients with moderate-to-severe plaque psoriasis identified in a healthcare claims database completed a survey regarding experience with psoriasis treatments and preferred dosing frequency. Survey questions regarding preferences were posed in two ways: (1) by likelihood of choosing once per week or 2 weeks, or 12 weeks; and (2) by choosing one option among once every 1-2 or 3-4 weeks or 1-2 or 2-3 months. Data were analyzed by prior biologic history (biologic-experienced vs biologic-naïve, and with one or two specific biologics). RESULTS: Overall, 426 patients completed the survey: 163 biologic-naïve patients and 263 biologic-experienced patients (159 had some experience with etanercept, 105 with adalimumab, and 49 with ustekinumab). Among patients who indicated experience with one or two biologics, data were available for 219 (30 with three biologics and 14 did not specify which biologic experience). The majority of biologic-naïve (68.8%) and overall biologic-experienced (69.4%) patients indicated that they were very likely to choose the least frequent dosing option of once every 12 weeks (Table 1). In contrast, fewer biologic-naïve (9.1% and 16.7%) and biologic-experienced (22.5% and 25.3%) patients indicated that they were very likely to choose the 1-week and 2-week dosing interval options, respectively. In each cohort grouped by experience with specific biologics, among those with no experience with ustekinumab, the most chosen option was 1-2 weeks. The most frequently chosen option was every 2-3 months, among patients with any experience with ustekinumab, regardless of their experience with other biologics. CONCLUSIONS: The least frequent dosing interval was preferred among biologic naïve patients and patients who had any experience with ustekinumab. Dosing interval may influence the shared decision-making process for psoriasis treatment with biologics.

J Drugs Dermatol. 2017;16(3):220-226.

Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]).

BACKGROUND: Comparing effectiveness of biologics in real-world settings will help inform treatment decisions. OBJECTIVES: We sought to compare therapeutic responses among patients initiating infliximab, adalimumab, or etanercept versus ustekinumab during the Psoriasis Longitudinal Assessment and Registry (PSOLAR). METHODS: Proportions of patients achieving a Physician Global Assessment score of clear (0)/minimal (1) and mean decrease in percentage of body surface area with psoriasis were evaluated at 6 and 12 months. Adjusted logistic regression (Physician Global Assessment score 0/1) and analysis of covariance (percentage of body surface area with psoriasis) were performed to determine treatment factors associated with effectiveness. RESULTS: Of 2541 new users on registry, 2076 had efficacy data: ustekinumab (n = 1041), infliximab (n = 116), adalimumab (n = 662), and etanercept (n = 257). Patients receiving tumor necrosis factor-alpha(-α) inhibitors were significantly less likely to achieve Physician Global Assessment score 0/1 versus ustekinumab (infliximab [odds ratio {OR} 0.396, P < .0001], adalimumab [OR 0.686, P = .0012], etanercept [OR 0.554, P = .0003] at 6 months and infliximab [OR 0.449, P = .0040] at 12 months). Mean decrease in percentage of body surface area with psoriasis was significantly greater for ustekinumab versus adalimumab (point estimate 1.833, P = .0020) and etanercept (point estimate 3.419, P < .0001) at 6 months and versus infliximab (point estimate 3.945, P = .0005) and etanercept (point estimate 2.778, P = .0007) at 12 months. LIMITATIONS: Treatment selection bias and limited data for doing adjustments are limitations. CONCLUSIONS: In PSOLAR, effectiveness of ustekinumab was significantly better versus all 3 tumor necrosis factor-α inhibitors studied for the majority of comparisons at 6 and 12 months.

Characterizing patients with psoriasis on injectable biologics adalimumab, etanercept, and ustekinumab: A chart review study.

OBJECTIVE: This study examined plaque psoriasis (PsO) patient characteristics across injectable biologics. METHODS: Data were collected from 400 US dermatologists randomly selecting five charts each for patients with PsO (patient n = 2000): adalimumab (ADA; n = 447), etanercept (ETA; 539), ustekinumab (UST) 45 mg (511) and UST 90 mg (503). Physicians had to have been in practice 2-30 years, managing 10+ patients (5 + with biologics for PsO). Generalized estimating equation models, weighted according to inverse probability of patient selection and accounting for patient correlation within physicians, examined patient measures as a function of treatment (UST 90 mg = reference). RESULTS: Patients on UST 90 mg had higher odds of weighing >100 kg (adjusted mean = 34.4%) vs. ADA (10.9%), ETA (5.5%) or UST 45 mg (6.8%), greater body surface affected and higher odds of severe PsO prior to treatment and higher odds of prior biologics use. Mean prior biologics used was higher with UST 90 mg versus ADA or ETA. Number of comorbidities was higher with UST 90 mg versus ETA or UST 45 mg. CONCLUSIONS: Among biologics-treated patients with PsO, UST 90 mg appears to be used in patients with greater weight, baseline severity and prior biologics experience than ADA, ETA or UST 45 mg. UST 90 mg is used in patients with more comorbidities than other treatments except ADA.

Patient reported health outcomes and non-adherence in psoriasis patients receiving adalimumab or ustekinumab for moderate to severe plaque psoriasis.

OBJECTIVE: The objective of this study is to compare health outcomes of patients using biologic therapies ustekinumab (UST) or adalimumab (ADA) for moderate-to-severe plaque psoriasis (PsO) and assess biologics non-adherence. METHODS: Two phases of web-based survey data were collected, assessing adult patients with PsO from a Diplomat® Specialty Pharmacy US claims database (Diplomat Specialty Pharmacy; Flint, MI). Measures included demographics, treatment and health characteristics/behaviors, treatment satisfaction, health-related quality of life (HRQoL), and productivity. Pooled and stratified (by biologics experience) bivariate and multivariable analyses were conducted. RESULTS: UST (n = 262) versus ADA (n = 83) users more frequently had psoriasis cleared (40.5% versus 15.4%, respectively, with no visible signs), better HRQoL as per Dermatology Life Quality Index (DLQI) score = 0 (45.2% versus 19.2%), and higher current effectiveness satisfaction, all p < 0.05. Adjusting for covariates, UST versus ADA bio-naïve patients (n = 68) had better (53.4% lower) DLQI scores, lower percent body surface affected (%BSA; 0.85 versus 1.43), more %BSA improvement (-1.60 versus -1.03), and lower activity impairment (90.4% lower), all p < 0.05. Non-adherence to UST (11.8%) versus ADA (32.5%) was lower, p < 0.05, and more access versus forgetfulness-related. However, no significant differences emerged on outcomes between overall or bio-experienced UST and ADA users. CONCLUSIONS: UST versus ADA PsO bio-naïve patients reported higher clearing rates, better DLQI, and lower activity impairment.

Patient-reported treatment satisfaction and choice of dosing frequency with biologic treatment for moderate to severe plaque psoriasis.

BACKGROUND: Moderate to severe plaque psoriasis has a serious effect on health-related quality of life. Patients treated with biologic medications place importance on satisfaction and treatment frequency options. We assessed patient-reported treatment satisfaction and dosing frequency choice with biologics. METHODS: We used a health care claims database to identify patients with moderate to severe plaque psoriasis. Participants completed the Treatment Satisfaction Questionnaire for Medication. Results were compared between patients experienced with biologics (adalimumab, etanercept, or ustekinumab) or not (cyclosporine or methotrexate). Participants were asked for their choices of dosing options of once every 1-2 weeks, 3-4 weeks, 1-2 months, or 2-3 months. Participants were also asked for their choices of dosing options of every 1, 2, 3, and so on up to every 12+ weeks. RESULTS: A total of 426 patients completed the survey (263 biologic-experienced and 163 biologic-naïve patients). Patient satisfaction with psoriasis treatment was significantly higher in the biologic-experienced cohort. The most frequently chosen option (38.8% of all participating patients) was every 2-3 months; 37.3% chose once every 1-2 weeks. Significant differences were found in the percentage of biologic-naïve patients choosing 2-3-month (49.7%) over 1-2-week (20.9%) dosing (P<0.001). Among biologic-experienced patients, the difference between the percentage of patients choosing the 2-3-month (35.7%) and 1-2-week (41.8%) options was not significant (P=0.264). The two most often week-specific intervals chosen by biologic-naïve patients were 12+ weeks (42.3%) and 4 weeks (15.6%). The biologic-experienced patients most often chose 12+ weeks (31.2%) and 1 week (25.9%). CONCLUSION: Patients using biologics reported satisfaction with their treatment, which may positively affect outcomes. Longer dosing intervals were chosen most frequently among all patients combined. Reports of patient satisfaction with prior treatments and choices regarding dosing frequency, among all other considerations, should be evaluated in determining an appropriate biologic medication for psoriasis.

Cost-effectiveness of telaprevir in combination with pegylated interferon alpha and ribavirin in previously untreated chronic hepatitis C genotype 1 patients.

BACKGROUND: Telaprevir (T, TVR) is a direct-acting antiviral (DAA) used for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. The sustained virological response (SVR) rates, i.e., undetectable HCV RNA levels 24 weeks after the end of treatment, is what differentiate treatments. This analysis evaluated the cost-effectiveness of TVR combined with pegylated interferon (Peg-IFN) alfa-2a plus ribavirin (RBV), with Peg-IFN and RBV (PR) alone or with boceprevir (B, BOC) plus Peg-IFN alfa-2b and RBV, in naïve patients. METHODS: A Markov cohort model of chronic HCV disease progression reflected the pathway of naïve patients initiating anti-HCV therapy. SVR rates were derived from a mixed-treatment comparison including results from Phase II and III trials of TVR and BOC, and trials comparing both PR regimens. SVR has significant impact on survival, quality-of-life, and costs. Incremental cost per life year (LY) gained and quality-adjusted-life-year (QALY) gained were computed at lifetime, adopting the (National Health Service) NHS perspective. Cost and health outcomes were discounted at 3.5%. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. Sub-group analyses were also performed by interleukin (IL)-28B genotype and fibrosis stage. RESULTS: Higher costs and improved outcomes were associated with T/PR relative to PR alone, resulting in an ICER of £12,733 per QALY gained. T/PR retained a significant SVR advantage over PR alone and was cost-effective regardless of IL-28B genotype and fibrosis stages. T/PR regimen 'dominated' B/PR, generating 0.2 additional QALYs and reducing lifetime cost by £2758. Sensitivity analyses consistently resulted in ICERs less than £30,000/QALY for the T/PR regimen over PR alone. LIMITATIONS: No head-to-head trial provides direct evidence of better efficacy of T/PR vs B/PR. CONCLUSION: The introduction of TVR-based therapy for genotype 1 HCV patients is cost-effective for naïve patients at the £30,000 willingness-to-pay threshold, regardless of IL-28B genotype or fibrosis stage.

Cost-effectiveness of telaprevir in combination with pegylated interferon alpha and ribavirin in treatment-experienced chronic hepatitis C genotype 1 patients.

BACKGROUND: Telaprevir (TVR,T) and boceprevir (BOC,B) are direct-acting antivirals (DAAs) used for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection. This analysis evaluated the cost-effectiveness of TVR combined with pegylated interferon (Peg-IFN) alfa-2a plus ribavirin (RBV) compared with Peg-IFN alfa-2a and RBV (PR) alone or BOC plus Peg-IFN alfa-2b and RBV in treatment-experienced patients. METHODS: A Markov cohort model of chronic genotype 1 HCV disease progression reflected the pathway of experienced patients retreated with DAA therapy. The population was stratified by previous response to treatment (i.e., previous relapsers, partial responders, and null responders). Sustained virologic response (SVR) rates were derived from a mixed-treatment comparison that included results from separate Phase III trials of TVR and BOC. Incremental cost per life year (LY) gained and quality-adjusted-life-year (QALY) gained were computed at lifetime, adopting the NHS perspective. Costs and health outcomes were discounted at 3.5%. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. Sub-group analyses were carried out by interleukin (IL)-28B genotype. RESULTS: Higher costs and improved outcomes were associated with T/PR relative to PR alone for all experienced patients (ICER of £6079). T/PR was cost-effective for each sub-group population with high SVR advantage in relapsers (ICER of £2658 vs £7593 and £20,875 for partial and null responders). T/PR remained cost-effective regardless of IL-28B sub-type. Compared to B/PR, T/PR prolonged QALYs by 0.57 and reduced lifetime costs by £13,960 for relapsers. For partial responders T/PR was less costly but less efficacious than B/PR, equating to an ICER of £128,117 per QALY gained. LIMITATIONS: No head-to-head trial provides direct evidence of better efficacy of T/PR vs B/PR. CONCLUSION: T/PR is cost-effective compared with PR alone in experienced patients regardless of treatment history and IL-28B genotype. Compared to B/PR, T/PR is always cost-saving but only more effective in relapsers.

The burden of influenza complications in different high-risk groups: a targeted literature review.

OBJECTIVES: The objective was to review the published literature on seasonal influenza to assess the differences between complications and mortality rates for those adults at high risk of influenza complications, including the resource use of those hospitalized with influenza complications. METHODS: A targeted literature review was performed using electronic database keyword searches, specific inclusion criteria, quality rating of the reviewed full-text articles and abstraction of data to present published evidence on the incidence, complication rates and health service use associated with clinical influenza in different adult high-risk groups including those who are aged 65 years and older or those with different chronic underlying medical conditions. RESULTS: Key findings for incidence rates of clinical influenza were that incidence rates are similar among people with chronic cardiovascular or respiratory comorbidity, and may be higher in those with allogeneic stem cell transplants compared to those with autologous transplants. Rates of hospitalization and/or pneumonia or lower respiratory tract infection for those with chronic conditions or those who are immunocompromised are substantially higher than those in people over age 65 but without additional high-risk factors. A person who is hospitalized and has a laboratory-confirmed influenza diagnosis has a probability of intensive care unit admission of between 11.8-28.6% and of death of between 2.9-14.3%. CONCLUSIONS: These findings indicate that although the burden of influenza varied across high-risk groups, it also varied widely across studies within a single high-risk group. A key finding was that those over 65 years of age but without additional high-risk factors had a low risk of influenza complications. A limitation of the review is that most of the studies of hospitalized patients did not present outcomes data separately by high-risk group and only limited data were identified on rates of hospitalization or lower respiratory tract infection for most high-risk groups. Information about influenza complication rates and resource use, including influenza vaccines, chemoprophylaxis and/or treatment strategies for different high-risk groups, is needed to evaluate new interventions.

Medication adherence and hospitalization among patients with schizophrenia treated with antipsychotics.

OBJECTIVE: This analysis assessed rates of medication adherence and predictors of nonadherence and hospitalization among patients treated with long-acting injectable and oral antipsychotic therapies. METHODS: Data were from a retrospective analysis of Florida Medicaid recipients with schizophrenic disorder (ICD-9-CM code 295.XX) who received a prescription for an antipsychotic between July 1, 2004, and June 30, 2005. Patients were required to have filled one additional antipsychotic prescription during follow-up. Adherence measures included medication possession ratio (MPR), medication persistence, medication consistency, and maximum gap in treatment. Multivariate logistic regression models identified predictors of nonadherence and hospitalization. RESULTS: Patients were considered adherent if they had an MPR ≥ .8. A total of 12,032 patients met selection criteria. The mean ± SD MPR was .79 ± .23, medication persistence was 94.1% ± 16.4%, medication consistency was 83.3% ± 16.4%, and the maximum gap in treatment was 29.7 ± 41.4 days. Thirty-seven percent of patients were hospitalized for any cause, and 32% had a psychiatric hospitalization. Predictors of nonadherence included newly starting treatment; younger age; a substance abuse diagnosis; use of a mood stabilizer, antidepressant, anxiolytic, or anticholinergic; and receipt of long-acting first-generation antipsychotics. Receipt of long-acting second-generation therapy or receipt of both first- and second-generation medications was associated with lower likelihood of nonadherence. Predictors of hospitalization risk included a diagnosis of other psychoses or substance abuse, anticholinergic use, and nonadherence to therapy. CONCLUSIONS: Results document rates of antipsychotic adherence and predictors of nonadherence and hospitalization. Findings may be useful to health plan administrators, formulary decision makers, and physicians.

Effectiveness of guideline-recommended cardiac drugs for reducing mortality in the elderly medicare heart failure population: a retrospective, survey-weighted, cohort analysis.

BACKGROUND: Heart failure (HF) management guidelines recommend that most patients with HF receive an ACE inhibitor or an angiotensin II type 1 receptor antagonist (angiotensin receptor blocker [ARB]) and a ß-blocker (ß-adrenoceptor antagonist), collectively referred to as 'cardiac drugs', based on results from randomized controlled trials showing that these drugs reduce mortality. However, the results of randomized controlled trials may not be generalizable to the population most likely (i.e. the elderly) to receive these drugs in clinical practice. OBJECTIVE: To determine the effectiveness of cardiac drugs for reducing mortality in the elderly Medicare HF population. STUDY DESIGN: Retrospective, survey-weighted, cohort analysis of the 2002 Medicare Current Beneficiary Survey Cost and Use files. PARTICIPANTS: 12 697 beneficiaries, of whom 1062 had a diagnosis of HF and 577 were eligible to receive cardiac drugs. MEASUREMENTS: Association between mortality and cardiac drugs, adjusted for sociodemographics, co-morbidity and propensity to receive cardiac drugs. RESULTS: The mortality rate among the 577 eligible beneficiaries with HF was 9.7%. The mortality rate for those receiving an ACE inhibitor or ARB alone, a ß-blocker alone, or both an ACE inhibitor or ARB and a ß-blocker, was 6.1%, 5.9% and 5.3%, respectively; in the absence of any of the three cardiac drugs, the mortality rate was 20.0% (p < 0.0001). In multivariable analyses, mortality rates remained significantly lower for beneficiaries receiving an ACE inhibitor or ARB alone (odds ratio [OR] 0.24; 95% CI 0.11, 0.50), a ß-blocker alone (OR 0.17; 95% CI 0.07, 0.41), or both an ACE inhibitor or ARB and a ß-blocker (OR 0.24; 95% CI 0.10, 0.55) compared with patients who did not receive any of the three cardiac drugs. CONCLUSIONS: Use of guideline-recommended cardiac drugs is associated with reduced mortality in the elderly Medicare HF population. Providing evidence of the benefit of cardiac drugs among the elderly with HF will become increasingly important as the size of the Medicare population grows.

Effect of ustekinumab on physical function and health-related quality of life in patients with psoriatic arthritis: a randomized, placebo-controlled, phase II trial.

OBJECTIVE: To use data from a phase II clinical trial to evaluate the effect of ustekinumab, a human immunoglobulin monoclonal antibody that binds with high affinity to the shared p40 subunit of human interleukins-12 and -23, on physical disability and health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA). METHODS: In this multicenter, double-blind, placebo-controlled, crossover study of ustekinumab, patients with active PsA were randomized (1:1 ratio) to receive either ustekinumab at weeks 0, 1, 2, and 3 and placebo at weeks 12 and 16 (n = 76) or placebo at weeks 0, 1, 2, and 3 and ustekinumab at weeks 12 and 16 (n = 70). Physical function was assessed using the disability index from the Health Assessment Questionnaire-Disability Index (HAQ-DI) in all randomized patients. HRQoL was evaluated using the Dermatology Life Quality Index (DLQI) in a subset of patients (84.9%) with at least 3% body surface area (BSA) psoriasis involvement at baseline. RESULTS: At baseline, overall mean HAQ-DI and DLQI scores were 0.9 and 11.5, respectively, indicating impaired physical function and moderate effect on HRQoL. At week 12, ustekinumab patients had significantly more improvement (decrease) in the mean HAQ-DI (-0.31) and DLQI (-8.6) scores versus placebo (-0.04 and -0.8, respectively; p < 0.001 for both comparisons). At week 12, 58.7% (37/63) of ustekinumab-treated patients had a DLQI score of 0 or 1 (no negative effect of disease or treatment on HRQoL) versus 5.5% (3/55) for placebo (p < 0.001). The results also indicated a positive but weak correlation between improvement in physical function and HRQoL, pain, and skin response as well as between improvement in joint and skin responses in patients receiving ustekinumab or placebo. Potential limitations of the study include the short duration of the placebo-controlled period and the relatively small patient population. CONCLUSION: Ustekinumab significantly improved physical function and HRQoL in patients with PsA and psoriasis involving at least 3% BSA.

The burden of psoriatic arthritis: a literature review from a global health systems perspective.

OBJECTIVE: We sought to evaluate the clinical, economic, and humanistic burden of illness in patients with psoriatic arthritis (PsA). STUDY DESIGN: We performed a literature review. METHODS: Our literature search, conducted between 1998 and 2009, included published studies that (1) considered the direct and indirect costs of PsA; reported measures of clinical burden, including mortality, physical function, quality of life, and productivity; and (3) reported comorbid conditions in patients with PsA. RESULTS: We retrieved and reviewed a total of 49 studies. Compared with the general population, patients with PsA had lower health-related quality of life and an increased risk of co-morbid conditions, especially cardiovascular disease. In the U.S., the direct annual health care costs for PsA are estimated to be as high as $1.9 billion. Total indirect costs associated with PsA account for 52% to 72% of total costs. Both direct and indirect costs of PsA increase with worsening physical function and disease activity. CONCLUSION: PsA imposes a considerable economic and quality-of-life burden to patients and society. Clinical features of PsA, including comorbid conditions and disease activity, contribute to reduced physical and psychosocial health-related quality of life. The clinical burden of PsA contributes to direct medical costs attributable to the utilization of health care resources. As a result of the physical functioning limitations imposed by PsA, indirect costs such as disability and lost productivity are substantial drivers of the total costs of care.

Darbepoetin alfa therapeutic interchange protocol for anemia in dialysis.

BACKGROUND: Erythropoiesis-stimulating proteins, such as erythropoietin alfa and darbepoetin alfa, have positively impacted anemia management. These medications improve patient outcomes and quality of life. Their costs, however, remain a major barrier for health systems. OBJECTIVE: To evaluate the development, implementation, and cost-effectiveness of an inpatient therapeutic interchange protocol for erythropoiesis-stimulating proteins at a large, tertiary care, university-affiliated health system. METHODS: Virginia Commonwealth University Health System (VCUHS) developed and implemented a therapeutic interchange program to convert therapy for all inpatients undergoing dialysis from erythropoietin alfa to darbepoetin alfa for treatment of chronic kidney disease-related anemia. An evaluation of the economic impact of this program on drug expenditures over a fiscal quarter (2003) was conducted using historical comparator data (2002). RESULTS: Preliminary evaluation of the program demonstrated cost-savings and reduced drug utilization of erythropoiesis-stimulating proteins in hospitalized dialysis patients. For the first quarter of 2003 compared with the first quarter of 2002, VCUHS realized a cost-savings of nearly 10,000 US dollars, which was related to the program's aggressive screening procedure. When these data were normalized for equal numbers of patients in each group receiving one of the drugs, the actual cost-savings was over 2000 US dollars. These cost-savings are largely due to reduced utilization of these expensive biotechnology products with implementation of a dosing protocol. CONCLUSIONS: VCUHS has successfully developed and implemented a darbepoetin alfa therapeutic interchange protocol for hospitalized dialysis patients. This has translated into reduced use of erythropoiesis-stimulating proteins, resulting in cost-savings for the health system.