Search

BACKGROUND: In oncology, especially with accelerated regulatory approvals and niche populations, US payers appreciate all evidence that can help support formulary decision making, including evidenc...

Aim: HTX-011 (ZYNRELEF™) is an extended-release, dual-acting local anesthetic containing bupivacaine and meloxicam. In bunionectomy and herniorrhaphy studies, HTX-011 resulted in less postoperative pain and less opioid consumption versus bupivacaine HCl. Here we evaluate HTX-011 in patients aged ≥65 years. Materials & methods: Patients received placebo, bupivacaine HCl or HTX-011 following surgery. End points included pain intensity, total opioid consumption, opioid-free patients and safety. Results: HTX-011-treated patients reported lower postoperative pain through 72 h versus bupivacaine HCl and placebo. Elderly patients administered HTX-011 used fewer opioids versus bupivacaine HCl, and a greater proportion remained opioid-free through 72 h. HTX-011 was well tolerated with a safety profile similar to bupivacaine HCl and placebo. Conclusion: HTX-011 maintained effectiveness and was well tolerated in elderly patients. Clinical Trial registration numbers: NCT03295721 and NCT03237481

BACKGROUND: To support oncology formulary decisions, especially with accelerated regulatory approvals and niche populations, payers desire data beyond what regulators review. Economic models showin...

The treatment of postsurgical pain with prescription opioids has been associated with persistent opioid use and increased health care utilization and costs.To compare the health care burden between opioid-naive adult patients who were prescribed opioids after a major surgery and opioidnaive adult patients who were not prescribed opioids.Administrative claims data from the IBM Watson Health MarketScan Research Databases for 2010-2016 were used. Opioid-naive adult patients who underwent major inpatient or outpatient surgery and who had at least 1 year of continuous enrollment before and after the index surgery date were eligible for inclusion. Cohorts were defined based on an opioid pharmacy claim between 7 days before index surgery and 1 year after index surgery (opioid use during surgery and inpatient use were not available). To ensure an opioid-naive population, patients with opioid claims between 365 and 8 days before surgery were excluded. Acute medical outcomes, opioid utilization, health care utilization, and costs were measured during the post-index period (index surgery hospitalization and day of index outpatient surgery not included). Predicted costs were estimated from multivariable log-linked gamma-generalized linear models.The final sample consisted of 1,174,905 opioid-naive patients with an inpatient surgery (73% commercial, 20% Medicare, 7% Medicaid) and 2,930,216 opioid-naive patients with an outpatient surgery (74% commercial, 23% Medicare, and 3% Medicaid). Opioid use after discharge was common among all 3 payer types but was less common among Medicare patients (63% inpatient/43% outpatient) than patients with commercial (80% inpatient/75% outpatient) or Medicaid insurance (86% inpatient/81% outpatient). Across all 3 payers, opioid users were younger, were more likely to be female, and had a higher preoperative comorbidity burden than nonopioid users. In unadjusted analyses, opioid users tended to have more hospitalizations, emergency department visits, and pharmacy claims. Adjusted predicted 1-year post-period total health care costs were significantly higher (Filling an outpatient opioid prescription (vs. no opioid prescription) in the 1 year after inpatient or outpatient surgery was associated with increased health care utilization and costs across all payers.Funding for this study was provided by Heron Therapeutics, which participated in analysis and interpretation of data, drafting, reviewing, and approving the publication. All authors contributed to the development of the publication and maintained control over the final content. Brummett is a paid consultant for Heron Therapeutics and Recro Pharma and reports receipt of research funding from MDHHS (Sub K Michigan Open), NIDA (Centralized Pain Opioid Non-Responsiveness R01 DA038261-05), NIH0DHHS-US-16 PAF 07628 (R01 NR017096-05), NIH-DHHS (P50 AR070600-05 CORT), NIH-DHHS-US (K23 DA038718-04), NIH-DHHS-US-16-PAF06270 (R01 HD088712-05), NIH-DHHS-US-17-PAF02680 (R01 DA042859-05), and UM Michigan Genomics Initiative and holding a patent for peripheral perineural dexmedetomidine. Oderda is a paid consultant for Heron Therapeutics. Pawasauskas is a paid consultant to Heron Therapeutics and Mallinckrodt Pharmaceuticals. England and Evans-Shields are employees of Heron Therapeutics. Kong, Lew, Zimmerman, and Henriques are employees of IBM Watson Health, which was compensated by Heron Therapeutics for conducting this research. Portions of this work were presented as a poster at the AMCP Managed Care and Specialty Pharmacy Annual Meeting 2019; March 25-28, 2019; San Diego, CA.

Discarding unused drugs after dose changes or discontinuation can significantly affect pharmacy budgets. This is especially concerning for expensive oncology agents. However, few economic studies account for drug wastage, providing an inaccurate estimate of a drug's actual economic cost, cost-effectiveness, and value.To (a) compare the economic impact of drug wastage between ribociclib and palbociclib-clinically similar oral medications for metastatic breast cancer-using 3 approaches (Markov model, pharmacy acquisition cost model, and a retrospective claims analysis) and (b) compare the modeling results with a published estimate of drug wastage for palbociclib from a claims analysis.A Markov model and a pharmacy acquisitions cost model were developed to evaluate the economic impact of dose reductions for ribociclib and palbociclib over a 1-year time period. Data inputs were pharmacy costs (RED BOOK wholesale acquisition cost) and proportion of patients experiencing dose reductions from either ribociclib randomized clinical trials (MONALEESA-2, -3, or -7) or real-world observational data (Symphony Health retrospective claims analysis). The latter constituted the third approach for quantifying drug wastage. The economic impact of dose reductions for ribociclib and palbociclib in postmenopausal women with previously untreated HR-positive/HER2-negative advanced breast cancer was assessed. Drug wastage was defined as drug doses that could not be used by a patient following a dose reduction. The cost of drug wastage was defined as the cost associated with an unused drug resulting from a dose reduction. The predicted results from the 2 models were compared with a previously published claims analysis that estimated the effect of treatment costs and drug wastage for palbociclib based on the observed dosing patterns from the Symphony Health Solutions database.In the Markov model, relative to ribociclib, palbociclib users experienced drug wastage of $112,382 total, or $1,124 per treated patient, per year due to dose changes. In the pharmacy acquisition cost model, relative to ribociclib, palbociclib usage was associated with an increased cost of $7,196 per patient per year (based on a mid-cycle dose reduction) comprising dosing-based cost differences and drug wastage cost for palbociclib of $3,727. The previously published claims analysis found that palbociclib users experiencing a dose reduction had drug wastage costs of $5,471 per patient.In both models, dose reductions for ribociclib patients resulted in no wastage, since unused tablets could be administered in subsequent cycles, while dose reductions for palbociclib resulted in drug wastage and increased costs. The results from both models were consistent with previously published results from the claims analysis, demonstrating drug wastage costs for palbociclib.This study received financial support from Novartis Pharmaceuticals, which has products approved for treatment of breast cancer. Tang was employed by Novartis during this study; Zacker and Dalal are employed by Novartis and own company stock. Biskupiak, Brixner, and Oderda received payment from Novartis for this study. Brixner serves as a consultant for Millcreek Outcomes Group and also declares consulting fees from Abbvie, AstraZeneca, Abbott, Becton Dickinson, and Xcenda, unrelated to this study.

Surgical care episodes place opioid-naïve patients at risk for transitioning to new persistent postoperative opioid use. With one of the central principles being the application of multimodal pain interventions to reduce the reliance on opioid-based medications, enhanced recovery pathways provide a framework that decreases perioperative opioid use. The fourth Perioperative Quality Initiative brought together a group of international experts representing anesthesiology, surgery, and nursing with the objective of providing consensus recommendations on this important topic. Fourth Perioperative Quality Initiative was a consensus-building conference designed around a modified Delphi process in which the group alternately convened for plenary discussion sessions in between small group discussions. The process included several iterative steps including a literature review of the topics, building consensus around the important questions related to the topic, and sequential steps of content building and refinement until agreement was achieved and a consensus document was produced. During the fourth Perioperative Quality Initiative conference and thereafter as a writing group, reference applicability to the topic was discussed in any area where there was disagreement. For this manuscript, the questions answered included (1) What are the potential strategies for preventing persistent postoperative opioid use? (2) Is opioid-free anesthesia and analgesia feasible and appropriate for routine operations? and (3) Is opioid-free (intraoperative) anesthesia associated with equivalent or superior outcomes compared to an opioid minimization in the perioperative period? We will discuss the relevant literature for each questions, emphasize what we do not know, and prioritize the areas for future research.

Persistent postoperative opioid use is thought to contribute to the ongoing opioid epidemic in the United States. However, efforts to study and address the issue have been stymied by the lack of a standard definition, which has also hampered efforts to measure the incidence of and risk factors for persistent postoperative opioid use. The objective of this systematic review is to (1) determine a clinically relevant definition of persistent postoperative opioid use, and (2) characterize its incidence and risk factors for several common surgeries. Our approach leveraged a group of international experts from the Perioperative Quality Initiative-4, a consensus-building conference that included representation from anesthesiology, surgery, and nursing. A search of the medical literature yielded 46 articles addressing persistent postoperative opioid use in adults after arthroplasty, abdominopelvic surgery, spine surgery, thoracic surgery, mastectomy, and thoracic surgery. In opioid-naive patients, the overall incidence ranged from 2% to 6% based on moderate-level evidence. However, patients who use opioids preoperatively had an incidence of >30%. Preoperative opioid use, depression, factors associated with the diagnosis of substance use disorder, preoperative pain, and tobacco use were reported risk factors. In addition, while anxiety, sex, and psychotropic prescription are associated with persistent postoperative opioid use, these reports are based on lower level evidence. While few articles addressed the health policy or prescriber characteristics that influence persistent postoperative opioid use, efforts to modify prescriber behaviors and health system characteristics are likely to have success in reducing persistent postoperative opioid use.

To estimate the budget impact of adding capmatinib, the first FDA approved MET inhibitor, to a US commercial or Medicare health plan for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have a mutation that leads to MET exon 14 (METex14) skipping. Target population size was estimated using published epidemiology data. Clinical data were obtained from the GEOMETRY mono-1 capmatinib trial and published trials. Treatments in the market mix included crizotinib, pembrolizumab, ramucirumab, and chemotherapy. Uptake of capmatinib and testing rates were based on market research. All costs (drug acquisition and administration, pre-progression, progression, terminal care, adverse event, and testing) were estimated based on public sources (2020 USD). The number of patients eligible for capmatinib in the first three years was estimated to be 2–3 in a hypothetical 1 million member commercial plan and 34–44 in a hypothetical 1 million member Medicare plan each year. The estimated total budget impact ranged from $9,695 to $67,725 for a commercial plan and $141,350 to $985,695 for Medicare. With capmatinib included, a marginal per member per month budget impact was estimated (commercial: $0.0008 to $0.0056; Medicare: $0.0118 to $0.0821). Capmatinib inclusion resulted in lower medical costs (commercial: –$0.0003 to –$0.0007; Medicare: –$0.0037 to –$0.0106), partially offsetting increased drug costs ($0.0011 to $0.0064; $0.0154 to $0.0928, respectively), and were primarily driven by reductions in progression and terminal care costs (–$0.0003 to –$0.0009; –$0.0037 to –$0.0125, respectively). The results were most sensitive to capmatinib market share, capmatinib price, and treatment duration. Certain assumptions were applied to the model to account for inputs with limited evidence. The estimated budget impact of including capmatinib for mNSCLC with a METex14 skipping mutation is minimal, and the increased drug costs were partially offset by savings in AEs, and progression-related and terminal care costs.

Reliance on prescription opioids to manage pain has been associated with increases in diversion, overdose, and addiction. Prevalence of misuse and abuse has been shown to be higher among government-insured populations than commercially insured populations. However, the prevalence and costs of misuse/abuse among the Medicare fee-for-service (FFS) population has not been studied.To (a) determine the prevalence and costs of prescription opioid misuse/abuse and (b) evaluate the prevalence and costs associated with those identified as at risk for opioid misuse/abuse in Medicare FFS beneficiaries.This retrospective case-control study used Medicare claims data for the calendar years of 2010 and 2011 and included Medicare beneficiaries aged at least 18 years. The index date was the date of first diagnosed misuse/abuse or at risk for abuse and had to occur between July 1, 2010, and June 30, 2011, and beneficiaries had to have at least 6 months continuous eligibility before and after the index date. Matching (1:1) was used for comparing opioid misusers/abusers with nonabuser controls, as well as comparing patients at risk for opioid abuse with controls not at risk for abuse. Controls were matched to cases by gender, age, disability, and geographic region. The index date of the control patient was set equal to the index date of the matched case.Prevalence of misuse/abuse in the Medicare FFS population was 13.1 per 1,000 persons, with the majority among patients receiving Medicare based on disability (76.2%). The prevalence of at risk for misuse/abuse was 117.4 per 1,000 persons. Approximately half of the Medicare FFS patients used an opioid. Overall total annual unadjusted mean costs of health care resources were significantly greater for abusers than for matched controls ($46,194 vs. $21,964; P0.0001), with a mean annual excess cost of $24,230. The overall total adjusted 6-month post-index mean costs of health care resources for abusers was significantly greater than that of matched controls ($33,942 vs. $10,754; P0.0001), with a mean excess cost of $23,188.The prevalence of diagnosed abuse among Medicare FFS population (13.1 per 1,000 persons) was higher than other payer groups studied using similar ICD-9-CM codes, and the majority of abuse was among those receiving Medicare based on disability (76.2%). The prevalence of at-risk abuse was 9 times higher than the prevalence of diagnosed abuse. As with other studies, health care resource utilization and costs were significantly greater for diagnosed abuse than matched controls.This study was sponsored by Pfizer. Roland is a Pfizer employee and stockholder and was involved in all aspects of the study as part of a mid-career fellowship in pharmacoeconomics with the University of Utah. Ye and Stevens are employees of University of Utah, and Oderda was an employee of University of Utah, which received financial support from Pfizer in connection with the development of this manuscript. Oderda also reports consulting fees from Pfizer, Trevena, and Pacira, unrelated to this study. The results of this study were presented at the Academy of Managed Care Pharmacy Nexus 2015; October 26-29, 2015; Orlando, FL, and the AMCP Managed CareSpecialty Pharmacy Annual Meeting 2016; April 19-22, 2016; San Francisco, CA.

The combination of a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor with the aromatase inhibitor letrozole is a safe and effective alternative to letrozole monotherapy for first-line hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This study evaluates the budget impact of using the CDK 4/6 inhibitor ribociclib plus letrozole as a first-line treatment option for postmenopausal women with HR+/HER2- advanced breast cancer, from a United States (US) payer perspective.A cohort-based budget impact model was used to calculate the incremental cost of introducing ribociclib plus letrozole over three years for the target population. The analysis compared two scenarios: treatment options excluding or including ribociclib plus letrozole. Market shares were derived from market research and the assumption was the introduction of ribociclib plus letrozole would only displace existing CDK-based therapies. Treatment duration was based on the median time to treatment discontinuation or median progression-free survival for first-line treatment, and on clinical trial data for second- and third-line treatment. Acquisition costs were based on wholesale acquisition costs and considered co-payment. Costs for drug administration and monitoring, subsequent therapy, and relevant adverse events were included.Of 1 million insured members, 263 were eligible for CDK 4/6 inhibitor treatment. Cumulative total savings with ribociclib plus letrozole were $3.01M over three years, corresponding to a cumulative incremental cost saving of $318.11 per member treated per month.In the US, ribociclib plus letrozole represents a cost-saving first-line treatment option for postmenopausal women with HR+/HER2- advanced breast cancer.

Rheumatoid arthritis (RA) management requires monitoring of disease activity to determine course of treatment. Global assessments are used in clinical practice to determine RA disease activity. Monitoring disease activity via biomarkers may also help providers optimize biologic and nonbiologic drug use while decreasing overall drug spend by delaying use of expensive biologic therapies. By testing multiple biologic domains at the same time, a multibiomarker disease activity test may have utility in RA patient management, through improved intra- and inter-rater reliability. This report provides a comprehensive review of studies of objective measures, single biomarkers and multibiomarker disease activity tests as disease activity measures to decrease uncertainty in treatment decisions, and of biomarkers’ potential impact on economic and clinical outcomes of treatment choices.

The aim of this manuscript is to systematically review the current literature on surgical management of the short penis, focusing on surgical and functional outcomes and postoperative complications. Penile size still represents a major concern among a large proportion of men regardless of age and socio-cultural background. On the other hand, there is still no clear agreement on the definition of a short penis. Penile inadequacy can be secondary to a variety of clinical conditions, either organic or psychogenic; moreover, the causes of a short penis could be divided in congenital or acquired. A surgical intervention is often requested to address these conditions, with a variety of different techniques that reflect the vast heterogeneity of the etiologies of the disease. Surgical and patients’ satisfaction outcomes are extremely variable, as long as the different techniques are hardly comparable. As a general statement, a lack of objective data, mainly concerning postoperative lengthening results, must be emphasized. To date, penile lengthening procedures remain highly controversial. Recent evidences show better results in case of intrinsic or “false” penile shortness, while there is a lack of standardized studies concerning patients affected by penile dysmorphic disorder.

Opioid-induced respiratory depression (OIRD) and postoperative nausea and vomiting (PONV) are challenging, resource-intensive, and costly opioid-related adverse events (ORAEs). Utilizing the Premier Healthcare Database, we identified patients18 years old, who underwent at least one surgical procedure of interest (i.e., cardiothoracic/vascular, general/colorectal, obstetric/gynecologic, orthopedic, or urologic), and received at least one dose of intravenous morphine, hydromorphone, or fentanyl for acute postoperative pain. The incidence of OIRD and PONV using ICD-9 codes, factors influencing these AEs, length of stay (LOS) and related costs were analyzed. Among 592,127 inpatient stays, rates of respiratory depression ranged from 3% (obstetric/gynecologic) to 17% (cardiothoracic/vascular) and nausea/vomiting from 44% (obstetric/gynecologic) to 72% (general/colorectal). Increased odds of OIRD were associated with older age (cardiothoracic/vascular, general/colorectal, obstetric/gynecologic); obesity, respiratory conditions, and sleep apnea (all surgery groups); opioid dose (cardiothoracic/vascular, general/colorectal, orthopedic); and sedative use after day 1. Increased odds of PONV were associated with younger age, female sex, and major disease severity. When respiratory depression or nausea/vomiting was present versus absent, LOS was significantly longer, and hospital costs were higher. In this analysis, OIRD and PONV were more prevalent than previously reported, were associated with identifiable risk factors, and had substantial effects on resource utilization and costs.

Enhanced recovery pathways have quickly become part of the standard of care for patients undergoing elective surgery, especially in North America and Europe. One of the central tenets of this multidisciplinary approach is the use of multimodal analgesia with opioid-sparing and even opioid-free anesthesia and analgesia. However, the current state is a historically high use of opioids for both appropriate and inappropriate reasons, and patients with chronic opioid use before their surgery represent a common, often difficult-to-manage population for the enhanced recovery providers and health care team at large. Furthermore, limited evidence and few proven successful protocols exist to guide providers caring for these at-risk patients throughout their elective surgical experience. Therefore, the fourth Perioperative Quality Initiative brought together an international team of multidisciplinary experts, including anesthesiologists, nurse anesthetists, surgeons, pain specialists, neurologists, nurses, and other experts with the objective of providing consensus recommendations. Specifically, the goal of this consensus document is to minimize opioid-related complications by providing expert-based consensus recommendations that reflect the strength of the medical evidence regarding: (1) the definition, categorization, and risk stratification of patients receiving opioids before surgery; (2) optimal perioperative treatment strategies for patients receiving preoperative opioids; and (3) optimal discharge and continuity of care management practices for patients receiving opioids preoperatively. The overarching theme of this document is to provide health care providers with guidance to reduce potentially avoidable opioid-related complications including opioid dependence (both physical and behavioral), disability, and death. Enhanced recovery programs attempt to incorporate best practices into pathways of care. By presenting the available evidence for perioperative management of patients on opioids, this consensus panel hopes to encourage further development of pathways specific to this high-risk group to mitigate the often unintentional iatrogenic and untoward effects of opioids and to improve perioperative outcomes.

Supplemental Digital Content is available in the text., New melanoma therapies have shifted the expectations of patients and providers. Evaluating the impact of treatment characteristics may enhance shared decision making. A survey, including a discrete choice experiment, was utilized to evaluate perceived trade-offs of different melanoma treatments and to estimate out-of-pocket (OOP) willingness-to-pay (WTP) thresholds (January 2016 to March 2016). Participants included patients with melanoma at Huntsman Cancer Institute and their cancer care providers. Stakeholder focus groups were conducted to identify treatment attributes. Descriptive and comparative statistics and multinomial logit model were used to evaluate responses. Response rates were 41.9% (N = 220) for patients and 37.7% (N = 20) for providers. Immunotherapy and targeted therapy attributes considered important by participants were overall survival, immunotherapy-related side effects, and skin toxicities. Patients and providers had significantly different views of quality-of-life expectations, anxiety toward melanoma, trust to make treatment decisions, sharing concerns about treatment, time to discuss treatment, understanding OOP costs, and willingness to undergo/recommend treatment (half of the patients would undergo treatment if it was effective for > 24 months). Among patients, the average monthly OOP WTP for combination immunotherapy with nivolumab + ipilimumab was $ 2357 and for BRAF/MEK inhibitor was $1648. Among providers, these estimates were $ 2484 and $1350, respectively. Discordance existed between patients’ and providers’ perceptions about quality of life expectations, degree of anxiety, sharing of opinions, and progression-free survival. Our study suggests that patients and providers exhibit a higher OOP WTP for combination immunotherapy treatment compared with BRAF/MEK inhibitors, influenced predominately by overall survival expectations.

Objective To evaluate the relationships between benzodiazepine use and (1) health care utilization and (2) suicide risk in veterans diagnosed with posttraumatic stress disorder (PTSD). Methods This propensity-matched retrospective cohort study included veterans diagnosed with 1 ICD-9 code for PTSD who were active users of the Veterans Affairs health care system between January 1, 2001, and December 31, 2014. Exposure included at least 1 thirty-day prescription of a benzodiazepine within 1 year following PTSD diagnosis among patients with no recent history of benzodiazepine use. The primary outcomes were health care utilization and suicidal behavior. Results A total of 242,493 of 1,134,201 eligible veterans were included in the propensity-matched cohort, 80,831 (7.13%) of whom were prescribed benzodiazepines. Veterans with PTSD who received benzodiazepines had significantly more hospitalizations (incident rate ratio [IRR] = 1.27; 95% CI, 1.10-1.47) and emergency department (IRR = 1.16; 95% CI, 1.13-1.20), general outpatient (IRR = 1.19; 95% CI, 1.16-1.21), outpatient mental health (IRR = 1.49; 95% CI, 1.41-1.57), and total mental health (IRR = 1.37; 95% CI, 1.34-1.40) visits. Benzodiazepine users had a significantly greater risk of death due to suicide (hazard ratio [HR] = 2.74; 95% CI, 2.40-3.13) and were significantly more likely to have medically documented suicide attempts (HR = 1.85; 95% CI, 1.65-2.08) and suicidal ideation (HR = 1.57; 95% CI, 1.48-1.67). Conclusions Benzodiazepine users had higher rates of health care utilization and were more likely to attempt and complete suicide than patients without benzodiazepine exposure. This study strengthens the empirical evidence against the use of benzodiazepines in veterans with PTSD. Prescribers should weigh the benefits and risks-especially the almost 3-fold increase in suicide risk-when prescribing benzodiazepines in these patients.

U.S. regulatory approvals of the cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors ribociclib and palbociclib as add-ons to letrozole greatly enhance the prospects for treating postmenopausal women with hormone receptor-positive (HR+)/human epidermal receptor 2-negative (HER2-) advanced or metastatic breast cancer. Clinical trials have established that the combination of a CDK 4/6 inhibitor with letrozole can significantly improve progression-free survival (PFS) versus letrozole monotherapy and is safe and well tolerated. Cost-effectiveness studies are required to inform payers and clinical decision makers on the money value of combination treatment in clinical practice.To evaluate the cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole and versus letrozole monotherapy in the first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer from a U.S. private third-party payer perspective.A partitioned survival model including 3 health states (progression free, with either overall response or stable disease; progressed disease; and death) simulated lifetime costs and outcomes over a 40-year lifetime horizon with a 1-month cycle length. Clinical efficacy data (PFS and overall survival [OS]) were derived from a phase III trial of ribociclib plus letrozole (MONALEESA-2; NCT01958021), a phase II trial of palbociclib plus letrozole (PALOMA-1; NCT00721409), and a Bayesian network meta-analysis. Health care costs included drug acquisition and monitoring, disease management, subsequent therapies, and serious drug-related adverse events. Effectiveness was measured in life-years, derived from survival projections, and in quality-adjusted life-years (QALYs), calculated from time spent in each state combined with health-state utility values. A one-way deterministic sensitivity analysis explored the impact of uncertainty in key model parameters on results, and probabilistic uncertainty was assessed through a Monte Carlo probabilistic sensitivity analysis.Ribociclib plus letrozole was dominant versus palbociclib plus letrozole, with a cost saving of $43,037 and a gain of 0.086 QALYs. Compared with letrozole monotherapy, ribociclib plus letrozole was associated with an incremental cost of $144,915 and an incremental QALY of 0.689, equating to an incremental cost-effectiveness ratio of $210,369 per QALY. Key model drivers included OS HRs for palbociclib plus letrozole versus letrozole and for ribociclib plus letrozole versus letrozole, the PFS HR for palbociclib plus letrozole versus letrozole, PD health-state costs, utility of response, and cost discount rate. The probabilities that ribociclib plus letrozole was cost-effective versus letrozole at thresholds of $50,000, $100,000 and $200,000 per QALY gained were 1.6%, 6.3%, and 50.5%, respectively.In the United States, ribociclib plus letrozole is a cost-effective alternative to palbociclib plus letrozole for the first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. Ribociclib plus letrozole is also cost-effective versus letrozole monotherapy at willingness-to-pay thresholds greater than $198,000 per QALY (for probabilistic analysis).Funding for this study was provided by Novartis, which manufactures ribociclib and provided input on the study design and data collection, analysis, and interpretation. Mistry, May, Suri, and Young are employees of PAREXEL. Tang, Mishra, D. Bhattacharyya, and Dalal are employees of Novartis. S. Bhattacharyya was an employee of Novartis during the study period. Tang and Dalal hold stock in Novartis. Brixner, Oderda, and Biskupiak were paid by Millcreek Outcomes Group as consultants for work on this project. Brixner has also consulted for AstraZeneca, UCB, Regeneron, and Abbott.

Painful diabetic neuropathy (PDN) affects nearly half of patients with diabetes. The objective of this study was to compare the cost-effectiveness of starting patients with PDN on pregabalin (PRE), duloxetine (DUL), gabapentin (GABA), or desipramine (DES) over a 10-year time horizon from the perspective of third-party payers in the United States. A Markov model was used to compare the costs (2013 $US) and effectiveness (quality-adjusted life-years [QALYs]) of first-line PDN treatments in 10,000 patients using microsimulation. Costs and QALYs were discounted at 3% annually. Probabilities and utilities were derived from the published literature. Costs were average wholesale price for drugs and national estimates for office visits and hospitalizations. One-way and probabilistic (PSA) sensitivity analyses were used to examine parameter uncertainty. Starting with PRE was dominated by DUL as DUL cost less and was more effective. Starting with GABA was extendedly dominated by a combination of DES and DUL. DES and DUL cost $23,468 and $25,979, while yielding 3.05 and 3.16 QALYs, respectively. The incremental cost-effectiveness ratio for DUL compared with DES was $22,867/QALY gained. One-way sensitivity analysis showed that the model was most sensitive to the adherence threshold and utility for mild pain. PSA showed that, at a willingness-to-pay (WTP) of $50,000/QALY, DUL was the most cost-effective option in 56.3% of the simulations, DES in 29.2%, GABA in 14.4%, and PRE in 0.1%. Starting with DUL is the most cost-effective option for PDN when WTP is greater than $22,867/QALY. Decision makers may consider starting with DUL for PDN patients.

A 2009 systematic review found that the total cost of prescription opioid abuse in 2001 in the United States was approximately $8.6 billion and medical expenses were estimated to be $15,884 for opioid abusers and $1,830 for nonabusers. A search was conducted for English publications on the cost of prescription opioid abuse and misuse from 2009 to 2014. The initial literature search identified 5,412 citations. Title and abstract review selected 59 for further review. The final review process resulted in 16 publications for inclusion that examined cost from the payer perspective. Mean costs to the payer for abusers were $23,000–$25,000 per year and excess costs approximately $15,000 per patient. Three papers were identified that presented societal costs, including direct and indirect costs such as criminal justice costs and costs associated with lost productivity. The strongest evidence suggests that societal cost is in excess of $50 billion per year in the United States. Prescription opioid abuse and misuse is a common and important problem throughout the world that has significant associated societal costs and excess medical costs.

Objective The purpose of this study was to analyze the 1-year cost of cardiovascular (CV) events by body mass index (BMI) subgroups from a US employer health plan perspective. Design and Methods Patients aged 20-64 years from the GE Centricity Electronic Medical Record, National Health and Nutrition Examination Survey, and MarketScan databases were used to determine prevalence of risk factors (RFs) and CV events and 1-year costs. Risk factors included hypertension (HTN), diabetes, and hyperlipidemia (HLD) and CV events included myocardial infarction, angina, heart failure, and stroke. CV event costs were determined from claims by ICD-9 code in patients with overweight/obesity. Results Of 220,136 patients identified in GE, BMI was 25-26.9 in 19.4%, 27-29.9 in 30.4%, 30-34.9 in 27.9%, and ≥35 in 22.3%. Patients with diabetes, HTN, and HLD increased with BMI from 1.8% (25-26.9) to 11.4% (≥35) in males and 1.1% to 6.8% in females. Prevalence of CV events increased from 0.1% with no RFs up to 10.2% with multiple RFs. The average 1-year cost per patient increased from $1122 to $2383 as BMI increased. Conclusions Patients with higher BMI values had an increased prevalence of RFs and CV events, which lead to higher average 1-year costs.

This retrospective study utilized a large, national hospital database to assess the impact of opioid-related adverse events (ORADE) on patient outcomes following selected surgical procedures known to require postoperative pain control.Outcomes of patients with administratively documented ORADE were compared to those without. Multivariate regression determined differences in hospital costs; length of stay (LOS); odds of individuals being an outlier in total cost and LOS; and having a 30-day all-cause readmission.Among 319,898 surgeries of interest, 12.2% of patients experienced an ORADE. Patients had higher adjusted mean costs ($22,077 [95% CI 21,823-22,333] vs. $17,370 [95% CI 17,238-17,503]; p0.0001) and greater LOS (7.6 [95% CI 7.5-7.6] vs. 4.2 days [95% CI 4.2-4.2]; p0.0001). Adjusted odds of being a total cost and LOS outlier were 2.8 (95% CI 2.7-2.8) and 3.2 (95% CI 3.1-3.3) times greater in the ORADE group. These patients were more likely to be readmitted (OR 1.06, 95% CI 1.02-1.09).Patients exhibiting a documented ORADE had greater overall costs, longer hospitalizations, and increased likelihood for readmission. These results highlight the economic impact associated with opioid use for postsurgical pain management.

This study compared patient characteristics and health care costs between newly treated diabetic painful neuropathy (DPN) patients receiving mono- pharmacotherapy and those receiving combination pharmacotherapy. A retrospective cohort was developed through Inovalon's Medical Outcomes Research for Effectiveness and Economics Registry (MORE2) database. Patients included were ≥18 years on the date of first DPN prescription: tricyclic antidepressant, opioids, duloxetine, gabapentin, pregabalin, or lidocaine. The authors conducted a simple proportional hazards model comparing times to discontinuation, switch, or addon. Multiple logistic regression was used to identify predictors of combination pharmacotherapy. There were 7145 patients on mono-pharmacotherapy and 421 patients on combination pharmacotherapy. Patients receiving combination pharmacotherapy were 130% more likely to discontinue their medications than patients receiving mono-pharmacotherapy. Female patients and those with7 comorbidities were more likely to be started with combination pharmacotherapy. Elderly patients were less likely to be started with combination pharmacotherapy. The total cost of care difference between mono- and combination pharmacotherapy was not statistically significant (P = .66); therefore, newly treated DPN patients should add on another medication sooner than 30 days when considering combination pharmacotherapy. All first-line medications have similar efficacy; for this reason, cost should be considered in the treatment decision.

The study objective was to assess methodological quality of opioid conversion systematic reviews. The electronic databases PubMed, EMBASE, and Scopus were used to identify the systematic reviews from the earliest available date until April 2012. Studies were not restricted based on type of opioid, country, or languages. Methodological quality was evaluated using the "Assessment of Multiple Systematic Reviews (AMSTAR)." A total of 2772 articles were found from which five met inclusions criteria. No review mentioned about the duplicate study selection and data extraction. Two reviews included a list of studies that were excluded studies. One study did not provided information on the characteristics of primary studies that were included. Of the three reviews that evaluated the quality of primary studies, two used the quality of included studies in formulating conclusions. Only two reviews provided information about conflicts of interest. Of the five included systematic reviews, three reached a moderate score; two had poor quality. Specific recommendations to improve methodological quality would include performing the data selection and extraction in duplicate, listing or showing the flowchart of studies that were included and excluded along with the reasons, including the main studies data illustrating tables, and including an assessment of the quality of the primary included studies.

Pain and depression are major reasons for pharmacotherapy, making the relationship between these two complaints important in defining optimal pharmacotherapy for both. Although the association between the two has been documented in the literature, most of the available work only focused on specific disease group or patients with certain type of pain. Whether the association exists for the general population is still an unsettled issue. The goal of this study was to examine the association between pain and depression and explore the some determinants of depression using national representative survey data for the general population in the United States. This work employed data from Medical Expenditure Panel Survey (MEPS) 2009, with people older than 18 were included in the study. Ordered logistic regression and generalized ordered logistic regression were performed while incorporating complex survey features. Estimation results suggested that depression and physical pain were positively associated. In addition, individuals with better perceived health, older age, male gender, higher family income, and employed were less depressed. Divorced or separated marital status was associated with higher depression level. This work fills the gap in the literature by using nationally representative survey data set to examine the association between physical pain and depression. Levels of physical pain and many socioeconomic factors were found significantly associated with depression.

BACKGROUND: Comparative effectiveness research (CER) has been proposed in the United States as a way to compare new drugs and technologies with established alternatives and determine not just whether a therapy works, but how well it works compared to other options. OBJECTIVES: To define the current use of CER in the development of new drugs and technologies and explore what is needed for this research approach to reduce or stabilize health care costs in the United States. SUMMARY: In 2010, the Patient-Centered Outcomes Research Institute (PCORI) was established by the Patient Protection and Affordable Care Act (PPACA) to coordinate federally funded CER and recommend research priorities. Hochman and McCormick’s (2010) evaluation of 328 randomized trials, observational studies, and meta-analyses involving medications published between June 2008 and September 2009 in 6 key journals showed that most published research did not fulfill the criteria of CER (defined as comparison to active treatment) and that most study design is driven by FDA requirements rather than the need to develop evidence to facilitate selection of the most effective therapy. Since PPACA provides alternative funding for CER, it could encourage funding more studies to help determine which treatment delivers the best value per unit of investment from clinical, humanistic, and economic perspectives. Manufacturers may avoid CER because it increases product development costs, but a drug proven more effective is more likely to be accepted by formulary committees, increasing the drug’s market share, whereas payers may reject or limit use of a new drug that performs less effectively in comparative studies. CONCLUSIONS: CER may not directly reduce expenditures for drugs and medical technologies. The results may vary widely from case to case; however, despite often significantly higher prices for new drugs, it is important to look beyond product costs to the overall impact on health care costs, including medical cost offsets that may occur through improved health or decreased morbidity. To truly decrease cost and improve quality, cost-effectiveness will have to be integrated into CER with the objective of prioritizing efficient therapies in the real-world health care system. If the methods and output of CER improve, the resulting cost-effectiveness ratios will also be more useful to the payer. CER should ultimately, therefore, be a useful tool to help patients, providers, and decision makers provide the most effective and most cost-effective interventions. J Manag Care Pharm. 2012;18(5):S6-S11 Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved. The rising cost of medical care in the United States has triggered an urgent need for a more efficient health care system that achieves greater demonstrated value. While the annual cost of health care was $147 per person in 1960, by 2008 it had escalated to $7,845 per person per year.1 Ten percent of overall health care spending in the United States in 2008 was for prescription drugs, compared with 31% for hospital expenses and 21% for physician services. The U.S. Department of Health and Human Services (HHS) projects that overall spending for prescription drugs will increase from $234.1 billion in 2008 to $457.8 billion in 2019.2 The average annual increase in drug spending has been 3%-9% per year since 2005, based on 4 key factors: the increased annual average number of prescriptions per person; drug price inflation; increases in the number of new drug approvals, especially those that address previously unmet medical needs; and the growing market share of expensive specialty drugs.2 The 2011 report by the Organisation for Economic Co-operation and Development (OECD) shows that the United States, compared with other OECD countries, has the highest spending on health care as a proportion of gross domestic product.3 From 1970 through 2009, U.S. health care expenditures increased faster than those in “all other high-income OECD countries,” with a 5-fold growth rate, even after taking population growth into account. While there are numerous reason why health care spending in the United States is higher than in other countries, the fact remains that U.S. health costs are some of the highest, and there is an increasing demand to find ways to reduce or stabilize costs while improving health care. As noted by OECD Secretary-General Jose Angel Gurria in an August 2009 announcement, “There are opportunities for all countries to improve the performance of their health care system, and making such improvements does not necessarily require higher spending.”4 There is hope that comparative effectiveness research (CER) can be used to help improve the performance of • The United States leads the world in health care spending as a proportion of gross domestic product. CER is being put forth as a possible way to stabilize or reduce health care costs. • Health care reform is a driving force behind the increase in CER, with the U.S. government funding research prioritization, infrastructure, and methodology development. • In 2009, the Institute of Medicine (IOM) released a priority list of 100 research topics derived from a broad stakeholder-input process to help direct future CER efforts. • Hochman and McCormick (2010) found that 32% (104 of 328) of studies involving medications published in 6 of the leading general medicine and internal medicine journals in 16 months through September 2009 met the definition of CER (i.e., involved active comparators). What is already known about this subject • The authors (a) describe the progress and development of CER as a health care reform strategy in the United States since 2009; (b) discuss the definition of CER and the types of therapies it can compare, along with possible reasons why a broad interpretation of CER (comparing a drug to a nondrug intervention, for example) may be less relevant to private and public health care payers for whom such broader investments are not considered as part of the budgeting process; and (c) examine the reasons why, from the payer perspective, cost-effectiveness comparison should be part of CER. What this article adds

BaCkgRound: Comparative effectiveness research (CER) is rapidly add- ing to the amount of data available to health care coverage and payment decision makers. Medicare’s decisions have a large effect on coverage and reimbursement policies throughout the health insurance industry and will likely influence the entire u.S. health care system; thus, examining its role in integrating CER into policy is crucial. oBjECtIvES: to describe the potential benefits of CER to support payment and coverage decisions in the Medicare program, limitations on its use, the role of the Centers for Medicare & Medicaid Services (CMS) in improv- ing the infrastructure for CER, and to discuss challenges that must be addressed to integrate CER into CMS’s decision-making process. SuMMaRy: a defining feature of CER is that it provides the type of evidence that will help decision makers, such as patients, clinicians, and payers, make more informed treatment and policy decisions. Because CMS is responsible for more than 47 million elderly and disabled beneficiaries, the way that Medicare uses CER has the potential to have a large impact on public and individual health. Currently many critical payment and coverage decisions within the Medicare program are made on the basis of poor- quality evidence, and CER has the potential to greatly improve the quality of decision making. despite common misconceptions, CMS is not prohibited by law from using CER apart from some reasonable limitations. CMS is, however, required to support the development of the CER infrastructure by making their data more readily available to researchers. While CER has substantial potential to improve the quality of the agency’s policy decisions, challenges remain to integrate CER into Medicare’s processes. these chal- lenges include statutory ambiguities, lack of sufficient staff and internal resources to take advantage of CER, and the lack of an active voice in set- ting priorities for CER and study design. ConCLuSIon: although challenges exist, CER has the potential to greatly enhance CMS’s ability to make decisions regarding coverage and payment that will benefit both the agency and their patient population. J Manag Care Pharm. 2012;18(4-a):S5-S8 Copyright © 2012, academy of Managed Care Pharmacy. all rights reserved. • Without comparative effectiveness research (CER), payers and Centers for Medicare & Medicaid Services (CMS) must make decisions based on the best evidence available, which often lacks headto-head data comparison, uses surrogate endpoints, and excludes the specific elderly or disabled population that Medicare covers. • There is a common misperception that the CMS is not allowed to use CER data when making decisions. What is already known about this subject • Contrary to a common misperception, CMS is allowed to use CER data when making coverage decisions, albeit with some limitations. • CER could be used when creating patient decision aids, establishing value-based insurance design, and in coding (determining whether there is enough of a significant therapeutic distinction for a particular product to assign it a new code). • CMS could use CER data in pricing decisions—specifically in the area of least-costly alternative (or reference pricing). What this article adds • Greater use of Coverage with Evidence Development is a mechanism to stimulate the generation of relevant CER for the Medicare

Background: Investigators have employed a number of different methods to calculate adherence estimates for patients taking lipid-modifying therapy (LMT), including measures with different numerator and denominator options. Although at least one method is known to correlate well with cardiovascular outcomes, most have not been evaluated in outcomes studies. Objectives: To evaluate different methods for measuring adherence, using LMT as a case example, and to determine whether estimates for adherence differ statistically and/or whether different methods can lead to different conclusions about patient adherence. Methods: Adherence ratios were calculated using 8 different methods for 12,448 patients who were in a managed-care system and were considered new starts with statin therapy. The calculated measures were compared and tested for differences. Patients were categorized as adherent by each method, using a threshold of 0.8, and the proportions of patients categorized as adherent were compared for differences between adherence calculation methods. Results: Adherence ratios calculated with like observation intervals did not vary substantially, regardless of which method for measuring medication availability was used. Those calculated with different observation intervals had substantial variability. Mean adherence ratios ranged between 0.777 and 0.798 for difference in days' observation intervals; they ranged between 0.618 and 0.630 for the predefined interval. Differences between ratios calculated using these different denominators were statistically significant (p < 0.008). Correlations between ratios were statistically significant for all comparisons (p < 0.001). Correlation coefficients ( r) were 0.64 for comparisons between ratios with different denominators versus 1.0 for comparisons with like denominators. Categorization as adherent or nonadherent differed between the methods for about 20% of patients. Conclusions: Significant differences were found to be based on observation period but not on medication availability. Studies of adherence should be interpreted with caution depending on which method is used, and particular interest should be paid to whether the choice of methods is consistent with study objectives and to the observation interval, as different methods may lead to different conclusions about patient adherence. Further research in LMT and other therapeutic areas is needed to determine which methods correlate best with positive patient outcomes, such as reductions in low-density lipoprotein cholesterol and cardiovascular events.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic, systemic autoimmune inflammatory disease that affects approximately 1% of the population. Initial symptoms include joint swelling, stiffness, and tenderness, which are all causes of disability. The diagnosis of RA is based on patient history of joint pain and stiffness, the documentation of symmetric polyarticular joint synovitis, and laboratory measures including radiographs, inflammatory markers, and autoantibodies. As the disease progresses, synovial inflammation leads to cartilage damage, bone erosions, and joint destruction, the major causes of long-term disability. RA is associated with many comorbidities and complications, including cardiovascular disease, which is responsible for higher rates of mortality among patients compared with the general population. Over the past 2 decades, advances in the development of synthetic disease-modifying antirheumatic drugs (DMARDs) and biologic agents for RA have markedly changed treatment goals and management strategies. OBJECTIVES: To review recent updates in the diagnosis and treatment of RA, as well as the importance of early and aggressive treatment and management strategies. SUMMARY: Borrowing from other medical fields, a paradigm of “tight control” of RA has been supported by evidence and is gaining wide acceptance in rheumatology. In 2010, the American College of Rheumatology and the European League Against Rheumatism (EULAR) published revised classification criteria for RA, which will assist in the diagnosis of early RA and facilitate appropriate treatment intervention. Over the last decade, many patients on biologic agents have demonstrated that early and aggressive treatment of RA is beneficial in treating synovial inflammation, delaying joint damage, and improving patient outcomes. Contemporary management strategies based on early diagnosis, aggressive treatment, and regular monitoring have helped a significant number of patients with RA achieve current treatment goals of low levels of disease activity and, in some cases, clinical remission. J Manag Care Pharm. 2011;17(9-b):S3-S8 Copyright © 2011, Academy of Managed Care Pharmacy. All rights reserved. Rheumatoid arthritis (RA) is a chronic, systemic autoimmune inflammatory arthritis that affects approximately 1% of the population.1 The disease affects people of all ages but is most common from the ages of 40-70 years.1 Initially polyarticular synovial inflammation, leading to joint swelling, stiffness, and tenderness, is the major cause of disability. Over time synovial inflammation leads to cartilage damage, bone erosions, and joint destruction, the major causes of long-term disability. In addition, patients with RA have increased mortality compared with the general population, largely attributed to an increased risk of cardiovascular disease.2 The burden of illness of RA not only impacts patients and families but also society through sick leave, loss of work productivity, and utilization of health care, stressing the importance of effective management of RA.3 Over the past 2 decades, optimal use of synthetic diseasemodifying antirheumatic drugs (DMARDs) and/or biologic agents has proven highly effective in treating inflammation, delaying joint damage, and improving patient outcomes. The goals of treatment have expanded from the treatment of inflammation and achievement of a low disease activity state, to the realistic goal of achieving and maintaining clinical remission in a significant number of patients. In addition to treating inflammation, the inhibition of progressive joint destruction is also an important goal. Finally, by using DMARDs and biologic agents, physicians and their patients are striving to decrease pain and stiffness associated with inflammation, retard progressive structural joint damage, reduce RA comorbidities, restore function and quality of life, and help patients to maintain their societal roles. It is commonly accepted that early intervention leads to improved patient outcomes. This paradigm is supported by a number of clinical trials. Therefore, it is critical that patients with symptoms of RA are identified early and referred to specialists with experience in treating RA, which will facilitate initiation of disease-modifying therapy that can be systematically modified in the pursuit of the treatment goals. In this article, we will review recent updates in the diagnosis and treatment of RA as well as the importance of early and aggressive treatment. Diagnosing Rheumatoid Arthritis The diagnosis of RA is a clinical diagnosis that combines the patient history of joint pain and stiffness, the physical examination documentation of symmetric polyarticular joint swelling (synovitis), and the laboratory tests including radiographs, inflammatory markers (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]), and autoantibodies (rheumatoid factor [RF] and anti-cyclic citrullinated peptide antibodies

This paper reviews the economic evaluation literature on pharmacotherapy for migraine and identifies important trends and gaps in the literature. Given the tremendous economic burden of migraine and the availability of various therapies for migraine treatment, economic evaluation of alternative therapies plays a critical role in identifying the most cost-effective therapy to optimize health care resource allocation and clinical decisions. Particularly, physicians and clinical administrators are expected to take an active role in resource allocation decisions at the clinical level. Thus, it is important for them to be familiar with the economic evaluation in migraine pain management, and most importantly, methodologies of economic analyses and the associated shortcomings of published estimates. In this paper, the methodological characteristics of these studies are examined and their results are compared and interpreted. Alternative treatment and health outcome measures are defined and data sources described while methods for assessing the direct and indirect costs are explored. Directions for future research are identified and discussed.

Background: Recent changes in national reimbursement policies expand the ability of pharmacists to seek reimbursement for cognitive services. The quality of pharmacist-provided cognitive services has, until now, remained unassessed. Pharmacists should demonstrate the quality and value of their work to ensure the continued and expanded acceptance of reimbursement for their services. A preliminary step in assessing quality is to compare agreement between pharmacists for basic problem identification. Objective: To quantify agreement between pharmacist reviewers for problem identification among Utah Medicaid recipients. Methods: Five pharmacists retrospectively reviewed drug regimens, patient characteristics, diagnosis codes, and procedures for 80 Medicaid patients in September 2008 and identified drug-related problems (DRPs) in 15 predetermined categories. Data for each patient were reviewed twice, and each combination of 2 pharmacists reviewed the same 8 patients' information. We calculated a reliability coefficient to compare the number of DRPs identified and used prevalence and bias adjusted κ (PABAK) to determine interrater reliability for the presence of a specific DRP. Results: Of the 15 DRPs categorized by pharmacist reviewers, 1 (untreated indications) had a PABAK coefficient of 0.20, indicating a relatively low level of agreement between reviewers. All other DRP categories had good to excellent agreement, with PABAK coefficients ranging between 0.43 and 0.98. Conclusions: Pharmacist reviewers exhibited less variability in DRP identification or categorization than had been expected for most categories. This work supports the conclusion that pharmacists in our center provide a basic and necessary level of quality for problem assessment. Future work is needed to document the impact of this quality on patient outcomes.

To determine in an eligible Utah Medicaid population (1) medical and drug costs associated with treating uterine fibroids (UFs) and (2) the cost and incidence of hysterectomy complications.Medical and drug cost analyses were based on data from 897 premenopausal patients with UFs included in the Utah Medicaid database from 1996 to 2004. UF-related medical and pharmacy costs were determined from first diagnosis of UFs until a related procedure or until estimated menopause. Outcomes for patients treated with a procedure (hysterectomy, myomectomy, or embolization), medication, and watchful waiting (no procedure, no UF-related drug) were compared. When determining hysterectomy complication rates for the population of women in the Medicaid database, a total of 1,323 pre- or postmenopausal patients with UFs were included.Overall, 20% of patients were treated with medication, 33% with a procedure, and 47% with watchful waiting. Mean total UF costs were: $11,996 (procedure), $2,703 (medication), and $2,118 (watchful waiting). Mean eligibility months were 8.8, 28.8, and 14.1, respectively. Costs/eligible month were: $1,358 (procedure), $151 (watchful waiting), and $94 (medication). The mean hysterectomy cost was $12,107.Treatment for UFs is expensive with a mean cost of $5,504 per study patient. The highest costs are seen in patients receiving procedures, which can lead to complications; 15% in this study. Costs for watchful waiting are similar to costs in patients receiving UF-related drugs. Consideration should be given to using non-surgical therapies for the treatment of UFs before procedures are performed.

Objective This study examines the prevalence of various cardiometabolic risk (CMR) factors that may contribute to metabolic syndrome in a primary care setting. These risk factors were accessed with use of a national electronic health record database. Methods In the database, from January 1, 2003 to December 31, 2004, patients aged 18 to 64 years with information regarding CMR factors were identified by clinical (biometrics), diagnosis (ICD-9 codes) or treatment (prescriptions) information. Results The study population consisted of 475,651 patients with information on indicators of CMR, excluding patients with bariatric surgery or a body mass index (BMI) ≥ 35 kg/m 2 . Of these, 72,593 (!5.3%) and 55,928 (11.8%) had metabolic syndrome according to the National Cholesterol Education Program (NCEP) and International Diabetes Federation (IDF) criteria, respectively. In addition, 162,521 (34.2%) had BMI (≥27 kg/m 2 ) as a risk factor. High blood pressure was identified as a risk factor in 266,371 patients (56.0%). High triglycerides were identified as a risk factor in 10.7% of the population, low high-density lipoprotein in 16.0%, impaired-fasting glucose in 8.8%, diabetes in 7.2%, and metabolic syndrome (diagnosis) in 0.1%. A total of 178,055 (37.4% of the study population) subjects had positive indicators of CMR as defined by the NCEP and IDF. Results indicated that obesity is the most prevalent CMR factor representing 90.6% of this at-risk population. Conclusions The distribution of CMR factors in a primary care database is similar to that established by prospective national health surveys. A key source of identification of risk factors are clinical outcomes including BMI and lab values. Future studies on metabolic syndrome need to link clinically based information with more readily available treatment and diagnosis information.

SUMMARYThe objectives of this study were to evaluate the economic impact of self-monitoring of blood glucose (SMBG) in a diabetic Medicaid population.The study was a retrospective, cross-sectional study in a Utah Medicaid population with a diagnosis of diabetes mellitus between 1 June 2001 and 31 December 2001. The main outcome measures were a change from baseline in total healthcare costs and diabetes-related healthcare costs following the initiation of SMBG as measured by a pharmacy claim for glucose monitoring reagent strips.A total of 665 insulin users and 885 oral agent (OA) users enrolled in the Utah Medicaid programme and were included in the study. OA users with a claim for glucose monitoring reagent strips were approximately 2 years older and had higher co-morbidity, as measured by the RxRisk score, than controls. Only 7.3% practiced SMBG according to American Diabetes Association guidelines. Insulin users with more than two, or more than three strips per day had 65.1% and 41.5% higher total heal...

Purpose The effects of i.v. acetaminophen on adverse events, hospital length of stay (LOS), and overall hospital costs for total hip or knee replacements were evaluated. Methods We conducted a matched-pairs analysis of adult inpatients who underwent elective total hip arthroplasty or total knee arthroplasty in hospitals participating in the Premier Healthcare Alliance from January 1, 2011, to November 30, 2012. Each case who received i.v. acetaminophen on the day of surgery was matched to a control who did not receive i.v. acetaminophen within the same hospital. Treatment groups were analyzed for differences in the rate of adverse effects, LOS, and hospital resource utilization. Results A total of 22,146 cases and controls were similar in terms of age, race, sex, marital status, insurance status, and preoperative comorbidities. Overall adverse events were significantly lower with i.v. acetaminophen (24.3%) than with controls (26.3%, p < 0.001), numerically less frequent in all subgroups, and significantly less frequent for renal, infectious, and miscellaneous adverse events (all p < 0.05). I.V. acetaminophen was also associated with a shorter LOS, with 1 out of 11 patients discharged one day earlier ( p < 0.001) and lower average hospital costs: $16,381 for cases compared with $16,927 for controls ( p < 0.001). Cost savings estimated by structural equation modeling of $547 per patient were due to $325 from direct effects and $222 from indirect effects, the latter mediated through adverse events and reduced LOS. Conclusion In this retrospective cohort study of case-matched patients who underwent total hip or knee replacement surgery, multimodal analgesia with i.v. acetaminophen was associated with improved clinical outcomes in terms of fewer adverse events, shortened LOS, and reduced total hospital resources compared with patients who did not receive i.v. acetaminophen

Currently several tyrosine kinase inhibitors (TKIs) are approved for treatment of chronic myeloid leukemia (CML). Our goal was to identify the optimal sequential treatment strategy in terms of effectiveness and cost-effectiveness for CML patients within the US health care context. We evaluated 18 treatment strategies regarding survival, quality-adjusted survival, and costs. For model parameters, the literature data, expert surveys, registry data, and economic databases were used. Evaluated strategies included imatinib, dasatinib, nilotinib, bosutinib, ponatinib, stem-cell transplantation (SCT), and chemotherapy. We developed a Markov state-transition model, which was analyzed as a cohort simulation over a lifelong time horizon with a third-party payer perspective and discount rate of 3%. Remaining life expectancies ranged from 5.4 years (3.9 quality-adjusted life years (QALYs)) for chemotherapy treatment without TKI to 14.4 years (11.1 QALYs) for nilotinib→dasatinib→chemotherapy/SCT. In the economic evaluation, imatinib→chemotherapy/SCT resulted in an incremental cost-utility ratio (ICUR) of $171,700/QALY compared to chemotherapy without TKI. Imatinib→nilotinib→chemotherapy/SCT yielded an ICUR of $253,500/QALY compared to imatinib→chemotherapy/SCT. Nilotinib→dasatinib→chemotherapy/SCT yielded an ICUR of $445,100/QALY compared to imatinib→nilotinib→chemotherapy/SCT. All remaining strategies were excluded due to dominance of the clinically superior strategies. Based on our analysis and current treatment guidelines, imatinib→nilotinib→chemotherapy/SCT and nilotinib→dasatinib→chemotherapy/SCT can be considered cost-effective for patients with CML, depending on willingness-to-pay.