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Previous studies have suggested an increased risk of cardiac events with azithromycin, but the predictors of such events are unknown. We sought to develop and validate two prediction models to identify such predictors. We used data from Truven Marketscan Database (01/2009 to 06/2015). Using a split-sample approach, we developed two prediction models, which included baseline demographics, clinical conditions (Model 1), concurrent use of any drug (Model 1) and therapeutic class (Model 2) with a risk of QT-prolongation (CQT-Rx). Patients enrolled in a health plan for 365 days before and five days after dispensing of azithromycin (episodes). Cardiac events included syncope, palpitations, ventricular arrhythmias, cardiac arrest as a primary diagnosis for hospitalization including death. For each model, a backward elimination of predictors using logistic regression was applied to identify predictors in 100 random samples of the training cohort. Predictors prevalent in >50% of the models were included in the final model. A score for the Assessment of Cardiac Risk with Azithromycin (ACRA) was generated using the training cohort then tested in the validation cohort. A cohort of 20,134,659 episodes with 0.03% cardiac events were included. Over 60% included females with mean age of 40.1±21.3 years. Age, sex, history of syncope, cardiac dysrhythmias, non-specific chest pain, and presence of a CQT-Rx were included as predictors for Model-1 (c-statistic = 0.68). For Model-2 (c-statistic = 0.64), predictors included age, sex, anti-arrhythmic agents, anti-emetics, antidepressants, loop diuretics, and ACE inhibitors. ACRA score is available online (bit.ly/ACRA_2020). The ACRA score may help identify patients who are at higher risk of cardiac events following treatment with azithromycin. Providers should assess the risk-benefit of using azithromycin and consider alternative antibiotics among high-risk patients.

Objective:Flavocoxid is a medical food used for the clinical dietary management of osteoarthritis (OA). The acquisition cost of flavocoxid is higher than most traditional, generic NSAIDs. However, flavocoxid may have more favorable gastrointestinal (GI) toxicity resulting in lower overall costs. These costs have not been previously examined. This study provides a decision analytic model to assess the net costs of using flavocoxid for OA from a Medicare perspective.Research design and methods:A decision model was developed to estimate the total costs associated with flavocoxid versus naproxen for the management of Medicare patients with mild to moderate OA. Probabilities were obtained from literature and expert opinion, and costs were obtained from Medicare. Sensitivity analyses were conducted by varying probabilities and costs within clinically relevant ranges.Results:The base case resulted in flavocoxid having lower total annual costs (1482 per patient) compared to naproxen (1592). Flavocoxid remained the lowest cost option when the cost inputs were varied by 25 (above and below the base case), and when the probability of GI events with flavocoxid were varied by 25. However, when GI rates from the literature and implied relative risks from the expert panel were used, or if the cost of PPIs was 0, then naproxen was the less costly alternative, though saving less than the annual cost of flavocoxid. Key limitations were the limited outcomes in the model (only GI events), lack of consideration of adherence or combination therapy, and the reliance on expert opinion due to a lack of data for flavocoxid.Conclusions:In patients over 65 years of age who suffer from mild to moderate OA, flavocoxid may result in lower overall costs, despite a higher acquisition cost. Managed care organizations should consider total health care costs in the decision to include flavocoxid as a covered benefit. [ABSTRACT FROM AUTHOR]

Objectives: To analyze, from a payer perspective, the net pharmaceutical and medical costs of prescribing divalproex sodium extended-release (DVPX-ER) versus valproic acid (VPA) in patients with bipolar disorder.Methods: The study used a decision analytic framework to compare the total costs associated with DVPX-ER relative to VPA in the treatment of bipolar disease. The decision model incorporated two primary outcomes: GI side effects and treatment success. Levels of health service utilization and probability values were obtained from an expert panel comprised of 15 psychiatrists. Unit costs were obtained from an academic medical center. Two-way sensitivity analysis and a Monte Carlo simulation were conducted to examine the stability of the results.Results: The average probability of GI side effects associated with VPA and DVPX-ER estimated by the expert panel was 0.36 and 0.10 respectively. The average probability of treatment success for VPA and DVPX-ER was estimated to be 0.45 and 0.58 respectively. In the base case analysis, the expected total cost per patient was $34 208.84 and $25 336.13 for VPA and DVPX-ER respectively, a difference (incremental cost) of −$8188.87. Probabilistic sensitivity analysis using Monte Carlo simulation indicated a negative incremental cost of using DVPX-ER relative to VPA in a majority (approximately 70%) of cases.Conclusions: The results from this decision analysis, based on probabilities of major events and associated utilization from an expert panel, suggest that divalproex sodium extended-release results in lower total costs than valproic acid in the treatment of bipolar disorder. Limitations of this study primarily involved the sources of data used in the model, including that derived from expert opinion. [ABSTRACT FROM AUTHOR]

Purpose: The accuracy of the forecasts of drug expenditures in nonfederal hospitals and clinics published annually in the American Journal of Health-System Pharmacy (AJHP) relative to the accuracy of forecasts produced by the Centers for Medicare and Medicaid Services (CMS) was evaluated., Methods: AJHP-published forecasts of drug expenditure growth for nonfederal hospitals (for the years 2003 through 2013) and clinics (for the years 2004 through 2013) were compared with data on actual growth. Data on actual and projected growth published by CMS were analyzed for the years 2003 through 2012. The mean absolute error and directional accuracy of the forecasts published in AJHP for nonfederal hospitals and clinics and the CMS forecasts were determined and compared., Results: Actual spending growth was within the range of the forecast published in AJHP for 2 of 11 years for nonfederal hospitals and for 3 of 10 years for clinics; the forecasts for nonfederal hospitals and clinics were directionally accurate 27.3% and 60.0% of the time, respectively. The mean absolute errors of the AJHP-published drug expenditure forecasts for the nonfederal hospital and clinic sectors were 2.0 and 4.7 percentage points, respectively. The CMS forecasts of overall drug spending were directionally accurate 70% of the time, and the mean absolute error (2.2 percentage points) was not statistically different from that of either sector forecast published in AJHP., Conclusion: The annual drug expenditure forecasts published in AJHP have been reasonably accurate for predicting growth in prescription expenditures when compared with other available drug expenditure forecasts., (Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Purpose: An analysis of trends in U.S. pharmaceutical spending is presented, including projections for drug expenditures in nonfederal hospital and clinic settings in 2015., Methods: Prescription drug expenditure data through September 2014 were obtained from the IMS Health National Sales Perspectives database and were analyzed descriptively. Other factors that may influence prescription spending in hospitals and clinics in 2015, including new drug approvals and patent expirations, were analyzed. Expenditure projections were based on a combination of quantitative and qualitative analyses and expert opinion., Results: Total prescription sales for the 12 months ending September 30, 2014, were $360.7 billion, 12.2% higher than during the previous 12 months. With $6.6 billion in expenditures in the first 9 months of 2014, sofosbuvir topped the overall list of drugs based on sales, followed by aripiprazole and insulin glargine. Pharmaceutical spending by clinics and nonfederal hospitals rose by 13.3% and 4.0%, respectively. For the first 9 months of 2014, the top drugs based on expenditures were infliximab, pegfilgrastim, and epoetin alfa in clinics and infliximab, rituximab, and pegfilgrastim in hospitals. Specialty drugs continued to constitute an increasing portion of drug expenditures and will contribute to higher expenditures in 2015., Conclusion: Growth in U.S. prescription drug expenditures is expected to continue to increase in 2015. The projected increases in total drug expenditures are 7-9% across all settings, 12-14% in clinics, and 5-7% in hospitals. Health-system pharmacy leaders should carefully examine their own local drug utilization patterns to determine their own organization's anticipated spending in 2015., (Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Purpose: An analysis of trends in U.S. pharmaceutical spending is presented, including projections for drug expenditures in nonfederal hospital and clinic settings in 2014., Methods: Trends in pharmaceutical expenditures and developments likely to influence future spending, including new drug approvals and patent expirations, were analyzed using data from the IMS Health National Sales Perspectives database. Projections were based on a combination of quantitative and qualitative analyses and expert opinion., Results: Total prescription sales for the 12 months ending September 2013 were approximately $326 billion, 0.7% lower than sales during the previous 12 months; pharmaceutical spending by clinics and nonfederal hospitals grew by 4.5% and 1.8%, respectively. Vaccines were among the products driving large sales increases in clinic settings, with alteplase and pegfilgrastim topping the list of fast-growing drugs by hospital expenditures. Few new drug approvals anticipated in 2014 are expected to result in major expenditures by hospitals and clinics. Expansion of access to health care and other changes related to the Patient Protection and Affordable Care Act, as well as continued improvement in the U.S. economy, may drive growth in pharmaceutical spending over the next 12-24 months., Conclusion: Growth in U.S. prescription drug expenditures is expected to rebound in 2014, with a projected 3-5% increase in total drug expenditures across all settings this year, including a 5-7% increase in clinic spending and a 1-3% increase in hospital spending. Health-system pharmacy leaders should carefully examine local drug-utilization patterns to determine their respective organization's anticipated spending in 2014.