Journal of managed care & specialty pharmacy
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J Manag Care Spec Pharm · Dec 2015
Comparative Study Observational StudyHealth Outcomes Associated with Initiation of Basal Insulin After 1, 2, or ≥ 3 Oral Antidiabetes Drug(s) Among Managed Care Patients with Type 2 Diabetes.
Type 2 diabetes mellitus (T2DM) is a progressive disease. Despite starting with single oral antidiabetes drug (OAD) therapy and then adding OAD(s), most patients eventually require insulin therapy to achieve and maintain glycemic control. The timely initiation of insulin therapy could help patients with T2DM whose glycemic control is not adequately maintained using OADs alone. ⋯ This real-world analysis shows that there are significant baseline differences in patients with T2DM on 1 OAD, 2 OADs, or ≥3 OADs when adding insulin therapy. All 3 groups had significant improvements in clinical and economic outcomes compared with baseline, yet at different magnitudes. These data contribute to a growing body of evidence supporting the timely initiation of insulin therapy for T2DM patients not maintaining glycemic control with OADs.
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J Manag Care Spec Pharm · Dec 2015
Comparative Study Observational StudyDemographic and Clinical Profiles of Type 2 Diabetes Mellitus Patients Initiating Canagliflozin Versus DPP-4 Inhibitors in a Large U.S. Managed Care Population.
Canagliflozin is the first sodium-glucose co-transporter-2 (SGLT-2) inhibitor-a new class of oral antidiabetic (OAD) medication-approved for type 2 diabetes mellitus (T2DM) treatment in the United States. Approved less than 2 years ago, use of canagliflozin is largely uncharacterized. ⋯ In this sample of commercially insured patients within a large managed care plan, canagliflozin was often initiated as second- or third-line therapy, with a relatively high share of patients receiving concomitant antidiabetic injectables, compared with DPP-4 initiators. Canagliflozin initiators had highly elevated A1c levels and were frequently diagnosed with other metabolic conditions. Baseline pharmacy utilization and costs were higher among canagliflozin patients. Future research is needed to assess real-world clinical outcomes after canagliflozin initiation, while taking these baseline differences into account.
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J Manag Care Spec Pharm · Dec 2015
Comparative StudyPrevalence of Low-Cost Generic Program Use in a Nationally Representative Cohort of Privately Insured Adults.
Administrative claims data are used for a wide variety of research and quality assurance purposes. Despite their utility, they are prone to medication exposure misclassification if medications are purchased without utilizing an insurance benefit. Low-cost generic programs (LCGPs) offered at major chain pharmacies are a relatively new and sparsely investigated source of exposure misclassification. Since they were implemented in 2006, LCGPs are now available at 8 of the 10 largest pharmacy chains and include a wide variety of medication classes. LCGP medications are often purchased out of pocket; thus, a pharmacy claim may never be submitted and exposure may go unobserved in claims data. There are little data regarding the utilization of these programs, and estimates of their use can provide important insights into the potential impact LCGPs may have on exposure misclassification in claims data. ⋯ There is a high rate of LCGP use in the privately insured adult population. Users of LCGPs tend to be older, have more chronic comorbidities, and use more medications than nonusers. Claims-based research and quality assurance programs focusing on the benefits and harms of medications available through these programs are at risk of greatly underestimating the true medication exposure in this population and should account for this in sensitivity analyses. Managed care organizations should incentivize the reporting of LCGP medication use or make adjustments to generic medication benefit structures to more effectively capture true medication exposure.
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J Manag Care Spec Pharm · Dec 2015
Geographic Variation in Rosiglitazone Use Surrounding FDA Warnings in the Department of Veterans Affairs.
Geographic variation in the use of prescription drugs, particularly those deemed harmful by the FDA, may lead to variation in patient exposure to adverse drug events. One such drug is the glucose-lowering drug rosiglitazone, for which the FDA issued a safety alert on May 21, 2007, following the publication of a meta-analysis that suggested a 43% increase in the risk of myocardial infarction with the use of rosiglitazone. This alert was followed by a black box warning on August 14, 2007, that was updated 3 months later. While large declines have been documented in rosiglitazone use in clinical practice, little is known about how the use of rosiglitazone and other glucose-lowering drugs varied within the Department of Veterans Affairs (VA), surrounding the FDA alerts. Understanding this variation within integrated health care systems is essential to formulating policies that enhance patient protection and quality of care. ⋯ Our results show statistically significant variation in the way VISNs within the VA responded to the FDA alerts, suggesting a need for mechanisms that disseminate information and guidelines for drug use in a consistent and reliable manner. Further study of regions that adopted ideal practices earlier may provide lessons for regional leadership and practice culture within integrated health care systems.
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J Manag Care Spec Pharm · Dec 2015
Comparative StudyA Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes.
Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there is an acute need for the development of analytics that reflect drug safety in heterogeneous, real-world populations. ⋯ This scoring system is based on estimated direct medical costs associated with postmarketing AEs and poor patient outcomes and thereby helps fill a large information gap regarding drug safety in real-world patient populations.