The American journal of managed care
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Guidance to industry from the FDA requires studies to evaluate the cardiovascular safety of novel type 2 diabetes (T2D) medications. Although the objectives of such cardiovascular outcomes trials (CVOTs) are similar, differences in features such as enrollment criteria present a challenge when trying to assess the applicability of these studies to real-world T2D populations. This study evaluated the proportions of US adults with T2D who met the eligibility criteria for each of the 4 sodium-glucose cotransporter-2 (SGLT2) inhibitor CVOTs. ⋯ There were considerable differences in the proportions of US adults with T2D who met the eligibility criteria for these studies.The DECLARE-TIMI 58 trial criteria were the most generalizable to the US T2D population.
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Cardiovascular outcomes trials (CVOTs) for evaluating the safety of novel antidiabetic agents are required by the FDA. CVOTs vary in their design and inclusion criteria, making it difficult to evaluate their applicability to the general population. This study examined the proportion of adults eligible for 7 ongoing or completed glucagon-like peptide-1 receptor agonist (GLP-1 RA) CVOTs. ⋯ Most adults with T2D in the United States would have qualified for enrollment into at least 1 of the GLP-1 RA CVOTs evaluated. EXSCEL had the most generalizable eligibility criteria of these trials and ELIXA the least.
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Oral anticancer medications (OAMs) are frequently used to treat patients with cancer. Unlike intravenous chemotherapy, OAMs are covered by prescription drug plans. We examined barriers to initiation of OAMs in 116 patients with prostate or kidney cancer (149 unique prescriptions). ⋯ Of 107 prescriptions with data available, 54% utilized financial assistance; these required significantly more phone calls (P = .0001) and led to a longer median time to drug obtainment (P = .003) compared with those that did not require financial assistance. In those prescriptions with both initial and final co-pay information available, the initial out-of-pocket mean and median co-pays were $1226.03 and $329.73, respectively, but these dropped to $124.57 and $25.00 after utilization of co-pay assistance programs, excluding those with a $0 final co-pay. These early observations suggest that a more efficient process for initiation of OAMs is needed.
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To provide actionable recommendations for improving care coordination programs for children with special healthcare needs (CSHCN) in Medicaid managed care. ⋯ States and Medicaid managed care organizations have many options for designing effective care coordination programs for CSHCN. Their choices should account for the diversity of conditions among CSHCN, families' capacity to coordinate care, and social determinants of health.
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The efficacy of dapagliflozin as add-on therapy to metformin has been assessed in randomized trials. However, its effectiveness has not been assessed in a US real-world setting. ⋯ In current US clinical practice, patients receiving D + M ± OAD had greater reductions in important clinical outcomes of T2D-A1C level, weight loss, and blood pressure-versus patients receiving M + OAD. This study supports the use of dapagliflozin as add-on therapy to metformin with or without other OADs for patients with T2D.