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P&T October 2018
President Donald Trump’s wide-ranging Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs has implications for P&T committees, PBMs, drug manufacturers, insurers, and of course, patients. As with everything else involving health care, it’s complicated.
Due to limited retrospective data, the use of enoxaparin in specialty populations—including those with renal dysfunction, extremes of body weight, pregnant patients and pediatric patients–has not been studied in clinical trials. The authors discuss the challenges in predicting the pharmacokinetics of enoxaparin dosing in these patients and the difficulty in obtaining antiXa levels in hospitalized patients.
The landscape of migraine therapy is set to change with the introduction of new classes of medications aimed at providing options for patients who have not responded to previous therapies. However, the pricing of the new agents will likely be a key determinant in the extent of their use in clinical practice.
We review sessions on large-scale aspirin and anticoagulation trials, weight loss therapies, fish oil, gout, endocarditis, and cardiomyopathy, with important implications for health care providers.
Part 2 of a 3-part series discusses medication safety risks related to labeling, patient education, and medication storage.
The FDA has made it easier for P&T committees to make formulary coverage decisions by expanding the health care economics information that drug manufacturers can provide to them.
Approvals, new indications, regulatory activities, and more
Ivosidenib (Tibsovo) for acute myeloid leukemia; elagolix (Orilissa) for endometriosis; and mogamulizumab-kpkc (Poteligeo) for mycosis fungoides or Sézary syndrome
Naldemedine (Symproic) for opioid-induced constipation