The American journal of managed care
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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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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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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.
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A long-held assumption and expectation has been that genomics-based precision medicine will provide clinicians with the tools and therapies they need to consistently deliver the right treatment to the right patient while simultaneously reducing waste and yielding cost savings for health systems. The pace of discovery within the field of precision medicine has been remarkable, yet optimal uptake of new genetic tests and genetically targeted therapies will occur only if payers recognize their value and opt to cover them. Coverage decisions require clear evidence of clinical effectiveness and utility and an understanding of how adoption will impact healthcare costs and utilization within a payer's network. ⋯ Collaboration among payers, scientists, and clinicians is essential for accelerating uptake and value creation. By pairing clinical outcomes with claims and cost data and collaboratively conducting well-designed pragmatic clinical or observational studies, all stakeholders can learn from more meaningful and relevant outcomes. In turn, there will be a collective understanding of how precision medicine innovations impact the health of populations and care delivery within healthcare systems.