Abstract
High-quality health care not only includes timely access to effective new therapies but timely abandonment of therapies when they are found to be ineffective or unsafe. Little is known about changes in use of medications after they are shown to be ineffective or unsafe. In this study, we examine changes in use of two medications: fenofibrate, which was found to be ineffective when used with statins among patients with Type 2 diabetes (ACCORD lipid trial); and dronedarone, which was found to be unsafe in patients with permanent atrial fibrillation (PALLAS trial). We examine the patient and provider characteristics associated with a decline in use of these medications. Using Medicare fee-for-service claims from 2008 to 2013, we identified two cohorts: patients with Type 2 diabetes using statins (7 million patient-quarters), and patients with permanent atrial fibrillation (83 thousand patient-quarters). We used interrupted time-series regression models to identify the patient- and provider-level characteristics associated with changes in medication use after new evidence emerged for each case. After new evidence of ineffectiveness emerged, fenofibrate use declined by 0.01 percentage points per quarter (95% CI − 0.02 to − 0.01) from a baseline of 6.9 percent of all diabetes patients receiving fenofibrate; dronedarone use declined by 0.13 percentage points per quarter (95% CI − 0.15 to − 0.10) from a baseline of 3.8 percent of permanent atrial fibrillation patients receiving dronedarone. For dronedarone, use declined more quickly among patients dually-enrolled in Medicare and Medicaid compared to Medicare-only patients (P < 0.001), among patients seen by male providers compared to female providers (P = 0.01), and among patients seen by cardiologists compared to primary care providers (P < 0.001).
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Acknowledgements
Research reported in this publication was supported a pilot Grant by the National Institute on Aging of the National Institutes of Health under Award Number P01AG005842. We also acknowledge support from the National Heart, Lung, and Blood Institute (R56 HL130496) and Agency for Healthcare Research and Quality (R01 HS025164). Laura Barrie Smith and Alexander Everhart and also acknowledge support from the AHRQ doctoral training program at the University of Minnesota (T32 HS000036). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This work was also supported in part by AHRQ’s Comparative Health System Performance Initiative under Grant # 1U19HS024075, which studies how health care delivery systems promote evidence-based practices and patient-centered outcomes research in delivering care.
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In the past 36 months, Dr. Shah has received research support through Mayo Clinic from the Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI), from the Agency for Healthcare Research and Quality (R01HS025402; R03HS025517), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HL131535), National Science Foundation, and from the Patient Centered Outcomes Research Institute (PCORI) to develop a Clinical Data Research Network (LHSNet). Support to Dr. Jena was provided by the Office of the Director, National Institutes of Health (1DP5OD017897). Dr. Jena reports receiving consulting fees unrelated to this work from Pfizer, Hill Rom Services, Bristol Myers Squibb, Novartis, Amgen, Eli Lilly, Vertex Pharmaceuticals, AstraZeneca, Celgene, Tesaro, Sanofi Aventis, Biogen, Precision Health Economics, and Analysis Group. Dr. Ross has received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices (U01FD004585), from the Food and Drug Administration to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Blue Cross Blue Shield Association to better understand medical technology evaluation, from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale. Dr. Herrin has recieved additional support for unrelated research from the Centers for Medicare and Medicaid Services and Mayo Clinic. Mr. Everhart and Mr. Higuera are paid research fellows at Medtronic for unrelated Projects. Dr. Jeffery is supported by two Grants that funded this study (NIH/R56 HL130496 and Agency for Healthcare Research and Quality/R01 HS025164); by an American Cancer Society funded study on biosimilar drug uptake (131611-RSGI-17-154-01-CPHPS); by the CERSI (U01FD 05938) for a Project addressing unsafe prescribing of opioids subject to REMS; and by NHLBI for a Project on step-down of asthma biologics (R21HL 140287). She has additional unrelated funding from NCATS (UL1TR 02377) and NIDA (UG3DA047003). Dr. Karaca-Mandic serves as the Principal Investigator to Grants that funded this study (NIA/P01AG005842; NIH/R56 HL130496 and Agency for Healthcare Research and Quality/R01 HS025164). She is also the Principal Investigator to an American Cancer Society funded study on biosimilar drug uptake (131611-RSGI-17-154-01-CPHPS). In the past 36 months, she reports receiving consulting fees unrelated to this work from Tactile Medical and Precision Health Economics.
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Smith, L.B., Desai, N.R., Dowd, B. et al. Patient and provider-level factors associated with changes in utilization of treatments in response to evidence on ineffectiveness or harm. Int J Health Econ Manag. 20, 299–317 (2020). https://doi.org/10.1007/s10754-020-09282-2
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DOI: https://doi.org/10.1007/s10754-020-09282-2