Journal of managed care & specialty pharmacy
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J Manag Care Spec Pharm · Nov 2017
Observational StudyExamining the Effect of Medication Adherence on Risk of Subsequent Fracture Among Women with a Fragility Fracture in the U.S. Medicare Population.
In the United States, osteoporosis affects approximately 10 million people, of whom 80% are women, and it contributes a significant clinical burden to the community. Poor adherence to osteoporosis medications adds to the overall burden of illness. ⋯ This study was funded by Eli Lilly. Xie, Keshishian, and Baser are employees of STATinMED Research, a paid consultant to Eli Lilly in connection with the study design, data analysis, and development of the manuscript for this study. Boytsov, Burge, Lombard, and Zhang are employees and stock owners of Eli Lilly. At the time of research, Krohn was an employee of Eli Lilly. Study concept and design were contributed by Burge and Lombard, along with the other authors. Xie, Baser, and Keshishian took the lead in data collection, assisted by the other authors. Data interpretation was performed by Krohn and Zhang, with assistance from the other authors. The manuscript was written by Keshishian and Boytsov, along with the other authors, and revised by Boytsov, Keshishian, and Burge, along with the other authors.
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J Manag Care Spec Pharm · Oct 2017
Optimization of Medication Use at Accountable Care Organizations.
Optimized medication use involves the effective use of medications for better outcomes, improved patient experience, and lower costs. Few studies systematically gather data on the actions accountable care organizations (ACOs) have taken to optimize medication use. ⋯ This research was sponsored and funded by the National Pharmaceutical Council (NPC), an industry funded health policy research group that is not involved in lobbying or advocacy. Employees of the sponsor contributed to the research questions, determination of the relevance of the research questions, and the research design. Specifically, there was involvement in the survey and interview instruments. They also contributed to some data interpretation and revision of the manuscript. Leavitt Partners was hired by NPC to conduct research for this study and also serves a number of health care clients, including life sciences companies, provider organizations, accountable care organizations, and payers. Westrich and Dubois are employed by the NPC. Wilks, Krisle, Lunner, and Muhlestein are employed by Leavitt Partners and did not receive separate compensation. Study concept and design were contributed by Krisle, Dubois, and Muhlestein, along with Lunner and Westrich. Krisle and Muhlestein collected the data, and data interpretation was performed by Wilks, Krisle, and Muhlestein, along with Dubois and Westrich. The manuscript was written primarily by Wilks, along with Krisle and Muhlestein, and revised by Wilks, Westrich, Lunner, and Krisle. Preliminary versions of this work were presented at the following: National Council for Prescription Drug Programs Educational Summit, November 1, 2016; Academy Health 2016 Annual Research Meeting, June 27, 2016; Accountable Care Learning Collaborative Webinar, June 16, 2016; the 21st Annual PBMI Drug Benefit Conference, February 29, 2016; National Value-Based Payment and Pay for Performance Summit, February 17, 2016; National Accountable Care Congress, November 17, 2015; and American Journal of Managed Care's ACO Emerging Healthcare Delivery Coalition, Fall 2015 Live Meeting, October 15, 2015.
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J Manag Care Spec Pharm · Oct 2017
Observational StudyThe FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. ⋯ This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.
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J Manag Care Spec Pharm · Sep 2017
Major Bleeding Risk During Anticoagulation with Warfarin, Dabigatran, Apixaban, or Rivaroxaban in Patients with Nonvalvular Atrial Fibrillation.
The use of non-vitamin K oral anticoagulants (NOACs) has increased steadily following marketing approval; however, their relative safety in nonvalvular atrial fibrillation (NVAF) patients in real-world clinical practice remains unclear. ⋯ This study was funded by Anthem. Adeboyeje, Sylwestrzak, and Barron are employees of HealthCore, a wholly owned and independently operated subsidiary of Anthem. White, Rosenberg, Abarca, and Crawford are employees of Anthem. Study concept and design were primarily contributed by Adeboyeje and Sylwestrzak, along with the other authors. Adeboyeje took the lead in data collection, along with Sylwestrzak and Barron. Data interpretation was performed primarily by Rosenberg, Crawford, and Redberg, with assistance from the other authors. The manuscript was written by all the authors and revised primarily by White, Abarca, and Redberg, along with the other authors.
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J Manag Care Spec Pharm · Aug 2017
Impact of a Patient Support Program on Patient Adherence to Adalimumab and Direct Medical Costs in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis.
AbbVie provides a free-to-patient patient support program (PSP) to assist adalimumab-treated patients with medication costs, nurse support, injection training, pen disposal, and medication reminders. The impact of these services on patient adherence to adalimumab and direct medical costs associated with autoimmune disease has not been assessed. ⋯ Design, study conduct, and financial support for this study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. All authors contributed to the development of the publication and maintained control over the final content. Rubin has received consulting fees or research support from AbbVie, Amgen, Emmi, Genentech, Ironwood, Janssen, Pfizer, Prometheus, Shire, and Takeda. Skup and Mittal are employees and stockholders of AbbVie. Chao was an employee of AbbVie at the time of the study and may hold AbbVie stock. Johnson and Davis are employees of Medicus Economics, which received payment from AbbVie to participate in this research. Study concept and design were contributed by Rubin, Mittal, Chao, and Skup, along with Davis and Johnson. Davis and Johnson took the lead in data collection, with assistance from the other authors, and data interpretation was performed by Rubin, Mittal, Chao, and Skup, with assistance from Davis and Johnson. All authors contributed to the writing and revision of the manuscript. The abstract for this study was published as Rubin DT, Skup M, Davis M, Johnson S, Chao J. Impact of AbbVie's patient support program on resource costs in Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. J Manag Care Spec Pharm. 2015;21(Suppl 4a):S74-75 (poster presentation at Academy of Managed Care, 27th Annual Meeting and Expo; April 7-10, 2015; San Diego, CA) and as abstract 2339 in Arthritis Rheumatol. 2015;67(Suppl 10; poster presentation at American College of Rheumatology 2015 ACR/AHRP Annual Meeting; November 7-11, 2015; San Francisco, CA).