Journal of managed care & specialty pharmacy
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It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics. ⋯ Adoption of 2-D barcodes in the European Union (EU) and standardized numerical identifiers in the United States addresses this need, since they include batch/lot numbers. These identifiers are already being implemented in the United States and the EU to improve patient safety, reduce medication errors, facilitate anticounterfeiting, and enable effective product recalls and adverse event reporting. Importantly, electronic identifiers will ameliorate safety reporting concerns with respect to biosimilars, while concurrently achieving these much broader public health objectives through more complete pharmacovigilance data.
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J Manag Care Spec Pharm · Dec 2017
Application of the FDA Biosimilar Extrapolation Framework to Make Off-Label Determinations.
The FDA's extrapolation framework allows for a biosimilar to obtain licensure for indications that were not explicitly studied in the context of a clinical trial by extending conclusions from studies in 1 population to make inferences in other populations. Within routine clinical care, drugs and biologics are routinely used for medically accepted off-label indications. The appropriateness of these products for off-label indications are typically curated by compendia and guidelines, which have established processes and criteria for reviewing and evaluating the evidence to make such determinations. The evidence paradigm for biosimilars is different from originator biologics and is one of comparability to a reference product, not to reestablish clinical benefit. Thus, this paradigm shift can be applied to the exercise of making off-label determinations for biosimilars, and the FDA's framework of extrapolation can be used by clinicians and coverage policy decision makers to determine appropriate off-label indications for biosimilars. ⋯ No outside funding supported this study. Li discloses that he has received honoraria and/or paid travel expenses as an advisory board and speaker's bureau participant for Pfizer; for speaking on behalf of Mylan and Apobiologix; and for participating on advisory boards for Eli Lilly and Mylan. Lobaina has nothing to disclose. Li was responsible for study design and manuscript revision. Li took the lead in data collection and interpretation and manuscript preparation, along with Lobaina.
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J Manag Care Spec Pharm · Nov 2017
Observational StudyFactors Associated with Direct Health Care Costs Among Patients with Migraine.
Migraine imposes substantial economic burden on patients and the health care system. Approximately 18% of women and 6% of men suffer from migraine in the United States. This is a heterogeneous group, and little data are available to evaluate factors associated with migraine costs. ⋯ This study was funded by Amgen and conducted by Truven Health Analytics. Bonafede, Cappell, and Kim are employees of Truven Health Analytics, which received compensation from Amgen for the overall conduct of the study and preparation of the manuscript. Cai was an employee of Truven Health Analytics at the time of this study. Sapra, Shah, and Desai are employees of Amgen. Katherine Widnell was an employee of Amgen when the manuscript draft was developed. Winner reports receiving research support from Allergan, Amgen, A-Z, Teva, Pfizer, Novartis, and Lilly. Study concept and design were contributed by Bonafede, Sapra, Shah, and Desai, along with Widnell and Winner. Kim and Cai took the lead in data collection, assisted by Bonafede and Cappell. Data interpretation was performed by Widnell and Winter, along with the other authors. All authors contributed to the writing and revision of the manuscript.
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J Manag Care Spec Pharm · Nov 2017
Opioid Abuse: A Detailed Examination of Cost Drivers over a 24-Month Follow-up Period.
Previous work has documented the considerable economic burden associated with opioid abuse, dependence, and overdose/poisoning (hereafter, "abuse"). Recent analyses have provided insights into the trajectory and drivers of the excess costs of abuse both before and after diagnosis, showing the important role of other substance abuse, mental health issues, and painful conditions. ⋯ This study was funded by Purdue Pharma. Howard was an employee of Purdue Pharma at the time that this study was conducted. Kirson, Scarpati, Jia, and Wen are employees of Analysis Group, which received funding from Purdue Pharma to conduct this study. Study concept and design were contributed by Kirson, Scarpati, and Howard, along with Jia and Wen. Jia and Wen took the lead in data collection, with assistance from Scarpati and Kirson. Data interpretation was performed by Scarpati, Kirson, and Howard, with assistance from Jia and Wen. The manuscript was written and revised by Scarpati, Kirson, and Howard.
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J Manag Care Spec Pharm · Nov 2017
Inhaled Corticosteroid-Containing Treatment Escalation and Outcomes for Patients with Asthma in a U.S. Health Care Organization.
Asthma is a common disorder that affects approximately 8% of the U.S. ⋯ This study was sponsored and funded by Boehringer-Ingelheim, which contracted with Optum to conduct the research. The sponsor collaborated with Optum on the preparation, writing, revision, and approval of the manuscript. Bengston, Cao, Hulbert, Wolbeck, Elliott, and Buikema are employees of Optum. Yu and Wang are employed by Boehringer-Ingelheim. Study concept and design were contributed by Bengston, Yu, and Wang. Cao, Hulbert, and Wolbeck collected the data, and data analysis was performed by Bengston, Yu, and Wang. The manuscript was written by Bengston, along with Yu and Wang, and revised by Bengston, Yu, and Wang, along with the other authors.