Journal of managed care & specialty pharmacy
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J Manag Care Spec Pharm · Dec 2017
ReviewA Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?
Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval process is different from the 351(a) pathway for original biologic approval and, as of August 2017, has been used to approve 5 biosimilars in the United States. ⋯ There was no external funding for this study. Hung reports employment as a pharmacist for CVS Health, an AHRQ F32 grant, and meeting/accommodation/travel support from AACP, DIA, and ISPOR, all outside the submitted work. Vu and Mostovoy have nothing to disclose. Study concept and design were contributed by Hung and Mostovoy, along with Vu. Hung and Vu collected the data, and data interpretation was performed primarily by Hung, along with Mostovoy. The manuscript was written by Hung and Vu and revised by all the authors. Some of the study results were previously presented as a poster at the ISPOR 22nd Annual International Meeting; May 20-24, 2017; in Boston, Massachusetts.
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J Manag Care Spec Pharm · Dec 2017
High-Cost Sarcoidosis Patients in the United States: Patient Characteristics and Patterns of Health Care Resource Utilization.
Sarcoidosis is a multisystem inflammatory disorder characterized by the presence of noncaseating granulomas in involved organs. Prior research has found that sarcoidosis imposes a significant economic burden to U.S. payers. However, the drivers of high health care costs among sarcoidosis patients are unknown. ⋯ This study was funded by Mallinckrodt Pharmaceuticals. Rice, White, and Lopez are employees of Analysis Group, which received funding from Mallinckrodt Pharmaceuticals to conduct this research. Nelson is an employee of Mallinckrodt Pharmaceuticals. Study concept and design were contributed by Rice, White, and Nelson, along with Lopez. Lopez took the lead in data collection, with assistance from Rice and White. Data interpretation was performed by all of the authors. The manuscript was written by Rice, Lopez, White, and Nelson and revised by Rice, along with White and Nelson.
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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.