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Kar I, Kronz M, Kolychev E, et al. Biosimilar strategic implementation at a large health system. Am J Health Syst Pharm. 2021;doi: 10.1093/ajhp/zxab410.
Kar, I., Kronz, M., Kolychev, E., Silverman, P., Mendiratta, P., Tomlinson, B. K. N., Prunty, J., Copley, M., Patel, S., Caudill, S., Farah, L., Wesolowski, B., Crissinger, T., Kendig, C., Szymczak, E., Duraj, L., Acheson, E., Lyamkin, S., Dumot, J., King, M., Mocilnikar, A., Cunningham, K., Paulic, N., Botzki, U., Lerman, R., Strosaker, R., Osborne, S., & Glotzbecker, B. (2021). Biosimilar strategic implementation at a large health system. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, . https://doi.org/10.1093/ajhp/zxab410
Kar, Indrani, et al. "Biosimilar strategic implementation at a large health system." American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists vol. (2021). doi: https://doi.org/10.1093/ajhp/zxab410
Kar I, Kronz M, Kolychev E, Silverman P, Mendiratta P, Tomlinson BKN, Prunty J, Copley M, Patel S, Caudill S, Farah L, Wesolowski B, Crissinger T, Kendig C, Szymczak E, Duraj L, Acheson E, Lyamkin S, Dumot J, King M, Mocilnikar A, Cunningham K, Paulic N, Botzki U, Lerman R, Strosaker R, Osborne S, Glotzbecker B. Biosimilar strategic implementation at a large health system. Am J Health Syst Pharm. 2021 Nov 09; doi: 10.1093/ajhp/zxab410. Epub 2021 Nov 09. PMID: 34752608.
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Am J Health Syst Pharm. 2021 Nov 09; doi: 10.1093/ajhp/zxab410. Epub 2021 Nov 09.

Biosimilar strategic implementation at a large health system.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

Indrani Kar, Margaret Kronz, Evelina Kolychev, Paula Silverman, Prateek Mendiratta, Benjamin K N Tomlinson, Jeremy Prunty, Melissa Copley, Seema Patel, Sara Caudill, Lisa Farah, Bryan Wesolowski, Tyler Crissinger, Colin Kendig, Eric Szymczak, Lindsey Duraj, Emily Acheson, Svetlana Lyamkin, John Dumot, Michelle King, Allyson Mocilnikar, Kevin Cunningham, Nikola Paulic, Uwe Botzki, Rachael Lerman, Robyn Strosaker, Shawn Osborne, Brett Glotzbecker

Affiliations

  1. System Pharmacy Services, University Hospitals Health System, Cleveland, OH, USA.
  2. Pharmacy, Alleghany Health Network, Pittsburgh, PA, USA.
  3. University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
  4. University Hospitals Seidman Cancer Center, Cleveland, OH, USA.
  5. Cleveland Clinic Foundation, Cleveland, OH, USA.
  6. University Hospitals Specialty Pharmacy, Warrensville Heights, OH, USA.
  7. University Hospitals Health System, Cleveland, OH, USA.
  8. University Hospitals Geauga Medical Center, Chardon, OH, USA.

PMID: 34752608 DOI: 10.1093/ajhp/zxab410

Abstract

DISCLAIMER: In an effort to expedite the publication of articles , AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

PURPOSE: This article highlights one health system's response to the market influx of biosimilars with the establishment of a process for formulary review and selection of preferred agents and support for therapeutic interchanges.

SUMMARY: Through assessment of available literature, insurance payor coverage, and manufacturer-anticipated approvals of biosimilars, a strategic stance was developed to guide biosimilar order preparation, review, adoption, and implementation. The electronic medical record (EMR) is prepared for biosimilar implementation at least 6 to 12 months ahead of anticipated formulary review. The review includes assessment of a class (reference product and available biosimilars) after at least 2 biosimilars become available. Key health-system departments and clinicians are enlisted to support review of clinical, safety, and economic implications. Implementation of a preferred product relies on standard education, formulary availability, and staff awareness to address any perceived patient safety concerns and gather provider support. The standard steps developed now apply to all future biosimilar reviews, adoption plans, and ongoing monitoring. Barriers evaluated include changes in payor coverage and challenges in preparation of the EMR for future biosimilars, meeting precertification team education needs, and providing operational support for pharmacy inventory.

CONCLUSION: To date, use of 5 preferred biosimilar products has led to significant cost savings to the institution, and the process has been endorsed by providers. The institution's successes can be attributed to clear communication with stakeholders and the development of a deliberate process, led by a multidisciplinary leadership team, for managing formulary, safety, and operational barriers in a thoughtful and systematic manner.

© American Society of Health-System Pharmacists 2021. All rights reserved. For permissions, please e-mail: [email protected].

Keywords: biosimilar; cost savings; filgrastim; health system; infliximab; pegfilgrastim; trastuzumab

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