IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v44y2021i3d10.1007_s40264-020-01017-z.html
   My bibliography  Save this article

Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program

Author

Listed:
  • Ameet Sarpatwari

    (Brigham and Women’s Hospital and Harvard Medical School)

  • Mengdong He

    (Brigham and Women’s Hospital and Harvard Medical School)

  • Frazer A. Tessema

    (Brigham and Women’s Hospital and Harvard Medical School)

  • Joshua J. Gagne

    (Brigham and Women’s Hospital and Harvard Medical School)

  • Aaron S. Kesselheim

    (Brigham and Women’s Hospital and Harvard Medical School)

Abstract

Introduction Risk evaluation and mitigation strategy (REMS) programs are intended to improve safe use of US Food and Drug Administration-approved drugs. However, controversy exists over whether they consistently accomplish this goal. Objective We aimed to assess how initiation of the erythropoiesis stimulating agents (ESAs) darbepoetin alfa and epoetin alfa changed following implementation and enforcement (following a 1-year post-implementation grace period) of a prominent REMS program warning physicians against use in cancer patients with hemoglobin above 10 g/dL. Methods Using claims data from a large US commercial insurance company, we conducted interrupted time-series analyses of darbepoetin alfa and epoetin alfa initiation among adult cancer patients in the 12 months before REMS program implementation, after REMS program implementation, and after REMS program enforcement. We also evaluated differences in inappropriate initiation (hemoglobin tests all above 10 g/dL in the prior month) between the periods. Results In total, we identified 3456 darbepoetin alfa initiators and 2632 epoetin alfa initiators. Over the study period, the monthly number of initiators per 100,000 patients with cancer fell from 119 to 32 for darbepoetin alfa and from 82 to 34 for epoetin alfa. However, non-significant post-REMS program implementation level and slope changes per 100,000 adult patients with cancer were observed for darbepoetin alfa (level 0.03 [95% confidence interval (CI) −14.98 to 15.05]; slope 1.94 [95% CI −0.22 to 4.10]) and epoetin alfa (level −4.10 [95% CI −16.85 to 8.65]; slope −0.52 [95% CI −2.35 to 1.32]). Non-significant post-REMS program enforcement level and slope changes were also seen for both drugs (darbepoetin alfa level 1.58 [95% CI −0.58 to 3.74, slope −0.28 [95% CI −15.29 to 14.73]; epoetin alfa level 1.58 (95% CI −0.26 to 3.42], slope 5.74 [95% CI −7.01 to 18.49]). Finally, non-significant changes in inappropriate darbepoetin alfa (60% vs. 53% vs. 57%, p = 0.68) and epoetin alfa (53% vs. 53% vs. 46%, p = 0.41) initiation were observed between the three study periods. Conclusion REMS program implementation and enforcement were not associated with significant changes in ESA initiation, adding to concerns over the degree to which certain REMS programs enhance patient safety.

Suggested Citation

  • Ameet Sarpatwari & Mengdong He & Frazer A. Tessema & Joshua J. Gagne & Aaron S. Kesselheim, 2021. "Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program," Drug Safety, Springer, vol. 44(3), pages 327-335, March.
    • Handle: RePEc:spr:drugsa:v:44:y:2021:i:3:d:10.1007_s40264-020-01017-z
    DOI: 10.1007/s40264-020-01017-z
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-020-01017-z
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s40264-020-01017-z?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Ameet Sarpatwari & Mayookha Mitra-Majumdar & Katsiaryna Bykov & Jerry Avorn & Steven Woloshin & Gita A. Toyserkani & Cynthia LaCivita & Claudia Manzo & Esther H. Zhou & Ellen Pinnow & Gerald J. Dal Pa, 2021. "A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs," Drug Safety, Springer, vol. 44(7), pages 743-751, July.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:drugsa:v:44:y:2021:i:3:d:10.1007_s40264-020-01017-z. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/40264 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.