Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020

Mufaddal Mahesri (), Ameet Sarpatwari, Krista F. Huybrechts, Joyce Lii, Su Been Lee, Gita A. Toyserkani, Cynthia LaCivita, Esther H. Zhou, Gerald J. Dal Pan, Aaron S. Kesselheim and Katsiaryna Bykov
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Mufaddal Mahesri: Brigham and Women’s Hospital and Harvard Medical School
Ameet Sarpatwari: Brigham and Women’s Hospital and Harvard Medical School
Krista F. Huybrechts: Brigham and Women’s Hospital and Harvard Medical School
Joyce Lii: Brigham and Women’s Hospital and Harvard Medical School
Su Been Lee: Brigham and Women’s Hospital and Harvard Medical School
Gita A. Toyserkani: Center for Drug Evaluation and Research, Food and Drug Administration
Cynthia LaCivita: Center for Drug Evaluation and Research, Food and Drug Administration
Esther H. Zhou: Center for Drug Evaluation and Research, Food and Drug Administration
Gerald J. Dal Pan: Center for Drug Evaluation and Research, Food and Drug Administration
Aaron S. Kesselheim: Brigham and Women’s Hospital and Harvard Medical School
Katsiaryna Bykov: Brigham and Women’s Hospital and Harvard Medical School

Drug Safety, 2024, vol. 47, issue 9, No 8, 909-919

Abstract: Abstract Introduction Lenalidomide, pomalidomide, and thalidomide are effective treatments for multiple myeloma but are teratogenic. To mitigate this risk, the US Food and Drug Administration (FDA) required risk evaluation and mitigation strategy (REMS) programs for these drugs, which include pregnancy testing among women of childbearing potential—twice before initiation, weekly in the first month on treatment, and every 2–4 weeks thereafter. Objective We evaluated dispensing trends of lenalidomide, pomalidomide, and thalidomide and assessed adherence to REMS pregnancy testing requirements among at-risk patients taking these drugs. Methods Using three US health insurance claims databases (Optum Clinformatics® [2004–2020], Merative Marketscan [2003–2019], and Medicaid [2000–2018]), we assessed monthly use of the drugs, patient characteristics and treatment persistence among drug initiators, and claims-based evidence for adherence to pregnancy testing requirements among initiators with child-bearing potential. Results Lenalidomide was the most prescribed agent following its approval in 2006 and through the end of the study period. A total of 48,311 lenalidomide (mean age = 59 years [standard deviation (SD) = 16]), 17,550 thalidomide (mean age = 65 years [SD = 12]), and 6560 pomalidomide initiators (mean age = 65 years [SD = 11]) were identified; 45% of initiators of each drug were women. Among initiators under follow-up on day 90, 70% were still on therapy. Initiators of childbearing potential comprised 3% (N = 1,920) of all initiators; among this cohort, 12% had evidence in claims data of two pregnancy tests before initiation, and 9% with at least 33 days of follow-up of four tests during the first month of treatment. By contrast, 52% who received a refill had claims-based evidence of a pregnancy test within 7 days of dispensing. Conclusion Although most patients who initiated lenalidomide, pomalidomide, and thalidomide were not of child-bearing potential, further investigation into actual non-adherence to pregnancy testing is needed.

Date: 2024
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DOI: 10.1007/s40264-024-01443-3

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