The Effect of the APPRISE Mandate on Use of Erythropoiesis-Stimulating Agents and Transfusion Rates in Patients With Ovarian Cancer Receiving Chemotherapy

Boone, Jonathan D.; Fauci, Janelle M.; Walters, C.; Whitworth, Jenny M.; Bevis, Kerri S.; Alvarez, Ronald D.

doi:10.1097/igc.0b013e318276d9da

Cited by 4 publications

(3 citation statements)

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“…This study confirmed findings from prior studies by demonstrating that, after the 2007 NCD, there was a substantial decrease in the concomitant use of CT and ESAs in patients with nonmyeloid cancers and a decrease in ESA administration after the end of CT that persisted until the end of the study period in 2018 7‐15 . In contrast with other studies, our study showed that the full implementation of the ESA REMS in 2011 had minimal impact on ESA administration beyond changes observed after NCD 9,15,17,18 …”

Section: Discussionsupporting

confidence: 89%

“…Some studies reported either no increase 17 or an increase 9,15,18 in RBC transfusions after REMS implementation. However, these studies examined selected cancers rather than all cancer types 9,15,17,18 and three were small in size 15,17,18 . The study that was conducted in a sample of Medicare patients included fewer than 2000 patients and was restricted to two cancer types 18 .…”

Section: Discussionmentioning

confidence: 99%

“…Six of nine studies assessing the impact of NCD on red blood cell (RBC) transfusions reported increased transfusion rates 8‐11,15,16 ; three showed no significant changes 7,12,14 . Four studies assessing the impact of the REMS reported decreased use of ESAs after REMS approval and inconsistent RBC transfusion results 9,15,17,18 …”

Section: Introductionmentioning

confidence: 99%

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Trends in Erythropoiesis‐stimulating agent use and blood transfusions for chemotherapy‐induced anemia throughout FDA's risk evaluation and mitigation strategy lifecycle

Vega

Zhang

Wong

et al. 2021

Pharmacoepidemiology and Drug

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Purpose Erythropoiesis‐stimulating agents (ESAs), indicated for treating some patients with chemotherapy‐induced anemia (CIA), may increase the risk of tumor progression and mortality. FDA required a Risk Evaluation and Mitigation Strategy (REMS) to mitigate these risks. We assessed REMS impact on ESA administration and red blood cell (RBC) transfusion as surrogate metrics for REMS effectiveness. Methods Retrospective cohort study including data from January 1, 2006 to December 31, 2018 for beneficiaries ≥65 years enrolled in Centers for Medicare & Medicaid Services (CMS) Medicare Parts A/B with a cancer diagnosis; patients with other indications for ESA use were excluded. Study time was divided into five periods demarcated by issuance of CMS National Coverage Determination (NCD) (Pre‐NCD, Pre‐REMS) and REMS milestones (Grace Period, REMS, post‐REMS). Study outcomes were monthly proportion of chemotherapy episodes (CTEs) with concomitant ESA administration, with post‐CTE ESA administration, and with RBC transfusions. Results Of 1 778 855 beneficiaries treated with CT, 308742 received concomitant ESA for CIA. The proportion of CTEs with concomitant and post‐CTE ESA administration decreased Pre‐REMS (9.0 percentage points [pp] and 3.5 pp, respectively). There were no significant post‐REMS changes in the proportion of CTEs with concomitant (0.0 pp) and post‐CTE ESA administration (0.1 pp). Fluctuation in RBC transfusions was <4 pp throughout the study period. Conclusions Medicare beneficiaries showed a substantive decrease in ESA administration after NCD, with minimal impact by the REMS and its removal. Small changes in RBC transfusion over the study period were likely due to a national secular trend.

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Section: Discussionsupporting

confidence: 89%