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Early insurance coverage of elexacaftor/tezacaftor/ivacaftor for cystic fibrosis in children 6 to 11 years of age
  • +2
  • Ashlee Anderson,
  • Lindsey McCoy,
  • Rebecca Pettit,
  • Brittany Wright,
  • Lisa Lubsch
Ashlee Anderson
Sanford Health North
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Lindsey McCoy
Medical University of South Carolina
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Rebecca Pettit
Riley Hospital for Children at Indiana University Health
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Brittany Wright
University of Iowa Hospitals and Clinics
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Lisa Lubsch
Southern Illinois University Edwardsville - School of Pharmacy
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Introduction: Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy (HEMT) originally approved in 2019 for use in patients 12 years of age and older with at least one F508del mutation or a mutation in the CFTR gene that is responsive based on in vitro data. This report describes coverage of ELX/TEZ/IVA for CF in children 6 to 11 years of age prior to the recent age expansion by the Food and Drug Administration (FDA). Methods: An email was sent to pharmacists and pharmacy technicians through the CF Foundation LISTSERV and all responses regarding ELX/TEZ/IVA use in children 6 to 11 years of age were collected. Results: A total of 65 children from 15 CF care centers were included in the study. A total of 55 children had early coverage of ELX/TEZ/IVA for an overall approval rate of 84.6%. The median time to approval was 15 days. Lung function and weight outcomes were also positive. Conclusions: Early insurance coverage of ELX/TEZ/IVA for CF in children 6 to 11 years was achieved regardless of insurance type and should be considered an option for patients in need of HEMT therapy.

Peer review status:ACCEPTED

23 Jun 2021Submitted to Pediatric Pulmonology
24 Jun 2021Submission Checks Completed
24 Jun 2021Assigned to Editor
25 Jun 2021Reviewer(s) Assigned
14 Jul 2021Review(s) Completed, Editorial Evaluation Pending
16 Jul 2021Editorial Decision: Revise Major
02 Aug 20211st Revision Received
03 Aug 2021Submission Checks Completed
03 Aug 2021Assigned to Editor
03 Aug 2021Reviewer(s) Assigned
23 Aug 2021Review(s) Completed, Editorial Evaluation Pending
26 Aug 2021Editorial Decision: Revise Minor
30 Aug 20212nd Revision Received
31 Aug 2021Assigned to Editor
31 Aug 2021Submission Checks Completed
31 Aug 2021Reviewer(s) Assigned
01 Sep 2021Review(s) Completed, Editorial Evaluation Pending
01 Sep 2021Editorial Decision: Accept