Early insurance coverage of elexacaftor/tezacaftor/ivacaftor for cystic
fibrosis in children 6 to 11 years of age
Ashlee Anderson, PharmD, BCPS, Sanford Health
Lindsey McCoy, PharmD, Medical University of South Carolina
Rebecca S. Pettit, PharmD, MBA, BCPS, BCPPS, FCCP, Riley Hospital for
Children at IU Health
Brittany A. Wright, PharmD, BCACP, University of Iowa Hospitals and
Clinics
Lisa Lubsch, PharmD, BCPPS, AE-C, FPPA, Southern Illinois University
Edwardsville School of Pharmacy and SSM Health Cardinal Glennon
Children’s Hospital
Corresponding author:
Ashlee Anderson, PharmD, BCPS, Sanford Health
Key words: cystic fibrosis, pharmacy services, medication access
Word count: 785 words
This research did not receive any specific grant from funding agencies
in the public, commercial, or not-for-profit sectors.
Conflicts of interest: none
Abstract
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.
To the Editor,