Rate and predictors of prescription of lumacaftor - Ivacaftor in the 18 months following approval in the United States

J Cyst Fibros. 2018 Nov;17(6):742-746. doi: 10.1016/j.jcf.2018.08.007. Epub 2018 Sep 7.

Abstract

Rationale: Lumacaftor-ivacaftor (LUM-IVA) was approved in the US in 2015 for patients with CF aged >12 homozygous for the delF508 mutation, and patients aged 6 to 12 in 2016.

Objectives: To examine the rate of initial LUM-IVA prescriptions following approval.

Methods: We compared patients eligible for LUM-IVA in the CF Foundation Patient Registry with and without prescriptions in 2015-2016.

Results: 5534 (53%) eligible patients had reported prescriptions. Prescription rate in children ages 6-11 was 19% and 61% among patients ≥12 years old. Individuals ≥12 with prescriptions more likely observed among those with private insurance, clinical trial participation, ages 18-30, FEV1 < 90%, more pulmonary exacerbations, and more use of chronic medications.

Conclusions: LUM-IVA uptake was less rapid than what was previously observed for ivacaftor, a CFTR modulator approved for a different population. Age, insurance status, disease severity and use of other therapies differed in those prescribed LUM-IVA in the initial post-approval period.

MeSH terms

  • Adolescent
  • Adult
  • Aminophenols / therapeutic use*
  • Aminopyridines / therapeutic use*
  • Benzodioxoles / therapeutic use*
  • Child
  • Chloride Channel Agonists / therapeutic use
  • Cystic Fibrosis* / drug therapy
  • Cystic Fibrosis* / epidemiology
  • Cystic Fibrosis* / genetics
  • Drug Combinations
  • Drug Prescriptions / statistics & numerical data*
  • Eligibility Determination / methods*
  • Female
  • Humans
  • Insurance Claim Review
  • Male
  • Product Surveillance, Postmarketing
  • Quinolones / therapeutic use*
  • Registries / statistics & numerical data
  • Severity of Illness Index
  • United States / epidemiology

Substances

  • Aminophenols
  • Aminopyridines
  • Benzodioxoles
  • Chloride Channel Agonists
  • Drug Combinations
  • Quinolones
  • lumacaftor, ivacaftor drug combination