Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA

Ther Innov Regul Sci. 2022 Mar;56(2):346-357. doi: 10.1007/s43441-021-00372-y. Epub 2022 Feb 3.

Abstract

Background: In the USA, drug costs associated with the inhaled corticosteroid (ICS) and long acting β agonist (LABA) combination products have been increasing since 2001. In January 2019, the first generic ICS/LABA drug product was approved by the U.S. Food and Drug Administration.

Methods: We investigated retrospectively the effects of the first approved generic ICS/LABA drug from 2019 to 2020 on the wholesale cost-savings and prescription dispensing using the IQVIA data system in the USA.

Results: The marketing of the first generic for fluticasone propionate and salmeterol xinafoate dry powder inhaler was associated with $941 million in drug cost-savings during the first year for this class of medications. Although the brand-name drug manufacturer concurrently introduced its authorized generic, these cost-savings were driven by the averaged unit cost of the approved generic at $115, compared to $169 for the authorized generic and $334 for the branded product. Generic initiation and substitution with the first generic were, respectively, higher compared to those with authorized generics; however, overall dispensing of the first generic was lower than that of its branded product. As in the case of budesonide and formoterol fumarate dry powder inhaler, marketing of authorized generics alone was not associated with any noticeable change in sales or prescription cost-saving.

Conclusion: We estimated that more than 20% of prescription cost-saving was achieved for the ICS/LABA dry powder inhalers in the first year following the introduction of the first approved generic, even though generic utilization remained lower than that of the branded counterpart.

Keywords: Adherence; Asthma; Authorized generics; COPD; First approved generic; Generic substitution; Persistence; Prescription cost-savings.

MeSH terms

  • Adrenal Cortex Hormones*
  • Drug Combinations
  • Drug Costs*
  • Formoterol Fumarate
  • Retrospective Studies
  • United States

Substances

  • Adrenal Cortex Hormones
  • Drug Combinations
  • Formoterol Fumarate