Medications listed in the tables and non-FDA approved indications that may be included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • April 28, 2023
  • April 23, 2021
  • March 2019
  • March 2017
  • Nov. 2015
  • March 2014
  • Aug. 2012
  • June 2012
  • Aug. 2010
  • July 2010
  • July 2007
  • Feb. 2003
  • Jan 2002
  • Jan. 2001
  • March 2000
  • Jan. 2000
  • Feb. 1999
  • March 1998
  • Aug. 1997
  • Feb. 1997
• Initially developed
  • Jan. 1995

Because asthma is comprised of both inflammatory and bronchoconstrictive components, asthma treatment plans include routine use of inhaled corticosteroids (ICS) to manage inflammatory processes in asthma patients requiring chronic treatment. Higher ICS doses may contribute to a decrease in linear growth velocity in children, but adult height does not appear to be significantly inhibited following ICS use in childhood. All ICS doses may contribute to decreased bone formation in children and bone mineral density in adults. Close monitoring of growth and bone formation markers in children and fracture risk in adults is warranted with long-term ICS use. The lowest effective ICS dose should be utilized for the shortest required time period.

ICS, both as individual agents and as combination therapy, are FDA-approved for managing chronic asthma and COPD and may be continued indefinitely, as both COPD and asthma are chronic, lifelong processes²². Additionally, current guideline recommendations include the use of combined formoterol and budesonide as maintenance and rescue therapy for most patients with asthma, including the use of this combination as needed²³. However, days’ supply per canister is limited based on the number of actuations per canister combined with the maximum recommended dose per day. Recommended days’ supply for available ICS as monotherapy or combined with long-acting beta2-agonists are summarized in Tables 5 and 6. Fluticasone is available as both the furoate and propionate salts; fluticasone propionate is available as four different formulations in three dosage strengths per formulation. Each dosage strength is associated with a maximum recommended dose (cited in Tables 1 and 3) which is used in combination with the number of actuations per drug canister to calculate days’ supply. Fluticasone/salmeterol inhalation powder formulations have also been approved for asthma management (AirDuo RespiClick and AirDuo Digihaler) with three different dosage formulations available; days’ supply can be calculated using dosages provided in Tables 2 and 4. Combined therapy with fluticasone furoate and vilanterol is available as two blister strips, with fluticasone in one strip and vilanterol in the second strip; similarly, triple therapy with fluticasone furoate, umeclidinium, and vilanterol is available as two blister strips, with fluticasone in one strip and umeclidinium and vilanterol in the second strip. Excessive use of ICS may be identified based on refill frequency. Inappropriate supply of ICS will be reviewed by monitoring refill requests.

Legend:

• + calculated based on canister size and maximum dose allowed per day (summarized in Tables 1 & 3)
• BD = bronchodilator
• ICS = inhaled corticosteroids
• OCS = oral corticosteroids

Legend:

• + calculated based on canister size and maximum allowed dose per day (summarized in Tables 2 & 4)
• * Salmeterol inhalation powder, alone or in combination with fluticasone as Advair Diskus®, may be used in children greater than 4 years of age
• # Budesonide/formoterol indicated in children 6 years of age and older and mometasone/formoterol inhalation aerosols is indicated for children 5 years of age and older
• ^ Fluticasone/salmeterol inhalation aerosol only indicated for children greater than or equal to 12 years of age
• $ Fluticasone/vilanterol powder not indicated for use in children

Concurrent use of inhaled corticosteroids with systemic corticosteroids may result in augmented adverse effects, especially when high doses of inhaled corticosteroids are utilized^1-11.

When using single maintenance and reliever therapy (SMART), the “2020 Focused Updates to the Asthma Management Guidelines” recommends using a single inhaled corticosteroid (ICS)/ long acting beta2-agonist combination inhaler as the preferred therapy as opposed to using a separate ICS inhaler. Additionally, the guidelines recommend intermittent use of a single ICS inhaler for patients 12 years of age and older with mild persistent asthma in certain situations when the patient is not already using ICS controller therapy²⁴. The Global Initiative for Asthma (GINA) “Global Strategy for Asthma Management and Prevention” guidelines recommend the use of combination ICS-LABA with budesonide and formoterol as maintenance and rescue therapy for most patients²³.

The concomitant use of two or more inhaled corticosteroids for the treatment of asthma is not recommended and will be reviewed.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug interactions considered clinically relevant for inhaled corticosteroids with or without beta agonists are summarized in Table 7. Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• +CP = Clinical Pharmacology
• COPD = chronic obstructive pulmonary disease
• ECG = electrocardiogram
• MAOIs = monoamine oxidase inhibitors
• TCAs = tricyclic antidepressants

1. IBM Micromedex DRUGDEX (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www-micromedexsolutions-com.libproxy.uthscsa.edu/.
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2023. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/.
3. Beclomethasone dipropionate HFA inhalation aerosol (QVAR Redihaler) package insert. Teva Respiratory, September 2022.
4. Budesonide inhalation powder (Pulmicort Flexhaler) package insert.  AstraZeneca, October 2019.
5. Ciclesonide inhalation aerosol (Alvesco) package insert. Covis Pharma, February 2023.
6. Fluticasone furoate inhalation powder (Arnuity Ellipta) package insert.  GlaxoSmithKline, February 2020.
7. Fluticasone propionate inhalation aerosol (Flovent HFA) package insert.  GlaxoSmithKline, August 2021.
8. Fluticasone propionate inhalation powder (Flovent Diskus) package insert.  GlaxoSmithKline, June 2022.
9. Fluticasone inhalation powder (ArmonAir™ Digihaler) package insert. Teva Respiratory, September 2022.
10. Mometasone furoate HFA inhalation aerosol (Asmanex HFA) package insert.  Merck & Co., June 2021.
11. Mometasone furoate inhalation powder (Asmanex Twisthaler) package insert. Merck & Co., June 2021.
12. Fluticasone/salmeterol inhalation aerosol (Advair HFA) package insert.  GlaxoSmithKline, August 2021.
13. Mometasone furoate/formoterol inhalation aerosol (Dulera) package insert.  Merck & Co., June 2021.
14. Fluticasone/salmeterol inhalation powder (Advair Diskus) package insert.  GlaxoSmithKline, October 2020.
15. Fluticasone/salmeterol inhalation powder (AirDuo RespiClick) package insert. Teva Pharmaceuticals, September 2022.
16. Budesonide/formoterol fumarate inhalation aerosol (Symbicort) package insert. AstraZeneca, July 2019.
17. Fluticasone/vilanterol inhalation powder (Breo Ellipta™) package insert. GlaxoSmithKline, July 2021.
18. Fluticasone/umeclidinium/vilanterol inhalation powder (Trelegy Ellipta) package insert. GlaxoSmithKline, December 2022.
19. Budesonide/ Glycopyrrolate/ formoterol fumarate inhalation aerosol (Breztri Aerosphere) package insert. January 2022.
20. Fluticasone/salmeterol inhalation powder (Wixela Inhub) package insert. Mylan Pharmaceuticals, Inc., August 2022.
21. Fluticasone/salmeterol inhalation powder (AirDuo Digihaler) package insert. Teva Pharmaceuticals, April 2022.
22. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease.  2023 report. Available at: https://goldcopd.org/2021-gold-reports/. Accessed March 20, 2023.
23. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. Available from: https://ginasthma.org/gina-reports/. Accessed March 16, 2023.
24. National Heart, Lung, and Blood Institute. 2020 focused updates to the asthma management guidelines: a report from the national asthma education and prevention program coordinating committee expert panel working group, 2021. Available from: https://www.nhlbi.nih.gov/health-topics/asthma-management-guidelines-2020-updates. Accessed March 20, 2023.