Long-Acting Muscarinic Antagonists (LAMA) (Tudorza, Seebri, Incruse Ellipta)

Long-Acting Muscarinic Antagonist (LAMA)

Self-Administered - oral inhalation

Step Therapy (ST)

Diagnosis considered for coverage:

• Tudorza Pressair
  • Chronic obstructive pulmonary disease (COPD) - Indicated for the long-term, maintenance treatment of bronchospasm associated with COPD.
• Seebri Neohaler
  • COPD - Indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD.
• Incruse Ellipta
  • COPD - Indicated for the maintenance treatment of patients with COPD.

Coverage Criteria:

Request for Tudorza Pressair, Seebri Neohaler, or Incruse Ellipta for the treatment of COPD:

• Dose does not exceed the maximum approved by the Food and Drug Administration (FDA); AND
  • Tudorza Pressair - 400 mcg (1 oral inhalation) twice daily.
  • Seebri Neohaler - 15.6 mcg (1 oral inhalation) twice daily.
  • Incruse Ellipta - 62.5 mcg (1 inhalation) once daily.
• Patient has tried and failed, contraindication, or intolerable side effects to Spiriva Handihaler or Spiriva Respimat.

Coverage Duration:

• Initial and reauthorizations: 12 months.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Preferred agents are Spriva Handihaler and Spiriva Respimat.
• LAMA medications are not rescue medicines and should not be used for treating sudden breathing problems.
• Seebri Neohaler was discontinued and removed from the market by the manufacturer in April 2020.

Policy Updates:

• 06/15/2021 – Utilization management of Tudorza Pressair, Seebri Neohaler, and Incruse Ellipta converted to step therapy with single step edit. Incruse Ellipta formulary status changed from preferred brand (PB) to non-preferred brand (NPB). Spiriva Respimat formulary status changed from NPB to PB.

References:

• Tudorza Prescribing Information. AstraZeneca Pharmaceuticals. Wilmington, DE. March 2019.
• Seebri Neohaler Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. January 2017.
• Incruse Prescribing Information. GlaxoSmithKline. Research Triangle Park, NC. April 2019.
• Centers for Disease Control and Prevention. Chronic obstructive pulmonary disease (COPD). https://www.cdc.gov/copd/index.html. Updated June 5, 2018[a]. Accessed January 5, 2019.
• Dahl R, Kaplan A. A systematic review of comparative studies of tiotropium Respimat and tiotropium Handihaler in patients with chronic obstructive pulmonary disease: does inhaler choice matter? BMC Pulm Med. 2016;16(1):135.
• Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. http://goldcopd.org/gold-reports/. 2019 Report. Accessed January 5, 2019.
• Ismaila AS, Huisman EL, Punekar YS, et al. Comparative efficacy of long-acting muscarinic antagonist monotherapies in COPD: a systematic review and network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2015;10:2495-2517.
• Ni H, Htet A, Moe S. Umeclidinium bromide versus placebo for people with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2017;6:CD011897.
• Ni H, Soe Z, Moe S. Aclidinium bromide for stable chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;9:CD010509.
• Oba Y, Lone NA. Comparative efficacy of long-acting muscarinic antagonists in preventing COPD exacerbations: a network meta-analysis and meta-regression. Ther Adv Respir Dis. 2015;9(1):3-15.
• Pleasants RA, Wang T, Gao J, et al. Inhaled umeclidinium in COPD patients: a review and meta-analysis. Drugs. 2016;76:343-361.
• Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369(16):1491-1501.