Chronic obstructive pulmonary disease (COPD) inhaler criteria

Last updated on January 17, 2025

On this page: Practitioner exemptions and Collaborative Prescriber Agreement | Spirometry requirements | Coverage of COPD inhalers and links to SA criteria | History of exacerbations | Resources

Abbreviations

  • SAMA: short-acting muscarinic antagonist
  • SABA: short-acting beta2 agonist
  • LABA: long-acting beta2 agonist

 

  • LAMA: long-acting muscarinic antagonist
  • ICS: inhaled corticosteroid

The information on this page reflects the 2020 review: COPD Drug Decision Summary (PDF, 195KB)

Practitioner exemptions and Collaborative Prescriber Agreement

Respirologist practitioner exemptions are in place for LABAs and dual combination therapy (i.e., ICS-LABA and LAMA-LABA) for the treatment of COPD. This means they do not need to request Special Authority (SA) coverage; patients are automatically covered. Respirologist inhaler exemptions are assumed SA; if filled under a respirologist, the patient will automatically be granted indefinite SA approval. 

Respirologists are invited to apply for a Collaborative Prescribing Agreement (CPA) for fluticasone furoate-umeclidinium-vilanterol (Trelegy Ellipta®) and budesonide-glycopyrronium-formoterol (Breztri Aerosphere®), to be exempt from applying for SA coverage.

Spirometry requirements

The spirometry requirement for the diagnosis of moderate-to-very-severe COPD requires a post-bronchodilator fixed ratio of FEV1/forced vital capacity (FVC) < 0.70.

COPD severity is further classified as follows:

  • Moderate COPD is defined as FEV1 less than 80% and greater than or equal to 50%
  • Severe CPOD is defined as FEV1 less than 50% and greater than or equal to 30%
  • Very severe COPD is defined as FEV1 less than 30%

Coverage of COPD inhalers and links to SA criteria

Coverage of COPD inhalers

Medication

Brand name, device (dose/inhalation)

Coverage

SABA

salbutamol

Ventolin HFA MDI, generics (100 mcg)

regular benefit

terbutaline

Bricanyl Turbuhaler (500 mcg)

regular benefit

SAMA

ipratropium

Atrovent HFA MDI, generics (20 mcg)

regular benefit

SAMA-SABA

ipratropium + salbutamol

Combivent Respimat inhalation solution (20 mcg/100 mcg)

regular benefit

LAMA

umeclidinium

Incruse Ellipta (62.5 mcg)

regular benefit

tiotropium

Spiriva Respimat inhalation solution (2.5 mcg)

Spiriva HandiHaler DPI, generics (18 mcg)

regular benefit

glycopyrronium

criteria and SA form

Seebri Breezhaler (50 mcg)

Limited coverage

  • after minimum 1-month trial of each regular benefit LAMA molecule
  • spirometry measures not required

aclidinium

criteria and SA form

Tudorza Genuair (400 mcg)

LABA
Respirologists exempt from submitting SA requests – patients automatically covered1

salmeterol
criteria and SA form

Serevent Diskus (50 mcg)

Limited coverage

  • unable to use LAMA
  • spirometry measures required

LAMA-LABA
Respirologists exempt from submitting SA requests – patients automatically covered1

aclidinium + formoterol
criteria and SA form

Duaklir Genuair (400mcg /12 mcg)

Limited coverage

  • after a 6-month trial of a LAMA or LABA
  • spirometry measures required

 

glycopyrronium + indacaterol
criteria and SA form

Ultibro Breezhaler (50 mcg/110 mcg)

tiotropium + olodaterol 
criteria and SA form

Inspiolto Respimat (2.5 mcg/2.5 mcg)

umeclidinium + vilanterol
criteria and SA form

Anoro Ellipta (62.5 mcg/25 mcg)

ICS-LABA
Respirologists exempt from submitting SA requests – patients automatically covered1

fluticasone propionate + salmeterol

criteria and SA form

Advair Diskus, generics DPI (100 mcg/50 mcg, 250 mcg/50 mcg, 500 mcg/50 mcg)

Advair HFA MDI, generics (125 mcg/25 mcg, or 250 mcg/25 mcg)

Limited coverage

  • after a 6-month trial of a LAMA or LABA
  • spirometry measures required
  • history of exacerbations*

fluticasone furoate + vilanterol
criteria and SA form

Breo Ellipta (100 mcg/25 mcg)

ICS-LAMA-LABA
Triple-therapy fixed-dose combination inhalers. Respirologists invited to apply a Collaborative Prescribing Agreement (CPA) using this form (PDF) to be exempt from applying for SA coverage.1

fluticasone furoate + umeclidinium + vilanterol

criteria and SA form

Trelegy Ellipta (100 mcg/62.5 mcg/25 mcg)

Limited coverage

  • after a 6-month trial of LAMA + LABA or ICS+LABA
  • spirometry measures required
  • history of exacerbations*

budesonide + glycopyrronium + formoterol
criteria and SA form

Breztri Aerosphere (160 mcg/7.2 mcg/5 mcg)

HFA: hydrofluoroalkane; MDI: metered dose inhaler; DPI: dry powder inhaler

1 These exemptions have assumed SA and the patient will be granted indefinite SA approval

*History of exacerbations

History of exacerbations is defined as follows:

  • History of ≥ 2 moderate exacerbations defined as requiring a prescribed antibiotic and/or using systemic glucocorticoids in the previous 12 months; or
  • History of ≥ 1 severe exacerbation defined as requiring a hospital admission or emergency department visit in the previous 12 months

Resources