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Chronic obstructive pulmonary disease (COPD) inhaler criteria

Last updated on July 26, 2024

Effective July 7, 2020, PharmaCare updated coverage of inhalers for the treatment of chronic obstructive pulmonary disease (COPD). The updates align the therapeutic approach for COPD with current best clinical practices, improve patient outcomes and safety, and ensure the appropriate use of health care resources.

On this page: Short-acting bronchodilators | Coverage updates | LAMAs | LAMA-LABAs | ICS-LABAs | New ICS-LAMA-LABA fixed-dose combination inhaler | Practitioner exemptions and CPA | Special Authority links

The July 7 updates:

  • Improve access to long-acting muscarinic antagonists (LAMA) by making tiotropium (Spiriva® Respimat®) and umeclidinium (Incruse® Ellipta®) regular benefits
  • Modify the limited coverage criteria for other LAMAs, LABAs, LAMA-LABAs and ICS-LABAs
  • List fluticasone-umeclidinium-vilanterol (Trelegy® Ellipta®) as a limited coverage benefit

  • SAMA: short-acting muscarinic antagonist
  • SABA: short-acting β2 adrenergic agonist
  • LABA: long-acting β2 adrenergic agonist
  • ICS: inhaled corticosteroid
  • LAMA: long-acting muscarinic antagonist

The following is a stepwise approach to PharmaCare coverage of COPD inhalers:

COPD diagram - PharmaCare coverage

Expand All | Collapse All
 

Short-acting bronchodilators

The short-acting beta2 agonists (SABAs), short-acting muscarinic antagonists (SAMAs) and SABA-SAMA combinations will remain regular benefits. There will be no changes to coverage for these drugs.

 

Coverage updates

 

  • Improve access to long-acting muscarinic antagonists (LAMA) by moving tiotropium (Spiriva® Respimat®) and umeclidinium (Incruse® Ellipta®) from limited coverage benefits to regular benefit coverage
  • Continue coverage for other LAMAs (Tudorza® Genuair®, Spiriva® Handihaler®, Seebri® Breezhaler®) as limited coverage benefits with changes in criteria: failure on a minimum one-month trial of each of the regular benefit LAMA products
  • Modify criteria for long-acting beta2 agonists (LABA) to include diagnosis1 of COPD by spirometry and contraindications or intolerance to a LAMA
  • Increase access to LAMA-LABA combination therapies for moderate to very severe2 patients with COPD by expanding the current forced expiratory volume in 1 second (FEV1) threshold requirement from < 65% to < 80% predicted, after a 6-month trial of either a LAMA or a LABA
  • Modify criteria for inhaled corticosteroids (ICS)-LABA combination inhalers to include diagnosis for moderate-to-very-severe COPD by spirometry, history of exacerbations3, and a 6-month trial of either a LAMA or a LABA
  • List Trelegy Ellipta, the new triple therapy fixed-dose combination (i.e., ICS-LABA-LAMA), as a limited coverage benefit for moderate-to-very-severe patients with COPD diagnosed by spirometry, history of exacerbations4, with a 6-month trial of either a LAMA-LABA combination or an ICS-LABA combination

1The 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.

2COPD severity is defined as follows:

  • Moderate COPD is defined as 50% <= FEV1 < 80% predicted
  • Severe COPD is defined as 30% <= FEV1 < 50% predicted 
  • Very severe COPD is defined as FEV1 < 30% predicted

3History 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.

4History 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.

Current coverage will be maintained for patients currently covered for COPD inhalers through PharmaCare, though some will have the option to switch.

Regular Benefit Drugs
Regular Benefit
No Coverage Change *New* Coverage Change
SAMA
(Atrovent®)		 SABA
(Ventolin®, Airomir™, Bricanyl® Turbuhaler®)		 SAMA-SABA
(Combivent® Respimat®)		 LAMA
(Incruse® Ellipta®, Spiriva® Respimat®)
Limited Coverage Drugs
Limited Coverage
*New* Criteria Modified Criteria *New* Drug Listing
LAMA
(Tudorza® Genuair®, Seebri® Breezhaler®, Spiriva® Handihaler®)		 LABA
(Onbrez® Breezhaler®, Serevent® Diskus®)		 LAMA-LABA
(Duaklir® Genuair®, Ultibro® Breezhaler®, Inspiolto® Respimat®, Anoro® Ellipta®)		 ICS-LABA
(Breo® Ellipta® 100 mcg/25 mcg, Advair® Diskus® 250 mcg/50 mcg, 500 mcg/50 mcg)		 ICS-LAMA-LABA
(Trelegy® Ellipta®)
 

How the updates affect LAMA coverage

PharmaCare will be improving access to long-acting muscarinic antagonists (LAMAs) by making the following products regular benefits:

  • tiotropium (Spiriva® Respimat®)
  • umeclidinium (Incruse® Ellipta®)

PharmaCare will continue to provide coverage for other LAMAs as limited coverage benefits.

Patients currently receiving coverage for a limited coverage LAMA will not be required to submit a new Special Authority request. Approval will continue automatically.

The limited coverage LAMA criteria will not require a trial of short-acting bronchodilators (i.e. SAMA or SAMA-SABA). Spirometry measures will also not be needed to apply for coverage of a LAMA.

For more information on the reasons for the LAMA coverage changes, please see the Drug Decision Summaries in the More Information section.

 

How the updates affect LAMA-LABA coverage

PharmaCare will be increasing eligibility of LAMA-LABA combination therapies for moderate-to-very-severe patients with COPD by expanding the current FEV1 threshold requirement from <= 65% to < 80% predicted.

The limited coverage criteria will no longer require a trial of short-acting bronchodilators (SAMA or SAMA-SABA combination therapy). The new criteria will require a 6-month trial of either a LAMA or a LABA. The trial of a LAMA can either be a regular benefit LAMA or a limited coverage LAMA.

 

How the updates affect ICS-LABA coverage

PharmaCare will be modifying the criteria for ICS-LABA to include diagnosis for moderate-to-very-severe COPD by spirometry, history of acute exacerbations and a 6-month trial of either a LAMA or a LABA.

Patients with COPD who had PharmaCare coverage for ICS-LABA products before July 7, 2020 will automatically receive coverage for a LAMA-LABA product without the need for a prescriber to apply for a Special Authority.

For more information on the reasons for the ICS-LABA coverage changes, please see the Drug Decision Summaries in the More Information section.

 

New listing for ICS-LAMA-LABA fixed-dose combination inhaler

Trelegy Ellipta and Breztri® Aerosphere® (as of November 2, 2022) are fixed-dose combination inhalers covered for moderate-to-very-severe COPD who need to use ICS-LAMA-LABA (i.e., triple therapy)*.

Patients with COPD who receive PharmaCare coverage for triple therapy (ICS-LAMA-LABA through multiple inhalers) prior to July 7, 2020, will automatically receive coverage for Trelegy Ellipta without the need for a prescriber to apply for a Special Authority. Multiple inhaler combinations eligible for this automatic coverage include ICS+LABA+LAMA; ICS-LABA + LAMA; or LABA-LAMA + ICS. All patients that use other combination inhalers will need to apply for Special Authority.

 

Practitioner exemptions and Collaborative Prescriber Agreement

Respirologist practitioner exemptions will be maintained for LABA and dual combination therapy (i.e., ICS-LABA and LAMA-LABA) for the treatment of COPD.

Effective July 7, 2020, all prescribers (including respirologists) will need to apply for Special Authority coverage for patients with COPD not previously covered for limited coverage LAMAs (e.g., Tudorza® Genuair®, Spiriva® Handihaler®, Seebri® Breezhaler®). As a reminder, there are two LAMAs that will be regular benefits (Spiriva® Respimat® and Incruse® Ellipta®).

For Trelegy® Ellipta®, respirologists are invited to apply for a Collaborative Prescribing Agreement (CPA). Respirologists who already have a CPA for fluticasone furoate-umeclidinium-vilanterol (Trelegy Ellipta) automatically have a CPA for Breztri Aerosphere. 

 

Special Authority links

For specific updated COPD drug coverage as of July 7, 2020, refer to the links beside the limited coverage products, which will take you to the Special Authority criteria.

SA and regular benefit information
Products Coverage
(as of July 7, 2020)
Short-acting bronchodilators
SAMA
  • ipratropium bromide (Atrovent®)
 regular benefit
SABA
  • salbutamol (Ventolin®)
  • salbutamol (Ventolin® Diskus®)
  • salbutamol (Airomir™)
  • salbutamol (generics)
  • terbutaline (Bricanyl® Turbuhaler)
 regular benefit
SAMA-SABA
  • ipratropium bromide-salbutamol sulfate (Combivent® Respimat®)
 regular benefit
Long-acting bronchodilators
LAMA
  • tiotropium (Spiriva® Respimat®)
  • umeclidinium (Incruse® Ellipta®)
 regular benefit
LAMA
limited coverage (criteria is a failure on a trial of each of regular benefit LAMA)
LABA
limited coverage
LAMA-LABA
limited coverage
Inhaled corticosteroids
ICS-LABA
limited coverage
Triple therapy
ICS-LABA-LAMA limited coverage

Spirometry tests

Due to a backlog for booking spirometry tests, SA is approving exceptional 6-month coverage of COPD inhalers on a case-by-case basis.

More information