Inhaled Agents for Asthma and COPD Form

The following are inhaled agents for asthma and/or chronic obstructive pulmonary disease (COPD) requiring prior authorization: • Short acting beta-2 agonist (SABA): albuterol (ProAir® Digihaler®) • Inhaled corticosteroid (ICS): budesonide (Pulmicort Respules®), ciclesonide (Alvesco®), fluticasone (ArmonAir® Digihaler™), mometasone (Asmanex® HFA, Asmanex® Twisthaler®, Flovent® HFA, Flovent® Diskus®) • Long acting beta-2 agonist (LABA): arformoterol (Brovana®), formoterol (Perforormist) • Long acting muscarinic antagonist (LAMA): aclidinium bromide (Tudorza® Pressair®), glycopyrrolate (Seebri™ Neohaler®, Lonhala® Magnair®), revefenacin (Yupelri®) • Combination ICS/LABA: budesonide/formoterol (Symbicort®, Symbicort Aerosphere®), fluticasone/salmeterol (Advair Diskus®, Advair HFA®, AirDuo® Digihaler™, AirDuo® RespiClick®), mometasone/formoterol (Dulera®) • Combination LABA/LAMA: aclidnium/formoterol (Duaklir® Pressair®), glycopyrrolate/formoterol (Bevespi Aerosphere™), indacaterol/glycopyrrolate (Utibron™ Neohaler®) ___ *Generic agents do not require prior authorization. FDA Approved Indication(s) ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease. ProAir Digihaler is also indicated for the prevention of exercise-induced bronchospasm (EIB) in patients 4 years of age and older. Asthma The other inhaled agents are indicated as follows: Drug Name ICS Alvesco ArmonAir Digihaler Asmanex HFA
Asmanex Twisthaler Pulmicort Respules Flovent Diskus, Flovent HFA LABA Brovana Perforomist X (Age ≥ 12 years) X (Age ≥ 4 years) X (Age ≥ 5 years) X (Age ≥ 4 years) X (Age 1-8 years) X (Age ≥ 4 years) COPD X X Page 1 of 16

CLINICAL POLICY Inhaled Agents for Asthma and COPD Drug Name LAMA Lonhala Magnair Seebri Neohaler Tudorza Pressair Yupelri ICS/LABA Advair Diskus Advair HFA AirDuo Digihaler AirDuo RespiClick Dulera Symbicort Symbicort Aerosphere LABA/LAMA Bevespi Aerosphere Duaklir Pressair Utibron Neohaler Asthma COPD X (Age ≥ 4 years) X (Age ≥ 12 years) X (Age ≥ 12 years) X (Age ≥ 12 years) X (Age ≥ 5 years) X (Age ≥ 6 years) X X X X X X X X X X Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that inhaled agents for asthma and COPD are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Inhaled Agents for Asthma or Chronic Obstructive Pulmonary Disease (must meet all):

1. Diagnosis of asthma or COPD as FDA-approved for the requested agent (see FDA Approved Indications section);

2. Age is one of the following (a or b): a. Asthma: Appropriate per the prescribing information for the requested agent (see FDA Approved Indications section); b. COPD: ≥ 18 years;

   3. Failure of the following formulary agent(s) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: Requested Agent ProAir Digihaler Required Step Through Agent(s) Two generic albuterol sulfate HFA products, each from a different manufacturer Age is between 1 to 8 years or documentation supports inability to use inhaler devices AND if request is for brand Pulmicort Respules, medical justification supports inability to use generic Pulmicort Respules (e.g., contraindications to excipients) Pulmicort Respules Page 2 of 16

   CLINICAL POLICY Inhaled Agents for Asthma and COPD Requested Agent Flovent HFA All other ICS: Alvesco, ArmonAir Digihaler, Asmanex HFA, Asmanex Twisthaler, Flovent Diskus LABA: Brovana, Perforomist LAMA: Lonhala Magnair, Seebri Neohaler, Tudorza Pressair, Yupelri Brand Advair Diskus Brand Advair HFA Brand Symbicort, Symbicort Aerosphere All other ICS/LABA: AirDuo Digihaler, AirDuo RespiClick, Dulera LABA/LAMA: Bevespi Aerosphere, Duaklir Pressair, Utibron Neohaler Required Step Through Agent(s) Fluticasone propionate HFA (Flovent HFA authorized generic) Qvar® RediHaler™ AND Pulmicort Flexhaler™ AND Arnuity® Ellipta® AND fluticasone proprionate HFA (Flovent HFA authorized generic) Generic (i.e., formoterol for Perforomist requests, arformoterol for Brovana requests) AND Arcapta® Neohaler® AND Serevent® Diskus® AND Striverdi® Respimat®, unless request is for a nebulized LABA and documentation supports inability to use inhaler devices Incruse® Ellipta® AND Spiriva® Handihaler®/ Respimat®, unless request is for a nebulized LAMA and documentation supports inability to use inhaler devices Medical justification supports inability to use generic fluticasone/salmeterol products (generic Advair Diskus, Wixela™ Inhub™) (e.g., contraindications to excipients) Medical justification supports inability to use fluticasone-salmeterol HFA (Advair HFA authorized generic) (e.g., contraindications to excipients) Medical justification supports inability to use generic Symbicort (e.g., contraindications to excipients) fluticasone-salmeterol HFA (Advair HFA authorized generic) AND budesonide/formoterol (Symbicort authorized generic) AND fluticasone/salmeterol (generic Advair Diskus or Wixela Inhub) AND Breo Ellipta® (brand Breo Ellipta or [fluticasone furoate- vilanterol] Breo Ellipta authorized generic) Anoro® Ellipta® AND Stiolto® Respimat®

   4. For requests for an agent with a digital component (e.g., Digihaler products): Medical justification supports necessity of the digital component (i.e., rationale why inhaler usage cannot be tracked manually);
   5. Request meets one of the following (a, b, or c): a. Requested quantity does not exceed the health plan quantity limit; b. Requested dose does not exceed the FDA-approved maximum dose for the relevant indication (see Section V); c. Request is for a Georgia member with asthma or other life-threatening bronchial ailments for inhalants prescribed by the treating physician. Approval duration: 12 months Page 3 of 16

   CLINICAL POLICY Inhaled Agents for Asthma and COPD B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
      II. Continued Therapy A. Inhaled Agents for Asthma or Chronic Obstructive Pulmonary Disease (must meet all):
3. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
4. Member is responding positively to therapy;

5. If request is for a dose increase, request meets one of the following (a, b, or c): a. Requested quantity does not exceed the health plan quantity limit; b. Requested dose does not exceed the FDA-approved maximum dose for the relevant indication (see Section V); c. Request is for a Georgia member with asthma or other life-threatening bronchial ailments for inhalants prescribed by the treating physician. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or Page 4 of 16

   CLINICAL POLICY Inhaled Agents for Asthma and COPD

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key COPD: chronic obstructive pulmonary disease EIB: exercise-induced bronchospasm
      FDA: Food and Drug Administration ICS: inhaled corticosteroid GINA: Global Initiative for Asthma GOLD: Global Initiative for Chronic Obstructive Lung Disease LABA: long acting beta-2 agonist LAMA: long acting muscarinic antagonist SABA: short acting beta-2 agonist Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
      Drug Name Dosing Regimen Dose Limit/ Maximum Dose Asthma: 2 inhalations of 230/21 mcg BID MDI: 12 puffs/day Nebulization solution: 4 doses/day or 10 mg/day
      Higher maximum dosages for inhalation products have been recommended in National Asthma Education and Prevention Program guidelines for acute exacerbations of asthma. Fluticasone-salmeterol HFA (Advair HFA authorized generic) albuterol (Proventil HFA®, Ventolin HFA®) Asthma: 2 inhalations BID (starting dosage is based on asthma severity) Metered-dose inhaler (MDI): 2 puffs every 4 to 6 hours as needed Nebulization solution: 2.5 mg via oral inhalation every 6 to 8 hours as needed Page 5 of 16

   CLINICAL POLICY Inhaled Agents for Asthma and COPD Drug Name Dosing Regimen COPD: 1 inhalation by mouth QD COPD: 75 mcg inhaled orally QD COPD: 75 mcg/day Anoro Ellipta (umeclidinium/ vilanterol) Arcapta Neohaler (indacaterol) Arnuity Ellipta (fluticasone furoate) Breo Ellipta (fluticasone/ vilanterol) budesonide/formoterol (Symbicort) Flovent Diskus (fluticasone) Flovent HFA (fluticasone) fluticasone/salmeterol (Advair Diskus, Wixela Inhub) Incruse Ellipta (umeclidinium) Pulmicort Flexhaler (budesonide) Qvar RediHaler (beclomethasone) Asthma: ≥ 12 years: 100-200 mcg inhaled QD 5-11 years: 50 mcg inhaled QD Asthma:
   Age ≥ 18 years: 1 inhalation of 100/25 or 200/25 mcg QD Age 12-17 years: 1 inhalation of 100/25 mcg QD Age 5-11 years: 1 inhalation of 50/25 mcg QD COPD: 1 inhalation of 100/25 mcg QD Asthma: 2 inhalations BID COPD: 2 inhalations (160/4.5 mcg) BID Asthma: 1 inhalation BID (starting dosage is based on asthma severity) Asthma: 1 inhalation BID Asthma: 1 inhalation BID (starting dosage is based on asthma severity COPD: 1 inhalation of 250/50 mcg BID COPD: 1 inhalation (62.5 mcg) QD Asthma: Starting dose of 180-360 mcg inhaled BID Asthma: ≥ 12 years: 40 mcg, 80 mcg, 160 mcg, or 320 mcg inhaled BID 4-11 years: 40 mcg or 80 mcg inhaled BID Serevent (salmeterol) Asthma/COPD: 1 inhalation (50 mcg) BID Page 6 of 16 Dose Limit/ Maximum Dose COPD: 1 inhalation/day
   Asthma: ≥ 12 years: 200 mcg/day 5-11 years: 50 mcg/day Asthma: 200/25 mcg/day COPD: 100/25 mcg/day Asthma/COPD: 160/4.5 mcg BID Asthma: 2,000 mcg/day Asthma: 1,760 mcg/day Asthma: 500/50 mcg BID COPD: 250/50 mcg BID COPD: 62.5 mcg/day Asthma: 720 mcg BID Asthma: ≥ 12 years: 640 mcg/day 4-11 years: 160 mcg/day Asthma/COPD: 100 mcg/day

   CLINICAL POLICY Inhaled Agents for Asthma and COPD Drug Name Dosing Regimen Spiriva Handihaler (tiotropium bromide monohydrate) Spiriva Respimat (tiotropium bromide monohydrate) Stiolto Respimat (tiotropium/olodaterol) Striverdi Respimat (olodaterol) Trelegy Ellipta (fluticasone/ umeclidinium/ vilanterol) COPD: 2 inhalations (18 mcg) QD Dose Limit/ Maximum Dose COPD: 18 mcg/day Asthma: 2 inhalations (1.25 mcg) QD Asthma: 2.5 mcg/day COPD: 2 inhalations (2.5 mcg) QD Two inhalations by mouth QD at the same time of day COPD: 5 mcg/day 2 inhalations/day COPD: 2 inhalations QD
   COPD: 5 mcg/day Asthma: 1 inhalation (100/62.5/26 mcg or 200/62.5/26 mcg) by mouth QD Asthma: 200/62.5/26 mcg/day COPD: 1 inhalation (100/62.5/26 mcg) by mouth QD COPD: 100/62.5/26 mcg/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o All agents: hypersensitivity to any component of the requested agent or the following as additionally specified:  Advair Diskus, AirDuo Digihaler/RespiClick, ArmonAir Digihaler, Asmanex Twisthaler, Tudorza Pressair, Trelegy Ellipta, Flovent Diskus: milk proteins  Brovana: racemic formoterol o Advair Diskus, AirDuo Digihaler/RespiClick, Alvesco, ArmonAir Digihaler, Asmanex HFA/Twisthaler, Dulera, Pulmicort Respules, Flovent Diskus, Flovent HFA: primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures
   o Bevespi Aerosphere, Brovana, Duaklir Pressair, Perforomist, Utibron Neohaler: use of a LABA without an ICS in patients with asthma
   • Boxed warning(s): none reported Appendix D: General Information • Although inhaler devices with a digital component may offer increased convenience with tracking of inhaler usage, there is currently no evidence that this leads to improved clinical outcomes, including safety and effectiveness. • Per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD guidelines, combination therapy (LAMA + LABA or ICS + LAMA + LABA) is recommended for Group B and ED patients (i.e., those who are very symptomatic or are at high risk of exacerbation). Selection of which combination to use depends on the individual patient: o For those with more severe symptoms, LAMA + LABA may be used.
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   CLINICAL POLICY Inhaled Agents for Asthma and COPD o For those who are inadequately controlled by dual therapy or with blood eosinophil counts at least 300 cells/uL, triple therapy with ICS + LAMA + LABA may be used. o As of the 2023 guideline update, use of LABA + ICS in COPD is no longer encouraged. If there is an indication for an ICS, then LABA + LAMA + ICS has been shown to be superior to LABA + ICS and is therefore the preferred choice. • Historical management of asthma has involved an as-needed short-acting beta agonist for reliever therapy, with stepwise approach to add on controller maintenance therapies such as inhaled corticosteroids and long-acting beta agonists. In 2019, the Global Initiative for Asthma (GINA) guidelines for asthma management and prevention began recommending that inhaled corticosteroids be initiated as soon as possible after diagnosis of asthma, including use as reliever therapy (to be administered as-needed alongside a short-acting beta agonist). The National Asthma Education and Prevention Program from the National Heart, Lung, and Blood Institute followed suit with their recommendations in 2020. • Alvesco: Use in pediatric patients < 12 years of age: Two identically designed randomized, double-blind, parallel, placebo-controlled clinical trials of 12-weeks treatment duration were conducted in 1,018 patients aged 4 to 11 years with asthma but efficacy was not established. In addition, one randomized, double-blind, parallel, placebo-controlled clinical trial did not establish efficacy in 992 patients aged 2 to 6 years with asthma. V. Dosage and Administration
   Indication Drug Name Advair Diskus Asthma Advair HFA AirDuo Digihaler AirDuo RespiClick Alvesco COPD Asthma Asthma Asthma Asthma ArmonAir Digihaler Asmanex HFA Asthma Asthma Dosing Regimen 1 inhalation BID (starting dosage is based on asthma severity) 1 inhalation of 250/50 mcg BID 2 inhalations BID (starting dosage is based on asthma severity) 1 inhalation BID (starting dosage is based on asthma severity) 1 inhalation BID (starting dosage is based on asthma severity) Starting dose for patients who received bronchodilators alone: 80 mcg inhaled BID Maximum Dose 500/50 mcg BID 250/50 mcg BID 2 inhalations of 230/21 mcg BID 232/14 mcg BID 232/14 mcg BID 320 mcg/day Starting dose for patients who received inhaled corticosteroids: 80 mcg inhaled BID 640 mcg/day Starting dose for patients who received oral corticosteroids: 320 mcg inhaled BID 1 inhalation BID (starting dosage is based on asthma severity and age) 2 inhalations BID (starting dosage is based on age and asthma severity) 640 mcg/day 232 mcg BID 800 mcg/day Page 8 of 16

   CLINICAL POLICY Inhaled Agents for Asthma and COPD Drug Name Asmanex Twisthaler Bevespi Aerosphere Brovana Duaklir Pressair Dulera Indication Asthma COPD COPD COPD Asthma Asthma Flovent Diskus Flovent HFA Asthma Lonhala Magnair Perforomist COPD COPD ProAir Digihaler Pulmicort Respules
   Treatment or prevention of bronchospasm Prevention of EIB Asthma Seebri Neohaler COPD Dosing Regimen Dose varies based on previous therapy and age: 1 inhalation QD- BID 2 inhalations BID One 15 mcg/2 mL vial inhaled via nebulizer every 12 hours One inhalation by mouth BID Age 5 to 11 years: 2 inhalations of 50/5 mcg BID
   Age ≥ 12 years: 2 inhalations of 100/5 mcg or 200/5 mcg BID (starting dosage is based on asthma severity) 1 inhalation BID (starting dosage is based on asthma severity) Patients aged 12 years and older: 88 mcg twice daily up to a maximum dosage of 880 mcg twice daily.
   Pediatric patients aged 4 to 11 years: 88 mcg twice daily One 25 mcg vial inhaled via nebulizer BID One 20 mcg/2 mL vial inhaled via nebulizer every 12 hours 2 inhalations every 4 to 6 hours Maximum Dose 880 mcg/day 4 inhalations/day 30 mcg/day 2 inhalations/day
   200/5 mcg/day 800/20 mcg/day 1,000 mcg BID 880 mcg BID 50 mcg/day 40 mcg/day 12 inhalations/day 2 inhalations 15 to 30 minutes before exercise Starting dose for patients who received bronchodilators alone or inhaled corticosteroids: 0.5 mg inhaled per day (0.5 mg QD or 0.25 mg BID; for inhaled corticosteroids, may go up to 0.5 mg BID)
   2 inhalations before exercise Bronchodilator alone: 0.5 mg/day Inhaled or oral corticosteroid: 1 mg/day Starting dose for patients who received oral corticosteroids: 1 mg inhaled per day (1 mg QD or 0.5 mg BID) One inhalation (15.6 mcg) BID 2 inhalations/day Page 9 of 16

   CLINICAL POLICY Inhaled Agents for Asthma and COPD Drug Name Symbicort Indication Asthma Dosing Regimen 2 inhalations BID (starting dosage is based on asthma severity) 2 inhalations (160/4.5 mcg) BID 2 inhalations (160/4.8 mcg) BID Maximum Dose 320/9 mcg BID 320/9 mcg BID 320/9.6 mcg BID COPD COPD Symbicort Aerosphere Tudorza Pressair Utibron Neohaler Yupelri COPD 1 inhalation (400 mcg) BID 800 mcg/day COPD COPD Inhalation of the contents of one capsule BID One 175 mcg mcg vial inhaled via nebulizer QD 2 capsules/day 175 mcg/day VI. Product Availability
   Drug Name Advair Diskus Advair HFA AirDuo Digihaler AirDuo RespiClick Alvesco ArmonAir Digihaler Asmanex HFA Asmanex Twisthaler Bevespi Aerosphere Brovana Duaklir Pressair Availability
   Inhalation powder containing fluticasone/salmeterol: 100/50 mcg, 250/50 mcg, 500/50 mcg Inhalation aerosol containing fluticasone/salmeterol: 45/21 mcg, 115/21 mcg, 230/21 mcg Inhalation powder: In each actuation: 55/14 mcg contains 55 mcg of fluticasone propionate and 14 mcg of salmeterol; 113/14 mcg contains 113 mcg of fluticasone propionate and 14 mcg of salmeterol; 232/14 mcg contains 232 mcg of fluticasone propionate and 14 mcg of salmeterol. AirDuo Digihaler contains a built-in electronic module Inhalation powder: In each actuation: 55 mcg/14 mcg contains 55 mcg of fluticasone propionate and 14 mcg of salmeterol; 113 mcg/14 mcg contains 113 mcg of fluticasone propionate and 14 mcg of salmeterol; 232 mcg/14 mcg contains 232 mcg of fluticasone propionate and 14 mcg of salmeterol Inhalation aerosol: 80 mcg/actuation, 160 mcg/actuation Inhalation powder containing 30 mcg, 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate per actuation. ArmonAir Digihaler contains a built- in electronic module Inhalation aerosol containing 50 mcg, 100 mcg, or 200 mcg of mometasone furoate per actuation Inhalation device: 110 mcg (delivers 100 mcg/actuation), 220 mcg (delivers 200 mcg/actuation)
   Inhalation aerosol: pressurized metered dose inhaler containing a combination of glycopyrrolate (9 mcg) and formoterol fumarate (4.8 mcg) per inhalation; two inhalations equal one dose Inhalation solution (unit-dose vial for nebulization): 15 mcg/2 mL Inhalation powder: 30 and 60 metered dose dry powder inhaler metering 400 mcg aclidinium bromide and 12 mcg formoterol fumarate per actuation Page 10 of 16

   CLINICAL POLICY Inhaled Agents for Asthma and COPD Drug Name Dulera Flovent Diskus Flovent HFA Lonhala Magnair Perforomist ProAir Digihaler Pulmicort Respules
   Seebri Neohaler Symbicort Symbicort Aerosphere Tudorza Pressair Utibron Neohaler Yupelri Availability
   Inhalation aerosol containing mometasone/formoterol: 50/5 mcg, 100/5 mcg, 200/5 mcg per actuation Inhalation powder: Inhaler containing fluticasone propionate (50, 100, or 250 mcg) as a powder formulation for oral inhalation Inhalation aerosol: 44 mcg, 110 mcg, 220 mcg per actuation Sterile solution for inhalation in a unit-dose vial: 25 mcg/mL Inhalation solution (unit dose vial for nebulization): 20 mcg/2 mL solution Inhalation powder: dry powder inhaler 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece per actuation. The inhaler is supplied for 200 inhalation doses. ProAir Digihaler includes a built-in electronic module Inhalation suspension: 0.25 mg/2 mL, 0.5 mg/2 mL, 1 mg/2 mL Inhalation powder in capsules: 15.6 mcg of glycopyrrolate inhalation powder for use with the Neohaler device Metered-dose inhaler: budesonide (80 or 160 mcg) and formoterol (4.5 mcg) as an inhalation aerosol Metered-dose inhaler: budesonide (160 mcg) and formoterol (4.8 mcg) as an inhalation aerosol Inhalation powder in a multi-dose dry powder inhaler: 400 mcg/actuation Inhalation powder in capsule, for use with the Neohaler device: 27.5 mcg of indacaterol and 15.6 mcg glycopyrrolate Inhalation solution (unit-dose vial for nebulization): 175 mcg/3 mL VII.