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ph-91191

Oral Inhalers Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91191

This program applies to Commercial, Blue Partner, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace

POLICY REVIEW CYCLE

Effective Date	Date of Origin
04-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Advair Diskus® (fluticasone propionate and salmeterol)* Inhalation powder	Twice-daily treatment of asthma in patients 4 years of age and older. Advair Diskus should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA). Twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Advair Diskus 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Advair Diskus 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength Advair Diskus 500/50 over Advair Diskus 250/50 has not been demonstrated. Limitations of Use: Advair Diskus is not indicated for the relief of acute bronchospasm.	*generic available	1
Alvesco® (ciclesonide) Inhalation aerosol	Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use: Alvesco is not indicated for the relief of acute bronchospasm. Alvesco is not indicated for children under 12 years of age.		2
Arnuity Ellipta® (fluticasone furoate) Inhalation powder	Maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use: Arnuity Ellipta is not indicated for the relief of acute bronchospasm.		3
Asmanex HFA® (mometasone furoate) Inhalation aerosol	Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Limitations of Use: Asmanex HFA is not indicated for the relief of acute bronchospasm.		4
Asmanex Twisthaler® (mometasone furoate) Inhalation powder	Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use: Asmanex Twisthaler is not indicated for the relief of acute bronchospasm. Asmanex Twisthaler is not indicated in children less than 4 years of age.		5
Flovent Diskus®, Fluticasone propionate aerosol powder (fluticasone propionate) Inhalation powder	Maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. Limitations of Use: Flovent Diskus is not indicated for the relief of acute bronchospasm.		6
Flovent HFA®, Fluticasone propionate HFA (fluticasone propionate) Inhalation aerosol	Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use: Flovent HFA is not indicated for the relief of acute bronchospasm.		7
QVAR RediHaler® (beclomethasone dipropionate HFA) Inhalation aerosol	Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use: QVAR RediHaler is not indicated for the relief of acute bronchospasm.		8

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Asthma

Asthma is a respiratory disease of chronic airway inflammation that is characterized by variable symptoms of wheezing, shortness of breath, chest tightness and/or cough, and expiratory airflow due to bronchoconstriction, airway wall thickening, and increased mucus. Asthma affects an estimated 300 million people worldwide of all ages and imposes a substantial burden on patients, their families, the community and on healthcare systems. The long-term goals of asthma management from a clinical perspective are to achieve good symptom control and maintain normal activity levels along with minimizing the risk of asthma-related death, exacerbations, persistent airflow limitation and side-effects. It is also important to determine the patient's own goals regarding their asthma.(9,10)

For the best outcomes, inhaled corticosteroid (ICS)-containing treatment should be started as soon as possible after the diagnosis of asthma is made. Current guidelines provide no preference on the specific type of ICS to use and note that recommendations for broad populations will be different compared to individual patients that need to consider their own goals and preferences, characteristics and phenotype, along with practical issues such as cost, adherence, and availability.(9,10)

COPD

Long-term monotherapy with an inhaled corticosteroid (ICS) in not recommended for the treatment of chronic obstructive pulmonary disease (COPD). If there is an indication for an ICS, the preferred combination is long-acting-beta2 agonist (LABA) + long-acting muscarinic antagonist (LAMA) + ICS which can be administered as single or multiple inhaler therapy. If patients with COPD have features of asthma, treatment should always include an ICS. Guidelines do not recommend one type of ICS over another. Guidelines recommend the patient and the prescriber to make the decision together based on the patient's abilities, goals, and preferences with an emphasis on adherence to therapy.(11)

Safety

Advair Diskus is contraindicated in the following:(1)

Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients.

Alvesco is contraindicated in the following:(2)

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Patients with known hypersensitivity to ciclesonide or any of the ingredients of Alvesco. Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported.

Arnuity Ellipta is contraindicated in the following:(3)

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate or any of the excipients.

Asmanex HFA and Asmanex Twisthaler are contraindicated in the following:(4,5)

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Patients with known hypersensitivity to milk proteins or any ingredients of Asmanex HFA/Twisthaler.

Flovent Diskus is contraindicated in the following:(6)

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate.

Flovent HFA is contraindicated in the following:(7)

Primary treatment of status asthmaticus or acute episodes of asthma where intensive measures are required.
Hypersensitivity to any of the ingredients.

QVAR RediHaler is contraindicated in the following:(8)

Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR RediHaler.

REFERENCES

Number	Reference
1	Advair Diskus prescribing information. GlaxoSmithKline LLC. June 2023.
2	Alvesco prescribing information. Covis Pharma US, Inc. February 2023.
3	Arnuity Ellipta prescribing information. GlaxoSmithKline LLC. October 2023.
4	Asmanex HFA prescribing information. Organon LLC. June 2021
5	Asmanex Twisthaler prescribing information. Organon LLC. June 2021.
6	Flovent Diskus prescribing information. GlaxoSmithKline LLC. August 2023.
7	Flovent HFA prescribing information. GlaxoSmithKline LLC. September 2023.
8	QVAR RediHaler prescribing information. Teva Respiratory, LLC. September 2022.
9	Cloutier MM, Baptist AP, Blake KV, et al. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. Journal of Allergy and Clinical Immunology. 2020;146(6):1217-1270. doi:10.1016/j.jaci.2020.10.003
10	Global Initiative for Asthma - GINA. 2024 GINA Main Report - Global Initiative for Asthma - GINA. Global Initiative for Asthma - GINA. Published June 30, 2024. https://ginasthma.org/2024-report/
11	2024 GOLD Report - Global Initiative for Chronic Obstructive Lung Disease - GOLD. Global Initiative for Chronic Obstructive Lung Disease - GOLD. Published November 12, 2023. https://goldcopd.org/2024-gold-report/

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

			60	Capsules	30	DAYS
Advair diskus	Fluticasone-Salmeterol Aer Powder BA 100-50 MCG/DOSE	100-50 MCG/ACT	1	Inhaler	30	DAYS
Advair diskus	Fluticasone-Salmeterol Aer Powder BA 250-50 MCG/DOSE	250-50 MCG/ACT	1	Inhaler	30	DAYS
Advair diskus	Fluticasone-Salmeterol Aer Powder BA 500-50 MCG/DOSE	500-50 MCG/ACT	1	Inhaler	30	DAYS
Advair hfa ; Fluticasone propionate/sa	Fluticasone-Salmeterol Inhal Aerosol 115-21 MCG/ACT	115-21 MCG/ACT	1	Inhaler	30	DAYS
Advair hfa ; Fluticasone propionate/sa	Fluticasone-Salmeterol Inhal Aerosol 230-21 MCG/ACT	230-21 MCG/ACT	1	Inhaler	30	DAYS
Advair hfa ; Fluticasone propionate/sa	Fluticasone-Salmeterol Inhal Aerosol 45-21 MCG/ACT	45-21 MCG/ACT	1	Inhaler	30	DAYS
Airduo digihaler 113/14	Fluticasone-Salmeterol Aer Powder BA	113-14 MCG/ACT	1	Inhaler	30	DAYS
Airduo digihaler 232/14	Fluticasone-Salmeterol Aer Powder BA	232-14 MCG/ACT	1	Inhaler	30	DAYS
Airduo digihaler 55/14	Fluticasone-Salmeterol Aer Powder BA	55-14 MCG/ACT	1	Inhaler	30	DAYS
Airduo respiclick 113/14 ; Fluticasone propionate/sa	Fluticasone-Salmeterol Aer Powder BA 113-14 MCG/ACT	113-14 MCG/ACT	1	Inhaler	30	DAYS
Airduo respiclick 232/14 ; Fluticasone propionate/sa	Fluticasone-Salmeterol Aer Powder BA 232-14 MCG/ACT	232-14 MCG/ACT	1	Inhaler	30	DAYS
Airduo respiclick 55/14 ; Fluticasone propionate/sa	Fluticasone-Salmeterol Aer Powder BA 55-14 MCG/ACT	55-14 MCG/ACT	1	Inhaler	30	DAYS
Airsupra	albuterol-budesonide inhalation aerosol	90-80 MCG/ACT	3	Inhalers	30	DAYS
Albuterol sulfate hfa ; Proventil hfa ; Ventolin hfa	Albuterol Sulfate Inhal Aero 108 MCG/ACT (90MCG Base Equiv)	108 MCG/ACT	2	Inhalers	30	DAYS
Alvesco	Ciclesonide Inhal Aerosol 160 MCG/ACT	160 MCG/ACT	2	Inhalers	30	DAYS
Alvesco	Ciclesonide Inhal Aerosol 80 MCG/ACT	80 MCG/ACT	1	Inhaler	30	DAYS
Anoro ellipta	Umeclidinium-Vilanterol Aero Powd BA 62.5-25 MCG/INH	62.5-25 MCG/ACT	1	Inhaler	30	DAYS
Armonair digihaler	Fluticasone Propionate Aer Pow BA	55 MCG/ACT	1	Inhaler	30	DAYS
Armonair digihaler	Fluticasone Propionate Aer Pow BA	113 MCG/ACT	1	Inhaler	30	DAYS
Armonair digihaler	Fluticasone Propionate Aer Pow BA	232 MCG/ACT	1	Inhaler	30	DAYS
Arnuity ellipta	Fluticasone Furoate Aerosol Powder Breath Activ 100 MCG/ACT	100 MCG/ACT	1	Inhaler	30	DAYS
Arnuity ellipta	Fluticasone Furoate Aerosol Powder Breath Activ 200 MCG/ACT	200 MCG/ACT	1	Inhaler	30	DAYS
Arnuity ellipta	Fluticasone Furoate Aerosol Powder Breath Activ 50 MCG/ACT	50 MCG/ACT	1	Inhaler	30	DAYS
Asmanex hfa	Mometasone Furoate Inhal Aerosol Suspension 100 MCG/ACT	100 MCG/ACT	1	Inhaler	30	DAYS
Asmanex hfa	Mometasone Furoate Inhal Aerosol Suspension 200 MCG/ACT	200 MCG/ACT	1	Inhaler	30	DAYS
Asmanex hfa	Mometasone Furoate Inhal Aerosol Suspension 50 MCG/ACT	50 MCG/ACT	1	Inhaler	30	DAYS
Asmanex twisthaler 120 me ; Asmanex twisthaler 14 met ; Asmanex twisthaler 30 met ; Asmanex twisthaler 60 met	Mometasone Furoate Inhal Powd 220 MCG/INH (Breath Activated)	220 MCG/INH	1	Inhaler	30	DAYS
Asmanex twisthaler 30 met	Mometasone Furoate Inhal Powd 110 MCG/INH (Breath Activated)	110 MCG/INH	1	Inhaler	30	DAYS
Atrovent hfa	Ipratropium Bromide HFA Inhal Aerosol 17 MCG/ACT	17 MCG/ACT	2	Inhalers	30	DAYS
Bevespi aerosphere	Glycopyrrolate-Formoterol Fumarate Aerosol 9-4.8 MCG/ACT	9-4.8 MCG/ACT	1	Inhaler	30	DAYS
Breo ellipta	fluticasone furoate-vilanterol aero powd ba	50-25 MCG/INH	1	Inhaler	30	DAYS
Breo ellipta ; Fluticasone furoate/vilan	Fluticasone Furoate-Vilanterol Aero Powd BA 100-25 MCG/INH	100-25 MCG/ACT	1	Inhaler	30	DAYS
Breo ellipta ; Fluticasone furoate/vilan	Fluticasone Furoate-Vilanterol Aero Powd BA 200-25 MCG/INH	200-25 MCG/ACT	1	Inhaler	30	DAYS
Breztri aerosphere	Budesonide-Glycopyrrolate-Formoterol Aers	160-9-4.8 MCG/ACT	1	Inhaler	30	DAYS
Combivent respimat	Ipratropium-Albuterol Inhal Aerosol Soln 20-100 MCG/ACT	20-100 MCG/ACT	2	Inhalers	30	DAYS
Duaklir pressair	Aclidinium Br-Formoterol Fum Aero Pow Br Act 400-12 MCG/ACT	400-12 MCG/ACT	1	Inhaler	30	DAYS
Dulera	Mometasone Furoate-Formoterol Fumarate Aerosol 100-5 MCG/ACT	100-5 MCG/ACT	3	Inhalers	30	DAYS
Dulera	Mometasone Furoate-Formoterol Fumarate Aerosol 200-5 MCG/ACT	200-5 MCG/ACT	3	Inhalers	30	DAYS
Dulera	Mometasone Furoate-Formoterol Fumarate Aerosol 50-5 MCG/ACT	50-5 MCG/ACT	3	Inhalers	30	DAYS
Flovent diskus ; Fluticasone propionate di	Fluticasone Propionate Aer Pow BA 100 MCG/BLISTER	100 MCG/ACT ; 100 MCG/BLIST	1	Inhaler	30	DAYS
Flovent diskus ; Fluticasone propionate di	Fluticasone Propionate Aer Pow BA 250 MCG/BLISTER	250 MCG/ACT ; 250 MCG/BLIST	4	Inhalers	30	DAYS
Flovent diskus ; Fluticasone propionate di	Fluticasone Propionate Aer Pow BA 50 MCG/BLISTER	50 MCG/ACT ; 50 MCG/BLIST	1	Inhaler	30	DAYS
Flovent hfa ; Fluticasone propionate hf	Fluticasone Propionate HFA Inhal Aer 110 MCG/ACT (125/Valve)	110 MCG/ACT	1	Inhaler	30	DAYS
Flovent hfa ; Fluticasone propionate hf	Fluticasone Propionate HFA Inhal Aer 220 MCG/ACT (250/Valve)	220 MCG/ACT	2	Inhalers	30	DAYS
Flovent hfa ; Fluticasone propionate hf	Fluticasone Propionate HFA Inhal Aero 44 MCG/ACT (50/Valve)	44 MCG/ACT	1	Inhaler	30	DAYS
Incruse ellipta	Umeclidinium Br Aero Powd Breath Act 62.5 MCG/INH (Base Eq)	62.5 MCG/INH	1	Inhaler	30	DAYS
Levalbuterol tartrate hfa ; Xopenex hfa	Levalbuterol Tartrate Inhal Aerosol 45 MCG/ACT (Base Equiv)	45 MCG/ACT	2	Inhalers	30	DAYS
Levalbuterol tartrate hfa ; Xopenex hfa	Levalbuterol Tartrate Inhal Aerosol 45 MCG/ACT (Base Equiv)	45 MCG/ACT	2	Inhalers	30	DAYS
Proair digihaler	Albuterol Sulfate Aer Pow BA	108 MCG/ACT	2	Inhalers	30	DAYS
Proair respiclick	Albuterol Sulfate Aer Pow BA 108 MCG/ACT (90 MCG Base Equiv)	108 MCG/ACT	2	Inhalers	30	DAYS
Pulmicort flexhaler	Budesonide Inhal Aero Powd 180 MCG/ACT (Breath Activated)	180 MCG/ACT	2	Inhalers	30	DAYS
Pulmicort flexhaler	Budesonide Inhal Aero Powd 90 MCG/ACT (Breath Activated)	90 MCG/ACT	1	Inhaler	30	DAYS
Qvar redihaler	Beclomethasone Diprop HFA Breath Act Inh Aer 40 MCG/ACT	40 MCG/ACT	1	Inhaler	30	DAYS
Qvar redihaler	Beclomethasone Diprop HFA Breath Act Inh Aer 80 MCG/ACT	80 MCG/ACT	2	Inhalers	30	DAYS
Serevent diskus	Salmeterol Xinafoate Aer Pow BA 50 MCG/DOSE (Base Equiv)	50 MCG/DOSE	1	Inhaler	30	DAYS
Spiriva handihaler	Tiotropium Bromide Monohydrate Inhal Cap 18 MCG (Base Equiv)	18 MCG	30	Capsules	30	DAYS
Spiriva respimat	Tiotropium Bromide Monohydrate Inhal Aerosol 1.25 MCG/ACT	1.25 MCG/ACT	1	Inhaler	30	DAYS
Spiriva respimat	Tiotropium Bromide Monohydrate Inhal Aerosol 2.5 MCG/ACT	2.5 MCG/ACT	1	Inhaler	30	DAYS
Stiolto respimat	Tiotropium Br-Olodaterol Inhal Aero Soln 2.5-2.5 MCG/ACT	2.5-2.5 MCG/ACT	1	Inhaler	30	DAYS
Striverdi respimat	Olodaterol HCl Inhal Aerosol Soln 2.5 MCG/ACT (Base Equiv)	2.5 MCG/ACT	1	Inhaler	30	DAYS
Symbicort	Budesonide-Formoterol Fumarate Dihyd Aerosol 160-4.5 MCG/ACT	160-4.5 MCG/ACT	3	Inhalers	30	DAYS
Symbicort	Budesonide-Formoterol Fumarate Dihyd Aerosol 80-4.5 MCG/ACT	80-4.5 MCG/ACT	3	Inhalers	30	DAYS
Trelegy ellipta	Fluticasone-Umeclidinium-Vilanterol AEPB	200-62.5-25 MCG/ACT	1	Inhaler	30	DAYS
Trelegy ellipta	Fluticasone-Umeclidinium-Vilanterol AEPB 100-62.5-25 MCG/INH	100-62.5-25 MCG/ACT	1	Inhaler	30	DAYS
Tudorza pressair	Aclidinium Bromide Aerosol Powd Breath Activated 400 MCG/ACT	400 MCG/ACT	1	Inhaler	30	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
			Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Advair diskus	Fluticasone-Salmeterol Aer Powder BA 100-50 MCG/DOSE	100-50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Advair diskus	Fluticasone-Salmeterol Aer Powder BA 250-50 MCG/DOSE	250-50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Advair diskus	Fluticasone-Salmeterol Aer Powder BA 500-50 MCG/DOSE	500-50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Advair hfa ; Fluticasone propionate/sa	Fluticasone-Salmeterol Inhal Aerosol 115-21 MCG/ACT	115-21 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Advair hfa ; Fluticasone propionate/sa	Fluticasone-Salmeterol Inhal Aerosol 230-21 MCG/ACT	230-21 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Advair hfa ; Fluticasone propionate/sa	Fluticasone-Salmeterol Inhal Aerosol 45-21 MCG/ACT	45-21 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Airduo digihaler 113/14	Fluticasone-Salmeterol Aer Powder BA	113-14 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Airduo digihaler 232/14	Fluticasone-Salmeterol Aer Powder BA	232-14 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Airduo digihaler 55/14	Fluticasone-Salmeterol Aer Powder BA	55-14 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Airduo respiclick 113/14 ; Fluticasone propionate/sa	Fluticasone-Salmeterol Aer Powder BA 113-14 MCG/ACT	113-14 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Airduo respiclick 232/14 ; Fluticasone propionate/sa	Fluticasone-Salmeterol Aer Powder BA 232-14 MCG/ACT	232-14 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Airduo respiclick 55/14 ; Fluticasone propionate/sa	Fluticasone-Salmeterol Aer Powder BA 55-14 MCG/ACT	55-14 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Airsupra	albuterol-budesonide inhalation aerosol	90-80 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Albuterol sulfate hfa ; Proventil hfa ; Ventolin hfa	Albuterol Sulfate Inhal Aero 108 MCG/ACT (90MCG Base Equiv)	108 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Alvesco	Ciclesonide Inhal Aerosol 160 MCG/ACT	160 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Alvesco	Ciclesonide Inhal Aerosol 80 MCG/ACT	80 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Anoro ellipta	Umeclidinium-Vilanterol Aero Powd BA 62.5-25 MCG/INH	62.5-25 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Armonair digihaler	Fluticasone Propionate Aer Pow BA	55 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Armonair digihaler	Fluticasone Propionate Aer Pow BA	113 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Armonair digihaler	Fluticasone Propionate Aer Pow BA	232 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Arnuity ellipta	Fluticasone Furoate Aerosol Powder Breath Activ 100 MCG/ACT	100 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Arnuity ellipta	Fluticasone Furoate Aerosol Powder Breath Activ 200 MCG/ACT	200 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Arnuity ellipta	Fluticasone Furoate Aerosol Powder Breath Activ 50 MCG/ACT	50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Asmanex hfa	Mometasone Furoate Inhal Aerosol Suspension 100 MCG/ACT	100 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Asmanex hfa	Mometasone Furoate Inhal Aerosol Suspension 200 MCG/ACT	200 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Asmanex hfa	Mometasone Furoate Inhal Aerosol Suspension 50 MCG/ACT	50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Asmanex twisthaler 120 me ; Asmanex twisthaler 14 met ; Asmanex twisthaler 30 met ; Asmanex twisthaler 60 met	Mometasone Furoate Inhal Powd 220 MCG/INH (Breath Activated)	220 MCG/INH	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Asmanex twisthaler 30 met	Mometasone Furoate Inhal Powd 110 MCG/INH (Breath Activated)	110 MCG/INH	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Atrovent hfa	Ipratropium Bromide HFA Inhal Aerosol 17 MCG/ACT	17 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Bevespi aerosphere	Glycopyrrolate-Formoterol Fumarate Aerosol 9-4.8 MCG/ACT	9-4.8 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Breo ellipta	fluticasone furoate-vilanterol aero powd ba	50-25 MCG/INH	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Breo ellipta ; Fluticasone furoate/vilan	Fluticasone Furoate-Vilanterol Aero Powd BA 100-25 MCG/INH	100-25 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Breo ellipta ; Fluticasone furoate/vilan	Fluticasone Furoate-Vilanterol Aero Powd BA 200-25 MCG/INH	200-25 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Breztri aerosphere	Budesonide-Glycopyrrolate-Formoterol Aers	160-9-4.8 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Combivent respimat	Ipratropium-Albuterol Inhal Aerosol Soln 20-100 MCG/ACT	20-100 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Duaklir pressair	Aclidinium Br-Formoterol Fum Aero Pow Br Act 400-12 MCG/ACT	400-12 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dulera	Mometasone Furoate-Formoterol Fumarate Aerosol 100-5 MCG/ACT	100-5 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dulera	Mometasone Furoate-Formoterol Fumarate Aerosol 200-5 MCG/ACT	200-5 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dulera	Mometasone Furoate-Formoterol Fumarate Aerosol 50-5 MCG/ACT	50-5 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Flovent diskus ; Fluticasone propionate di	Fluticasone Propionate Aer Pow BA 100 MCG/BLISTER	100 MCG/ACT ; 100 MCG/BLIST	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Flovent diskus ; Fluticasone propionate di	Fluticasone Propionate Aer Pow BA 250 MCG/BLISTER	250 MCG/ACT ; 250 MCG/BLIST	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Flovent diskus ; Fluticasone propionate di	Fluticasone Propionate Aer Pow BA 50 MCG/BLISTER	50 MCG/ACT ; 50 MCG/BLIST	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Flovent hfa ; Fluticasone propionate hf	Fluticasone Propionate HFA Inhal Aer 110 MCG/ACT (125/Valve)	110 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Flovent hfa ; Fluticasone propionate hf	Fluticasone Propionate HFA Inhal Aer 220 MCG/ACT (250/Valve)	220 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Flovent hfa ; Fluticasone propionate hf	Fluticasone Propionate HFA Inhal Aero 44 MCG/ACT (50/Valve)	44 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Incruse ellipta	Umeclidinium Br Aero Powd Breath Act 62.5 MCG/INH (Base Eq)	62.5 MCG/INH	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Levalbuterol tartrate hfa ; Xopenex hfa	Levalbuterol Tartrate Inhal Aerosol 45 MCG/ACT (Base Equiv)	45 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Levalbuterol tartrate hfa ; Xopenex hfa	Levalbuterol Tartrate Inhal Aerosol 45 MCG/ACT (Base Equiv)	45 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Proair digihaler	Albuterol Sulfate Aer Pow BA	108 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Proair respiclick	Albuterol Sulfate Aer Pow BA 108 MCG/ACT (90 MCG Base Equiv)	108 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Pulmicort flexhaler	Budesonide Inhal Aero Powd 180 MCG/ACT (Breath Activated)	180 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Pulmicort flexhaler	Budesonide Inhal Aero Powd 90 MCG/ACT (Breath Activated)	90 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qvar redihaler	Beclomethasone Diprop HFA Breath Act Inh Aer 40 MCG/ACT	40 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qvar redihaler	Beclomethasone Diprop HFA Breath Act Inh Aer 80 MCG/ACT	80 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Serevent diskus	Salmeterol Xinafoate Aer Pow BA 50 MCG/DOSE (Base Equiv)	50 MCG/DOSE	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Spiriva handihaler	Tiotropium Bromide Monohydrate Inhal Cap 18 MCG (Base Equiv)	18 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Spiriva respimat	Tiotropium Bromide Monohydrate Inhal Aerosol 1.25 MCG/ACT	1.25 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Spiriva respimat	Tiotropium Bromide Monohydrate Inhal Aerosol 2.5 MCG/ACT	2.5 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Stiolto respimat	Tiotropium Br-Olodaterol Inhal Aero Soln 2.5-2.5 MCG/ACT	2.5-2.5 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Striverdi respimat	Olodaterol HCl Inhal Aerosol Soln 2.5 MCG/ACT (Base Equiv)	2.5 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Symbicort	Budesonide-Formoterol Fumarate Dihyd Aerosol 160-4.5 MCG/ACT	160-4.5 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Symbicort	Budesonide-Formoterol Fumarate Dihyd Aerosol 80-4.5 MCG/ACT	80-4.5 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trelegy ellipta	Fluticasone-Umeclidinium-Vilanterol AEPB	200-62.5-25 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trelegy ellipta	Fluticasone-Umeclidinium-Vilanterol AEPB 100-62.5-25 MCG/INH	100-62.5-25 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Tudorza pressair	Aclidinium Bromide Aerosol Powd Breath Activated 400 MCG/ACT	400 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
QL	Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
3. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.