Corticosteroid Oral Inhalation Limit Policy 158-H 10-2022 - Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan

Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan

Subject: Corticosteroid Oral Inhalation Limit Policy 158-H 10-2022

Drug
CORTICOSTEROID ORAL INHALATION
ALVESCO (ciclesonide)
ARMONAIR DIGIHALER (fluticasone propionate)
ARNUITY ELLIPTA (fluticasone furoate)
ASMANEX HFA (mometasone furoate)
ASMANEX TWISTHALER (mometasone furoate)
FLOVENT DISKUS (fluticasone propionate)
FLOVENT HFA (fluticasone propionate)
PULMICORT FLEXHALER (budesonide)
PULMICORT RESPULES (budesonide)
QVAR REDIHALER® (beclomethasone)

Policy:

FDA-APPROVED INDICATIONS
Alvesco
Alvesco is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

ArmonAir Digihaler
ArmonAir Digihaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older.

Arnuity Ellipta
Arnuity Ellipta is indicated for the once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older.

Asmanex HFA
Asmanex HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older.

Asmanex Twisthaler
Asmanex Twisthaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older.

Flovent Diskus
Flovent Diskus is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.

Flovent HFA
Flovent HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.

Pulmicort Flexhaler
Pulmicort Flexhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older.

Pulmicort Respules
Pulmicort Respules is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.

QVAR Redihaler
QVAR Redihaler is indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older.

Important Limitations of Use
Oral inhaled corticosteroids are NOT indicated for the relief of acute bronchospasm.

LIMIT CRITERIA Limits do not accumulate together; patient is allowed the maximum limit for each drug and strength PLEASE NOTE: Since manufacturer package sizes may vary, it is the discretion of the dispensing pharmacy to fill quantities per package size up to these quantity limits. In such cases the filling limit and day supply may be less than what is indicated.
Medication**	Starting Dose	Maximum Daily Dose**	Package Size	1 Month Limit* 3 Months Limit*
Alvesco 80mcg** (ciclesonide)	1-3 inhalations twice daily	6 inhalations**	60 inhalations per 6.1gm canister	3 packages (6.1gm each) / 25 days 9 packages (6.1gm each) / 75 days
Alvesco 160mcg (ciclesonide)	1-2 inhalations twice daily	4 inhalations (640mcg)	60 inhalations per 6.1gm canister	2 packages (6.1gm each) / 25 days 6 packages (6.1gm each) / 75 days
ArmonAir Digihaler 30mcg** (fluticasone propionate)	1 inhalation twice daily	2 inhalations**	60 inhalations per inhaler	1 package / 25 days 3 packages / 75 days
ArmonAir Digihaler 55mcg** (fluticasone propionate)	1 inhalation twice daily	2 inhalations**	60 inhalations per inhaler	1 package / 25 days 3 packages / 75 days
ArmonAir Digihaler 113mcg** (fluticasone propionate)	1 inhalation twice daily	2 inhalations**	60 inhalations per inhaler	1 package / 25 days 3 packages / 75 days
ArmonAir Digihaler 232mcg (fluticasone propionate)	1 inhalation twice daily	2 inhalations (464mcg)	60 inhalations per inhaler	1 package / 25 days 3 packages / 75 days
Arnuity Ellipta 50mcg (fluticasone furoate)	1 inhalation once daily	1 inhalation	30 blisters per inhaler	1 package (30 blisters) / 25 days 3 packages (30 blisters each) / 75 days
Arnuity Ellipta 100mcg** (fluticasone furoate)	1 inhalation once daily	1 inhalation**	30 blisters per inhaler	1 package (30 blisters) / 25 days 3 packages (30 blisters each) / 75 days
Arnuity Ellipta 200mcg (fluticasone furoate)	1 inhalation once daily	1 inhalation (200mcg)	30 blisters per inhaler	1 package (30 blisters) / 25 days 3 packages (30 blisters each) / 75 days
Asmanex HFA 50mcg (mometasone furoate)	2 inhalations twice daily	4 inhalations	120 inhalations per 13gm canister	1 package (13gm each) / 25 days 3 packages (13gm each) / 75 days
Asmanex HFA 100mcg** (mometasone furoate)	2 inhalations twice daily	4 inhalations**	120 inhalations per 13gm canister	1 package (13gm each) / 25 days 3 packages (13gm each) / 75 days
Asmanex HFA 200mcg (mometasone furoate)	2 inhalations twice daily	4 inhalations (800mcg)	120 inhalations per 13gm canister	1 package (13gm each) / 25 days 3 packages (13gm each) / 75 days
Asmanex Twisthaler 110mcg** (mometasone furoate)	1 inhalation once daily	2 inhalations**	30 inhalation units per package	2 packages / 25 days 6 packages / 75 days
Asmanex Twisthaler 220mcg (mometasone furoate)	1-2 inhalations once to twice daily	4 inhalations (880mcg)	30 inhalation units per package	4 packages / 25 days 12 packages / 75 days
			60 inhalation units per package	2 packages / 25 days 6 packages / 75 days
			120 inhalation units per package	1 package / 25 days 3 packages / 75 days
Flovent Diskus 50mcg** (fluticasone propionate)	1-3 inhalations twice daily	6 inhalations**	60 blisters per device	3 packages (60 blisters each) / 25 days 9 packages (60 blisters each) / 75 days
Flovent Diskus 100mcg** (fluticasone propionate)	1-4 inhalations twice daily	8 inhalations**	60 blisters per device	4 packages (60 blisters each) / 25 days 12 packages (60 blisters each) / 75 days
Flovent Diskus 250mcg (fluticasone propionate)	1-4 inhalations twice daily	8 inhalations (2000mcg)	60 blisters per device	4 packages (60 blisters each) / 25 days 12 packages (60 blisters each) / 75 days
Flovent HFA 44mcg** (fluticasone propionate)	2-4 inhalations twice daily	8 inhalations**	120 inhalations per 10.6gm canister	2 packages (10.6gm each) / 25 days 6 packages (10.6gm each) / 75 days
Flovent HFA 110mcg** (fluticasone propionate)	1-3 inhalations twice daily	6 inhalations**	120 inhalations per 12gm canister	2 packages (12gm each) / 25 days 6 packages (12gm each) / 75 days
Flovent HFA 220mcg (fluticasone propionate)	1-4 inhalations twice daily	8 inhalations (1760mcg)	120 inhalations per 12gm canister	2 packages (12gm each) / 25 days 6 packages (12gm each) / 75 days
Pulmicort Flexhaler 90mcg** (budesonide)	2-3 inhalations twice daily	6 inhalations**	60 inhalations per device	3 packages / 25 days 9 packages / 75 days
Pulmicort Flexhaler 180mcg (budesonide)	1-4 inhalations twice daily	8 inhalations (1440mcg)	120 inhalations per device	2 packages / 25 days 6 packages / 75 days
Pulmicort Respules 0.25mg** (budesonide)	nebulization of 1-2 respules (2-4mL) daily	3 respules**	30 respules (2mL each) per carton	3 packages (90 respules x 2mL) / 25 days 9 packages (270 respules x 2mL) / 75 days
Pulmicort Respules 0.5mg (budesonide)	nebulization of 1-2 respules (2-4mL) daily	2 respules (1mg)	30 respules (2mL each) per carton	2 packages (60 respules x 2mL) / 25 days 6 packages (180 respules x 2mL) / 75 days
Pulmicort Respules 1mg (budesonide)	nebulization of 1 respule (2mL) daily	1 respule (1mg)	30 respules (2mL each) per carton	1 package (30 respules x 2mL) / 25 days 3 packages (90 respules x 2mL) / 75 days
QVAR Redihaler 40mcg** (beclomethasone)	1-3 inhalations twice daily	6 inhalations**	120 inhalations per 10.6gm canister	2 packages (10.6gm each) / 25 days 6 packages (10.6gm each) / 75 days
QVAR Redihaler 80mcg (beclomethasone)	1-4 inhalations twice daily	8 inhalations (640mcg)	120 inhalations per 10.6gm canister	2 packages (10.6gm each) / 25 days 6 packages (10.6gm each) / 75 days
The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing. *Utilize higher strength available.

Place of Service:

Outpatient

The above policy is based on the following references:

Alvesco [package insert]. Zug, 6300 Switzerland: Covis Pharma; December 2021.
ArmonAir Digihaler [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; April 2022.
Arnuity Ellipta [package insert]. Research Triangle Park, NC: GlaxoSmithKline; February 2020.
Asmanex HFA [package insert]. Jersey City, NJ: Organon Global Inc.; June 2021.
Asmanex Twisthaler [package insert]. Jersey City, NJ: Organon Global Inc.; June 2021.
Flovent Diskus [package insert]. Research Triangle Park, NC: GlaxoSmithKline; June 2022.
Flovent HFA [package insert]. Research Triangle Park, NC: GlaxoSmithKline; August 2021.
Pulmicort Flexhaler [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals, LP; October 2019.
Pulmicort Respules [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals, LP; October 2019.
QVAR Redihaler [package insert]. Parsippany, NJ: Teva Respiratory, LLC.; April 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 23, 2023

Additional Information

Clinical Policy Bulletin Notes

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