Prior Auth Protocol

FDA Approved Indications:

Long-term, once-daily, maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Once-daily treatment of asthma in patients aged 18 years and older.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of COPD

OR

Asthma in patients ≥18 years old

Coverage is Not Authorized For:

The relief of acute bronchospasm.
Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

Breo Ellipta is not approved for asthma treatment in patients aged 12-17 years due to increased risk of exacerbations and hospitalizations as shown from Trial 5 (Breo Ellipta vs. fluticasone furoate).

COPD/Asthma

Black Box Warning

Breo Ellipta is not indicated for relief of acute bronchospasm or for treatment of asthma. The potential of long-acting beta2-adrenergic agonists (LABA) such as vilanterol, an active ingredient in Breo Ellipta, increase the risk of asthma-related death.
LABA increases the risk of asthma-related hospitalization in pediatric and adolescent patients.

Warnings/Precautions

For the treatment of asthma, physicians should only prescribe Breo Ellipta for patients not adequately controlled on a long-term asthma control medication, such as an ICS, or whose disease severity clearly warrants initiation of treatment with combination ICS and LABA.
Do not use Breo Ellipta for patients whose asthma is adequately controlled on low- or medium-dose ICS.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Advair Diskus^R (fluticasone propionate/salmeterol)	COPD 1 oral inhalation (250 mcg/ fluticasone/50 mcg salmeterol) BID Asthma Dry powder inhaler: 1 oral inhalation (100 mcg/50 mcg, 250 mcg/50 mcg, 500 mcg/50 mcg) BID Inhalation aerosol: 2 oral inhalations (45 mcg/21 mcg, 115/21, 230/21) BID	COPD: 250 mcg/50 mcg twice daily Asthma: 500 mcg/50 mcg twice daily 2 inhalations (230 mcg/21 mcg) twice daily
Symbicort^R (budesonide/formoterol)	COPD 2 oral inhalations (160 mcg/4.5 mcg per inhalation) BID Asthma 2 oral inhalations (80 mcg/4.5 mcg, 160 mcg/4.5 mcg) BID	COPD: 320 mcg/9 mcg twice daily Asthma: 2 inhalations (160 mcg/4.5 mcg) twice daily
Dulera^R (mometasone/formoterol)	Asthma Previously on medium-dose ICS: 2 oral inhalations (100 mcg/5 mcg) BID Previously on high-dose ICS: 2 oral inhalations (200 mcg/5 mcg) BID	Asthma: 400 mcg/20 mcg daily 800 mcg/20 mcg daily
Atrovent^TM HFA and 0.02% Solution for Inhalation (ipratropium bromide)	COPD HFA: 2 puffs (36 mcg) 4 times per day Solution for inhalation: the usual dose is 500 mcg (1 unit dose vial) administered TID to QID by nebulization, with doses 6 to 8 hours apart.	HFA: 3 puffs 4 times per day
Spiriva^R (tiotropium bromide)	COPD Inhale the contents of 1 capsule (18 mcg) QD via Handihaler.	1 capsule per day
Tudorza^TM Pressair^TM (aclidinium bromide)	COPD Inhale 1 puff (400 mcg) BID	1 puff twice daily
Serevent^R Diskus (salmeterol xinafoate)	COPD 1 inhalation (50 mcg) BID, approximately 12 hours apart Asthma 1 oral inhalation (50mcg) BID	COPD: 1 inhalation (50 mcg) twice daily Asthma: 1 inhalation (50mcg) twice daily
Foradil^RAerolizer^R, Perforomist^R (formoterol fumarate)	COPD Foradil: Inhale the contents of one 12 mcg capsule Q12H using the Aerolizer inhaler. Perforomist: Inhale 20 mcg BID via nebulizer	Foradil: 1 capsule every 12 hours Perforomist: 40 mcg per day
Combivent Respimat^R and Duoneb^RInhalation Solution (albuterol sulfate/ ipratropium bromide)	COPD Combivent Respimat: 1 inhalation QID Duoneb: one 3 ml vial (0.5 mg ipratropium bromide and 3 mg albuterol sulfate) administered QID via nebulization.	Combivent Respimat: 6 inhalations per day Duoneb: six 3 ml vials per day
Arcapta^TM Neohaler^TM (indacaterol)	COPD Inhale 75 mcg QD via a Neohaler device	75 mcg once daily
Brovana^R (arformoterol)	COPD Inhale 15 mcg (2 mL) BID via nebulizer	15 mcg twice daily
Advair HFA (fluticasone/salmeterol inhalation aerosol)	Asthma 2 oral inhalations (45 mcg/21 mcg, 115 mcg/21 mcg, 230 mcg/21 mcg) BID	2 inhalations (230 mcg/21 mcg) twice daily
Pulmicort (budesonide)	Asthma 1 oral inhalation (180 or 360 mcg) BID	720 mcg twice daily
Aerospan (flunisolide)	Asthma 2 oral inhalations (80 mcg) BID	Up to 4 inhalations (320 mcg) twice daily
Arnuity Ellipta (fluticasone furoate)	Asthma 1 oral inhalation (100 or 200 mcg) QD	1 inhalation (200 mcg) once daily
Asmanex HFA (mometasone furoate)	Asthma 2 oral inhalations (100 or 200 mcg) BID	800 mcg daily
Flovent HFA (fluticasone propionate)	Asthma 1 oral inhalation (88-220 mcg) BID	1 inhalation (440 mcg) twice daily
Qvar (beclomethasone dipropionate)	Asthma 1 oral inhalation (40, 80, 160 mcg) BID	320 mcg twice daily
Alvesco (ciclesonide)	Asthma 1 oral inhalation (80 mcg) BID	320 mcg twice daily

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Breo Ellipta	COPD 1 oral inhalation (100 mcg/25 mcg) QD Asthma 1 oral inhalation (100 mcg/25 mcg, 200 mcg/25 mcg) QD	Length of Benefit

Product Availability:

Inhalation powder: Disposable light grey and pale blue plastic inhaler containing 2 foil blister strips of powder formulation for oral inhalation. One strip contains fluticasone furoate (100 mcg or 200 mcg per blister) and the other contains vilanterol (25 mcg per blister).

References:

1. Breo Ellipta [Prescribing Information]. Research Triangle Park, NC: GlaxoSmithKline; April 2015.

2. Bateman ED, OByrne PM, Busse WW, et al. Once-daily fluticasone furoate (FF)/vilanterol (VI) reduces risk of severe exacerbations in asthma versus FF alone. Thorax 2014;69:312-319.

3. Micromedex^R Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 1, 2015.

4. Breo Ellipta. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 10, 2014.

5. National Heart, Lung and Blood Institute, National Asthma Education and Prevention Program: Expert Panel Report 3. Guidelines for the Diagnosis and Management of Asthma. Available at http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf. Accessed June 2015.

6. National Heart, Lung and Blood Institute, National Asthma Education and Prevention Program: Expert Panel Report 3. Asthma Quick Care Reference: Diagnosing and Managing Asthma. Available at http://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf. Accessed June 2015.