Prior Auth Protocol

FDA Approved Indications:

Seebri Neohaler is an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

Health Net Approved Indications and Usage Guidelines:

Diagnosis of COPD including chronic bronchitis and/or emphysema

Coverage is Not Authorized For:

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.
The relief of acute bronchospasm.

General Information:

Seebri should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Seebri has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.

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^R Aerolizer^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^R Inhalation 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
Breo^R Ellipta^R (fluticasone furoate/vilanterol)	COPD 1 oral inhalation (100 mcg/25 mcg) QD Asthma 1 oral inhalation (100 mcg/25 mcg, 200 mcg/25 mcg) QD	100 mcg/25 mcg daily
Incruse Ellipta^R (umeclidinium inhalation powder)	COPD 1 oral inhalation(62.5 mcg) QD	62.5 mcg daily

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Seebri Neohaler	COPD 1 capsule by oral inhalation BID	Length of Benefit

Product Availability:

Inhalation powder: contains Seebri (glycopyrrolate (15.6 mcg) inhalation powder) orange transparent capsules packaged in aluminium blister cards, one Neohaler device. Unit Dose (blister pack), Box of 60 (10 blister cards with 6 orange transparent capsules each). The neohaler device consists of a white protective cap and a base with mouthpiece, capsule chamber and 2 orange push buttons.

References:

1. Seebri Neohaler [Prescribing Information]. East Hanover, NJ: Novartis; October 2015.
2. Micromedex^RHealthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed November 15, 2015.
3. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2015. Available at http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015_Feb18.pdf. Accessed November 11, 2015.

Interim Guidelines; Final Review and Approval by the P&T Committee Pending