Prior Auth Protocol

FDA Approved Indications:

Cinqair is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of severe asthma (see General Information) in patients ≥ 18 years old

AND

Prescribed by or in consultation with a Pulmonologist or Allergist

AND

Use of an inhaled or oral corticosteroid and a long-acting beta-agonist (LABA). If a long-acting beta-agonist is contraindicated, a second controller agent must be used in combination with an inhaled corticosteroid. Patients must be compliant with controller medication therapy.

AND

Patient has a blood eosinophil count of greater than or equal to 400 cells/mcL within the past 3 months

AND

Patient experiences two (2) exacerbations requiring a course of oral/systemic corticosteroids (or increase in dose if already on oral corticosteroid), hospitalization or an emergency room visit in a twelve (12) month period; or one exacerbation requiring intubation

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.

General Information:

Cinqair is not indicated for treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus
Asthma exacerbations (primary endpoint) was defined as 1) use of systemic steroid, or ≥2-fold increase in the use of ICS for 3 or more days; 2) asthma related emergency treatment by nebulizer, a visit to the ED or asthma related hospitalization.
Controller medications are: inhaled glucocorticoids (Flovent, Pulmicort, Qvar, Asmanex), long-acting beta-agonists (LABAs) such as salmeterol, formoterol, or vilanterol, and antileukotriene agents (montelukast [Singulair^R], zafirlukast [Accolate^R] or Zyflo^R [zileuton]). Theophylline is also a controller agent, however, it is not as efficacious as LABAs.
Patients could potentially meet criteria for both Xolair and Cinqair. The combination has not been studied. Approximately 30% of patients in the Nucala study also were candidates for therapy with Xolair.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Inhaled corticosteroids Beclomethasone (Qvar^R)	40 mcg, 80 mcg/actuation 1-4 actuations twice daily	4 actuations twice daily
Budesonide (Pulmicort^R)	200 mcg/actuation 1-2 actuations once or twice daily	2 actuations twice dails
Alvesco^R (ciclesonide)	80 mcg, 160 mcg per actuation 1-2 actuations twice daily	2 actuations twice daily
Aerospan^R (flunisolide)	80 mcg per actuation 1-2 actuations twice daily	2 actuations twice daily
Flovent^R (fluticasone propionate)	44-250 mcg per actuation 1-2 actuations twice daily	2 actuations twice daily
Arnuity Ellipta^R (fluticasone furoate)	100 mcg, 200 mcg per actuation 1 actuation once daily	1 actuation once daily
Asmanex^R (mometasone)	110 mcg, 220 mcg 1-2 inhalations once to twice daily	2 inhalations twice daily
Spiriva Respimat^TM (tiotropium bromide)	2 inhalations (1.25 mcg each) Once daily	2 inhalations (1.25 mcg each) Once daily
Long-acting beta-agonists Foradil^R (formoterol)	12 mcg capsule for inhalation 1 capsule twice daily	24 mcg per day
Serevent^R (salmeterol)	5 mcg per dose 1 inhalation twice daily	1 inhalation twice daily
Combination products Dulera^R (mometasone/ formoterol)	100/5 mcg, 200/5 mcg per actuation 2 actuations twice daily	4 actuations per day
Breo Ellipta^R (fluticasone/ vilanterol)	100/25 mcg, 200/25 mcg per actuation 1 actuation once daily	1 actuation once daily
Advair^R (fluticasone/ salmeterol)	100/50 mcg, 250/50 mcg, 500/50 mcg per actuation 1 actuation twice daily	1 actuation twice daily
Symbicort^R (budesonide/formoterol)	80 mcg/4.5 mcg; 160 mcg/4.5 mcg per actuation 1-2 actuations twice daily	2 actuations twice daily
Antileukotriene agents Montelukast (Singulair^R)	4 to 10 mg PO QD	10 mg per day
Zafirlukast (Accolate^R)	10 to 20 mg PO BID	40 mg per day
Zyflo^R (zileuton)	1200 mg PO BID	2400 mg per day
Oral glucocorticoids Dexamethasone (Decadron)	0.75 to 9 mg/day PO in 2 to 4 divided doses	Varies
Methylprednisolone (Medrol)	40 to 80 mg PO in 1 to 2 divided doses	Varies
Injectable therapies Xolair* (omalizumab)	0.016 mg/kg/IgE SC every 4 weeks	750 mg per 4 weeks
Nucala* (mepolizumab)	100 mg SC every 4 weeks	100 mg per 4 weeks

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Cinqair	3 mg/kg once every 4 weeks by IV infusion over 20-50 minutes. Cinqair should be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis.	3 months initial authorization If documentation by medical records of a reduction in asthma exacerbation is provided, then renew for 6 months or to members renewal period, whichever is longer

Product Availability:

Vial: 100 mg/10 mL solution in single-use vials

References:

1. Cinqair [Prescribing Information]. Frazer, PA: Teva Pharmaceutical Industries Ltd.; March 2016.