SINGULAIR, Montelukast Sodium Form

Montelukast (Singulair®) is a leukotriene receptor antagonist. Prior authorization is required for the oral granules. FDA Approved Indication(s) Singulair is indicated for the: • Prophylaxis and chronic treatment of asthma in patients 12 months of age and older • Acute prevention of exercise-induced bronchoconstriction in patients 6 years of age and older • Relief of symptoms of allergic rhinitis: seasonal allergic rhinitis in patients 2 years of age and older, and perennial allergic rhinitis in patients 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies. Limitation(s) of use: Singulair is not indicated to treat an acute asthma attack. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Singulair oral granules are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Request for Singulair Oral Granules (must meet all):

1. Age ≥ 6 months;
   
   2. Member meets one of the following (a or b): a. Age < 6 years; b. Documentation supports member’s inability to use regular or chewable montelukast tablets;
2. If request is for brand Singulair granules, member must use generic montelukast granules, unless contraindicated or clinically significant adverse effects are experienced;

3. Dose does not exceed 4 mg (1 packet of oral granules) per day. Approval duration: 12 months
   B. Other diagnoses/indications: Not applicable Page 1 of 4

   CLINICAL POLICY Montelukast Oral Granules II. Continued Therapy A. Request for Singulair Oral Granules (must meet all):

4. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member meets one of the following (a or b): a. Age < 6 years; b. Documentation supports member’s continued inability to use regular or chewable montelukast tablets;

6. If request is for brand Singulair granules, member must use generic montelukast granules, unless contraindicated or clinically significant adverse effects are experienced; If request is for a dose increase, new dose does not exceed 4 mg (1 packet of oral granules) per day. Approval duration: 12 months
   B. Other diagnoses/indications: Not applicable III. Diagnoses/Indications for which coverage is NOT authorized: Not applicable IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable
   Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to any component of this product • Boxed warning(s): serious neuropsychiatric events V. Dosage and Administration
   Indication Asthma Acute prevention of exercise-induced bronchoconstriction Relief of symptoms of allergic rhinitis Dosing Regimen PO QD PO at least 2 hours before exercise PO QD
   Maximum Dose Dosing based on age: • ≥ 15 years: 10 mg tablet • 6-14 years: 5 mg chewable tablet • 2-5 years: 4 mg chewable tablet or oral granules • 6-23 months: 4 mg oral granules Page 2 of 4

   CLINICAL POLICY Montelukast Oral Granules VI. Product Availability
   • Film-coated tablet: 10 mg • Chewable tablets: 4 mg, 5 mg • Oral granules: 4 mg VII.