MOMETASONE POWDER

RATIONALE FOR INCLUSION IN PA PROGRAM

Background Mometasone is a corticosteroid demonstrating potent anti-inflammatory activity able to decrease inflammation through a mechanism of action that is not known. However, corticosteroids are

thought to act by the induction of phospholipase A2, which leads to the inhibition of a common precursor for potent inflammatory mediators. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption (1).

Mometasone is commercially available in the following dosage forms: topical cream, topical lotion, topical ointment, nasal spray and as a powder for inhalation.

Regulatory Status FDA approved topical indication: Mometasone is a corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age and older (1).

The safety and efficacy of mometasone have not been established in pediatric patients below 2 years of age (1).

Summary Topical steroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. Mometasone is FDA-approved for inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses in patients 2 years of age and older. The safety and efficacy of mometasone have not been established in pediatric patients below 2 years of age (1). Mometasone is commercially available in the following dosage forms: topical cream, topical lotion, topical ointment, nasal spray and as powder for inhalation.

Mometasone powder may be considered medically necessary in a topical formulation for patients 2 years of age or older for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Mometasone powder may be considered investigational in a topical formulation for patients

Mometasone Powder FEP Clinical Rationale MOMETASONE POWDER

under the age of 2 years, or in patients without a diagnosis of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of mometasone powder while maintaining optimal therapeutic outcomes.

References Elocon [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; Revised April 2013.

Mometasone Powder FEP Clinical Rationale