ODACTRA (house dust mite allergen extract)

ODACTRA (house dust mite allergen extract)

SELF ADMINISTRATION

Indications for Prior Authorization:

• Indicated for patients 18 to 65 years of age for the treatment of House Dust Mite (HDM)-induced allergic rhinitis with or without conjunctivitis

Patients must meet the following criteria for the indication(s) above:

• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with an allergist, immunologist, or an otolaryngologist (ENT) physician specialist, AND
• Diagnosis of house dust mite-induced allergic rhinitis confirmed by meeting one of the following conditions:
  • Patient has a positive skin test response to house dust mite allergen extracts, OR
  • Patient has a positive in vitro test (e.g. a blood test for allergen-specific IgE antibodies) for house dust mite, AND
• Patient does not have severe, unstable or uncontrolled asthma; history of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy; history of eosinophilic esophagitis; or hypersensitivity to any inactive ingredients in Odactra™ 

Dosing:

• 1 tablet sublingually daily
• Administer first dose of Odactra™ under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. Observe patients in the office for at least 30 minutes following the initial dose.

Approval:

• 1 year