Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] — United Healthcare
mitigation of allergic reactions, including anaphylaxis, due to accidental exposure to peanuts in patients with confirmed peanut allergy
Initial criteria
- Diagnosis and clinical history of peanut allergy documented by BOTH of the following: (1) serum peanut-specific IgE level ≥ 0.35 kUA/L AND (2) mean wheal diameter at least 3 mm larger than negative control on skin-prick testing for peanut
- ONE of the following: (1) BOTH of the following: patient age 1–17 years AND in the initial dose escalation phase; OR (2) BOTH of the following: patient age ≥ 1 year AND in the up-dosing or maintenance phase of therapy
- Used in conjunction with a peanut-avoidant diet
- Patient does NOT have ANY of the following: (1) history of eosinophilic esophagitis (EoE) or eosinophilic gastrointestinal disease; (2) history of severe or life-threatening anaphylaxis or anaphylactic shock within past 2 months; (3) severe or poorly controlled asthma
- Prescribed by or in consultation with an allergist/immunologist
- Prescriber is certified/enrolled in the Palforzia REMS Program
Reauthorization criteria
- Documentation of positive clinical response to Palforzia therapy
- Used in conjunction with a peanut-avoidant diet
- Prescribed by or in consultation with an allergist/immunologist
- Prescriber is certified/enrolled in the Palforzia REMS Program
Approval duration
12 months