PALFORZIA (peanut (arachis hypogaea) allergen powder-dnfp)

PALFORZIA (peanut (arachis hypogaea) allergen powder-dnfp)

SELF-ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients with a confirmed diagnosis of peanut allergy
   

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

• Diagnosis and clinical history of peanut allergy as documented by ONE of the following:
  • A serum peanut-specific IgE level of greater than or equal to 0.35 kUA/L, OR
  • A positive skin prick test to peanut ≥ 3mm compared to control, AND
• Prescribed by or in consultation with an allergist/immunologist, AND
• Patient is 4 to 17 years of age at initiation of therapy, AND
• Patient is using in conjunction to peanut allergen avoidance to reduce risk of anaphylaxis due to accidental exposure, AND
• Patient has a confirmed prescription for an auto-injectable epinephrine agent, AND
• Chart note documentation confirming initial dosing was completed in office, AND
• Patient does not have any of the following:
  • History of eosinophilic esophagitis (EoE) or eosinophilic gastrointestinal disease 
  • History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within the past 2 months 
  • Severe or poorly controlled asthma

Reauthorization Criteria:

• Chart note documentation confirming the first dose has been administered in office (for up-dosing) and positive response to therapy

Limitations of use:

• Not indicated for the emergency treatment of allergic reactions, including anaphylaxis
  • Used in conjunction with a peanut-avoidant diet
     

Contraindications:

• Patients with uncontrolled asthma
• History of eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal diseases
• History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within the past 2 months 
• Boxed warning: anaphylaxis

Dosing:

• REMS program- because of the risk of anaphylaxis, peanut allergen powder is available only through a restricted program under a REMS called Palforzia REMS
• Administered orally: Open capsule(s) or sachet and empty the entire dose of PALFORZIA powder onto a few spoonfuls of refrigerated or room temperature semisolid food (e.g., applesauce, yogurt, pudding). Do not use liquid (e.g., milk, water, juice) to prepare; do not swallow capsules
• Administered in 3 sequential phases:
  • Initial Dose Escalation (Children ≥4 years and Adolescents ≤17 years)
    • Should be completed on a single day under direct supervision of a certified health care provider able to manage severe allergic reactions
  • Up-Dosing (Children ≥4 years and Adolescents)
    • Should begin the day after initial dose-escalation phase or within 4 days; if not started within 4 days, the initial dose-escalation phase must be repeated
    • The first dose of EACH up-dose should be administered under direct supervision of a health care provider and the patient should be observed for at least 60 minutes
  • Maintenance dosing phase (Children ≥4 years and Adolescents)
    • Initial dose-escalation phase and up-dosing phase should be completed prior to maintenance dosing
  • Missed doses:
    • Missed 1 to 2 consecutive days: resume dose at same dose level
    • Missed ≥ 3 consecutive days: has not been studied.  Contact health care provider; resuming dose should only be done under direct supervision of health care provider

Coverage Duration:

• Initial: 6 months
• Continuation: 1 year 

Authorization is Not Covered for the following:

• Non-FDA approved indications that are not listed in this policy do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Contraindications: uncontrolled asthma, history of eosinophilic esophagitis or other eosinophilic gastrointestinal diseases

Review History:

• 7/6/2020 – New policy.

References:

• Palforzia (peanut [Arachis hypogaea] allergen powder) [prescribing information]. Brisbane, CA: Aimmune Therapeutics Inc; January 2020.
• PatrawalaM, Shih J, Lee G, Vickery B. Peanut oral immunotherapy: A current perspective. Curr Allergy Asthma Rep. 2020;20(5):12. doi: 10.1007/s11882-020-00908-6. [PubMed 32314071]
• Pitsios C, Tsoumani M, Bilò MB, et al. Contraindications to immunotherapy: a global approach. Clin Transl Allergy. 2019;9:45. doi: 10.1186/s13601-019-0285-4. [PubMed 31528333]
• Vickery BP, Vereda A, Casale TB, et al; PALISADE Group of Clinical Investigators. AR101 oral immunotherapy for peanut allergy. N Engl J Med. 2018;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. [PubMed 30449234]