WHA
 

Palforzia [Peanut (Arachis hypogaea)] - PA, NF

Indications for Prior Authorization

Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp]
  • For diagnosis of Peanut Allergy
    Indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.

    PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 year of age and older.

    PALFORZIA is to be used in conjunction with a peanut-avoidant diet.

    Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Criteria

Palforzia

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of peanut allergy, as confirmed by both of the following:
    • Positive clinical history of peanut allergy (e.g., immediate reaction of typical systemic allergy symptoms such as hives, swelling, or wheezing, following isolated ingestion of peanut) [A, 4]
      • AND
    • One of the following: [A-C, 3]
      • A serum peanut-specific IgE level of greater than or equal to 0.35 kUA/L
      • A mean wheal diameter that is at least 3mm larger than the negative control on skin-prick testing for peanut
      • An Ara h 2 sIgE level greater than or equal to 0.35 kUA/L
    AND
  • One of the following:
    • Both of the following:
      • Patient is 1 to 17 years of age
      • Patient is in the initial dose escalation phase of therapy
      OR
    • Both of the following:
      • Patient is 1 year of age and older
      • Patient is in the up-dosing or maintenance phase of therapy
    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
    AND
  • Prescribed by or in consultation with one of the following:
    • Allergist
    • Immunologist
Palforzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Prescribed by or in consultation with one of the following:
    • Allergist
    • Immunologist
Palforzia

Non Formulary

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) documenting diagnosis of peanut allergy, as confirmed by both of the following:
    • Positive clinical history of peanut allergy (e.g., immediate reaction of typical systemic allergy symptoms such as hives, swelling, or wheezing, following isolated ingestion of peanut) [A, 4]
      • AND
    • One of the following: [A-C, 3]
      • A serum peanut-specific IgE level of greater than or equal to 0.35 kUA/L
      • A mean wheal diameter that is at least 3mm larger than the negative control on skin-prick testing for peanut
      • An Ara h 2 sIgE level greater than or equal to 0.35 kUA/L
    AND
  • One of the following:
    • Both of the following:
      • Patient is 1 to 17 years of age
      • Patient is in the initial dose escalation phase of therapy
      OR
    • Both of the following:
      • Patient is 1 year of age and older
      • Patient is in the up-dosing or maintenance phase of therapy
    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
    AND
  • Prescribed by or in consultation with one of the following:
    • Allergist
    • Immunologist

  • Guideline ID
    GL-506319

  • Formulary
    premium

  • Effective date
    Apr 1, 2026

  • P&T approval date
    Nov 14, 2019

P & T Revisions

2026-01-26, 2025-03-12, 2025-02-05, 2024-09-04, 2024-01-23, 2023-01-31, 2022-01-28, 2021-11-16, 2021-02-04, 2020-04-28, 2020-02-13

  1. Palforzia Prescribing Information. Aimmune Therapeutics, Inc. Bridgewater, NJ. July 2024.
  2. NIAID-Sponsored Expert Panel. Guidelines for the diagnosis and management of food allergy in the United States: Report of the NIAID-sponsored Expert Panel. J Allergy Clin Immunol. 2010; 126(6):S1-S58.
  3. Greenhawt M, Shaker M, Wang J, et al. Peanut allergy diagnosis: A 2020 practice parameter update, systematic review, and GRADE analysis. J Allergy Clin Immunol. 2020; 146(6):1302-1334.
  4. Wang J, Sicherer SH, TePas E. Peanut, tree nut, and seed allergy: Diagnosis. Wolters Kluwer. Updated November 4, 2025. Accessed January 24, 2026. Available with subscription at https://www.uptodate.com.
  5. Togias A, Cooper SF, Acebal ML, et al. Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel. J Allergy Clin Immunol. 2017; 139(1):29-44.
  6. The PALISADE Group of Clinical Investigators. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 379(21):1991-2001.
  1. Detailed medical history often provides evidence for the type of food-induced allergic reaction and the potential causative foods triggers, but history alone is not sufficient to make a diagnosis of food allergy. Further evaluation (e.g., laboratory studies or oral food challenges) is required to confirm a diagnosis of food allergy. Diagnostic testing is not suggested in patients with low to very low pretest probability of peanut allergy. In patients with high pretest probability for peanut allergy, skin prick test or whole peanut-specific serum IgE testing is suggested. Ara h 2 diagnostic testing is suggested in patients with suspected peanut allergy for which a single diagnostic test is to be used due to high specificity. The routine use of component testing (e.g., Ara h 2) in addition to skin prick test or serum IgE to whole peanut to increase diagnostic accuracy is not suggested. Using more than one test does not significantly increase diagnostic accuracy. [2-4]
  2. A peanut serum IgE level of less than 0.35 kUA/L has strong negative predictive value for the diagnosis of peanut allergy. [5]
  3. In the PALISADE pivotal trial, included participants had diagnosed peanut allergy with either a serum peanut-specific IgE level of 0.35 kUA/L or higher or a mean wheal diameter of at least 3 mm larger than the negative control to a skin-prick test for peanut. [6]
  • 2026-01-26: Annual Review 2026 - Separated positive clinical history and diagnostic clinical requirements from single to individual criterion points and updated PA verbiage from "diagnosis as documented" to "diagnosis as confirmed". Updated diagnostic clinical requirement to require one of the listed options and added Ara h 2 levels as additional option. Updated prescriber requirement formatting with no change to clinical intent. Background updates.
  • 2025-03-12: Added new formulations to guideline with existing criteria to apply.
  • 2025-02-05: Annual review: No criteria changes. Background updates.
  • 2024-09-04: Expanded age indication to align with updated PI. Updated NF criteria with standard language.
  • 2024-01-23: 2024 annual review. No changes to clinical criteria. Update to references.
  • 2023-01-31: Annual review - no changes.
  • 2022-01-28: Annual review - no changes.
  • 2021-11-16: Program update to include NF criteria
  • 2021-02-04: Annual review - updated references.
  • 2020-04-28: Added GPIs to initial authorization section.
  • 2020-02-13: New program.