Pharmacy Prior Authorization Criteria

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 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years 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 and clinical history of peanut allergy as documented by both of the following:
• 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
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 an allergist/immunologist

Palforzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Prescribed by or in consultation with an allergist/immunologist

Palforzia

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of peanut allergy
AND
• Submission of medical records (e.g., chart notes) confirming both of the following:
• 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
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 an allergist/immunologist

P & T Revisions

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

References

1. Palforzia prescribing information. Aimmune Therapeutics, Inc. Brisbane, CA. July 2024.
2. The PALISADE Group of Clinical Investigators. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 379(21):1991-2001.

---

Revision History

• 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.

---