POLICY INACTIVATED 8/01/2022. May 11, 2022 MBHPC.
Peanut allergy is a condition in which the body’s immune system mistakenly identifies even small amounts of peanut as harmful. Allergic reactions to peanut are unpredictable in occurrence and in how they present, with some individuals experiencing severe reactions from even trace amounts. Physical symptoms can develop within seconds of exposure and may include skin reactions, digestive discomfort, or more dangerous reactions such as constriction of the throat and airways, and loss of adequate blood flow to vital organs of the body. Peanut allergen powder is an oral immunotherapy that is manufactured from peanuts and packaged in capsules for dose escalation and up-dosing, and in a sachet for maintenance treatment. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food that the patient then consumes.
The U.S. Food and Drug Administration (FDA) has approved peanut (Arachis hypogaea) allergen powder (Palforzia™) 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. Palforzia™ is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Serious adverse reactions have occurred in patients treated with peanut allergen powder, including anaphylaxis, which may be life-threatening and can occur at any time during Palforzia™ therapy. Due to these safety concerns, the FDA requires the prescribing information for peanut allergen powder to include a black box warning. Patients should be prescribed injectable epinephrine, and Palforzia™ should not be administered to patients with uncontrolled asthma. Palforzia™ is available only through a restricted program called the Palforzia REMS.
Note: When peanut allergen powder (Palforzia™) will be self-administered for maintenance dosing, please refer to the applicable pharmacy benefit plan.
I. Review for Peanut Allergen Powder (Palforzia™)
For initial dose escalation, up-dosing, and restarting therapy, peanut allergen powder may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:
II. Experimental/Investigative Uses
All other uses of peanut allergy powder are considered EXPERIMENTAL/ INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
Table 1. FDA Labeled Contraindications
FDA Labeled Contraindications
Peanut allergen powder (Palforzia™)
History of eosinophilic esophagitis or other eosinophilic gastrointestinal disease
Table 2. Dosing
NOTE: See documentation submission requirements below if the requested dose is higher or more frequent than the dosing criteria provided in this table.
FDA Labeled Indications
Initial dose escalation:
Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted:
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