CurrentCignaPolicy N/A

Allergen Immunotherapy - Palforzia Prior Authorization Policy

This policy governs prior authorization and medical necessity criteria for Palforzia (peanut allergen powder) for members covered by Cigna-administered health benefit plans. It specifies eligibility, required diagnostic evidence, prescribing clinician qualifications, and exclusions.

Policy Summary

PayerCigna

PolicyAllergen Immunotherapy - Palforzia Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateApr 8, 2026

Key ActionObtain prior authorization and document confirmed IgE‑mediated peanut allergy with positive skin prick or peanut‑specific IgE and prescriber attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yrinitial approval duration

ages 1+min age

uncontrolled asthmacontraindication

allergist/immunologistprescriber

Coverage and Medical Necessity Criteria

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FDA-Approved Indication (Peanut Allergy)

Approve for 1 year if the patient meets ALL of the following (A–F):

Palforzia approval criteria: Patient meets all A–F below

A) Age: Patient is 1 to 17 years of age; OR patient is ≥ 18 years of age AND was previously started on Palforzia prior to turning 18.

Initial dose escalation is limited to ages 1–17; up-dosing/maintenance can continue in patients ≥ 1 year of age.

B) Clinical reaction history: Per the prescriber, the patient has a history of an allergic reaction to peanut that: (i) demonstrated signs and symptoms of a significant systemic allergic reaction (examples include hives, swelling, wheezing, hypotension, gastrointestinal symptoms); AND (ii) occurred within a short period of time after known ingestion of peanut or peanut-containing food; AND (iii) was significant enough to require a prescription for an epinephrine self-administered injectable or nasal product (e.g., EpiPen, EpiPen Jr., Auvi-Q, generic epinephrine autoinjectors, Neffy).

C) Diagnostic testing: Patient has a positive skin prick test response to peanut; OR patient has a positive in vitro (blood) test for peanut-specific IgE.

Current criteria require either positive SPT or positive specific IgE.

D) Concurrent management: Prescriber attests Palforzia will be used in conjunction with a peanut-avoidant diet.

E) Asthma status: Patient does NOT have uncontrolled asthma.

Uncontrolled asthma is a contraindication to Palforzia.

F) Prescriber qualification: Medication is prescribed by or in consultation with an allergist or immunologist.

Approvals require specialist involvement.

Palforzia is contraindicated in patients with uncontrolled asthma and in patients with a history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease. Prior to initiation, the prescriber should verify the patient has an epinephrine self‑injectable product and has been instructed on its appropriate use. Palforzia is intended to be used in conjunction with a peanut‑avoidant diet and is not indicated for emergency treatment of allergic reactions, including anaphylaxis.

Product and Coding

Covered productmixedCovered

drug product

Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp for oral administration - Aimmune)

Skin prick / IgE thresholds — historical notes

Prior historic threshold (skin prick)Wheal diameter ≥ 3 mm larger than negative control (previous requirement for combined testing)

Prior alternate historic threshold (skin prick)Wheal diameter ≥ 8 mm larger than negative control (previous standalone threshold)

Prior historic threshold (peanut-specific IgE)Peanut-specific IgE ≥ 0.35 kUA/L when combined with skin prick ≥3 mm requirement

Prior alternate historic threshold (peanut-specific IgE)Peanut-specific IgE ≥ 14 kUA/L as a standalone threshold

Current test requirementPolicy now requires either a positive skin prick test response to peanut OR a positive in vitro (blood) test for peanut-specific IgE without numeric thresholds

Prescriber Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Palforzia. Approvals are issued for 1 year when all coverage criteria are met. Therapy must be prescribed by or in consultation with an allergist or immunologist due to required evaluation, monitoring, and specialized care.

Approval duration: 1 year when criteria met
Prescriber requirement: allergist or immunologist (or consult)
Prior authorization: required

Documentation Required

Documentation to Confirm IgE‑Mediated Peanut Allergy

Documented evidence must support a confirmed IgE‑mediated peanut allergy. Acceptable documentation includes a clinical history of an allergic reaction with signs/symptoms occurring within 2 hours of known oral peanut exposure PLUS supportive testing demonstrating sensitization to peanut.

Clinical history: signs/symptoms of systemic allergic reaction (e.g., hives, swelling, wheeze, hypotension, gastrointestinal symptoms) within 2 hours of known peanut ingestion
Evidence of sensitization: positive skin prick test OR positive serum peanut‑specific IgE (psIgE) within the past 12 months
Examples: physician‑diagnosed IgE‑mediated peanut allergy with documented reaction and supportive positive skin or serologic testing; in infants/toddlers (1–3 years) a physician diagnosis plus psIgE within 12 months is acceptable

Denial Risk

Additional Provider Actions and Denial‑Risk

Prescribers must attest that Palforzia will be used in conjunction with a peanut‑avoidant diet and that the patient does not have uncontrolled asthma. Also document that the prior allergic reaction was significant enough to warrant a prescription for an epinephrine autoinjector or nasal epinephrine. Use of Palforzia outside the FDA‑approved indication is considered not medically necessary and may be denied.

Treatment plan: statement that Palforzia will be used with peanut avoidance
Asthma status: documentation that asthma is controlled
Epinephrine requirement: prior reaction required prescription for epinephrine (e.g., EpiPen, Auvi‑Q, Neffy)
Denial risk: requests for any indications other than the FDA‑approved indication are not medically necessary

Key Definitions

Palforzia — product and intended use

ProductPalforzia (peanut [Arachis hypogaea] allergen powder-dnfp) for oral administration

Intended useOral immunotherapy to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut

Use contextUsed in conjunction with a peanut-avoidant diet; not indicated for emergency treatment of allergic reactions

Confirmed IgE-mediated peanut allergy — definition

Clinical time windowSigns or symptoms of allergy occurring within 2 hours of known peanut (oral) exposure

Supportive testing — skin prickPositive skin prick test response to peanut (as supportive evidence)

Supportive testing — specific IgEPositive in vitro (blood) test for peanut-specific IgE (as supportive evidence)

Background

Palforzia is an oral immunotherapy (peanut [Arachis hypogaea] allergen powder) approved to mitigate allergic reactions, including anaphylaxis, that may occur with accidental peanut exposure in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation is for ages 1–17 years, with up‑dosing and maintenance able to continue in patients aged ≥1 year. It is used as an adjunct to a peanut‑avoidant diet and is not intended for emergency treatment of allergic reactions.