CurrentCignaPolicy IP0141

Allergen Immunotherapy - Palforzia

Cigna coverage policy governing prior authorization and medical necessity criteria for Palforzia (peanut allergen powder) oral immunotherapy for patients with confirmed peanut allergy under Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyAllergen Immunotherapy - Palforzia

Policy CodePolicy IP0141

Change TypeAnnual revision with multiple clarifications

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide documentation of a positive skin prick test OR positive in vitro peanut-specific IgE plus evidence of prior significant reaction and epinephrine prescription.

SourceLink

POLICY UPDATE CHANGES

Policy name updated from 'Peanut (Arachis hypogaea) Allergen Powder-dnfp' to 'Allergen Immunotherapy - Palforzia.'

Removed the option allowing a positive food challenge at or before the 100 mg challenge dose as an alternative to SPT or psIgE testing.

Removed requirement that the individual must not have eosinophilic esophagitis or other eosinophilic gastrointestinal disease.

Updated age requirement to approve if the patient is 1 to 17 years of age (with allowance for those started prior to 18y).

Criteria updated to require either a positive skin prick test response to peanut OR a positive in vitro IgE test (psIgE) rather than prior more complex thresholds.

References to 'epinephrine auto-injectors' updated to 'epinephrine self-administered injectable or nasal products' and Neffy added as example.

Added 'documentation provided that' language to criterion 1C.

Removed the criterion stating Palforzia is not for emergency treatment of allergic reactions, including anaphylaxis.

1 yearapproval duration

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1–17 yrsinitiation age

SPT or psIgEdiagnostic evidence

Coverage Criteria for Palforzia (Peanut Allergen Powder)

FDA-Approved Indication

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

Main: All criteria A through F must be met

Age requirementPatient is 1 to 17 years of age OR is ≥ 18 years of age and was previously started on Palforzia prior to turning 18

See age-related initiation/continuation

B: History of allergic reaction to peanutsPrescriber documents the patient had signs and symptoms of a significant systemic allergic reaction that occurred shortly after known ingestion of peanut or peanut-containing food and was significant enough to require a prescription for an epinephrine self-administered injectable or nasal product

Examples of epinephrine products include EpiPen, EpiPen Jr., Auvi-Q, generic epinephrine auto-injectors, and Neffy

C: Diagnostic testing for peanut allergyPositive skin prick test response to peanut OR positive in vitro test for peanut-specific IgE

Documentation of the test result is required

Dietary planPalforzia will be used in conjunction with a peanut-avoidant diet as stated by the prescriber

E: Asthma controlPatient does NOT have uncontrolled asthma

Uncontrolled asthma is a contraindication per prescribing information

F: Prescriber specialtyMedication is prescribed by or in consultation with an allergist or immunologist

Specialist involvement required

Use of Palforzia for any purpose other than the FDA‑approved peanut oral immunotherapy indication is considered not medically necessary and is not covered under this policy.

Specifically, Palforzia for any indication other than peanut allergy is considered not medically necessary and will not be approved unless future published evidence supports additional indications.

Coding and Age Considerations

Covered CPT Codesmixed

No codes listed

Age for initiation

Initiation age rangePatient 1 to 17 years of age to initiate therapy

Continuation past age 18Patients ≥18 years of age who were started on Palforzia prior to turning 18 may continue therapy

Approval durationApprovals provided for 1 year when criteria are met

Provider Responsibilities, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for Palforzia. Approvals are provided for the durations specified in the policy (e.g., 1 year when criteria are met). Prescriptions must be written by or in consultation with a physician who specializes in the condition being treated (allergist or immunologist).

Approvals measured in months use 1 month = 30 days.
Receipt of sample product does not satisfy criteria for coverage.

Note

Therapy regimen guidance

Therapy regimen guidance — Dosage, frequency, duration, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature. Regimen should be adjusted based on severity, alternative treatments available, and the patient’s previous response to therapy.

Prescriber must document that Palforzia will be used in conjunction with a peanut-avoidant diet.
Ongoing monitoring for adverse events and long-term efficacy is expected due to specialized skills required.

Background on Palforzia

Palforzia is an oral immunotherapy product containing peanut allergen powder intended to mitigate allergic reactions, including anaphylaxis, from accidental peanut exposure in patients with confirmed peanut allergy. Its use is intended as part of a peanut‑avoidant diet and per the FDA‑approved regimen for eligible patients.

Definitions

Palforzia

Generic name and formulationPeanut (Arachis hypogaea) allergen powder-dnfp for oral administration

Brand namePalforzia

Intended useUsed as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, from accidental peanut exposure in patients with confirmed peanut allergy

Significant systemic allergic reaction

Typical signs and symptomsHives (urticaria) and swelling (angioedema)

Respiratory and cardiovascular signsWheezing and hypotension

Gastrointestinal symptoms

Policy Summary

PayerCigna

PolicyAllergen Immunotherapy - Palforzia

Policy CodePolicy IP0141

Change TypeAnnual revision with multiple clarifications

Effective Date

Next Review Date

SourceLink

On This Page

Documentation Required

Evidence of IgE-mediated peanut allergy

Evidence of IgE-mediated peanut allergy — Documentation of allergen testing is required. Acceptable documentation includes chart notes, laboratory reports, or test results demonstrating a positive skin prick test OR a positive in vitro peanut-specific IgE.

Patient must meet ONE: positive skin prick test to peanut (documentation required) OR positive in vitro test for peanut-specific IgE (documentation required).
Documentation may be submitted as chart notes, lab reports, or test results and should be retained in the medical record for review.

Documentation Required

History of significant reaction and epinephrine prescription

History of significant reaction and epinephrine prescription — The prescriber must document a prior allergic reaction to peanuts that included signs/symptoms of a significant systemic allergic reaction occurring shortly after known ingestion and that was significant enough to require a prescription for an epinephrine self‑administered injectable or nasal product.

Signs/symptoms may include hives, swelling, wheezing, hypotension, and gastrointestinal symptoms.
Examples of epinephrine self‑administered injectable or nasal products include EpiPen, EpiPen Jr., Auvi‑Q, generic epinephrine auto‑injectors, and Neffy.

Billing Rule

Coding and claims compliance

Coding and claims compliance — Claims submitted without covered diagnosis or procedure codes consistent with this Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate codes effective on the date of submission.

Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this Coverage Policy.
Ensure applicable covered diagnosis/procedure codes are included with the request and claims to avoid denial.

Nausea, vomiting, abdominal pain or other GI symptoms occurring shortly after ingestion

Clinical significance and required actionReaction significant enough to warrant prescription of an epinephrine self-administered injectable or nasal product