CurrentCignaPolicy N/A

Allergen Immunotherapy - Palforzia Prior Authorization Policy

Defines prior authorization criteria and coverage rules for Palforzia (peanut allergen powder) for Cigna-administered health benefit plans, including patient eligibility, required testing, prescribing specialist, and duration of approval.

Policy Summary

PayerCigna

PolicyAllergen Immunotherapy - Palforzia Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria revised and clarified

Effective DateN/A

Next Review DateApr 16, 2025

Key ActionSubmit prior authorization with documentation of positive peanut testing, history of systemic allergic reaction, confirmation of epinephrine prescription, and absence of uncontrolled asthma.

SourceLink

POLICY UPDATE CHANGES

Age requirement updated to approve patients 1 to 17 years of age (with allowance for patients ≥18 who started therapy before turning 18).

Allergy testing criteria simplified to require either a positive skin prick test response to peanut or a positive in vitro peanut-specific IgE test (removed prior combined thresholds).

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

Criterion requiring patient does NOT have uncontrolled asthma was added.

Coveredcoverage stance for FDA-approved indication

1–17primary approved age range for initiation

1 yr

Policy Summary

PayerCigna

PolicyAllergen Immunotherapy - Palforzia Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria revised and clarified

Effective DateN/A

Next Review DateApr 16, 2025

SourceLink

On This Page

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Coverage Criteria for Palforzia

FDA-Approved Indication

Covered when ALL of the following are met

FDA-Approved Indication for Peanut Allergy

Age: Patient is 1 to 17 years of age OR patient is ≥ 18 years of age AND has been previously started on therapy with Palforzia prior to becoming 18 years of age
History of allergic reaction: According to the prescriber, the patient has a history of an allergic reaction to peanut that met ALL of the following: (i) demonstrated signs and symptoms of a significant systemic allergic reaction (eg, hives, swelling, wheezing, hypotension, gastrointestinal symptoms); (ii) the reaction occurred within a short period of time after known ingestion of peanut or peanut-containing food; and (iii) the prescriber deemed the reaction 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 autoinjectors, and Neffy
Objective testing: Patient has either a positive skin prick test response to peanut OR a positive in vitro (blood) test for peanut-specific IgE
Previously numeric thresholds were replaced by requirement for one positive test
Concomitant conditions and prescribing: Palforzia will be used in conjunction with a peanut-avoidant diet; patient does NOT have uncontrolled asthma; and the medication is prescribed by or in consultation with an allergist or immunologist
Palforzia is contraindicated in patients with uncontrolled asthma and those with eosinophilic esophagitis or other eosinophilic gastrointestinal disease

Operational: Approve for 1 year when all criteria are met

Prior to initiation, prescriber should verify patient has injectable epinephrine and instruction on its use

Palforzia is covered only for the FDA‑approved peanut allergy indication when all specified approval criteria are met. It is not medically necessary for any other uses beyond this indication. The policy specifically excludes use of Palforzia in patients with uncontrolled asthma and in patients with a history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease.

Use of Palforzia for any indications other than the FDA‑approved peanut allergy indication described in the coverage criteria is not medically necessary. Coverage will be updated only if new published data support additional indications.

Provider Requirements and Billing Actions

Prior Authorization

Prior authorization required — 1 year approvals

Prior authorization is required for Palforzia; approvals are provided for 1 year when all specified clinical criteria are met.

Step Therapy

Step therapy — none specified

No step therapy requirements are specified for Palforzia in this policy.

Documentation Required

Required documentation — allergic reaction, testing, epinephrine, diet

The prescriber must document a history of an allergic reaction to peanut with signs/symptoms of a significant systemic allergic reaction, objective testing showing a positive skin prick test or positive peanut-specific IgE, and that Palforzia will be used with a peanut-avoidant diet; prescriber must also confirm the patient has or was prescribed an epinephrine self‑administered injectable or nasal product.

Background

Palforzia is an oral immunotherapy indicated to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation is for patients aged 1 to 17 years, and up‑dosing and maintenance may continue in patients aged ≥ 1 year. It is intended to be used with a peanut‑avoidant diet, is not for emergency treatment of anaphylaxis, and prescribers should verify that the patient has an epinephrine self‑administered injectable or nasal product and has been instructed on its use prior to initiation.

Key Definitions

Palforzia product

Generic name (term)Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp for oral administration)

IndicationOral immunotherapy for mitigation of allergic reactions, including anaphylaxis, due to accidental peanut exposure in patients with confirmed peanut allergy

Age guidanceInitial dose escalation: patients 1–17 years; up-dosing and maintenance may be continued in patients ≥1 year

Use settingTo be used in conjunction with a peanut-avoidant diet; not for emergency treatment of anaphylaxis

Prescriber responsibilitiesPrescriber should verify patient has injectable epinephrine and instruction on its use prior to initiation

Uncontrolled asthma (contraindication)