CurrentCareSourcePolicy N/A

Palforzia (peanut oral immunotherapy) — Pharmacy benefit coverage criteria

Defines pharmacy benefit coverage, prior authorization, dosing limits, and clinical criteria for Palforzia (peanut allergen powder) for members; applies to pharmacy benefit claims and prescribers (allergists).

Policy Summary

PayerCareSource

PolicyPalforzia (peanut oral immunotherapy) — Pharmacy benefit coverage criteria

Policy CodePolicy N/A

Change TypeAnnual review — no changes

Effective Date01/01/2022

Next Review DateN/A

Key ActionObtain prior authorization and submit chart documentation confirming diagnosis, confirmatory testing, allergist management, and absence of exclusion conditions.

SourceLink

POLICY UPDATE CHANGES

New policy for Palforzia created.

Annual review performed with no changes.

1 pack/30dquantity limit

4–17 yrsinitial authorization age

6 monthsinitial approval

6 monthsreauthorization

Office/Homesite of service

Coverage Criteria for Palforzia

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial authorization main criteria: Member is between 4 and 17 years of age; medication prescribed and managed by an allergist; documentation confirming peanut allergy (serum IgE >0.35 kUa/L OR skin prick test wheal >3 mm compared to control); chart notes show the member does not have any of the following: anaphylaxis in the last 60 days, uncontrolled asthma, eosinophilic esophagitis or other eosinophilic gastrointestinal disease, cardiovascular disease or uncontrolled hypertension; member has been assessed for ability to comply with daily dosing and can adhere to the daily dosing schedule; member understands to continue a peanut-avoidant diet.

If all requirements met, approve for 6 months; dosing and packet schedule described in policy.

Continuation / Reauthorization

Covered when ALL of the following are met for reauthorization:

Reauthorization main criteria: Chart notes show no worsening of asthma or emergence of eosinophilic gastrointestinal disease; if the member is now over 17 years of age, therapy must have been initiated between ages 4 and 17; chart notes show the member tolerates therapy and has not had anaphylaxis requiring a higher level of care; member is compliant with the daily dosing regimen.

Policy Summary

PayerCareSource

PolicyPalforzia (peanut oral immunotherapy) — Pharmacy benefit coverage criteria

Policy CodePolicy N/A

Change TypeAnnual review — no changes

Effective Date01/01/2022

Next Review DateN/A

Key ActionObtain prior authorization and submit chart documentation confirming diagnosis, confirmatory testing, allergist management, and absence of exclusion conditions.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

If reauthorization requirements met, approve for additional 6 months.

CareSource considers Palforzia (Peanut (Arachis hypogaea) Allergen Powder) not medically necessary for the treatment of diagnoses that are not listed in this policy. Explicit conditions identified in the policy as exclusions include: anaphylaxis in the last 60 days, uncontrolled asthma, eosinophilic esophagitis or other eosinophilic gastrointestinal disease, and cardiovascular disease or uncontrolled hypertension.

See the policy 'List of Diagnoses Considered Not Medically Necessary' for additional detail. Palforzia is not medically necessary when used to treat any disease or diagnosis that is not specifically enumerated as covered in this document.

Billing and Diagnostic Criteria

BillingNDC

NDC required

Must use valid NDC code

inv-06: Serum IgE threshold

Serum IgE threshold>0.35 kUa/L

Test purposeConfirmatory evidence of peanut allergy for initial authorization

Use in documentationChart notes must include serum specific IgE >0.35 kUa/L as proof of allergy

inv-07: Skin prick test threshold

Skin prick test thresholdWheal >3 mm compared to control

Test purposeConfirmatory evidence of peanut allergy for initial authorization

Use in documentationChart notes must include skin prick test result showing wheal >3 mm vs control

Provider Requirements, Prior Authorization, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for Palforzia (non-preferred product). Prescribers must obtain PA before dispensing.

Quantity limit: 1 dose pack (30 sachets) per 30 days.
Site of service allowed: Office or Home.
Billing: Must use a valid NDC code; benefit type = Pharmacy.

Note

Provider must follow specialty-prescribing and monitoring pathways. Ensure allergist is managing therapy and patient/caregiver counseling on daily dosing and peanut-avoidant diet is documented.

Documentation Required

Required Documentation

Submit chart notes documenting diagnosis, confirmatory testing (serum IgE > 0.35 kUa/L OR skin prick test wheal >3 mm vs control), prescribing allergist information, baseline assessment for asthma and eosinophilic gastrointestinal disease, assessment of ability to adhere to daily dosing, and monitoring for adverse events.

Confirmatory test results (IgE or skin prick) must be included.
Documentation that therapy is prescribed and managed by an allergist.
Baseline and ongoing asthma control notes and absence of eosinophilic gastrointestinal disease.
Patient education and informed consent including continuation of peanut-avoidant diet.

Denial Risk

Denial Triggers

Denial may result if age criteria, confirmatory testing, prescribing/management by an allergist, or documentation of contraindications/comorbid conditions are not met.

Failure to meet age criteria (initial authorization: 4–17 years).
Lack of documented confirmatory testing for peanut allergy.
No documentation that an allergist prescribes/manages therapy.
Evidence of exclusionary conditions (e.g., anaphylaxis within prior 60 days, uncontrolled asthma, eosinophilic esophagitis, uncontrolled cardiovascular disease).
Noncompliance with daily dosing or inadequate monitoring documentation.

Background

Palforzia is an oral immunotherapy product composed of peanut allergen powder intended to reduce allergic reactions to peanut in selected patients. The policy requires clinical confirmation of peanut allergy (see confirmatory testing thresholds) and management by an allergist as part of the coverage criteria.

Definitions

inv-13: Serum IgE >0.35 kUa/L or skin prick test wheal >3 mm compared to control

Confirmatory testing criteriaSerum IgE >0.35 kUa/L OR skin prick test wheal >3 mm compared to control

When requiredRequired for initial authorization as documentation confirming peanut allergy

Documentation locationMust be included in submitted chart notes for prior authorization review