ModifiedCentenePolicy CP PMN.220

Clinical Policy: Peanut Allergen Powder-dnfp (Palforzia)

Defines medical necessity and prior authorization criteria for Palforzia (peanut allergen powder-dnfp) for members of Centene-affiliated health plans across specified lines of business, including initial and continued therapy requirements.

Policy Summary

PayerCentene

PolicyClinical Policy: Peanut Allergen Powder-dnfp (Palforzia)

Policy CodePolicy CP PMN.220

Change TypeMaterial: minimum age lowered to 1 yeardosing updated

Effective Date03.01.20

Next Review Date

Key ActionSubmit prior authorization with documentation confirming peanut allergy, positive testing (skin test or peanut-specific IgE ≥ 0.35 kUA/L), prescriber specialty, age, epinephrine prescription, and dose ≤ 300 mg/day.

SourceLink

POLICY UPDATE CHANGES

Updated minimum age from 4 years to 1 year (along with corresponding dosing) per newly approved pediatric extension.

Modified example of medical justification during 1Q 2022 annual review.

References reviewed and updated across multiple annual reviews (2021-2025) with no significant changes.

1 yearupdated minimum approved patient age

300 mg/daymaximum maintenance dose

6 monthsinitial approval duration

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continued therapy approval duration

1-17 yrsage range for initiation

Commercial/HIM/MedicaidLines of business

Coverage Criteria for Palforzia (peanut allergen powder-dnfp)

Initial Therapy

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

Initial Approval - Palforzia: 1. Diagnosis of peanut allergy.

Initial Approval - Palforzia: 2. Prescription is written by an allergist or immunologist.

Initial Approval - Palforzia: 3. Confirmation of peanut sensitization by positive skin test OR peanut-specific serum IgE >= 0.35 kUA/L.

Initial Approval - Palforzia: 4. Age at therapy initiation is >= 1 year and < 17 years.

Initial Approval - Palforzia: 5. Palforzia is prescribed concurrently with an injectable epinephrine prescription.

Medical justification or history of systemic reaction (ONE of)

Option 1: Medical justification supports the need for oral immunotherapy despite peanut avoidance (e.g., member lacks sufficient mental capacity to effectively avoid peanuts).
Option 2: Member has a history of >= 1 systemic allergic reaction to peanuts requiring hospitalization, emergency department visit, or use of injectable epinephrine.

Initial Approval - Palforzia: 7. Prescribed maintenance dose does not exceed 300 mg per day.<= 300 mg/day

Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy - Palforzia: 1. Member is currently receiving Palforzia via the Centene benefit OR previously met initial approval criteria.

Continued Therapy - Palforzia: 2. If member required use of injectable epinephrine while on Palforzia, medical justification supports continued therapy.

Continued Therapy - Palforzia: 3. For members aged >= 18 years, medical justification supports continued necessity for oral immunotherapy despite peanut avoidance (e.g., lacks sufficient mental capacity to effectively avoid peanuts).

Continued Therapy - Palforzia: 4. If the request is for a dose increase, the new dose does not exceed 300 mg per day.<= 300 mg/day

Non‑FDA approved indications that are not specifically addressed in this clinical policy are excluded from coverage unless there is sufficient documentation of safety and efficacy and the use is supported per the applicable off‑label use policies (for example, CP CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, or CP.PMN.53 for Medicaid) or other evidence of coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers and reviewers should follow the applicable state Medicaid manual and any state‑specific coverage rules in place for Medicaid members.

Palforzia is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. It is an oral immunotherapy administered in a controlled setting with REMS requirements and is intended to mitigate reactions from accidental peanut exposure rather than to treat acute allergic events; patients must have injectable epinephrine available for immediate use.

Product Presentations, Codes and Key Values

Product presentations / strengthsmixed

N/A	Pull-apart capsules: 0.5 mg, 1 mg, 10 mg, 20 mg, 100 mg; Sachet: 300 mg

inv-07: Peanut-specific serum IgE — reported threshold/value

Peanut-specific serum IgE threshold>= 0.35 kUA/L

Evidence type acceptedPositive skin test OR peanut-specific serum IgE meeting threshold

Use in initial approvalRequired as part of confirmation of peanut allergy for initial authorization

inv-08: Maximum maintenance dose — 300 mg/day

Maximum maintenance dose300 mg/day

Maintenance regimenMaintenance dose specified as 300 mg PO daily in dosing guidance

Dose limit for approval

Provider Responsibilities, Documentation, and Authorization

Prior Authorization

Prior Authorization / Initial Approval Requirements

Prior authorization requires documentation that the member meets initial approval criteria, including diagnosis, confirmatory testing, prescriber specialty, age limits, concurrent epinephrine prescription, history of systemic reaction, dosing limits, and medical justification for oral immunotherapy when avoidance is not feasible. Providers must submit supporting clinical records (office notes, labs, evidence of prior reactions, REMS enrollment documentation, and other relevant information) with the request.

Diagnosis of peanut allergy;
Positive skin test or peanut-specific serum IgE ≥ 0.35 kUA/L;
Prescribed by an allergist or immunologist;
Age ≥ 1 year and < 17 years at therapy initiation;
Palforzia prescribed concurrently with injectable epinephrine;
History of ≥1 systemic allergic reaction to peanuts requiring hospitalization, ER visit, or use of injectable epinephrine;
Dose does not exceed 300 mg per day;
Medical justification that oral immunotherapy is necessary despite peanut avoidance

Background on Palforzia and Clinical Context

Palforzia (peanut allergen powder-dnfp) is an oral immunotherapy product indicated to reduce allergic reactions, including anaphylaxis, that may result from accidental peanut exposure in patients with confirmed peanut allergy. Its use is intended to be part of an overall management plan that includes continued peanut avoidance, patient and prescriber enrollment in the REMS program, and availability of injectable epinephrine; health care settings must be certified and equipped to monitor and manage potential anaphylactic reactions during initial dose escalation and up‑dosing.

Definitions and Contraindications

inv-19: Definition — Systemic allergic reaction refers to events coded to anaphylactic reaction of any severity, including anaphylaxis

DefinitionSystemic allergic reaction refers to events coded to anaphylactic reaction of any severity, including anaphylaxis.

ContextIncludes severe anaphylactic reactions observed in clinical trials and safety reports

ImplicationHistory of at least one systemic allergic reaction can satisfy criteria for therapy consideration

inv-20: Contraindications — Uncontrolled asthma and history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease are contraindications to Palforzia

ContraindicationsUncontrolled asthma

ContraindicationsHistory of eosinophilic esophagitis

Policy Revision History

2025-08-25annual_reviewLatest

3Q 2025 annual review — references reviewed and updated (P&T Approval Date: 08.25).

2024-08-01pediatric_extension

RT4: Updated minimum approved patient age from 4 years to 1 year and corresponding dosing per newly approved pediatric extension (Date: 08.01.24).

2024-08-24p&t_approval

Policy Summary

PayerCentene

PolicyClinical Policy: Peanut Allergen Powder-dnfp (Palforzia)

Policy CodePolicy CP PMN.220

Change TypeMaterial: minimum age lowered to 1 yeardosing updated

Effective Date03.01.20

Next Review Date

SourceLink

On This Page

Dose must not exceed 300 mg/day for initial and continued therapy

Prior Authorization

Potential Prior Authorization Requirement

Coverage determinations require adherence to Health Plan-level administrative policies and may require prior authorization. Requests for uses not specifically covered by this policy (including non‑FDA approved indications) may be denied unless addressed through the relevant off‑label, formulary, or non‑formulary policies.

Follow applicable Health Plan administrative policies and procedures.
Non‑FDA approved indications require sufficient documentation per off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (HIM), CP.PMN.53 (Medicaid).
For formulary or PDL drugs, see: CP.CPA.190 (commercial), HIM.PA.33 (HIM), CP PMN.255 (Medicaid).
For non‑formulary drugs, see: CP.CPA.190 (commercial), HIM.PA.103 (HIM), CP PMN.16 (Medicaid).

Note

Coverage Decisions and Benefit Administration

Coverage decisions and benefit administration are subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents and applicable state and federal requirements. This policy provides guidance on medical necessity but does not guarantee payment.

Decisions subject to evidence of coverage, certificate of coverage, policy, contract of insurance, and Health Plan administrative policies.
This policy is not a contract or guarantee of payment.

Documentation Required

REMS Documentation Required

Palforzia is distributed under a REMS program. Providers, patients, pharmacies, and health care settings must be enrolled/certified as required. Documentation of REMS enrollment for prescribers, patients, and certified health care settings must be provided with authorization requests.

Prescribers must be certified in the REMS program.
Patients must be enrolled prior to initiation and informed about injectable epinephrine availability and monitoring requirements.
Health care settings must be certified and equipped to manage anaphylaxis.
Pharmacies must be certified and dispense only to certified settings or enrolled patients as applicable.

Documentation Required

Provider Responsibility Reminder

Providers remain responsible for exercising professional medical judgment and for maintaining documentation supporting the medical necessity of requests. Submission of complete clinical records is required to evaluate requests.

Providers must retain and submit office notes, labs, evidence of prior reactions, and any other clinical information upon request.
Clinical judgment should guide treatment decisions consistent with this policy and the REMS requirements.

Step Therapy

Referenced Step / Coverage Pathways

If the requested diagnosis/indication is not listed or is addressed by other coverage pathways, follow the referenced step/coverage policies for the applicable line of business.

Refer to CP.CPA.190, HIM.PA.33, CP PMN.255 for formulary/no coverage pathways as applicable.
Refer to CP.CPA.190, HIM.PA.103, CP PMN.16 for non‑formulary pathways.
Refer to CP.CPA.09, HIM.PA.154, CP.PMN.53 for off‑label use review.

ContraindicationsOther eosinophilic gastrointestinal disease

inv-21: Clinical policy definition — Clinical policy: guidance used to assist in making coverage decisions and administering benefits, not a contract or guarantee of payment

Clinical policy purposeGuidance used to assist in making coverage decisions and administering benefits; does not constitute a contract or guarantee of payment.

ScopeCoverage decisions and benefit administration remain subject to all terms, conditions, exclusions, and limitations of the Health Plan's coverage documents and applicable laws

Effective authorityPolicy effective date determined by the Health Plan; legal/regulatory requirements govern if discrepant

RT4 pediatric extension reflected in policy with P&T Approval Date: 08.24 (updated minimum age and dosing).

2023-08-23annual_review

3Q 2023 annual review — no significant changes; references reviewed and updated (P&T Approval Date: 08.23).

2022-10-06template_update

Template changes applied to other diagnoses/indications and continued therapy section (Date: 10.06.22).

2022-02-22p&t_approval

1Q 2022 annual review — modified example of medical justification; references reviewed and updated (P&T Approval Date: 02.22).

2021-02-21p&t_approval

1Q 2021 annual review — no significant changes; references reviewed and updated (P&T Approval Date: 02.21).

2020-10-20annual_review

1Q 2021 annual review entry recorded (Date: 10.20.20) — references reviewed and updated.

2020-03-01effective_date

Policy effective date established (03.01.20).