CurrentAvMedPolicy N/A

Palforzia (Peanut Allergen Powder) prior authorization — Coverage Criteria

Defines pharmacy prior authorization, coverage criteria, dosing, and reauthorization requirements for Palforzia for AvMed members, affecting prescribers, specialty pharmacies, and members aged 1–17 initiating therapy.

Policy Summary

PayerAvMed

PolicyPalforzia (Peanut Allergen Powder) prior authorization — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete AvMed prior authorization form signed by the prescribing physician and submit clinical documentation confirming peanut allergy and eligibility.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12initial authorization duration (months)

1-17age range

1 sachet/daymaintenance dose

1 kit/yrinitial escalation kit limit

Coverage Criteria

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Age: Member must be at least 1 to 17 years of age at initiation of therapyage 1-17 at initiation

Diagnosis: Member must have diagnosis of peanut allergy

Prescriber: Prescribed by or in consultation with an Allergist or Immunologist

Diagnostic confirmation

Option A: Clinical history plus serum peanut-specific IgE > 0.35 kUA/L and skin prick test mean wheal >=3 mm larger than negative controlIgE > 0.35 kUA/L; SPT >=3 mm over control
Option B (if no clinician-supervised food challenge): Positive skin prick test to peanut >=8 mm compared to control AND serum IgE to peanut >=14 kUA/LSPT >=8 mm; IgE >=14 kUA/L

Concomitant measures: Palforzia will be used in conjunction with a peanut-avoidance diet; member must be prescribed injectable epinephrine and trained in its use

Verification via chart notes or pharmacy paid claims

Exclusionary conditions: Request may NOT be approved if member has severe or poorly controlled asthma; history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease; or history of severe or life-threatening anaphylaxis within the past 2 months

Additional exclusions: Request may NOT be approved if member has history of mast cell disorder (including mastocytosis), urticarial pigmentosa, hereditary or idiopathic angioedema; currently has paid claims for Berinert, Cinryze, Haegarda, Firazyr, Takhyzyro or Ruconest; or is in the buildup phase of another allergen immunotherapy

REMS enrollment: Health care provider, health care setting, and member must be enrolled in the Palforzia REMS program

Reauthorization

Covered on reauthorization (one-time reauthorization after initial 12-month approval) when ALL are met

Tolerance: Member must continue to tolerate the prescribed daily dose of Palforzia

Adherence: Member is compliant with Palforzia therapy (verified by pharmacy paid claims)

Asthma control: Member has NOT experienced recurrent asthma exacerbations

Adverse events: Member has NOT experienced treatment-restricting adverse effects (e.g., repeated systemic allergic reaction or severe anaphylaxis)

Reauthorization requirement: Provider note: a one-time reauthorization is required after the initial 12-month approval

Requests for Palforzia will be denied when any of the explicit exclusion conditions are present. Exclusionary conditions include: severe or poorly controlled asthma; a history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease; a history of severe or life‑threatening anaphylaxis or anaphylactic shock within the past 2 months. Additional exclusions include a history of mast cell disorder (including mastocytosis), urticarial pigmentosa, hereditary or idiopathic angioedema; current paid claims for C1‑esterase/C1‑inhibitor or related therapies (for example, Berinert, Cinryze, Haegarda, Firazyr, Takhyzyro, or Ruconest); or when the individual is currently in the buildup phase of another allergen immunotherapy (has not reached maintenance dosing).

Use of manufacturer or pharmacy samples to initiate Palforzia does not satisfy step edit or preauthorization requirements. Prior therapies and treatment history will be verified through pharmacy paid claims or submitted chart notes, and sample initiation cannot be relied upon as sufficient documentation of prior therapy or medical necessity.

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Palforzia requires prior authorization. Complete and submit the AvMed PA form signed by the prescribing physician, and include all supporting documentation. Incomplete, incorrect, or illegible information can delay or prevent authorization.

Fax completed form to 1-305-671-0200
Prescriber signature required (preprinted stamps not valid)
Medication: Palforzia (Peanut Allergen Powder-dnfp)

Documentation Required

Required Submission Information

Required submission information — Authorization may be delayed or denied if member or drug information is incomplete. Prescriber must provide member and prescriber details, diagnosis and ICD code (if applicable), dosing schedule, length of therapy, weight and date weight obtained (if applicable), office contact, phone/fax numbers, and prescriber NPI. Include documentation to support clinical criteria and REMS enrollment.

Member name, AvMed ID, date of birth
Prescriber name, signature, date, NPI, office contact, phone and fax
Drug name/form/strength, dosing schedule, length of therapy, quantity requested
Diagnosis and ICD-10 code (if applicable)
Weight and date weight obtained (if applicable)
Documentation of peanut allergy confirmation (see clinical criteria)
Verification of prescription for injectable epinephrine and training documentation
Proof of enrollment in Palforzia REMS program

Step Therapy

Step-edit / Sample Rule

Step-edit / sample rule — Use of samples to initiate therapy does not meet step-edit/preauthorization criteria. Prior therapies will be verified via pharmacy paid claims or submitted chart notes.

Samples used to start therapy are not acceptable to meet preauthorization requirements
Previous therapies may be confirmed through pharmacy paid claims or chart notes

Denial Risk

Triggers for Denial

Triggers for denial — Requests may be denied if documentation is incomplete, incorrect, or illegible, or if required diagnostic documentation is missing. Requests that do not meet the listed clinical criteria (including age, diagnosis confirmation, specialist prescribing/consultation, REMS enrollment, contraindications) may be denied.

Missing or illegible prescriber signature or contact information
Absent diagnosis confirmation (lab results, skin prick test, or clinician-supervised food challenge documentation as required)
Failure to document weight when applicable or date weight obtained
Lack of documentation for injectable epinephrine prescription or training
Member with excluded conditions (e.g., severe/poorly controlled asthma, eosinophilic esophagitis, recent severe anaphylaxis)

Initial Therapy Criteria

Initial Dose Escalation

Initial Dose Escalation dosing configurations

Ages 1-3 single-day escalation: Dose steps A–D with total doses from 0.5 mg up to 3 mg using specified capsule combinations: A=0.5 mg (one 0.5 mg capsule); B=1 mg (one 1 mg capsule); C=1.5 mg (one 0.5 mg + one 1 mg); D=3 mg (three 1 mg capsules)see dosing config

Single-day supervised escalation using Initial Dose Escalation Kit

Ages 4-17 single-day escalation: Dose steps A–E with total doses from 0.5 mg up to 6 mg using specified capsule combinations: A=0.5 mg (one 0.5 mg capsule); B=1 mg (one 1 mg capsule); C=1.5 mg (one 0.5 mg + one 1 mg); D=3 mg (three 1 mg capsules); E=6 mg (six 1 mg capsules)see dosing config

Single-day supervised escalation using Initial Dose Escalation Kit

Maintenance / Continuation Criteria

Maintenance / Continuation

Maintenance and continuation requirements

Maintenance dose: Maintenance daily dose is 300 mg (one 300 mg sachet)300 mg/day

Maximum one sachet per day

Reauthorization timing: A one-time reauthorization is required after the initial 12-month approval

Step	Requirement
1	Previous therapies will be verified through pharmacy paid claims or submitted chart notes; use of samples to initiate therapy does not meet step edit/prior authorization requirements.

Quantity Limits

Palforzia Initial Dose Escalation Kit — quantity limit

ProductPalforzia Initial Dose Escalation Kit

Quantity limit1 kit per 365 days

PurposeSingle-day supervised initial dose escalation (per dosing configurations)

Palforzia Up‑Dosing Kits — quantity limit

ProductPalforzia Up-Dosing Kits (Levels 1-11)

Quantity limit1 kit per 365 days

UseSupplies sequential up-dosing levels (Levels 1–11) for escalation to maintenance

Palforzia 300 mg sachets — maintenance limit

ProductPalforzia 300 mg sachet

Daily maintenance limit1 sachet per day (300 mg/day)

RoleMaintenance daily dose following up‑dosing phase

Site of Care Requirements

Note

Initial dose escalation must be supervised in REMS‑enrolled setting

Initial single-day dose escalation must be performed under supervision in a healthcare setting enrolled in the Palforzia REMS program (eg, office or infusion center) consistent with REMS requirements for provider, setting, and patient.

Initial dose escalation requires REMS-enrolled provider and setting
Must be supervised in a healthcare setting (office or infusion center)

Definitions & REMS

REMS — Risk Evaluation and Mitigation Strategy

RequirementEnrollment in the Palforzia REMS program is required for the prescriber, health care setting, and patient

Setting implicationInitial dose escalation must occur in a healthcare setting consistent with REMS enrollment

DocumentationProvider must verify REMS enrollment as part of authorization documentation

Initial dose escalation — supervised single‑day escalation

ProcedureSingle-day supervised initial dose escalation using the Initial Dose Escalation Kit

Age-specific configurationsAges 1–3: dose steps A–D up to 3 mg; Ages 4–17: dose steps A–E up to 6 mg (see dosing configurations)

Supervision requirementEscalation must be supervised by trained health care personnel in an enrolled REMS setting

Background

Palforzia (peanut allergen powder) is an oral immunotherapy indicated for treatment of peanut allergy in eligible pediatric patients. Therapy follows a structured escalation and up‑dosing regimen (including a single‑day, supervised Initial Dose Escalation) followed by a daily maintenance dose, and must be provided with a concurrent peanut‑avoidance diet, prescription of injectable epinephrine, caregiver training, and enrollment of the provider, setting, and patient in the Palforzia REMS program.