CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Palforzia (oral peanut immunotherapy) — Coverage Criteria

Covers criteria, authorization, quantity limits, and clinical use requirements for Palforzia (peanut allergen powder) for mitigation of allergic reactions including anaphylaxis in patients with peanut allergy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPalforzia (oral peanut immunotherapy) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (up to 12 months) with documentation of confirmed peanut allergy, prescriber REMS enrollment, appropriate prescriber specialty or consultation, and clinical justification for the treatment phase.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period when criteria met

11up-dosing levels

300 mgmaintenance dose

A-E (5)initial escalation levels

Coverage and Medical Necessity Criteria

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inv-01: Authorization / Medical Necessity — Covered when ALL of the following are met

Covered when ALL of the following are met

Authorization / Medical Necessity

Confirmed diagnosis: Diagnosis of peanut allergy confirmed by serum-specific IgE testing or skin-prick testing.
Indication: Requested drug is prescribed for mitigation of allergic reactions, including anaphylaxis, due to peanut exposure.
Concomitant management: Use is in conjunction with a peanut-avoidant diet.
REMS enrollment: Prescriber is certified/enrolled in the Palforzia REMS Program.
Prescriber qualifications: Prescribed by or in consultation with an allergist or immunologist; initial dose escalation and the first dose of each up-dosing level must be administered in a healthcare setting equipped to monitor and manage anaphylaxis.
Age requirements (one of)
- Initiation age: Patient is 1 to 17 years of age at initiation of therapy.
- Up-dosing/maintenance age: Request is for up-dosing or maintenance phase in a patient 1 year of age or older.
Contraindications / exclusions: Patient does not have uncontrolled asthma and has no history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease.
Authorization period: Authorization may be granted for up to 12 months when all criteria are met.

Operational note: Documentation should include confirmation of diagnosis (IgE or skin-prick), prescriber REMS certification, prescriber specialty or documentation of consultation with an allergist/immunologist, and clinical justification for the phase of therapy (initial escalation, up-dosing, or maintenance).

Product Codes, Dosing, and Packaging

Palforzia Product GPI Listingsmixed

PEANUT POWDER-DNFP STARTER PACK	0.5 & 1 & 1.5 & 3 & 6 MG (Initial dose escalation)
PEANUT POWDER-DNFP CAP SPRINKLE PACK	3 x 1 mg (3 mg dose) - Level 1
PEANUT POWDER-DNFP CAP SPRINKLE PACK	6 x 1 mg (6 mg dose) - Level 2
PEANUT POWDER-DNFP PACK	2 x 1 mg & 10 mg (12 mg dose) - Level 3
PEANUT POWDER-DNFP CAP SPRINKLE PACK	20 mg (20 mg dose) - Level 4
PEANUT POWDER-DNFP CAP SPRINKLE PACK	2 x 20 mg (40 mg dose) - Level 5
PEANUT POWDER-DNFP CAP SPRINKLE PACK	4 x 20 mg (80 mg dose) - Level 6
PEANUT POWDER-DNFP PACK	20 mg & 100 mg (120 mg dose) - Level 7
PEANUT POWDER-DNFP PACK	3 x 20 mg & 100 mg (160 mg dose) - Level 8
PEANUT POWDER-DNFP PACK	2 x 100 mg (200 mg dose) - Level 9

1–10 of 13

1/2

Maintenance dose300 mg daily

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 12 months may be granted when all required clinical and administrative criteria are met.

Authorization duration: up to 12 months
Prescriber must be certified/enrolled in the Palforzia REMS Program
Prescriber must be an allergist or immunologist or the request must be in consultation with one

Documentation Required

Required documentation must be submitted with the prior authorization request to support medical necessity.

Confirmed diagnosis of peanut allergy documented by positive specific IgE testing or skin-prick testing
Indication: prescribed for mitigation of allergic reactions, including anaphylaxis, in a patient with confirmed peanut allergy
Documentation of use in conjunction with a peanut-avoidant diet
Patient age and treatment phase (initial dose escalation, up-dosing, or maintenance) clearly stated
Documentation that the patient does not have uncontrolled asthma or a history of eosinophilic esophagitis/other eosinophilic gastrointestinal disease
Evidence that initial doses and up-dosing visits will occur in a healthcare setting equipped to monitor and manage anaphylaxis (Initial Dose Escalation and first dose of each up-dosing level)
If prescriber is not an allergist/immunologist, documentation of consultation with an allergist/immunologist

Step Therapy

Sequential Phase Requirement

Treatment must follow the sequential phased dosing regimen: Initial Dose Escalation, Up‑Dosing through all levels in order, then Maintenance dosing.

Initial Dose Escalation: administered on a single day in sequential order beginning at dose level A (levels A–E total), with each incremental dose separated by 20–30 minutes of observation; the initial escalation must be given under supervision in a setting prepared to manage anaphylaxis
Up‑Dosing Phase: consists of 11 dose levels given in sequential order at approximately 2‑week intervals; no dose level should be omitted; the first dose of each up‑dosing level must be administered in a healthcare setting equipped to monitor and manage anaphylaxis
Maintenance Phase: all up‑dosing levels must be completed before initiating maintenance; maintenance dosing is 300 mg daily and daily administration is required to maintain effect with periodic assessment for adverse reactions
Age requirements: requests for up‑dosing or maintenance must be for patients aged 1 year or older; initiation of therapy should be within age 1–17 for pediatric starts as applicable

Therapy Phase Definitions and Dosing Terms

Initial Dose Escalation (levels A–E)

Procedure formatSingle‑day supervised Initial Dose Escalation administering sequential doses in one visit

Dose levelsFive levels labeled A–E administered in order

Observation intervalEach dose separated by 20–30 minutes of observation

Setting requirementsAdminister under supervision in a healthcare setting equipped to monitor and manage anaphylaxis

PurposeMonitor for and manage potentially severe allergic reactions, including anaphylaxis

Up‑Dosing (11 levels)

ScheduleUp‑dosing consists of 11 dose levels administered in sequential order at approximately 2‑week intervals

No omissionsNo dose level should be omitted — doses and phases must be followed in order

Supervision for first doseThe first dose of each up‑dosing level must be administered under supervision to manage potentially severe allergic reactions

Operational noteUp‑dosing is part of the sequential phased therapy leading to maintenance

Maintenance phase

Maintenance dose and timingDaily 300 mg dosing after completion of all up‑dosing levels

AssessmentPatients on maintenance should be regularly assessed for adverse reactions

Continuation age rangeUp‑dosing and maintenance may be continued in patients 1 year of age and older

Relation to product packsMaintenance corresponds to Palforzia Level 11 maintenance packet (300 mg)