CurrentUnitedHealthcarePolicy 2026 P 2182-9

Palforzia (Peanut Allergen Powder) prior authorization / medical necessity

Defines medical necessity criteria and prior authorization requirements for Palforzia (peanut allergen oral immunotherapy) for patients receiving UnitedHealthcare-covered benefits. Applies to prescribers and pharmacy/medical benefit reviewers processing initial and reauthorization requests.

Policy Summary

PayerUnitedHealthcare

PolicyPalforzia (Peanut Allergen Powder) prior authorization / medical necessity

Policy CodePolicy 2026 P 2182-9

Change TypeAnnual review — no material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization demonstrating all initial authorization criteria are met and document REMS enrollment; authorizations are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Annual reviews noted; most recent entry (3/2026) indicates annual review with no changes.

12authorization duration for initial and reauthorization approvals

>=0.35required minimum serum peanut-specific IgE

>=3 mmrequired minimum mean wheal diameter vs negative control on skin prick test

1-17allowed for initial dose escalation

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Medical Necessity Criteria for Palforzia

Initial Authorization - Palforzia

Palforzia will be approved when ALL of the following are met:

Diagnosis and confirmation

Serum peanut-specific IgE level >= 0.35 kUA/L>= 0.35 kUA/L
Mean wheal diameter on skin prick testing at least 3 mm larger than negative control>= 3 mm larger than negative control

Age/therapy phase requirement (one of the following)

Initial dose escalation eligibility
- Patient age 1 to 17 years1-17 years
- Patient is in the initial dose escalation phase of therapy
Up-dosing or maintenance eligibility
- Patient age 1 year and older>= 1 year
- Patient is in the up-dosing or maintenance phase of therapy

Used in conjunction with a peanut-avoidant diet

Exclusion criteria (patient must NOT have any of the following)

History of eosinophilic esophagitis (EoE) or eosinophilic gastrointestinal disease
History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within the past 2 monthswithin past 2 months
Severe or poorly controlled asthma

Prescribed by or in consultation with an allergist/immunologist

Prescriber is certified/enrolled in the Palforzia REMS Program

Reauthorization (Renewal) - Palforzia

Palforzia will be approved for reauthorization when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Palforzia therapy
Used in conjunction with a peanut-avoidant diet
Prescribed by or in consultation with an allergist/immunologist
Prescriber is certified/enrolled in the Palforzia REMS Program

Codes and Program Identifier

ICD-10 (diagnosis codes referenced for automated approval processes)ICD-10

No codes listed

Program / Policy Identifiermixed

2026 P 2182-9

UnitedHealthcare Pharmacy Clinical Pharmacy Programs - Palforzia prior authorization program number

What Providers Must Do

Prior Authorization

Prior authorization required based on criteria

Provider must obtain prior authorization demonstrating that all initial authorization criteria are met, including diagnostic confirmation, age/therapy phase, use with a peanut-avoidant diet, absence of exclusion criteria, prescribing by or in consultation with an allergist/immunologist, and prescriber REMS enrollment. Authorization will be issued for 12 months.

Authorization length = 12 months

Documentation Required

Diagnostic documentation required

Provider must document diagnostic confirmation with a serum peanut-specific IgE level of greater than or equal to 0.35 kUA/L and a mean wheal diameter on skin prick testing at least 3 mm larger than the negative control.

Serum peanut-specific IgE threshold = >= 0.35 kUA/L
Skin prick test threshold = >= 3 mm larger than negative control

Clinical and Administrative Thresholds

Thresholds and Key Limits

Serum peanut-specific IgE>= 0.35 kUA/L

Skin prick test mean wheal diameter>= 3 mm larger than negative control

Age for initial dose escalation1-17 years

Age for up-dosing and maintenance>= 1 year

Recent severe anaphylaxis exclusion windowno severe or life-threatening anaphylaxis within past 2 months

Clinical Background

Palforzia is an oral immunotherapy indicated to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Initial dose escalation is authorized for patients aged 1 through 17 years, while up-dosing and maintenance may be continued in patients 1 year of age and older. Therapy must be used in conjunction with a peanut-avoidant diet. Prescribers must be certified/enrolled in the Palforzia REMS Program and REMS enrollment should be documented with the authorization request.

Authorization length for both initial and reauthorization approvals is 12 months. State mandates and the member’s specific benefit plan may further affect coverage, and UnitedHealthcare may use automated approval or reauthorization processes based on prior claims, medication history, or diagnosis coding in some programs. Supply limits may apply.

Defined Terms

Definitions

Initial dose escalationThe initial rapid escalation phase of Palforzia dosing generally administered under clinical supervision (documented as the initial phase in the request).

Up-dosingThe subsequent dose escalation phase after initial escalation to increase tolerated dose toward maintenance.

MaintenanceOngoing daily dosing phase intended to maintain desensitization.

REMSRisk Evaluation and Mitigation Strategy program; prescribers must be certified/enrolled in the Palforzia REMS Program.

Policy Updates

3/2026Annual reviewLatest

Annual review completed in March 2026 with no material changes; notes prior substantive updates earlier that added age requirements and the prescriber REMS certification.

4/2025Policy update

Updated age range based on changes to the prescribing information.

3/2020Policy update

Added age requirements for the initial phase and up-dosing/maintenance, specified use with a peanut-avoidant diet, and added that prescribers must be certified/enrolled in the Palforzia REMS Program.

Operational Details & Scope

Policy metadata

Policy number2026 P 2182-9

Effective date2026-06-01

Last review2026-03

Next review

Coverage stancecovered_with_criteria

StatusCURRENT

Scope summaryDefines medical necessity criteria and prior authorization requirements for Palforzia (peanut allergen oral immunotherapy) for patients receiving UnitedHealthcare-covered benefits. Applies to prescribers and pharmacy/medical benefit reviewers processing initial and reauthorization requests.