CurrentUnitedHealthcarePolicy 2025 P 2182-8

Prior Authorization - Medical Necessity - Palforzia (Peanut Allergen Powder-dnfp)

UnitedHealthcare prior authorization policy defining medical necessity criteria for initial and reauthorization coverage of Palforzia (peanut allergen oral immunotherapy) including required diagnostics, age/stage-specific rules, exclusions, prescriber requirements, and duration of authorization.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization - Medical Necessity - Palforzia (Peanut Allergen Powder-dnfp)

Policy CodePolicy 2025 P 2182-8

Change TypeAge range update (4/2025)

Effective DateJul 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization demonstrating the diagnostic tests and clinical/stage criteria, exclusions, prescriber specialty, and REMS enrollment to secure coverage.

SourceLink

POLICY UPDATE CHANGES

Effective 7/1/2025 policy updated following P&T approvals through 4/2025 with an updated age range based on prescribing information.

Initial age requirements for dosing phases and requirement that therapy be used in conjunction with a peanut-avoidant diet were added previously.

Prescriber must be certified/enrolled in the Palforzia REMS Program and be an allergist/immunologist or in consultation with one.

2Authorization Phases Covered (Initial, Reauthorization)

12 monthsAuthorization Duration

>=0.35IgE threshold

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>=3 mmSkin-prick wheal differential

Coverage Summary

UnitedHealthcare prior authorization policy: Palforzia is covered with criteria for both initial authorization and reauthorization. Initial authorization requires documentation of diagnosis and testing, age/stage-specific rules (initial dose escalation for ages 1 to 17 years; up-dosing/maintenance for patients 1 year of age and older), exclusion evaluation, prescriber REMS certification, and allergist/immunologist involvement. Reauthorization requires documentation of a positive clinical response, continued use with a peanut-avoidant diet, continued REMS enrollment and specialist involvement. Authorization will be issued for 12 months.

Key Thresholds and Authorization Details

Serum peanut-specific IgE>= 0.35 kUA/L

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

Age for initial dose escalation1 to 17 years

Age for up-dosing/maintenance>= 1 year

Recent severe anaphylaxis exclusion windowhistory within the past 2 months excludes coverage

Authorization Duration12 months

Authorization Phases CoveredInitial, Reauthorization

Initial Therapy Criteria

Initial Authorization

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

ALL of the following

Diagnosis and clinical history of peanut allergy as documented by both of the following:
- A serum peanut-specific IgE level of greater than or equal to 0.35 kUA/L>= 0.35 kUA/L
- A mean wheal diameter that is at least 3mm larger than the negative control on skin-prick testing for peanut>= 3 mm larger than negative control
ONE of the following staging options
- Initial dose escalation criteria

Continuation (Reauthorization) Criteria

Reauthorization (Continuation)

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

Unproven / Exclusionary Conditions

Exclusionary Conditions

Patient has any of the following exclusionary conditions

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

Applicable Codes

No codes listed in policymixed

No codes listed

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required based on medical necessity criteria

Prior authorization is required and must demonstrate that medical necessity criteria are met, including diagnostic testing and thresholds, the patient’s treatment stage/age, absence of exclusionary conditions, appropriate prescriber specialty or consultation, and prescriber certification/enrollment in the Palforzia REMS Program.

Required documentation: serum IgE, skin-prick test results
PA duration: 12 months

Documentation Required

Document diagnostic evidence of peanut allergy

Submit serum peanut-specific IgE with a value greater than or equal to 0.35 kUA/L and skin‑prick test results showing a mean wheal diameter at least 3 mm larger than the negative control to document peanut allergy.

Documentation Required

Clinical Evidence & References

PALISADE (AR101)Key trial referenced — The PALISADE (AR101) trial (N Engl J Med. 379(21):1991-2001)

July 2024Manufacturer prescribing information — Palforzia prescribing information, Aimmune Therapeutics (July 2024)

Key evidence includes the PALISADE (AR101) trial published in N Engl J Med. 379(21):1991-2001, which is referenced as the pivotal clinical trial supporting Palforzia.

Additional supporting information is the manufacturer’s Palforzia prescribing information (Aimmune Therapeutics, July 2024).

Background

Palforzia is an oral peanut allergen immunotherapy indicated to mitigate allergic reactions, including anaphylaxis, from accidental peanut exposure in patients with confirmed peanut allergy. Initial dose escalation may be administered to patients 1 through 17 years of age; up-dosing and maintenance may be continued in patients 1 year of age and older. Palforzia must be used in conjunction with a peanut-avoidant diet.

Palforzia REMS Program: a Risk Evaluation and Mitigation Strategy specific to Palforzia; prescriber certification/enrollment in the Palforzia REMS Program is required for prescribing or dispensing.

Revision History

4/2025revisedLatest

Effective 7/1/2025 policy updated following P&T approvals through 4/2025 with an updated age range based on prescribing information.

3/2020added

Added initial age requirements for dosing phases (initial dose escalation ages 1–17; up‑dosing/maintenance ≥1 year) and requirement that therapy be used in conjunction with a peanut‑avoidant diet.

3/2020added

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization - Medical Necessity - Palforzia (Peanut Allergen Powder-dnfp)

Policy CodePolicy 2025 P 2182-8

Change TypeAge range update (4/2025)

Effective DateJul 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization demonstrating the diagnostic tests and clinical/stage criteria, exclusions, prescriber specialty, and REMS enrollment to secure coverage.

SourceLink

On This Page

Patient is 1 to 17 years of age1 to 17 years
Patient is in the initial dose escalation phase of therapyinitial dose escalation

Up-dosing or maintenance criteria

Patient is 1 year of age and older>= 1 year
Patient is in the up-dosing or maintenance phase of therapyup-dosing or maintenance

Used in conjunction with a peanut-avoidant diet

Patient does not have any of the following exclusionary conditions:

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

Prescribed by or in consultation with an allergist/immunologist

Prescriber is certified/enrolled in the Palforzia REMS Program

Prior Authorization

Reauthorization interval

Authorization will be issued for 12 months; reauthorization requires documentation of positive clinical response to therapy, continued enrollment/certification in the Palforzia REMS Program, and that the prescriber is an allergist/immunologist or is consulting with one.

Denial Risk

Exclusionary conditions may deny coverage

Coverage is excluded if the patient has any of the listed exclusionary conditions: eosinophilic esophagitis or eosinophilic gastrointestinal disease, a history of severe or life‑threatening anaphylaxis within the past 2 months, or severe or poorly controlled asthma.

Document exclusion evaluation

Confirm and document the absence of eosinophilic esophagitis or eosinophilic gastrointestinal disease, no history of severe or life‑threatening anaphylaxis within the past 2 months, and that the patient does not have severe or poorly controlled asthma.

Documentation Required

Prescriber requirements

Prescriber must be an allergist/immunologist or be in consultation with one, and must be certified/enrolled in the Palforzia REMS Program prior to prescribing.

Prior Authorization

Reauthorization interval

Authorization will be issued for 12 months. Reauthorization requires documentation of positive clinical response to Palforzia therapy, ongoing use with a peanut‑avoidant diet, continued prescriber certification/enrollment in the Palforzia REMS Program, and that the prescriber is an allergist/immunologist or in consultation with one.

Added requirement that prescribers be certified/enrolled in the Palforzia REMS Program and that therapy be prescribed by or in consultation with an allergist/immunologist.