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ph-91128

Peanut Allergy Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91128

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
01-01-2025	07-01-2020

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Palforzia® (Peanut [Arachis hypogaea] Allergen Powder-dnfp) Powder for oral administration	Mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Palforzia is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients aged 1 through 17 years. Up-dosing and maintenance may be continued in patients 1 year of age and older. Palforzia is to be used in conjunction with a peanut-avoidant diet. Limitation of use: not indicated for the emergency treatment of allergic reactions, including anaphylaxis.		1

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Peanut Allergy

Palforzia administration occurs in three sequential phases: initial dose escalation, up-dosing, and maintenance. Initial dose escalation is administered on a single day under the supervision of a health care professional in a health care setting with the ability to manage potentially severe allergic reactions, including anaphylaxis. The initial dose escalation is administered in sequential order on a single day beginning at level A. The dose configurations for each phase of dosing are provided below:(1)

Discontinue Palforzia if symptoms requiring medical intervention (e.g., use of epinephrine) occur with any dose during initial dose escalation. Patients 1 through 3 years of age who tolerate all doses (Level A – D) of Palforzia during Initial Dose Escalation must return to the health care setting for initiation of Up-Dosing. Patients 4 through 17 years of age who tolerate at least the 3 mg single dose (Level D) of Palforzia during Initial Dose Escalation must return to the health care setting for initiation of Up-Dosing. If possible, begin up-dosing the day after initial dose escalation. Repeat initial dose escalation in a health care setting if the patient is unable to begin up-dosing within 4 days.(1)

Dosing Configuration for Initial Dose Escalation Ages 1 through 3 years (Single Day Dose Escalation):(1)

Dose Level	Total Dose	Dose Configuration
A	0.5 mg	One 0.5 mg capsule
B	1 mg	One 1 mg capsule
C	1.5 mg	One 0.5 mg capsule; One 1 mg capsule
D	3 mg	Three 1 mg capsules

Dosing Configuration for Initial Dose Escalation Ages 4 through 17 years (Single Day Dose Escalation):(1)

Dose Level	Total Dose	Dose Configuration
A	0.5 mg	One 0.5 mg capsule
B	1 mg	One 1 mg capsule
C	1.5 mg	One 0.5 mg capsule; One 1 mg capsule
D	3 mg	Three 1 mg capsules
E	6 mg	Six 1 mg capsules

Complete Initial Dose Escalation before starting Up-Dosing. Patients 1 through 3 years of age: Up-Dosing consists of 12 dose levels and is initiated at a 1 mg dose (Level 0) and up-dosed to Level 11. Patients 4 through 17 years of age: Up-Dosing consists of 11 dose levels and is initiated at a 3 mg dose (Level 1) and up-dosed to Level 11. The first dose of each new up-dosing level is administered under the supervision of a health care professional in a health care setting with the ability to manage potentially severe allergic reactions, including anaphylaxis. Observe patients after administering the first dose of a new Up-Dosing level for at least 60 minutes until suitable for discharge. If the patient tolerates the first dose of the increase dose level, the patient may continue that dose level at home. All dose levels in the up-dosing schedule should be administered in sequential order at 2-week intervals if tolerated. No more than 1 dose should be consumed per day. Consider dose modification or discontinuation for patients who do not tolerate up-dosing as scheduled in label.(1)

Daily Dosing Configuration for Up-Dosing:(1)

Dose Level	Total Daily Dose	Daily Dose Configuration	Dose Duration (weeks)	Patient age (years)
0	1 mg	One 1 mg capsule	2	1-3
1	3 mg	Three 1 mg capsules	2	1-17
2	6 mg	Six 1 mg capsules	2	1-17
3	12 mg	Two 1 mg capsules; One 10 mg capsule	2	1-17
4	20 mg	One 20 mg capsule	2	1-17
5	40 mg	Two 20 mg capsules	2	1-17
6	80 mg	Four 20 mg capsules	2	1-17
7	120 mg	One 20 mg capsule; One 100 mg capsule	2	1-17
8	160 mg	Three 20 mg capsules; One 100 mg capsule	2	1-17
9	200 mg	Two 100 mg capsules	2	1-17
10	240 mg	Two 20 mg capsules; Two 100 mg capsules	2	1-17
11	300 mg	One 300 mg sachet	2	1-17

All dose levels of the up-dosing must be completed before starting maintenance. The maintenance dose of Palforzia is 300 mg daily. Daily maintenance is required to maintain the effect of Palforzia. During maintenance, patients should be contacted and assessed at regular intervals for adverse reactions to Palforzia.(1)

Temporary dose modification may be required for patients who experience allergic reactions during up-dosing or maintenance, for patients who miss doses, or for practical reasons of patient management. Allergic reactions, including gastrointestinal reactions, that are severe, recurrent, bothersome, or last longer than 90 minutes during up-dosing or maintenance should be actively managed with dose modifications. Use clinical judgment to determine the best course of action, which can include maintaining the dose level for longer than 2 weeks, reducing, withholding, or discontinuing Palforzia doses. Following 1 to 2 consecutive days of missed doses, patients may resume Palforzia at the same dose level. Data are insufficient to inform resumption of Palforzia following 3 or more consecutive days of missed doses. Patients who miss 3 or more consecutive days of Palforzia should consult their healthcare providers; resumption of Palforzia should be done under medical supervision.(1)

Discontinue Palforzia for:(1)

Patients 1 through 3 years of age who are unable to tolerate any dose during the Initial Dose Escalation.
Patients 4 through 17 years of age who are unable to tolerate doses up to and including the 3 mg dose during the Initial Dose Escalation.
Patients with suspected eosinophilic esophagitis.
Patients unable to comply with the daily dosing requirements.
Patients with recurrent asthma exacerbations or persistent loss of asthma control.

It should be verified prior to initiation and during therapy with Palforzia that the patient has injectable epinephrine and has been instructed on its use.(1)

Efficacy

Peanut oral immunotherapy was studied in a phase 3 trial (NCT02635776) with patients 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge.(2) Subjects were required to have serum IgE to peanut greater than or equal to 0.35 kUA/L within 12 months before study entry and/or a mean wheal diameter on skin prick test to peanut greater than or equal to 3 mm greater than the negative control. At study entry, subjects reacted at 100 mg or less of peanut protein in a double-blind, placebo-controlled food challenge (DBPCFC).(1) Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program. Participants who completed the regimen (i.e., received 300 mg per day of the maintenance regimen for approximately 24 weeks) underwent a double-blind, placebo-controlled food challenge at trial exit. The primary efficacy end point was the proportion of participants 4 to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose limiting symptoms.(2)

Of the 551 participants who received AR101 or placebo, 496 were 4 to 17 years of age; of these, 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge (difference, 63.2 percentage points; 95% confidence interval, 53.0 to 73.3; P <0.001). During the exit food challenge, the maximum severity of symptoms was moderate in 25% of the participants in the active-drug group and 59% of those in the placebo group and severe in 5% and 11%, respectively. Adverse events during the intervention period affected more than 95% of the participants 4 to 17 years of age. A total of 34.7% of the participants in the active-drug group had mild events, as compared with 50.0% of those in the placebo group; 59.7% and 44.4% of the participants, respectively, had events that were graded as moderate, and 4.3% and 0.8%, respectively, had events that were graded as severe. Efficacy was not shown in the participants 18 years of age or older.(2)

Safety

Palforzia has a boxed warning for anaphylaxis:(1)

Palforzia can cause anaphylaxis, which may be life-threatening and can occur at any time during Palforzia therapy.
Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
Do not administer Palforzia to patients with uncontrolled asthma.
Dose modifications may be necessary following an anaphylactic reaction.
Observe patients during and after administration of the Initial Dose Escalation and the first dose of each new Up-Dosing level, for at least 60 minutes.
Palforzia is available only through a restricted program called the Palforzia REMS.

Palforzia is contraindicated in the following:(1)

Patients with uncontrolled asthma.
Patients with a history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease.

REFERENCES

Number	Reference
1	Palforzia prescribing information. Aimmune Therapeutics, Inc. July 2024.
2	AR101 oral immunotherapy for peanut allergy. New England Journal of Medicine. 2018;379(21):1991-2001. doi:10.1056/nejmoa1812856

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Palforzia level 11 (maint ; Palforzia level 11 (titra	peanut allergen powder-dnfp maintenance packet ; peanut allergen powder-dnfp titration packet	300 MG	M ; N ; O ; Y	N
Palforzia initial dose es ; Palforzia level 1 ; Palforzia level 10 ; Palforzia level 2 ; Palforzia level 3 ; Palforzia level 4 ; Palforzia level 5 ; Palforzia level 6 ; Palforzia level 7 ; Palforzia level 8 ; Palforzia level 9	peanut powder-dnfp cap sprinkle pack ; peanut powder-dnfp pack ; peanut powder-dnfp starter pack	0.5 & 1 & 1.5 & 3 & 6 MG ; 1 MG ; 100 MG ; 2 x 1 MG & 10 MG ; 2 x 20 MG & 2 x 100 MG ; 20 MG ; 20 MG & 100 MG ; 3 x 20 MG & 100 MG	M ; N ; O ; Y	N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted Nd Cs When Exclusions Exist

Palforzia initial dose es	Peanut Powder-dnfp Starter Pack 0.5 & 1 & 1.5 & 3 & 6 MG	0.5 & 1 & 1.5 & 3 & 6 MG	1	Kit	180	DAYS
Palforzia level 1	Peanut Powder-dnfp Cap Sprinkle Pack 3 x 1 MG (3 MG Dose)	1 MG	90	Capsules	30	DAYS
Palforzia level 10	Peanut Powder-dnfp Pack 2 x 20 MG & 2 x 100 MG (240 MG Dose)	2 x 20 MG & 2 x 100 MG	120	Capsules	30	DAYS
Palforzia level 11 (maint	Peanut Allergen Powder-dnfp Maintenance Packet 300 MG	300 MG	30	Packets	30	DAYS
Palforzia level 11 (titra	Peanut Allergen Powder-dnfp Titration Packet 300 MG	300 MG	30	Packets	30	DAYS
Palforzia level 2	Peanut Powder-dnfp Cap Sprinkle Pack 6 x 1 MG (6 MG Dose)	1 MG	180	Capsules	30	DAYS
Palforzia level 3	Peanut Powder-dnfp Pack 2 x 1 MG & 10 MG (12 MG Dose)	2 x 1 MG & 10 MG	90	Capsules	30	DAYS
Palforzia level 4	Peanut Powder-dnfp Cap Sprinkle Pack 20 MG (20 MG Dose)	20 MG	30	Capsules	30	DAYS
Palforzia level 5	Peanut Powder-dnfp Cap Sprinkle Pack 2 x 20 MG (40 MG Dose)	20 MG	60	Capsules	30	DAYS
Palforzia level 6	Peanut Powder-dnfp Cap Sprinkle Pack 4 x 20 MG (80 MG Dose)	20 MG	120	Capsules	30	DAYS
Palforzia level 7	Peanut Powder-dnfp Pack 20 MG & 100 MG (120 MG Dose)	20 MG & 100 MG	60	Capsules	30	DAYS
Palforzia level 8	Peanut Powder-dnfp Pack 3 x 20 MG & 100 MG (160 MG Dose)	3 x 20 MG & 100 MG	120	Capsules	30	DAYS
Palforzia level 9	Peanut Powder-dnfp Pack 2 x 100 MG (200 MG Dose)	100 MG	60	Capsules	30	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Palforzia initial dose es ; Palforzia level 1 ; Palforzia level 10 ; Palforzia level 2 ; Palforzia level 3 ; Palforzia level 4 ; Palforzia level 5 ; Palforzia level 6 ; Palforzia level 7 ; Palforzia level 8 ; Palforzia level 9	peanut powder-dnfp cap sprinkle pack ; peanut powder-dnfp pack ; peanut powder-dnfp starter pack	0.5 & 1 & 1.5 & 3 & 6 MG ; 1 MG ; 100 MG ; 2 x 1 MG & 10 MG ; 2 x 20 MG & 2 x 100 MG ; 20 MG ; 20 MG & 100 MG ; 3 x 20 MG & 100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 11 (maint ; Palforzia level 11 (titra	peanut allergen powder-dnfp maintenance packet ; peanut allergen powder-dnfp titration packet	300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Palforzia initial dose es	Peanut Powder-dnfp Starter Pack 0.5 & 1 & 1.5 & 3 & 6 MG	0.5 & 1 & 1.5 & 3 & 6 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 1	Peanut Powder-dnfp Cap Sprinkle Pack 3 x 1 MG (3 MG Dose)	1 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 10	Peanut Powder-dnfp Pack 2 x 20 MG & 2 x 100 MG (240 MG Dose)	2 x 20 MG & 2 x 100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 11 (maint	Peanut Allergen Powder-dnfp Maintenance Packet 300 MG	300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 11 (titra	Peanut Allergen Powder-dnfp Titration Packet 300 MG	300 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 2	Peanut Powder-dnfp Cap Sprinkle Pack 6 x 1 MG (6 MG Dose)	1 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 3	Peanut Powder-dnfp Pack 2 x 1 MG & 10 MG (12 MG Dose)	2 x 1 MG & 10 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 4	Peanut Powder-dnfp Cap Sprinkle Pack 20 MG (20 MG Dose)	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 5	Peanut Powder-dnfp Cap Sprinkle Pack 2 x 20 MG (40 MG Dose)	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 6	Peanut Powder-dnfp Cap Sprinkle Pack 4 x 20 MG (80 MG Dose)	20 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 7	Peanut Powder-dnfp Pack 20 MG & 100 MG (120 MG Dose)	20 MG & 100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 8	Peanut Powder-dnfp Pack 3 x 20 MG & 100 MG (160 MG Dose)	3 x 20 MG & 100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Palforzia level 9	Peanut Powder-dnfp Pack 2 x 100 MG (200 MG Dose)	100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
PA	Target Agent(s) will be approved when ALL of the following are met: ONE of the following: The patient has been treated with the requested agent within the past 30 days OR The prescriber states the patient has been treated with the requested agent within the past 30 days AND is at risk if therapy is changed OR BOTH of the following: The patient has a diagnosed peanut allergy confirmed by ONE of the following: A serum peanut-specific IgE level greater than or equal to 0.35 kUA/L OR A positive skin-prick test determined by a mean wheal diameter that is at least 3mm larger than the negative control upon skin-prick testing for peanut OR The patient has a positive result to an oral peanut food challenge AND The patient was 1-17 years of age at the time of initiating therapy AND The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND The patient has injectable epinephrine on hand AND The requested agent is to be used in conjunction with a peanut-avoidance diet AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Target Agent(s) will be approved when ALL of the following are met:

ONE of the following:
1. The patient has been treated with the requested agent within the past 30 days OR
2. The prescriber states the patient has been treated with the requested agent within the past 30 days AND is at risk if therapy is changed OR
3. BOTH of the following:
  1. The patient has a diagnosed peanut allergy confirmed by ONE of the following:
    1. A serum peanut-specific IgE level greater than or equal to 0.35 kUA/L OR
    2. A positive skin-prick test determined by a mean wheal diameter that is at least 3mm larger than the negative control upon skin-prick testing for peanut OR
    3. The patient has a positive result to an oral peanut food challenge AND
  2. The patient was 1-17 years of age at the time of initiating therapy AND
The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
The patient has injectable epinephrine on hand AND
The requested agent is to be used in conjunction with a peanut-avoidance diet AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit

Length of Approval: up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ Peanut_Allergy_PAQL _ProgSum_ 01-01-2025