II-241-002

Medical Policy:

II-241-002

Topic:

Peanut Allergy Therapy

Section:

Medicine

Effective Date:

August 3, 2020

Issued Date:

May 31, 2021

Last Revision Date:

May 2020

Annual Review:

May 2021

POLICY INACTIVATED 8/01/2022. May 11, 2022 MBHPC.

Peanut allergy is a condition in which the body’s immune system mistakenly identifies even small amounts of peanut as harmful. Allergic reactions to peanut are unpredictable in occurrence and in how they present, with some individuals experiencing severe reactions from even trace amounts. Physical symptoms can develop within seconds of exposure and may include skin reactions, digestive discomfort, or more dangerous reactions such as constriction of the throat and airways, and loss of adequate blood flow to vital organs of the body. Peanut allergen powder is an oral immunotherapy that is manufactured from peanuts and packaged in capsules for dose escalation and up-dosing, and in a sachet for maintenance treatment. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food that the patient then consumes.

The U.S. Food and Drug Administration (FDA) has approved peanut (Arachis hypogaea) allergen powder (Palforzia™) for the 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 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older. Palforzia™ is to be used in conjunction with a peanut-avoidant diet. Palforzia™ is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Serious adverse reactions have occurred in patients treated with peanut allergen powder, including anaphylaxis, which may be life-threatening and can occur at any time during Palforzia™ therapy. Due to these safety concerns, the FDA requires the prescribing information for peanut allergen powder to include a black box warning. Patients should be prescribed injectable epinephrine, and Palforzia™ should not be administered to patients with uncontrolled asthma. Palforzia™ is available only through a restricted program called the Palforzia REMS.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Note: When peanut allergen powder (Palforzia™) will be self-administered for maintenance dosing, please refer to the applicable pharmacy benefit plan.

I. Review for Peanut Allergen Powder (Palforzia™)

For initial dose escalation, up-dosing, and restarting therapy, peanut allergen powder may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:

Age 4-17 years at the time of approval; AND
Diagnosis of peanut allergy; AND
Total serum peanut-specific IgE level ³ 0.35 kUA/L; AND
Prescribed by an allergist; AND
No FDA labeled contraindications to peanut allergen powder (see table 1 below); AND
Dose is within the FDA labeled dose for the indication (see table 2 below).

II. Experimental/Investigative Uses

All other uses of peanut allergy powder are considered EXPERIMENTAL/ INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

J3490

Table 1. FDA Labeled Contraindications

Agent

FDA Labeled Contraindications

Peanut allergen powder (Palforzia™)

Uncontrolled asthma

History of eosinophilic esophagitis or other eosinophilic gastrointestinal disease

Table 2. Dosing

NOTE: See documentation submission requirements below if the requested dose is higher or more frequent than the dosing criteria provided in this table.

FDA Labeled Indications

Dosing

Peanut allergy

Initial dose escalation:

Total Dose	Dose Configuration
0.5 mg	One 0.5 mg capsule
1 mg	One 1 mg capsule
1.5 mg	One 0.5 mg capsule; One 1 mg capsule
3 mg	Three 1 mg capsules
6 mg	Six 1 mg capsules

Up dosing:

Total Daily Dose	Daily Dose Configuration
3 mg	Three 1 mg capsules
6 mg	Six 1 mg capsules
12 mg	Two 1 mg capsules; One 10 mg capsule
20 mg	One 20 mg capsule
40 mg	Two 20 mg capsules
80 mg	Four 20 mg capsules
120 mg	One 20 mg capsule; One 100 mg capsule
160 mg	Three 20 mg capsules; One 100 mg capsule
200 mg	Two 100 mg capsules
240 mg	Two 20 mg capsules; Two 100 mg capsules
300 mg	One 300 mg sachet

Documentation Submission:

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted:

Clinical notes describing the diagnosis and clinical features of the diagnosis.
The dose being requested. If the requested dose is higher or more frequent than the dosing guidelines provided in the table above, a clear explanation for the medical necessity of the requested dose MUST be submitted, including prior dosing (strength and frequency) associated with inadequate response.
For patients restarting therapy after 3 or more days, documentation supporting restart must be provided.

Links

Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Acknowledgements: