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Peanut Allergy Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1128

 

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 

07-01-2024            

07-01-2020

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Palforzia®

(peanut [Arachis hypogaea] allergen powder-dnfp)

Capsules

Sachets

Palforzia is an oral immunotherapy indicated 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.

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

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)

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 should be administered sequentially beginning at level A. Discontinue Palforzia if symptoms requiring medical intervention (e.g., use of epinephrine) occur with any dose during initial dose escalation. Patients who tolerate at least the 3 mg single dose 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)

Palforzia Initial Dose Escalation:(1)

Dose Level

Total Dose (mg)

Dose Configuration

A

0.5

1 x 0.5 mg capsule

B

1

1 x 1 mg capsule

C

1.5

1 x 0.5 mg capsule + 1 x 1 mg capsule

D

3

3 x 1 mg capsules

E

6

6 x 1 mg capsules

Up-dosing consists of 11 dose levels and is initiated at the 3 mg dose. 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. 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)

Palforzia Daily Dosing Configuration for Up-Dosing:(1)

Dose Level

Total Daily Dose (mg)

Daily Dose Configuration

Dose Duration (weeks)

1

3

3 x 1 mg capsules

2

2

6

6 x 1 mg capsules

2

3

12

2 x 1 mg capsules; 1 x 10 mg capsule

2

4

20

1 x 20 mg capsule

2

5

40

2 x 20 mg capsules

2

6

80

4 x 20 mg capsules

2

7

120

1 x 20 mg capsule; 1 x 100 mg capsule

2

8

160

3 x 20 mg capsules; 1 x 100 mg capsule

2

9

200

2 x 100 mg capsules

2

10

240

2 x 20 mg capsules; 2 x 100 mg capsules

2

11

300

1 x 300 mg sachet

2

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 reaction 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. Discontinue Palforzia for: patients who are unable to tolerate doses up to and including the 3 mg dose during 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)

Safety

Palforzia is contraindicated in the following:(1)

  • Uncontrolled asthma
  • A history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease

Palforzia has the following boxed warning:(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 Up-Dosing level, for at least 60 minutes.
  • Palforzia is available only through a restricted program called the Palforzia REMS

REFERENCES                                                                                                                                                                           

Number

Reference

1

Palforzia prescribing information. Aimmune Therapeutics. March 2023.

2

Vickery, B. P., Vereda, A., Casale, T. B., Beyer, K., du Toit, G., Hourihane, J. O., Jones, S. M., Shreffler, W. G., Marcantonio, A., Zawadzki, R., Sher, L., Carr, W. W., Fineman, S., Greos, L., Rachid, R., Ibanez, D., Tilles, S., Assa’ad, A. H., Nilsson, C., … Burks, A. wesley. (2018). AR101 Oral Immunotherapy for Peanut Allergy. New England Journal of Medicine, 379(21), 1991–2001. https://doi.org/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 NDCs 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

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

  1. 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. ALL 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
    4. If the requested agent is Palforzia, the patient was 4-17 years of age at the time of initiating therapy AND
  2. 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
  3. The patient has injectable epinephrine on hand AND
  4. The requested agent is to be used in conjunction with a peanut-avoidance diet AND
  5. 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:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. 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_ 07-01-2024