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    Palforzia™

    Drug - Palforzia™ (Peanut [Arachis hypogaea] Allergen Powder-dnfp) [Aimmune Therapeutics]

    July 2020

    Therapeutic area - Anti-Allergens, Oral

    Initial approval criteria:

    • Patient must be 4 to 17 years of age; AND
    • Patient must have a documented clinical history of allergy to peanuts or peanut-containing foods; AND
    • Confirmed diagnosis of peanut allergy based on: 
      • Serum immunoglobulin E (IgE) to peanut ≥ 14 kUA/L (kilos of allergen-specific units per liter) within the past 12 months; OR
      • Skin prick test (SPT) to peanut with a mean wheal diameter of ≥ 8 mm compared to control; OR
      • Clinical history of systemic reaction to peanut within the last 2 years with evidence of sensitization to peanut (serum IgE ≥ 0.35 and/or peanut SPT ≥ 3 mm); OR 
      • Documented reaction to peanut upon supervised oral food challenge at a dose of ≤ 100 mg peanut protein (≤ 200 mg peanut flour); AND
    • Patient does NOT have any of the following:
      • Severe asthma (e.g., currently treated with high-dose inhaled corticosteroid/long-acting beta-agonist therapy; has forced expiratory volume in 1 second [FEV1] < 60% of predicted); OR
      • Persistently uncontrolled mild to moderate asthma (defined as FEV1 < 80% predicted; OR
      • Three to four of the following symptoms: daytime asthma symptoms > twice/week, and nighttime awakening due to asthma symptoms, asthma reliever medication use > twice/week [excluding reliever taken for exercise], or any activity limitation due to asthma); AND
    • Patient has NOT received systemic corticosteroid therapy (oral, intramuscular, intravenous) for the treatment of asthma in any of the following manners:
      • Daily systemic corticosteroid for > 1 month during the past year; OR
      • More than 2 burst systemic corticosteroid courses in the past year with ≥ 1 week in duration; OR
      • Burst systemic corticosteroid course within 3 months prior to starting Palforzia; AND
    • Patient has NOT been hospitalized for asthma within 1 year prior to starting Palforzia; AND
      • Patient has NOT had emergency department (ED) visit for an asthma exacerbation within 6 months prior to starting Palforzia; AND
    • Patient does NOT have a history of eosinophilic esophagitis, and/or other eosinophilic gastrointestinal diseases; AND
    • Patient does NOT have uncontrolled atopic dermatitis; AND
    • Patient does NOT have a medical condition that inhibits their ability to survive anaphylaxis, such as significantly reduced lung function, severe mast cell disorder, or cardiovascular disease; AND
    • Patient is NOT currently taking medications that can alter the effects of epinephrine (e.g., beta-blockers [oral], angiotensin-converting enzyme (ACE) inhibitor; angiotensin receptor blocker [ARB], calcium channel blocker [CCB], alpha-adrenergic blocker, ergot alkaloid); AND
    • Patient has NOT experienced severe anaphylaxis resulting in hypotensive shock, use of > 2 doses of epinephrine, and/or intubation within the prior 60 days; AND 
    • Palforzia is being prescribed by a specialist (Allergy and Immunology specialists)
    • Patient has been prescribed and/or has a refill history of epinephrine auto-injector; AND 
    • All appointments for doses administered up to Level 6 of Up-Dosing phase are scheduled and documented in patient chart notes.
    • Prescriber attestation for the following: 
      • Patient/caregiver understand how to use injectable epinephrine; AND 
      • Patient/caregiver must be able to recognize the signs and symptoms of a serious allergic reaction and anaphylaxis; AND 
      • Patient/caregiver understands the importance of continual daily dosing of Palforzia to sustain desensitization and will adhere to a daily dosing regimen, including maintenance phase, of Palforzia as prescribed; AND
      • Patient/caregiver will have the capacity to adhere to the complex up-dosing schedule that requires frequent visits to the administering healthcare facility (e.g., adequate transportation to and from administering healthcare facility)
      • Patient/caregiver will temporarily withhold Palforzia and contact the prescriber if the patient experiences an acute asthma exacerbation; AND
      • Patient/caregiver understands dose timing considerations (e.g., strenuous exercise, hot shower/bath); AND 
      • Healthcare facility’s administrative staff has reviewed the directions for prior authorizations requests and billing for Palforzia below; AND
    • The following documentation must be provided at time of request:
      • Healthcare facility’s written processes and procedures to ensure Palforzia will be initiated at a REMS-certified healthcare facility; the initial dose escalation phase and the first dose of each of the 11 up-dosing phases will be given at a REMS-certified healthcare facility; AND
      • Healthcare facility’s Palforzia administration protocol must include ALL of the following:
        • Availability of qualified healthcare provider to administer Palforzia and to assess the patient for anaphylaxis for at least 60 minutes during and after administering the initial Dose Escalation and the first dose of each Up-Dosing level
        • Schedule modification and product discontinuation
        • Management of patients who miss 3 or more consecutive days of Palforzia
        • All written instructional materials that will be provided to the patient during the Initial Dose Escalation, Up-Dosing, and Maintenance phases
        • Processes and procedures to contact patient at regular intervals to assess for adverse events
    • Initial approval will be for Initial Dose Escalation and Up-Dosing Levels 1 through 6 

    Renewal criteria:

    Renewal criteria for Level 7 through 11 of the Up-Dosing Phase:

    • Patient continues to be under the care of the existing provider; AND
    • Patient continues to keep scheduled appointments as documented in chart notes.  If patient misses schedule appointments, any risk mitigation strategies used to assist patient to remain at any level in the Up-Dosing phase must be documented in chart notes and submitted at time of requests; AND
    • Patient must continue to tolerate the prescribed daily doses of Palforzia; AND
    • Patient has not experienced recurrent asthma exacerbations; AND
    • Patient has not have experienced any treatment-restricting adverse effects (e.g., repeated systemic allergic reaction and/or severe anaphylaxis)
    • Renewal approval will be for Up-Dosing Level 7 through 11

    OR

    • Patient must continue to meet the above initial criteria if the patient is under the care of a new provider; AND
    • Patients ≥ 18 years of age who met the initial approval criteria may continue Level 7 through 11 of the Up-Dosing Phase; AND
    • Patient continues to keep scheduled appointments as documented in chart notes.  If patient misses schedule appointments, any risk mitigation strategies used to assist patient to remain at any level in the Up-Dosing phase must be documented in chart notes and submitted at time of requests; AND
    • Patient must continue to tolerate the prescribed daily doses of Palforzia; AND
    • Patient has not experienced recurrent asthma exacerbations; AND
    • Patient has not experienced any treatment-restricting adverse effects (e.g., repeated systemic allergic reaction and/or severe anaphylaxis)
    • Renewal approval will be for Up-Dosing Level 7 through 11

    Renewal criteria for Maintenance Phase:

    • Patient must continue to meet the above initial criteria; AND
    • Patient must continue to tolerate the prescribed daily doses of Palforzia; AND
    • Patient has not experienced recurrent asthma exacerbations; AND
    • Patient has not have experienced any treatment-restricting adverse effects (e.g., repeated systemic allergic reaction and/or severe anaphylaxis); AND
    • Prescriber contacts patient at regular intervals to assess for adverse events to Palforzia as documented in chart notes; AND
    • Patients ≥ 18 years of age who met the initial approval criteria may continue maintenance treatment upon renewal
    • Renewal approval for the Maintenance Phase will be for 12 months

    Directions for prior authorization requests and billing for Palforzia

    Initial request

    Prescriber must request prior authorization (PA) approval and bill for Palforzia as follow:

    • Complete MHCP Authorization Form (DHS-4695) (PDF) to request prior authorization approval for the Initial Dose Escalation Package
      • Initial Dose Escalation Package must be billed as a medical claim
      • A specific PA approval number and effective date will be issued for the approved Initial Dose Escalation Package
    • Complete Drug Prior Authorization Form (DHS-4424) (PDF) to request prior authorization approval for the Up-Dosing Levels 1-through 6 Packages
      • Up-Dosing Levels 1 through 6 Packages must be billed as pharmacy claims
      • A specific PA approval ID number, quantity, and effective dates will be issued for each of the Level Package (i.e,a specific PA number will be issued for a specific NDC).  It is the responsibility of the prescriber and dispensing pharmacy to maintain a record of the approval numbers and to use a new and distinct PA approval ID number each time a new Level Package is dispensed
      • If quantity and effective dates for any Level Package must be extended, the prescriber must call MHCP agent to request a new PA approval ID number.  Any delay in requesting a new PA approval ID number will delay the claim adjudication process and dispensing of additional supplies needed by the patient.

    Renewal request for Up-Dosing Level 7 through 11

    • Complete Drug Prior Authorization Form (DHS-4424) (PDF) to request prior authorization approval for the Up-Dosing Levels 7 through 11 Packages
      • Renewal requests for Up-Dosing Level 7 through 11 must be submitted at least 7 days prior to the patient’s anticipated start of Level 7
      • Up-Dosing Levels 7 through 11 Packages must be billed as pharmacy claims
      • A specific PA approval ID number, quantity, and effective dates will be issued for each of the Level Package (i.e., a specific PA number will be issued for a specific NDC).  It is the responsibility of the prescriber and dispensing pharmacy to maintain a record of the approval numbers and to use a new and distinct PA approval ID number each time a new Level Package is dispensed
      • If quantity and effective dates for any Level Package must be extended, the prescriber must call MHCP PA agent to request a new PA approval ID number.  Any delay in requesting a new PA approval ID number will delay the claim adjudication process and dispensing of additional supplies needed by the patient.

    Renewal request for Maintenance Phase

    • Complete Drug Prior Authorization Form (DHS-4424) (PDF) to request prior authorization approval for the Maintenance Package
      • Renewal requests for Maintenance Package must be submitted at least 7 days prior to the patient’s anticipated start of Maintenance Phase
      • Maintenance Package must be billed as a pharmacy claim
      • A specific PA approval ID number, quantity, and effective dates will be issued for the Maintenance Package (i.e., a specific PA number will be issued for a specific NDC).  

    Quantity limits:

    • Initial Dose Escalation kit: 1 kit total (contains 5 doses)
    • Up-Dosing kit: 11 kits (1 kit per each dose level);
      • Temporary dose modifications may be encountered during the Up-Dosing phase, thereby extending the duration of any dosing level beyond 2 weeks). This may result in the need for > 11 kits
    • Maintenance: 30 sachets (300 mg each)/30days

    Questions?

    MHCP Provider Call Center 651-431-2700 or 1-800-366-5411

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