Palforzia (peanut allergen powder-dnfp) — Coverage Criteria
Customize your policy alerts
Sign up for univerahealthcare Policy PHARMACY-88 alerts
Get alerted when Policy PHARMACY-88 changes without checking for updates manually.
Monitor payer policy activity
Defines Univera Healthcare's coverage, prior authorization, and utilization management criteria for Palforzia (peanut allergen powder-dnfp) for mitigation of allergic reactions to accidental peanut exposure; applies to multiple commercial and individual lines of business listed in the policy.
No material clinical or coverage changes in this revision.
Coverage Criteria for Palforzia
Initial therapy (IDE and beginning Up-Dosing)
Covered when ALL of the following are met
Up-Dosing and Maintenance may be continued in patients ≥1 year of age
Examples: systemic hives, facial/lip edema, wheezing/coughing, difficulty breathing, hypotension, gastrointestinal symptoms
Initial doses and the first dose of each Up‑Dosing level must be given in REMS-certified healthcare settings
Maintenance therapy
Covered when ALL of the following are met
Required for initial maintenance approval
Provider must attest to tolerability
Recertification approvals may be for 1 year
Experimental / investigational
Non‑FDA approved indications for Palforzia will not be approved. The policy explicitly states that the safety and effectiveness of Palforzia have not been established in persons younger than 1 year of age. Additionally, the safety and effectiveness of initiating the Initial Dose Escalation (IDE) phase have not been established in persons older than 17 years.
Initiation of the Initial Dose Escalation (IDE) phase in persons older than 17 years is not established and therefore will not be authorized. Treatment may, however, be continued after age 17 only if the patient began treatment and completed IDE at age 17 years or younger. Palforzia is contraindicated in patients with uncontrolled asthma and in those with a history of eosinophilic esophagitis or other eosinophilic gastrointestinal disease.
Coding Guidance
| No codes listed |
Provider Actions and Requirements
Prior authorization required; initial approvals set to 6 months
Prior authorization is required for Palforzia; initial approval will be for 6 months to allow for the Initial Dose Escalation and Up‑Dosing phases. Initial approval of the maintenance phase is also 6 months; recertification is required for continued therapy and ongoing maintenance recertification approvals may be for 1 year when provider attests to continued benefit and tolerability.
- Initial approval (IDE + Up‑Dosing): 6 months
- Initial maintenance approval: 6 months; recertification may be approved for 1 year with documentation
Follow staged phases: IDE → Up‑Dosing → Maintenance (300 mg/day)
Therapy must follow staged phases: an in‑office Initial Dose Escalation (IDE) under supervision in a certified healthcare setting, followed by Up‑Dosing with progressive UD levels (first dose of each new level administered in a healthcare setting) up to maintenance dosing of 300 mg once daily.
- IDE administered 20–30 minutes apart under supervision in a healthcare setting.
- Up‑Dosing progresses approximately every 2 weeks through UD‑Level 11 to 300 mg daily.
- First dose of each UD level must be given in the healthcare setting; if tolerated, remaining doses at that level may be taken at home.
Submit clinical documentation with each request (initial and recertification)
Clinical documentation must be submitted with every prior authorization request (initial and recertification). Supporting documentation should include progress notes, prior treatment history, diagnostic testing and laboratory results, and any other relevant clinical data; continued approval requires documentation that the drug is providing ongoing benefit.
- Progress notes documenting previous treatments/treatment history
- Diagnostic testing and laboratory test results
- Documentation at recertification that patient is benefiting (improvement or stability) and has tolerated therapy
Denial risk if diagnostic confirmation or REMS attestation not provided
Requests that do not include required diagnostic confirmation (serum peanut‑specific IgE ≥ 0.35 kUA/L or skin prick test to peanut ≥ 3 mm) or that lack the prescriber attestation of REMS certification and patient REMS enrollment may be denied.
- Required diagnostic confirmation: serum peanut‑specific IgE ≥ 0.35 kUA/L OR skin prick test ≥ 3 mm vs control
- Prescriber must attest that healthcare setting, prescriber, and pharmacy are Palforzia REMS‑certified and that the patient is enrolled
Do not request coadministration with monoclonal antibodies — considered experimental
Requests for coadministration of Palforzia with monoclonal antibodies (for example, omalizumab or dupilumab) are considered experimental/investigational and will not be authorized.
- Coadministration with monoclonal antibodies for mitigation of peanut reactions or to improve tolerability is not studied and is not authorized
Background
Palforzia is the first FDA‑approved oral immunotherapy indicated to mitigate allergic reactions, including anaphylaxis, from accidental peanut exposure. Use of Palforzia involves distinct phases (Initial Dose Escalation, Up‑Dosing, and Maintenance) intended to desensitize patients over time; standard care otherwise remains strict peanut avoidance and access to rescue epinephrine. Providers should follow the FDA label and REMS requirements when administering therapy and be aware of age‑related safety limitations noted above.
Definitions and Phase Descriptions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.