CurrentCignaPolicy N/A

Palforzia — Drug Quantity Management (per Rx)

Defines per-prescription drug quantity management (maximum dispensed amounts and limited overrides) for Palforzia (peanut allergen oral immunotherapy) for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyPalforzia — Drug Quantity Management (per Rx)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMar 19, 2025

Key ActionApprove Palforzia quantity exceptions for up to 1 year when criteria are met; follow specified per-dispensing maximums and limited up-dosing overrides.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 sachetsMaintenance pack retail max

90 sachetsMaintenance pack home delivery max

7 capsulesInitial Dose Pack (1-3 yrs)

13 capsulesInitial Dose Pack (4-17 yrs)

15 sachetsLevel 11 up-dosing pack max

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Drug Quantity Limits (default coverage and allowable overrides)

Palforzia products are covered as medically necessary when dispensed within the specified per‑prescription quantity limits. All approvals are for 1 year. Exceptions and larger quantities for extended up‑dosing are permitted only as specified below.

Per-product quantity limits

Initial Dose Packs: Initial Dose Pack (1–3 years): maximum 7 capsules per prescription (retail and home delivery). Initial Dose Pack (4–17 years): maximum 13 capsules per prescription (retail and home delivery).7 or 13 capsules
No overrides recommended for initial dose packs
Up‑Dosing Packs standard limits: Level‑specific retail and home delivery maximums are specified per package; standard per‑dispensing limits apply unless an allowed override is met.per package as listed
Standard per‑dispensing limits apply
Maintenance Pack: 300 mg Maintenance Pack: retail maximum 30 sachets per prescription; home delivery maximum 90 sachets per prescription.30 sachets retail; 90 sachets home delivery
Daily maintenance dosing required

Up‑dosing extended‑duration override: If the patient requires greater than a 2‑week up‑dosing duration, approve the increased total quantity per dispensing as specified for each up‑dosing level (examples: Level 0 = 30 capsules; Level 1 = 90 capsules; Level 2 = 180 capsules; Level 11 = 30 sachets).per‑level expanded quantities

Allowed override only when up‑dosing duration > 2 weeks

Any request for a quantity exception that does not meet the policy's listed criteria is considered not medically necessary. The Drug Quantity Management policy defines specific per-dispensing maximums and limited up-dosing overrides; exceptions outside those specifications are not covered.

Requests that exceed the specified package per-dispensing maximums without meeting the policy criteria — including the limited extended up-dosing override described for Levels 0–11 — are not medically necessary. Providers must follow the per-product quantity limits (for example, the 300 mg Maintenance Pack retail maximum of 30 sachets per Rx and home delivery maximum of 90 sachets per Rx) or the specified per-level extended quantities when the >2-week up-dosing condition applies.

Provider Requirements and Approval Details

Prior Authorization

Quantity management and approval duration

All approvals are provided for 1 year in duration. The Drug Quantity Management program defines quantities sufficient for a one-day Initial Dose Escalation, each two‑week Up‑Dosing level, or 30 days of maintenance. If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria in this policy.

Approvals: 1 year duration.
Quantities sized to one-day Initial Dose Escalation, each two‑week Up‑Dosing level, or 30 days maintenance.
If Drug Quantity Management rule not met at point of service, adjudicate per criteria.

Denial Risk

Quantity rule noncompliance

If the requested quantity does not meet the Drug Quantity Management rule at the point of service, coverage will be determined by the policy criteria rather than an automatic approval. Providers should expect adjudication that considers plan terms, applicable laws/regulations, relevant collateral materials, and the specific facts of the case.

Noncompliance at point of service triggers criteria-based determination.
Decisions are made per benefit plan and applicable laws/regulations.

Note

Decision context

Coverage determinations require consideration of: (1) the terms of the applicable benefit plan document in effect on the date of service; (2) any applicable laws and regulations; (3) relevant collateral source materials including coverage policies; and (4) the specific facts of the individual case. Medical directors retain discretion to exercise clinical judgment in individual coverage decisions.

Adjudicate per benefit plan, laws/regulations, collateral materials, and facts.
Each request reviewed on its own merits; medical director clinical judgment applies.

Step Therapy

Dosing sequence requirements

Palforzia administration follows three sequential phases: Initial Dose Escalation, Up‑Dosing, and Maintenance. Initial Dose Escalation is given on a single day under supervision in a healthcare setting with doses administered sequentially (20–30 minutes apart) and observation for 60 minutes after the last dose; no dose level should be omitted. Up‑Dosing consists of defined dosing levels (Level 0–11) with the first dose of each new level administered under supervision in a healthcare setting and a 60‑minute observation; if tolerated, subsequent daily dosing is at home. Maintenance is 300 mg once daily (QD) supplied in a sachet and requires daily dosing to maintain effect. Dose modifications are not allowed during Initial Dose Escalation; temporary modifications may be appropriate during Up‑Dosing or Maintenance for missed doses or adverse reactions per labeling.

Initial Dose Escalation: supervised single‑day, doses 20–30 minutes apart, monitor 60 minutes after last dose; do not omit dose levels.
Up‑Dosing: first dose of each level supervised with 60‑minute observation; if tolerated, continue daily at home; specified Level 0–11 schedules.
Maintenance: 300 mg QD sachet; daily dosing required; monitor patient periodically.
Dose modification: not during Initial Dose Escalation; may modify during Up‑Dosing or Maintenance per clinical judgment and labeling.

Dosing Phase Definitions

inv-09: Initial Dose Escalation — single-day supervised administration, age-dependent levels and observation period

Setting and supervisionInitial Dose Escalation is administered on a single day under supervision in a healthcare setting capable of managing anaphylaxis.

Age-dependent levelsPatients 4–17 years progress through dose Levels A–E; patients 1–3 years progress through Levels A–D.

Dosing intervalEach dose is given 20–30 minutes apart during the single-day escalation.

Post-dose observationAfter the last dose, patients should be monitored for 60 minutes.

Omission ruleNo dose level should be omitted; Palforzia should be discontinued if symptoms require medical intervention after any dose.

inv-10: Up-Dosing — multi-level up-dosing phase with 11–12 levels; supervised first dose of each new level

Level count by ageUp-Dosing consists of 12 levels for patients 1–3 years (starting at Level 0) and 11 levels for patients 4–17 years (starting at Level 1).

Initiation timingIf possible, Up-Dosing should begin the day after Initial Dose Escalation; if >4 days elapse, Initial Dose Escalation must be repeated.

Supervised first dose at each levelThe first dose of each new up-dosing level must be administered under supervision in a healthcare setting with at least 60 minutes of monitoring.

Continuation at homeIf the new dose level is tolerated during supervised administration, the patient may continue daily dosing at that level at home.

inv-11: Maintenance — once daily 300 mg sachet dosing after up-dosing completion; ongoing monitoring

Maintenance dose and formMaintenance dosing is 300 mg once daily (QD) supplied in a sachet following completion of Up-Dosing.

Daily administration requirementDaily maintenance dosing is required to maintain Palforzia's effect.

Ongoing monitoringThe patient should be contacted at regular intervals during maintenance to assess for adverse reactions.

Dose modification guidanceTemporary dose modification may be appropriate during Maintenance if doses are missed or for management of adverse events; clinical judgment required.

OpenPayer

Palforzia — Drug Quantity Management (per Rx)

Coverage and Quantity Limits

Provider Requirements and Approval Details

Dosing Phase Definitions

Product Background