CurrentCignaPolicy N/A

Palynziq (pegvaliase) — Drug Quantity Management and Coverage Criteria

Defines Cigna's drug quantity management limits and approval criteria for Palynziq (pegvaliase) syringes for treatment of phenylketonuria (PKU), including dispensing quantities for retail and home delivery and criteria for exceptions.

Policy Summary

PayerCigna

PolicyPalynziq (pegvaliase) — Drug Quantity Management and Coverage Criteria

Policy CodePolicy N/A

Change TypeEarly Annual Revision

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests following Drug Quantity Limits; approvals are issued for 1 year.

SourceLink

POLICY UPDATE CHANGES

Criteria for Palynziq 2.5 mg/0.5 mL updated to approve 60 syringes retail or 180 syringes home delivery when patient requires 5 mg/day due to blood phenylalanine < 30 micromol/L while taking > 5 mg/day.

8 syringesRetail max per Rx (2.5 mg)

90 syringesRetail max per Rx (10 mg)

60 syringesRetail max per Rx (20 mg)

180 syringesHome delivery max (20 mg)

1 yearApproval duration

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Coverage Criteria for Palynziq (pegvaliase)

2.5 mg syringe quantity exception

Palynziq 2.5 mg/0.5 mL syringe - exception to standard quantity limits

Criteria for 2.5 mg syringe exception: If the patient requires a dose of 5 mg per day due to blood phenylalanine concentrations below 30 micromol/L while taking a dose > 5 mg per day, approve 60 syringes per dispensing at retail or 180 syringes per dispensing at home delivery.blood Phe < 30 micromol/L while on >5 mg/day

Approvals provided for 1 year

20 mg syringe quantity exception

Palynziq 20 mg/1 mL syringe - exception for high maintenance dose

Criteria for 20 mg syringe exception: If the patient requires a maintenance dose of 60 mg per day, approve 90 syringes per dispensing at retail or 270 syringes per dispensing at home delivery.maintenance dose = 60 mg/day

Approvals provided for 1 year

10 mg syringe guidance

Palynziq 10 mg/0.5 mL syringe

10 mg syringe: No overrides recommended. Patients on ≥ 20 mg/day should be referred to the 20 mg/1 mL syringe.

No quantity override provided

Any request for a quantity of Palynziq that does not meet the policy's specified Drug Quantity Limits is considered not medically necessary. Quantity limits for retail and home delivery are established by strength and formulation and must be met for coverage.

Any exception that is not explicitly listed in the policy's coverage criteria is considered not medically necessary. Requests for quantities or dispensing that fall outside the stated criteria and exceptions will be denied as not medically necessary.

Product Strengths, Forms, and Clinical Thresholds

Product strengths/forms listedmixed

pegvaliase-pqpz	Palynziq (pegvaliase) 10 mg/0.5 mL syringe
Palynziq 2.5 mg/0.5 mL	Palynziq 2.5 mg/0.5 mL syringe
Palynziq 20 mg/1 mL	Palynziq 20 mg/1 mL syringe

inv-07: Blood phenylalanine concentration — key clinical thresholds including > 600 micromol/L indication and < 30 micromol/L dose/quantity trigger

Indication threshold> 600 micromol/L (uncontrolled blood phenylalanine on existing management)

Dose/quantity triggerBlood phenylalanine < 30 micromol/L while taking > 5 mg/day — enables 2.5 mg syringe quantity exception

Baseline monitoringBaseline blood phenylalanine concentration should be obtained before initiating treatment

Prior Authorization, Quantity Limits, and Provider Requirements

Prior Authorization

Prior Authorization Required

This Drug Quantity Management program has been developed to manage potential dose escalation of Palynziq and to provide a sufficient quantity for approvable indications. If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the Criteria below. All approvals are provided for 1 year.

All approvals: 1 year

Billing Rule

Drug Quantity Limits

Palynziq drug quantity limits vary by strength and dispensing channel. Retail and Home Delivery maximum quantities per Rx are enforced; requests exceeding these Drug Quantity Limits may be denied at point of service if Drug Quantity Management rules are not met.

Background: Indication and Drug Overview

Palynziq (pegvaliase) is a subcutaneous enzyme substitution therapy indicated to reduce blood phenylalanine concentrations in adults with phenylketonuria (PKU) who have uncontrolled phenylalanine levels despite current management. Dosing is provided in multiple syringe strengths and individualized by clinicians experienced in PKU; the policy defines specific dispensing quantities and exceptions by strength and route (retail versus home delivery).

Indication, Titration, and Key Definitions

inv-13: Indication — key-value for indication reducing blood phenylalanine >600 micromol/L in adult PKU

PopulationAdult patients with phenylketonuria (PKU)

Coverage indicationReduce blood phenylalanine concentrations for patients with uncontrolled blood Phe > 600 micromol/L on existing management

PrescriberTreatment should be managed by a healthcare provider experienced in PKU

inv-14: Titration schedule — stepwise induction and titration starting at 2.5 mg weekly to maintenance (20–60 mg/day) as table 1

Initiation (induction)2.5 mg once weekly for 4 weeks

Early titration steps2.5 mg twice weekly (1 week) → 10 mg once weekly (1 week) → 10 mg twice weekly (1 week) → 10 mg four times/week (1 week) → 10 mg daily (1 week)

Policy Summary

PayerCigna

PolicyPalynziq (pegvaliase) — Drug Quantity Management and Coverage Criteria

Policy CodePolicy N/A

Change TypeEarly Annual Revision

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests following Drug Quantity Limits; approvals are issued for 1 year.

SourceLink

On This Page

2.5 mg/0.5 mL syringe: Retail max = 8 syringes; Home Delivery max = 8 syringes
10 mg/0.5 mL syringe: Retail max = 30 syringes; Home Delivery max = 90 syringes
20 mg/1 mL syringe: Retail max = 60 syringes; Home Delivery max = 180 syringes

Prior Authorization

Quantity Limits and Formulation Routing for Higher Doses

For patients who require higher maintenance doses, specific dispensing overrides apply when clinical criteria are met. If the patient requires 5 mg/day due to blood Phe <30 µmol/L while previously on >5 mg/day, approve 60 syringes (retail) or 180 syringes (home delivery) for the 2.5 mg/0.5 mL syringe. For a maintenance dose of 60 mg/day using the 20 mg/1 mL syringe, approve 90 syringes (retail) or 270 syringes (home delivery). Patients receiving ≥20 mg/day should be routed to the 20 mg/1 mL syringe formulation.

2.5 mg/0.5 mL syringe override: 60 syringes (retail) / 180 syringes (home delivery) when indicated
20 mg/1 mL syringe override: 90 syringes (retail) / 270 syringes (home delivery) for 60 mg/day maintenance
Patients on ≥20 mg/day: use 20 mg/1 mL syringe formulation

Documentation Required

Required Baseline and Ongoing Monitoring

Baseline blood phenylalanine (Phe) concentration must be obtained before initiating treatment. During titration and maintenance, monitor blood Phe; dosage adjustments may be needed if blood Phe falls below 30 µmol/L (dosage may be reduced and/or dietary protein/phenylalanine intake modified).

Obtain baseline blood Phe prior to initiation
Monitor blood Phe during treatment; adjust dose if <30 µmol/L

Denial Risk

Denial Risk for Noncompliant Quantity Requests

If the Drug Quantity Management rules are not met at the point of service (for example, requesting quantities above the listed maximums or not using the recommended formulation for patients on ≥20 mg/day), coverage may be denied and the request will be adjudicated against the clinical Criteria. Ensure documentation supports overrides and clinical rationale to avoid denial.

Coverage may be denied when quantity-management rules or formulation routing are not met at point of service
Provide supporting clinical documentation for any override requests to reduce denial risk

Maintenance range20–60 mg once daily (maintenance doses with durations: 20 mg QD – 24 weeks; 40 mg QD – 16 weeks; up to 60 mg QD)

Tolerability noteAdditional time may be required prior to each dosage escalation based on patient tolerability