CurrentCignaPolicy N/A

Phenylketonuria - Palynziq Drug Quantity Management Policy - Per Rx

Defines quantity limits and medically necessary exceptions for Palynziq syringes for members covered under Cigna-administered benefit plans; applies to providers requesting Palynziq dispensing.

Policy Summary

PayerCigna

PolicyPhenylketonuria - Palynziq Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionApprove exceptions to quantity limits only when specified clinical criteria are met; all approvals are issued for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8Retail 2.5 mg per Rx

30Retail 10 mg per Rx

60Retail 20 mg per Rx

180Home 20 mg per Rx

1 yrApproval duration

Coverage Criteria

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Drug quantity limits and exception criteria

Quantity limits apply per strength/form and exceptions are allowed only when specified clinical criteria are met; approvals are for 1 year.

Palynziq 2.5 mg/0.5 mL syringe - default limit: Retail maximum per Rx = 8 syringes; Home Delivery maximum per Rx = 8 syringes

See exception node for override criteria

Exception for 2.5 mg syringe: 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 phenylalanine < 30 micromol/L

Chunk 10 provides exception details

Palynziq 10 mg/0.5 mL syringe: Retail maximum per Rx = 30 syringes; Home Delivery maximum per Rx = 90 syringes. No overrides recommended. For patients receiving ≥ 20 mg/day, refer to the 20 mg/1 mL syringe.

Chunks 9 and 12

Palynziq 20 mg/1 mL syringe - default limit: Retail maximum per Rx = 60 syringes; Home Delivery maximum per Rx = 180 syringes.

Chunk 9

Exception for 20 mg syringe: 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

Chunk 11

Any exception to the listed quantity limits that is not specifically described in the criteria is considered not medically necessary.

Overrides to quantity limits other than the enumerated exceptions are considered not medically necessary.

Coding / Clinical Thresholds

Indication blood Phe — > 600 micromol/L

Indication (blood phenylalanine)> 600 micromol/L

PopulationAdult patients with phenylketonuria (PKU)

ContextUncontrolled blood phenylalanine on existing management

Lower blood Phe threshold for dose adjustment — < 30 micromol/L

Dose-adjustment threshold (blood Phe)< 30 micromol/L

Recommended actionReduce Palynziq dose and/or modify dietary protein/phenylalanine intake

Maintenance dose range (reference)May be adjusted between 5 mg/day and 60 mg/day based on efficacy and tolerability

Provider Actions & Operational Notes

Prior Authorization

Quantity limits and exception approvals

All approvals under this Drug Quantity Management program are provided for 1 year. Exceptions to quantity limits are considered covered when the member meets the coverage criteria in this policy and appropriate documentation is supplied with the request; approvals issued via exception are also valid for 1 year.

Approvals under this program are time-limited to 1 year.
Exceptions to quantity limits require documentation and are evaluated against the policy criteria.

Documentation Required

Coverage determination considerations

Coverage determinations require consideration of the applicable benefit plan and supporting materials. Specifically, reviewers must consider: the terms of the member's benefit plan document in effect on the date of service, applicable laws and regulations, relevant collateral materials (including this coverage policy), and the specific clinical facts of the individual case. Medical Directors retain clinical judgment and discretion when making individual determinations.

Review the member's specific benefit plan document (e.g., Evidence of Coverage, SPD) — it supersedes this policy if conflicts exist.
Apply applicable federal/state laws and any plan-specific mandates.
Use this coverage policy and other collateral materials as guidance; evaluate each request on its own merits.

Step Therapy

Step guidance for dosing/formulation

For patients receiving ≥ 20 mg/day, direct prescribing and dispensing to the 20 mg/1 mL syringe product; no overrides are recommended for using the 10 mg/0.5 mL syringe when higher dosing is required.

Palynziq 10 mg/0.5 mL syringe: no overrides recommended.
Patients on ≥ 20 mg/day should be referred to the 20 mg/1 mL syringe formulation.

Denial Risk

Denial triggers for quantity rule

If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria in this policy and the applicable benefit plan. Claims or requests that fail to meet the quantity rule may be denied unless an exception is approved based on the policy criteria and supporting documentation.

Noncompliant requests at point of service default to policy criteria review.
Denials may occur when quantity rules are not met and no approved exception exists.

Background

Palynziq (pegvaliase-pqpz) is indicated to reduce blood phenylalanine concentrations in adults with phenylketonuria (PKU) who have uncontrolled blood phenylalanine > 600 micromol/L on existing management. Dosing is individualized with a titration schedule per the prescribing information and maintenance dosing ranging up to 60 mg/day; baseline blood phenylalanine should be obtained prior to initiation and concentrations < 30 micromol/L may warrant dose reduction or dietary modification.

This Drug Quantity Management program defines per-dispensing limits by strength and site of service and allows only the specific, enumerated exceptions. Standard retail maximums are 8 syringes for the 2.5 mg/0.5 mL syringe, 30 syringes for the 10 mg/0.5 mL syringe, and 60 syringes for the 20 mg/1 mL syringe (home delivery maximums are 8, 90, and 180 syringes, respectively). Approvals under this program are issued for 1 year.

Exceptions to these quantity limits are permitted only as described in the clinical criteria (for example, specific allowances for increased quantities when a patient requires a 60 mg/day maintenance dose or when dose adjustments are needed for very low blood phenylalanine levels). If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria; any other exception or override is considered not medically necessary.

Initial Therapy Criteria

Induction/Titration

Titration schedule per prescribing information.

Titration schedule: Induction: 2.5 mg once weekly for 4 weeks; then 2.5 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). Maintenance commonly progresses to 20 mg once daily (maintenance durations: 20 mg QD for 24 weeks, 40 mg QD for 16 weeks) with a maximum of 60 mg once daily. Additional time may be required prior to each dosage escalation based on tolerability.

Per Table 1 in prescribing information (chunk 6)

Step	Requirement
{"text":"1","status":""}\|{"text":"For patients who are receiving ≥ 20 mg/day, refer the patient to the 20 mg/1 mL syringe; no overrides recommended for the 10 mg/0.5 mL syringe.","status":""}

Quantity Limits

Palynziq 2.5 mg/0.5 mL syringe — retail limit

Product strength & formPalynziq 2.5 mg/0.5 mL syringe

Retail maximum per Rx8 syringes

Per Rx unitsyringes

Palynziq 10 mg/0.5 mL syringe — retail limit

Product strength & formPalynziq 10 mg/0.5 mL syringe

Retail maximum per Rx30 syringes

Per Rx unitsyringes

Palynziq 20 mg/1 mL syringe — retail limit

Product strength & formPalynziq 20 mg/1 mL syringe

Retail maximum per Rx60 syringes

Per Rx unitsyringes

Palynziq 2.5 mg/0.5 mL syringe (home delivery)

Product strength & formPalynziq 2.5 mg/0.5 mL syringe (home delivery)

Home delivery maximum per Rx8 syringes

Per Rx unitsyringes

Palynziq 10 mg/0.5 mL syringe (home delivery)

Product strength & formPalynziq 10 mg/0.5 mL syringe (home delivery)

Home delivery maximum per Rx90 syringes

Per Rx unitsyringes

Palynziq 20 mg/1 mL syringe (home delivery)

Product strength & formPalynziq 20 mg/1 mL syringe (home delivery)

Home delivery maximum per Rx180 syringes

Per Rx unitsyringes

Policy Summary

PayerCigna

PolicyPhenylketonuria - Palynziq Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionApprove exceptions to quantity limits only when specified clinical criteria are met; all approvals are issued for 1 year.

SourceLink

On This Page

OpenPayer

Phenylketonuria - Palynziq Drug Quantity Management Policy - Per Rx

Coverage Criteria

Coding / Clinical Thresholds

Provider Actions & Operational Notes

Background

Definitions

Initial Therapy Criteria

Continuation / Approval Duration

Step Therapy & Formulation Guidance

Quantity Limits