CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Akansas PASSE

Defines pharmacy benefit coverage requirements, prior authorization, dosing limits, and reauthorization criteria for Palynziq (pegvaliase-pqpz) for treatment of phenylketonuria (PKU) for CareSource Arkansas PASSE.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Akansas PASSE

Policy CodePolicy N/A

Change TypeRemoval

Effective DateJan 1, 2022

Next Review Date

Key ActionPrior authorization is required; providers must submit baseline blood phenylalanine concentration with chart notes before initiating treatment and provide chart notes showing symptomatic improvement for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Removed 'Member does not have any of the following' section

1Covered Indications

40 mgMaximum Daily Dose

12 moApproval Duration

Coverage Summary

Palynziq (pegvaliase-pqpz) is indicated for adult patients with phenylketonuria (PKU) with elevated blood phenylalanine concentrations. This policy defines pharmacy benefit coverage for CareSource Arkansas PASSE and requires prior authorization; dosing and titration follow the FDA-labeled regimen (initiate 2.5 mg subcutaneously once weekly with step-wise titration to 20 mg once daily, and may increase to a maximum of 40 mg once daily per tolerability and response). Approval durations include 12 months for initial authorization and 12 months for reauthorization when criteria are met.

Initial Therapy Criteria (Phenylketonuria)

Initial Authorization (Phenylketonuria)

Covered when ALL of the following are met:

ALL of the following

Age: Member is 18 years old or older>= 18 years
Diagnosis and lab: Member has diagnosis of phenylketonuria and has uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management> 600 micromol/L
Baseline Phe: Member's baseline blood phenylalanine concentration submitted with chart notes before initiating treatment
Dosing and approval duration: Recommended initial dosage is 2.5 mg subcutaneously once weekly for 4 weeks with step-wise titration over at least 5 weeks as tolerated to achieve 20 mg subcutaneously once daily; may consider increasing to a maximum of 40 mg subcutaneously once daily in patients who have been on 20 mg once daily continuously for at least 24 weeks and who have not achieved either a 20% reduction in blood phenylalanine concentration from pre-treatment baseline or a blood phenylalanine concentration <= 600 micromol/LMaximum 40 mg once daily
If member meets all initial requirements, medication will be approved for 12 months

Continuation / Reauthorization Criteria

Reauthorization (Phenylketonuria)

Reauthorization approved when ALL of the following are met:

ALL of the following

Clinical improvement: Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease
Response criteria: Member achieved at least a 20% reduction in blood phenylalanine concentration from pre-treatment baseline OR a blood phenylalanine concentration <= 600 micromol/L after 16 weeks of continuous treatment with the maximum dosage of 40 mg once daily>= 20% reduction OR <= 600 micromol/L after 16 weeks at 40 mg daily
Reauthorization duration: If member meets all reauthorization requirements, medication will be approved for an additional 12 months

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Palynziq is non-preferred and prior authorization is required for coverage.

Documentation Required

Submit baseline Phe level and chart notes

Providers must submit the member's baseline blood phenylalanine concentration with chart notes before initiating treatment. For reauthorization, chart notes must show symptomatic improvement (improvement of signs and symptoms) and meet the reauthorization blood Phe response thresholds.

Billing Rule

Use valid NDC and pharmacy benefit

Must use a valid NDC code and bill under the pharmacy benefit. Site of service allowed: home.

Step Therapy

Non-preferred status

Palynziq is a non-preferred product. An alternative preferred product includes Kuvan; step or preference pathways may apply.

Clinical Evidence & Regulatory Basis

Evidence: FDA approval is documented by the FDA media release and the Palynziq package insert referenced in 2018; dosing and titration in this policy reflect the FDA-labeled regimen. Definition: PKU (Phenylketonuria) — a clinically diagnosed metabolic disorder characterized by elevated blood phenylalanine concentrations requiring management and monitoring to reduce phenylalanine levels.

Background

Background: Palynziq (pegvaliase-pqpz) is indicated for adults with phenylketonuria (PKU) and elevated blood phenylalanine concentrations. This policy governs coverage under the pharmacy benefit for CareSource Arkansas PASSE, requires prior authorization, and provides dosing and titration guidance that reflects the FDA-labeled regimen (recommended initiation at 2.5 mg subcutaneously once weekly with step-wise titration over at least 5 weeks to 20 mg subcutaneously once daily, and consideration of increasing to a maximum of 40 mg once daily in specified circumstances).

Revision History

2022-01-01effective_date

Document effective date

2021-12-21revisionLatest

Removed 'Member does not have any of the following' section (flagged non-material)

2021-12-21last_review

Document last reviewed