CurrentMass General Brigham Health PlanPolicy N/A

Palynziq (pegvaliase-pqpz) coverage

Defines prior authorization, coverage criteria, and limits for Palynziq (pegvaliase-pqpz) under the pharmacy benefit for Mass General Brigham Health Plan Commercial/Exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPalynziq (pegvaliase-pqpz) coverage

Policy CodePolicy N/A

Change TypeMaterial revisions and quantity-limit additions

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of PKU diagnosis, age ≥18, baseline Phe ≥600 µmol/L, and prior trial or contraindication to sapropterin.

SourceLink

POLICY UPDATE CHANGES

Initial approval period changed from 33 weeks to 9 months.

Initial criteria updated to remove 'on current therapy' from diagnosis and lab requirements.

Quantity limits for Palynziq prefilled syringes were added.

Patient education requirement deleted from initial criteria.

≥600baseline Phe threshold

9 monthsinitial approval

12 monthsreauthorization

≥20% ↓

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continuation response

Commercial/Exchangeplan applicability

Coverage Criteria for Palynziq (pegvaliase-pqpz)

Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial criteria: Member has a diagnosis of phenylketonuria (PKU); Member is 18 years of age or older; Member has a baseline phenylalanine level of >=600 micromol/L; Member has had an inadequate response or adverse reaction or a contraindication to sapropterin (Kuvan)

Initial therapy criteria

Initiation: Diagnosis of PKU

Initiation: Age >= 18 years

Initiation: Baseline phenylalanine >= 600 micromol/L>=600 micromol/L

Initiation: Prior inadequate response or adverse reaction or documented contraindication to sapropterin (Kuvan)

Step therapy requirement: prior trial of sapropterin required unless inadequate response/adverse reaction/contraindication documented.

Palynziq (pegvaliase-pqpz) is designated as a specialty medication under the pharmacy benefit and must be dispensed by a contracted specialty pharmacy. Prior authorization is required for pharmacy benefit dispensing for Commercial/Exchange members. Initial approvals are granted to allow induction and titration to the therapeutic dose — initial approval duration: 9 months — and reauthorizations are issued for 12 months. Quantity limits apply to each prefilled syringe presentation: 2.5 mg/0.5 mL — 8 syringes per 28 days; 10 mg/0.5 mL — 30 syringes per 30 days; 20 mg/mL — 90 syringes per 30 days.

Initial Therapy — Authorization Requirements

Initial therapy criteria

Authorization may be granted when ALL of the following are met:

Continuation and Reauthorization Criteria

Continuation of Therapy

Requests for reauthorization will be approved when the member meets ONE of the following:

Response criteria: >= 20% reduction from baseline in blood phenylalanine20% reduction

Response criteria: Blood phenylalanine concentrations are <= 600 micromol/L<=600 micromol/L

Reauthorization criteria

Reauthorization requirements

Reauthorization:

Key Clinical Thresholds and Coding

inv-05: Baseline phenylalanine

Baseline phenylalanine threshold for initiation≥ 600 micromol/L

Supporting age requirementMember must be 18 years of age or older

Associated requirementDiagnosis of phenylketonuria (PKU) required

inv-06: Response for continuation

Response criterion for continuation>=20% reduction from baseline in blood phenylalanine

Alternative responseBlood phenylalanine concentrations ≤ 600 micromol/L

Use for reauthorization

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization required for pharmacy benefit dispensing for Commercial/Exchange members. Submit PA to the pharmacy benefit contact listed on the policy. These products are designated specialty and must be filled at a contracted specialty pharmacy.

Commercial/Exchange members only
Pharmacy benefit only
Specialty pharmacy requirement

Step Therapy

Sapropterin (Kuvan) Requirement

Prior trial of sapropterin (Kuvan) is required unless there is documented inadequate response, adverse reaction, or a contraindication to sapropterin. Documentation must indicate the trial and the reason for failure/intolerance/contraindication.

Sapropterin (Kuvan) trial required unless inadequate response/adverse reaction/contraindication documented

Step Therapy Requirements

Step	Requirement	Failure criteria
1	Prior trial of sapropterin (Kuvan) is required before initiating Palynziq (pegvaliase-pqpz)	Inadequate response, adverse reaction, or documented contraindication to sapropterin

Quantity Limits for Palynziq Presentations

inv-16: Palynziq 2.5 mg/0.5 mL prefilled syringe

Quantity limit (per 28 days)8 syringes per 28 days

Drug formulationPalynziq 2.5 mg/0.5 mL prefilled syringe

PurposeApplies to pharmacy benefit dispensing limits

inv-17: Palynziq 10 mg/0.5 mL prefilled syringe

Quantity limit (per 30 days)30 syringes per 30 days

Drug formulationPalynziq 10 mg/0.5 mL prefilled syringe

PurposeApplies to pharmacy benefit dispensing limits

Site of Care and Dispensing

Billing Rule

Dispense only via contracted specialty pharmacy

Palynziq is designated a specialty medication and must be dispensed by a contracted specialty pharmacy under the pharmacy benefit.

Definitions

inv-12: Phenylketonuria (PKU) definition

DefinitionPhenylketonuria (PKU) is a metabolic disorder characterized by elevated blood phenylalanine due to deficient phenylalanine hydroxylase activity

Target populationAdults with PKU who have uncontrolled blood phenylalanine concentrations > 600 micromol/L on existing management

Therapeutic approachTargeted by enzyme substitution therapy (e.g., Palynziq) to reduce blood Phe levels

Background

Palynziq (pegvaliase-pqpz) is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adults with phenylketonuria (PKU) who have uncontrolled blood Phe despite existing management. Therapy is targeted to adults with elevated baseline phenylalanine and typically requires induction and titration to an effective dose.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPalynziq (pegvaliase-pqpz) coverage

Policy CodePolicy N/A

Change TypeMaterial revisions and quantity-limit additions

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of PKU diagnosis, age ≥18, baseline Phe ≥600 µmol/L, and prior trial or contraindication to sapropterin.

SourceLink

On This Page

>=20% reduction from baseline in blood phenylalanine

Reauthorization: Blood phenylalanine concentrations <=600 micromol/L<=600 micromol/L

Member must meet one of the above to qualify for reauthorization

Documentation Required

Required Clinical Documentation

Provide documentation to support diagnosis, age, baseline phenylalanine level, prior sapropterin trial (including response or adverse effects), and current phenylalanine results. For reauthorization, include evidence of clinical response: either ≥20% reduction from baseline Phe or absolute Phe ≤600 µmol/L.

Diagnosis of phenylketonuria (PKU)
Member age (≥18 years)
Baseline phenylalanine level (≥600 µmol/L)
Documentation of sapropterin (Kuvan) trial and outcome or contraindication
Current phenylalanine level and percent change from baseline for continuation requests
If new to plan within 90 days, documentation of active treatment with the requested medication (samples and manufacturer patient assistance program supplies do not qualify)

Denial Risk

New-to-Plan Continuation Restriction

Authorization for members new to the plan within the past 90 days may be denied if the member is not currently receiving the medication; an exception applies when documentation shows the member is actively receiving treatment (excluding samples or manufacturer patient assistance program supplies).

New-to-plan defined as within past 90 days
Active treatment must be documented to continue therapy when new to plan

inv-18: Palynziq 20 mg/mL prefilled syringe

Quantity limit (per 30 days)90 syringes per 30 days

Drug formulationPalynziq 20 mg/mL prefilled syringe

PurposeApplies to pharmacy benefit dispensing limits