CurrentColorado Rocky Mountain Health PlansPolicy N/A

Palynziq (pegvaliase-pqpz) prior authorization

Prior authorization requirements for Palynziq (pegvaliase-pqpz) for treatment of adult patients with phenylketonuria (PKU); applies to pharmacy benefit reviewers and prescribers managing Colorado Rocky Mountain Health Plans / UnitedHealthcare members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPalynziq (pegvaliase-pqpz) prior authorization

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of PKU diagnosis, recent blood phenylalanine >600 µmol/L, and evidence of a phenylalanine‑restricted diet.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauth period

>600initiation threshold

20% or <600reauthorization response

No sapropterin/Sephiencecombination exclusion

Coverage Criteria for Palynziq (pegvaliase-pqpz)

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Initial Authorization

Covered when ALL of the following are met:

Initial Authorization criteria: Diagnosis of phenylketonuria (PKU)

Initial Authorization criteria: Patient has a blood phenylalanine concentration greater than 600 micromol/L

Initial Authorization criteria: Patient is actively on a phenylalanine-restricted diet

Initial Authorization criteria: Patient is not receiving Palynziq in combination with sapropterin dihydrochloride or Sephience (sepiapterin)

Authorization will be issued for 12 months

Reauthorization

Covered when ALL of the following are met:

Reauthorization criteria: Documentation of positive clinical response (e.g., blood phenylalanine concentration less than 600 micromol/L, or 20% reduction in blood phenylalanine concentration from pretreatment baseline)

Reauthorization criteria: Patient is actively on a phenylalanine-restricted diet

Reauthorization criteria: Patient is not receiving Palynziq in combination with sapropterin dihydrochloride or Sephience (sepiapterin)

Authorization will be issued for 12 months

Palynziq must not be used in combination with sapropterin dihydrochloride or Sephience (sepiapterin). Requests for Palynziq when the patient is receiving either of these agents may be denied and such combination use is explicitly excluded from coverage.

Treatment with Palynziq is limited to patients with a confirmed diagnosis of phenylketonuria (PKU) who meet the documented clinical thresholds; therapy is not supported for patients without a PKU diagnosis or for those with blood phenylalanine concentrations ≤600 micromol/L unless reauthorization criteria demonstrating a positive clinical response are met. Reauthorization may be considered when response criteria (for example, blood Phe <600 micromol/L or a ≥20% reduction from pretreatment baseline) are documented.

Continuation / Reauthorization Criteria

Continuation therapy criteria

Reauthorization requirements for continued coverage:

Reauthorization: Documentation of positive clinical response (e.g., blood phenylalanine concentration less than 600 micromol/L, or ≥20% reduction from pretreatment baseline)

Reauthorization: Patient remains actively on a phenylalanine-restricted diet

Reauthorization: Palynziq is not used in combination with sapropterin dihydrochloride or Sephience (sepiapterin)

Authorization will be issued for 12 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Palynziq. Initial and reauthorization approvals are contingent on meeting the clinical criteria listed below. Authorizations are issued for up to 12 months when criteria are met.

Prior authorization required for initial and continuation therapy
Authorization duration: up to 12 months

Note

Automated Approval Processes

UnitedHealthcare programs may use automated approval and re-approval processes. In some cases, initial approvals or reauthorizations can be granted based solely on previous claims or medication history, diagnosis (ICD-10) codes, and claim logic. Automated processes and any applicable medical necessity or supply limits vary by program and therapeutic class.

Automated approval/re-approval may be based on claims, medication history, and diagnosis codes
Use of automated processes varies by program; medical necessity and supply limits may apply

Documentation Required

Required Clinical Documentation

For initial authorization, include documentation showing the patient meets ALL of the following: diagnosis of phenylketonuria (PKU); blood phenylalanine (Phe) concentration > 600 micromol/L; and evidence the patient is actively managed on a phenylalanine-restricted diet. For reauthorization, include documentation of positive clinical response (e.g., blood Phe < 600 micromol/L or ≥20% reduction from pretreatment baseline) and continued diet management. Requests missing any of these required initiation or continuation criteria may be denied or returned for more information.

Initial authorization required documentation: PKU diagnosis, recent blood Phe > 600 micromol/L, evidence of phenylalanine-restricted diet
Reauthorization required documentation: positive clinical response (blood Phe < 600 micromol/L or ≥20% reduction from baseline), continued diet management
Requests missing diagnosis, blood Phe > 600 micromol/L (for initiation), or dietary management documentation may be denied

Denial Risk

Prohibited Combination Therapy

Palynziq must not be used concomitantly with sapropterin dihydrochloride or Sephience (sepiapterin). Requests that propose combination therapy with either agent may be denied.

Combination therapy with sapropterin dihydrochloride or Sephience (sepiapterin) is not allowed
Requests proposing Palynziq plus either agent may be denied

Program rule	Description
Use of automated approval or re-approval processes
UnitedHealthcare may approve initial and re-authorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic; automated approval and re-approval processes vary by program and therapeutic class.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPalynziq (pegvaliase-pqpz) prior authorization

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of PKU diagnosis, recent blood phenylalanine >600 µmol/L, and evidence of a phenylalanine‑restricted diet.

SourceLink

On This Page

OpenPayer

Palynziq (pegvaliase-pqpz) prior authorization

Coverage Criteria for Palynziq (pegvaliase-pqpz)

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Coding and Measurement

Provider Actions and Documentation Requirements

Background

Definitions

Step Therapy / Automated Approval Rules