By Counterforce Health Team in Palynziq (pegvaliase-pqpz) —

The Complete Requirements Checklist to Get Palynziq (pegvaliase-pqpz) Covered by Aetna (CVS Health) in New Jersey

Answer Box: Getting Palynziq Covered by Aetna in New Jersey

To get Palynziq (pegvaliase-pqpz) approved by Aetna (CVS Health) in New Jersey: 1) Confirm you're ≥18 with PKU and blood phenylalanine >600 µmol/L despite dietary management, 2) Submit prior authorization through Aetna's provider portal with Medical Policy Bulletin 0933 criteria documentation, and 3) Include REMS enrollment proof and auto-injectable epinephrine prescription. If denied, New Jersey offers robust external review through the Independent Health Care Appeals Program (IHCAP) within 180 days.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Pitfalls to Avoid
  10. New Jersey Appeals Process
  11. Quick Reference Checklist

Who Should Use This Checklist

This comprehensive guide helps patients, caregivers, and healthcare providers navigate Aetna (CVS Health) prior authorization for Palynziq in New Jersey. You'll need this if you're an adult with PKU whose blood phenylalanine remains above 600 µmol/L despite dietary management and potentially sapropterin therapy.

Expected outcome: Following this checklist increases your approval chances by ensuring all Aetna Medical Policy Bulletin 0933 requirements are met upfront. Most complete submissions receive decisions within 30-45 days for standard requests.

At Counterforce Health, we help patients turn insurance denials into successful appeals by creating evidence-backed, payer-specific rebuttals. Our platform analyzes denial letters and crafts targeted responses using the exact criteria insurers use internally.

Member & Plan Basics

Coverage Verification

Before starting your prior authorization, confirm these basics:

  • Active Aetna coverage: Log into Aetna.com or call the number on your ID card
  • Plan type: Commercial, Medicare Advantage, or Medicaid (different rules apply)
  • Specialty drug coverage: Palynziq is typically on specialty tier with higher cost-sharing
  • Deductible status: Know your remaining deductible as specialty drugs often apply
Tip: Palynziq appears on the CVS Specialty Pharmacy Distribution Drug List, meaning it's dispensed via CVS Specialty under Aetna/CVS Health plans.

Clinical Criteria Requirements

Aetna Medical Policy Bulletin 0933 Criteria

Aetna covers Palynziq only when all initial approval criteria are met:

Requirement What You Need Documentation
Confirmed PKU Phenylketonuria diagnosis Newborn screen, genetic testing, or enzymatic testing results
Age ≥18 years Adult patient Date of birth verification
Baseline Phe >600 µmol/L Recent blood phenylalanine level Lab reports within 90 days showing persistent elevation
Dietary management Active phenylalanine-restricted diet Metabolic specialist notes, dietitian documentation
Prescriber qualification Metabolic/genetic specialist Provider credentials and PKU experience
REMS compliance FDA-required safety program Enrollment confirmation and epinephrine prescription

Continuation Criteria

For ongoing coverage, Aetna requires either:

  • Blood Phe ≤600 µmol/L, or
  • Clinically meaningful reduction in blood Phe from baseline

Regular monitoring every 1-3 months during titration, then at intervals determined by your metabolic specialist.

Coding & Billing Information

Essential Medical Codes

Code Type Code Description Notes
ICD-10 E70.0 Classical phenylketonuria Primary diagnosis code
HCPCS J3590 Unclassified biologics Used for Palynziq billing
NDC Varies by strength Product-specific identifier Include on all claims
Note: Palynziq lacks a unique HCPCS J-code and uses J3590 (unclassified biologics). Prior authorization is mandatory, and claims typically pend for review.

Documentation Packet Essentials

Medical Necessity Letter Components

Your letter should address each Aetna criterion explicitly:

Patient Information:

  • Full name, DOB, Aetna member ID
  • PKU diagnosis confirmation with ICD-10 E70.0
  • Date of initial diagnosis and testing method

Phenylalanine Levels:

  • Recent lab values with exact numbers, units, and dates
  • Multiple data points showing persistent elevation >600 µmol/L
  • Clear statement: "Despite appropriate therapy, Phe remains above 600 µmol/L"

Dietary Management Documentation:

  • Start date of phenylalanine-restricted diet
  • Current dietary status and specialist oversight
  • Adherence efforts and barriers addressed
  • Explicit failure statement: "Dietary management alone has been insufficient to achieve target Phe levels"

Prior Pharmacologic Therapy:

  • Sapropterin trial details (dates, doses, outcomes)
  • Documented failure, intolerance, or contraindication
  • Specific results: "No ≥30% reduction in Phe after adequate trial"

Safety and Monitoring Plan:

  • REMS enrollment confirmation
  • Auto-injectable epinephrine prescription
  • Planned monitoring schedule
  • Treatment goals (Phe <600 µmol/L or ≥20% reduction)

Required Attachments

  • Recent Phe lab reports (within 90 days)
  • Chart notes documenting PKU history and current status
  • Dietitian notes showing dietary management
  • Sapropterin trial documentation
  • REMS enrollment proof
  • Current epinephrine auto-injector prescription

Submission Process

Electronic Submission (Preferred)

  1. Access Aetna Provider Portal: Log in at Aetna's precertification page
  2. Select Specialty Pharmacy Precertification
  3. Choose Palynziq (pegvaliase-pqpz) and reference Medical Policy Bulletin 0933
  4. Complete all required fields (member ID, NPI, diagnosis, dosing)
  5. Upload supporting documentation
  6. Submit and record confirmation number

Alternative: Paper Submission

Use Aetna's Medical Exception/Prior Authorization form and fax to the specialty drug prior authorization line listed on the form.

Critical: Use the specialty drug fax number, not the standard PA fax line.

Specialty Pharmacy Requirements

PALYNZIQ REMS Program

Palynziq is distributed exclusively through REMS-certified pharmacies due to anaphylaxis risk:

Prescriber Enrollment:

  • Complete training at PALYNZIQREMS.com
  • Submit enrollment form online, fax (1-866-713-8421), or mail
  • Must prescribe auto-injectable epinephrine with every Palynziq prescription

Patient Enrollment:

  • Complete Patient Enrollment Form (PEF) and Patient Consent Form (PCF)
  • Submit via BioMarin RareConnections or fax to 1-888-863-3361
  • Receive anaphylaxis education from certified prescriber

Pharmacy Verification:

  • Confirm CVS Specialty is REMS-certified for Palynziq
  • Contact PALYNZIQ REMS at 1-855-758-7367 to verify current certified pharmacies
  • Ensure all REMS requirements are met before dispensing

After Submission: What to Expect

Decision Timeline

  • Standard requests: 30-45 days for commercial plans
  • Expedited requests: ≤72 hours when clinical urgency documented
  • Medicare Advantage: Follow Medicare organization determination timelines

Status Tracking

  • Record your confirmation number
  • Check status through Aetna provider portal
  • Contact Aetna if no response within expected timeframe
  • Document all communications with dates and reference numbers

Potential Outcomes

  • Approved: Proceed with REMS-certified pharmacy fill
  • Denied: Review denial letter for specific reasons and prepare appeal
  • More information needed: Respond promptly with requested documentation

Common Pitfalls to Avoid

Pitfall How to Avoid Fix if It Happens
Incomplete REMS enrollment Verify both prescriber and patient are enrolled before submission Complete enrollment and resubmit with proof
Missing sapropterin documentation Include detailed trial history with dates and outcomes Gather complete records and submit appeal
Outdated lab values Use Phe levels within 90 days of submission Obtain recent labs and resubmit
Wrong pharmacy network Confirm CVS Specialty is REMS-certified Verify certified pharmacy list with REMS program
Insufficient dietary documentation Include dietitian notes and metabolic specialist oversight Request detailed dietary management records

New Jersey Appeals Process

If Aetna denies your Palynziq request, New Jersey offers strong consumer protections through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals (Required First)

  1. Request written denial letter specifying unmet criteria
  2. Submit internal appeal within 180 days
  3. Include additional documentation addressing denial reasons
  4. Await decision (typically 30-60 days)

External Review Through IHCAP

After completing internal appeals, you can request external review:

Eligibility:

  • NJ-regulated plan
  • Completed internal appeals process
  • Coverage denial based on medical necessity
  • Filed within 4 months (180 days) of final denial

Process:

  • Submit directly to Maximus Federal Services (contracted by NJ)
  • Physician reviewers with appropriate specialty expertise
  • No cost to patient
  • Decision within 45 days for standard cases

Timeline:

  • Preliminary review: 5 business days
  • Full review: 45 days after all information received
  • Expedited appeals: Much shorter timeframe when delay could cause serious harm
Important: If the external review overturns Aetna's denial, the insurer must comply and cover Palynziq. This decision is binding under New Jersey law (N.J.S.A. 26:2S-11).

Getting Help

  • NJ DOBI Consumer Hotline: 1-800-446-7467
  • IHCAP-specific number: 1-888-393-1062
  • Counterforce Health can help create targeted appeals that address each denial reason with evidence-backed rebuttals

Quick Reference Checklist

Before You Start

  • Active Aetna coverage confirmed
  • PKU diagnosis documentation ready
  • Recent Phe labs (>600 µmol/L within 90 days)
  • Dietary management history documented
  • Sapropterin trial records (if applicable)
  • Metabolic specialist involved in care

REMS Requirements

  • Prescriber enrolled in PALYNZIQ REMS
  • Patient enrollment forms completed
  • Auto-injectable epinephrine prescribed
  • CVS Specialty pharmacy REMS certification verified

Submission Packet

  • Aetna PA form completed (all required fields)
  • Medical necessity letter addressing all criteria
  • Recent lab reports attached
  • Chart notes included
  • Dietitian documentation
  • Sapropterin trial records
  • REMS enrollment proof

After Submission

  • Confirmation number recorded
  • Status check schedule established
  • All communications documented
  • Appeal strategy prepared if needed

Disclaimer: This information is for educational purposes and is not medical advice. Always consult with your healthcare provider and insurance plan for specific coverage details. For questions about New Jersey insurance appeals, contact the Department of Banking and Insurance at 1-800-446-7467.

Sources & Further Reading

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