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

How to Get Palynziq (pegvaliase-pqpz) Covered by Humana in Virginia: Forms, Appeals, and Provider Resources

Quick Answer: Getting Palynziq (pegvaliase-pqpz) Covered by Humana in Virginia

Palynziq requires prior authorization from Humana for all Virginia members with PKU whose phenylalanine levels exceed 600 µmol/L. Your fastest path to approval: 1) Have your prescriber complete Humana's prior authorization form and fax to 1-888-447-3430, 2) Include comprehensive clinical documentation showing failed dietary management and current Phe levels, 3) If denied, file an internal appeal within 65 days, then request external review through Virginia's Bureau of Insurance within 120 days. Virginia's external review process has overturned many specialty drug denials when proper documentation is provided.

Table of Contents

Coverage Requirements & Plan Verification

Before starting your Palynziq (pegvaliase-pqpz) request, verify your specific Humana plan type and formulary status. All Humana plans in Virginia require prior authorization for this specialty medication, which treats phenylketonuria (PKU) in adults.

Coverage at a Glance

Requirement Details Where to Verify Source
Prior Authorization Required for all plans Humana PA Search Tool Humana Provider Portal
Age Restriction Adults only (18+) FDA prescribing information FDA Access Data
Diagnosis Requirement PKU with Phe >600 µmol/L Plan medical policy Humana Formulary
Step Therapy May require sapropterin trial Plan-specific UHC Provider Guidelines
REMS Enrollment Mandatory due to anaphylaxis risk FDA requirement FDA REMS Program
Note: Virginia Medicaid members with Humana Healthy Horizons follow the same PA requirements but may use Virginia-specific forms.

Forms & Documentation Needed

Your prescriber must complete the official Humana Prior Authorization Request Form available through their provider portal. The submission requires:

Essential Clinical Documentation

  • Current phenylalanine levels (must be >600 µmol/L)
  • PKU diagnosis confirmation with ICD-10 code E70.0
  • Dietary management history and outcomes
  • Previous medication trials (especially sapropterin/Kuvan if BH4-responsive)
  • Contraindications to formulary alternatives
  • REMS program enrollment confirmation

Medical Necessity Letter Checklist

Your prescriber should include a detailed letter addressing:

  • Why dietary management alone is insufficient
  • Results of prior BH4 cofactor trials (if applicable)
  • Expected clinical outcomes with Palynziq
  • Monitoring plan for phenylalanine reduction
  • Risk assessment for anaphylaxis management
Clinician Tip: Reference the FDA prescribing information and published PKU management guidelines to strengthen your medical necessity argument.

Submission Portals & Methods

  • Availity Essentials Portal: Log in and navigate to pharmacy prior authorization section
  • Humana Provider Portal: Access through provider.humana.com
  • PromptPA: Available for select providers

Fax Submission

  • Primary Fax: 1-888-447-3430 (Humana Medication Intake Team)
  • Cover sheet: Include member ID, prescriber NPI, and "URGENT - PKU MEDICATION"
  • Virginia Medicaid: 502-508-9300 (for Humana Healthy Horizons members)

Phone Support

  • Provider Line: Contact for submission guidance and status updates
  • Expedited Requests: Call if patient requires urgent approval due to clinical deterioration

Specialty Pharmacy Setup

Palynziq must be dispensed through CenterWell Specialty Pharmacy, Humana's in-house specialty provider, once approved.

CenterWell Specialty Pharmacy Contacts

  • Provider Fax: 1-877-405-7940 (prescriptions only)
  • Provider Phone: 1-800-486-2668 (TTY: 711)
  • Hours: Monday-Friday 8 AM-11 PM ET, Saturday 8 AM-6:30 PM ET

Transfer Process

  1. E-prescribe to "CenterWell Specialty Pharmacy" in your system
  2. Fax prescription using CenterWell specialty forms
  3. Case management will contact patient for delivery coordination
  4. REMS training completed before first shipment
Important: Patients cannot transfer existing Palynziq prescriptions from other specialty pharmacies until CenterWell processes the new prescription and PA approval.

Support Lines & Case Management

For Providers

  • Prior Authorization Status: 1-800-486-2668
  • Clinical Programs: Same number for medication therapy management
  • Peer-to-Peer Reviews: Request through provider line when PA is denied

For Patients

  • Member Services: Number on back of insurance card
  • CenterWell Patient Support: 1-800-486-2668
  • Financial Assistance: Available through CenterWell clinical programs

What to Ask When Calling

  • "What's the status of PA request for member [ID] for Palynziq?"
  • "What additional documentation is needed?"
  • "Can we request an expedited review due to clinical urgency?"
  • "Is a peer-to-peer review available with the medical director?"

Appeals Process in Virginia

If your initial PA request is denied, Virginia provides robust appeal rights through multiple levels.

Internal Appeals (Humana)

  • Timeline: 65 days from denial notice
  • Method: Submit through member portal or mail to address on denial letter
  • Documentation: Include new clinical information, peer-reviewed studies, specialist recommendations

External Review (Virginia State)

  • Eligibility: After completing internal appeals or if Humana fails to respond timely
  • Timeline: 120 days from final internal denial
  • Form: Virginia Form 216-A (External Review Request)
  • Submission: Mail to State Corporation Commission Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218

Expedited Reviews

  • Criteria: Doctor certifies that delay could jeopardize health
  • Timeline: 72 hours for urgent cases
  • Form: Include Form 216-C (Physician Certification) with 216-A
Virginia Advantage: The state's external review process has successfully overturned specialty drug denials when independent medical experts review the case. Contact the Bureau of Insurance at 1-877-310-6560 for guidance.

Common Denial Reasons & Solutions

Denial Reason How to Address Documentation Needed
"Not meeting age criteria" Confirm patient is 18+ Birth certificate, ID copy
"Phe levels not documented" Submit recent lab results Labs showing Phe >600 µmol/L
"Dietary management not optimized" Show compliance and failure Nutritionist notes, food logs
"Step therapy not completed" Document sapropterin trial Trial results, intolerance notes
"REMS not enrolled" Complete enrollment REMS confirmation letter
"Not medically necessary" Strengthen clinical rationale Specialist consultation, guidelines

Cost Assistance Programs

Even with insurance approval, Palynziq's high cost (~$130,000-$443,000 annually) may create financial barriers.

Available Assistance

  • BioMarin Patient Assistance Program: Income-based free drug program
  • CenterWell Financial Assistance: Available through case management
  • PKU Foundation Grants: Emergency assistance for eligible families
  • Virginia State Programs: Check eligibility for additional state-based support

Contact information and applications are available through CenterWell case management at 1-800-486-2668.

FAQ

How long does Humana prior authorization take in Virginia? Standard PA decisions are typically made within 14 business days. Expedited requests (with physician certification of urgency) are processed within 72 hours.

What if Palynziq is not on Humana's formulary? Submit a formulary exception request using the Medicare Coverage Determination Form along with medical necessity documentation.

Can I request an expedited appeal in Virginia? Yes. If your doctor certifies that waiting could seriously jeopardize your health, Virginia provides expedited external review within 72 hours using Form 216-C.

Does step therapy apply if I've tried sapropterin outside Virginia? Yes, but you must provide documentation of the trial and failure/intolerance from your previous provider. Out-of-state medical records are accepted.

What happens if my appeal is denied? After exhausting Humana's internal appeals, you can file for external review through Virginia's Bureau of Insurance. Their decision is binding on the insurer.

How do I transfer my prescription to CenterWell? Your prescriber must send a new prescription directly to CenterWell Specialty Pharmacy. Existing prescriptions cannot be transferred; they must be newly written and submitted.

Getting specialized help with insurance approvals can make all the difference in complex cases like Palynziq coverage. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create targeted rebuttals that address payers' specific requirements—exactly what's needed for high-cost specialty medications like Palynziq in Virginia's complex insurance landscape.

For patients and providers navigating Palynziq approvals with Humana in Virginia, having expert support can significantly improve approval rates. Counterforce Health specializes in transforming denials into approvals by crafting appeals that meet each payer's exact criteria, including the detailed clinical documentation and policy-specific arguments that Humana requires for PKU treatments.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual circumstances and plan details. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with Virginia insurance regulations, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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