By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by UnitedHealthcare in Pennsylvania: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Givlaari Covered by UnitedHealthcare in Pennsylvania

Eligibility: UnitedHealthcare requires prior authorization for Givlaari (givosiran) with specific criteria: confirmed acute hepatic porphyria diagnosis, elevated ALA/PBG levels, at least 2 documented attacks in 6 months, and specialist involvement.

Fastest Path: Have your hematologist, hepatologist, or gastroenterologist submit a complete PA request through the UnitedHealthcare provider portal with all required documentation. If denied, you can appeal internally within 180 days, then use Pennsylvania's external review program within 4 months.

First Step Today: Contact your specialist to gather attack documentation, recent lab results (ALA/PBG levels), and genetic testing results if available.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Pennsylvania External Review Process
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is Givlaari Covered by UnitedHealthcare?

Yes, but Givlaari (givosiran) requires prior authorization through UnitedHealthcare's pharmacy benefit manager, OptumRx. The medication is typically covered for patients who meet specific medical necessity criteria for acute hepatic porphyria.

Which UnitedHealthcare Plans Cover Givlaari?

  • Commercial plans: Covered with PA requirements
  • Medicare Advantage: Covered with PA requirements and additional Medicare guidelines
  • Exchange/ACA plans: Covered with PA requirements
Note: Self-funded employer plans may have different requirements. Check your specific plan documents or contact member services.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Specialist Consultation (Patient action)
    • See a hematologist, hepatologist, or gastroenterologist
    • Ensure they're familiar with acute hepatic porphyria treatment
    • Timeline: Schedule within 1-2 weeks
  2. Gather Documentation (Clinic action)
    • Recent ALA/PBG levels (within past year)
    • Attack history documentation (past 6 months)
    • Genetic testing results if available
    • Timeline: 2-3 business days
  3. Submit PA Request (Provider action)
    • Use UnitedHealthcare provider portal or OptumRx system
    • Include all required documentation
    • Timeline: Same day submission possible
  4. Initial Review (UnitedHealthcare)
    • Standard review: 15 business days
    • Expedited review: 72 hours (if urgent)
    • Automated approval possible if all criteria met
  5. Follow Up (Patient/Provider)
    • Check status via provider portal
    • Respond to any requests for additional information
    • Timeline: Within 24-48 hours of any requests

Coverage Requirements at a Glance

Requirement What it Means Where to Find It Source
Prior Authorization Must get approval before filling PA requirements list UHC PA Requirements
Specialist Prescriber Hematologist, hepatologist, or gastroenterologist PA form requirements OptumRx Formulary
Age Requirement 18 years or older FDA labeling FDA Prescribing Information
Attack History ≥2 documented attacks in past 6 months Medical necessity criteria OptumRx PA Requirements
Lab Confirmation Elevated ALA/PBG levels within past year Clinical documentation OptumRx PA Requirements

Timing and Deadlines

How Long Does UnitedHealthcare PA Take?

  • Standard review: 15 business days
  • Expedited review: 72 hours (requires urgent medical need)
  • Automated approval: Same day (if all criteria clearly met)

When to Request Expedited Review

Request expedited review if:

  • Patient is experiencing frequent attacks (>1 per month)
  • Current treatment isn't controlling symptoms
  • Risk of serious medical complications

Medical Necessity Criteria

What UnitedHealthcare Requires for Approval

Essential Documentation:

  • Confirmed diagnosis of acute hepatic porphyria (any subtype)
  • Age 18 or older
  • Prescription by qualified specialist
  • At least 2 documented porphyria attacks in past 6 months requiring:
    • Hospitalization, OR
    • Urgent care visit, OR
    • IV hemin administration
  • Elevated urinary or plasma ALA/PBG levels within past year

Additional Requirements:

  • Dosing must comply with FDA labeling (2.5 mg/kg monthly)
  • Initial approval: 6 months
  • Renewal: 12 months with documented improvement

Clinician Corner: Medical Necessity Letter Checklist

For Healthcare Providers: Your medical necessity letter should include:Patient's specific AHP subtype and genetic confirmation (if available)Detailed attack history with dates, symptoms, and interventionsLaboratory results showing elevated ALA/PBG levelsPrevious treatments tried and their outcomesClinical rationale for Givlaari vs. alternativesExpected treatment goals and monitoring plan

Key Citations to Include:FDA Prescribing Information for GivlaariAmerican Porphyria Foundation Treatment GuidelinesRelevant peer-reviewed literature on givosiran efficacy

Costs and Financial Assistance

Understanding Your Out-of-Pocket Costs

Typical UnitedHealthcare Coverage:

  • Specialty tier: Usually 25-40% coinsurance
  • Annual out-of-pocket maximum: Varies by plan ($8,700-$18,200 for 2024)

Manufacturer Support Available:

Counterforce Health specializes in helping patients navigate complex prior authorization and appeal processes for specialty medications like Givlaari. Their platform can help identify the specific denial reasons and create targeted, evidence-backed appeals that align with UnitedHealthcare's requirements.

Alnylam Assist Copay Program:

  • Eligible patients may pay as little as $0
  • Requirements: Commercial insurance (not Medicare/Medicaid)
  • Contact: 1-833-256-2748
  • Enrollment: Provider submits Start Form

Patient Assistance Program:

  • For uninsured or underinsured patients
  • Income-based eligibility
  • May provide medication at no cost

Denials and Appeals

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Insufficient attack history Provide detailed attack logs Hospital records, urgent care visits, hemin administration records
Missing lab confirmation Submit recent ALA/PBG results Lab reports within past 12 months showing elevation
Non-specialist prescriber Get specialist involvement Consultation notes from hematologist/hepatologist/gastroenterologist
Continued hemin use Demonstrate medical necessity Clinical notes explaining why both treatments needed

UnitedHealthcare Internal Appeals Process

Level 1 Internal Appeal:

  • Deadline: 180 days from denial
  • Timeline: 15 business days (standard), 72 hours (expedited)
  • How to submit: UnitedHealthcare member portal, phone, or mail

Level 2 Internal Appeal:

  • Deadline: 60 days from Level 1 decision
  • Timeline: 15 business days (standard), 72 hours (expedited)
  • Requirements: Must exhaust Level 1 first

Pennsylvania External Review Process

Pennsylvania offers one of the strongest external review programs in the country, with over 50% of appeals resulting in overturned denials.

When to Use Pennsylvania External Review

  • After completing UnitedHealthcare's internal appeals
  • Within 4 months of final denial letter
  • For medical necessity disputes
  • Not available for self-funded employer plans

Pennsylvania External Review Timeline

Standard Review:

  1. Submit request: Online at pa.gov or by mail
  2. PID notifies UnitedHealthcare: Within 1 business day
  3. Eligibility confirmation: Within 5 business days
  4. IRO assignment: Within 1 business day
  5. Submit additional evidence: Within 15 days of IRO assignment
  6. Final decision: Within 45 days of IRO assignment

Expedited Review (for urgent cases):

  • IRO assigned: Within 24 hours
  • Final decision: Within 72 hours
  • Implementation: Within 24 hours of decision

Required Documents for External Review

  • Final Adverse Benefit Determination letter from UnitedHealthcare
  • Completed Pennsylvania external review request form
  • Supporting medical documentation
  • Any additional evidence supporting medical necessity

Specialty Pharmacy Requirements

Why Givlaari Goes Through Specialty Pharmacy

Givlaari requires:

  • Cold chain storage and handling
  • Healthcare provider administration
  • Patient monitoring and support
  • Insurance verification and prior authorization coordination

UnitedHealthcare Preferred Specialty Pharmacies

UnitedHealthcare typically uses OptumRx specialty pharmacies for Givlaari. Your doctor's office will coordinate with the specialty pharmacy for:

  • Insurance verification
  • Prior authorization processing
  • Delivery scheduling
  • Administration coordination

Troubleshooting Common Issues

Portal Problems

  • Provider portal down: Call OptumRx directly at pharmacy services number
  • Missing forms: Download from UnitedHealthcare provider resources
  • Status unclear: Use member services or provider phone support

Documentation Issues

  • Missing attack records: Contact previous hospitals/urgent care facilities
  • Lab results unavailable: Request from ordering physician or lab directly
  • Specialist referral delayed: Ask primary care for urgent referral

FAQ

Q: How long does UnitedHealthcare PA take in Pennsylvania? A: Standard review takes 15 business days, but expedited review for urgent cases takes 72 hours. Pennsylvania law doesn't change UnitedHealthcare's internal timelines.

Q: What if Givlaari is non-formulary on my plan? A: Non-formulary medications can still be covered through the prior authorization process if they meet medical necessity criteria. Focus on demonstrating that formulary alternatives are inappropriate or have failed.

Q: Can I request an expedited appeal in Pennsylvania? A: Yes, both UnitedHealthcare's internal appeals and Pennsylvania's external review offer expedited timelines for urgent medical situations.

Q: Does step therapy apply if I've tried hemin outside Pennsylvania? A: Yes, documented treatment failures from any location count toward meeting step therapy requirements, as long as you have proper medical records.

Q: What happens if I pay out-of-pocket during appeals? A: If your appeal is successful, UnitedHealthcare must provide retroactive coverage. Keep all receipts and documentation of payments.

Q: Can Counterforce Health help with my UnitedHealthcare appeal? A: Yes, Counterforce Health specializes in creating targeted, evidence-backed appeals for specialty medications like Givlaari, helping identify specific denial reasons and crafting point-by-point rebuttals aligned with payer requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department's consumer services at the numbers listed on their official website.

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