By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Aetna CVS Health in Pennsylvania: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Givlaari Covered by Aetna CVS Health in Pennsylvania

Yes, Givlaari (givosiran) can be covered by Aetna CVS Health in Pennsylvania, but requires prior authorization. Submit your PA request through Availity.com with complete AHP documentation including elevated ALA/PBG levels and attack history. If denied, Pennsylvania's new external review program has a 50% success rate overturning specialty drug denials. Start today: Have your provider submit the PA with biochemical confirmation and step therapy documentation—most approvals come within 24-72 hours when complete.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Required Documentation
  4. Step Therapy Requirements
  5. Timing and Deadlines
  6. Common Denial Reasons & Solutions
  7. Appeals Process in Pennsylvania
  8. Costs and Financial Assistance
  9. Renewal Requirements
  10. Specialty Pharmacy Transfer
  11. Frequently Asked Questions

Coverage Basics

Is Givlaari Covered by Aetna CVS Health?

Givlaari (givosiran) requires prior authorization from Aetna CVS Health for all members in Pennsylvania. The medication appears on Aetna's 2024 precertification list as a specialty drug, meaning coverage will not be granted without approved prior authorization.

Which Aetna Plans Cover Givlaari?

All Aetna CVS Health commercial plans in Pennsylvania follow the same prior authorization requirements for Givlaari, including:

  • Employer-sponsored plans
  • Individual/family marketplace plans (through Pennie)
  • Aetna Better Health Pennsylvania (Medicaid)

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Clinic): Collect insurance card, attack history, elevated ALA/PBG lab results, genetic testing if available, and hemin trial records.
  2. Submit PA Request (Provider): Use Availity provider portal or EHR system integration. Include all required clinical documentation.
  3. Track Status (Provider/Patient): Monitor through Availity or call the number on your member ID card. Most decisions within 24-72 hours for complete submissions.
  4. Specialty Pharmacy Setup (Upon Approval): Aetna will transfer prescription to CVS Specialty or approved network pharmacy for dispensing.
  5. Financial Assistance Enrollment (Patient): Apply for Alnylam Assist copay program if you have commercial insurance.
  6. Schedule First Dose (Patient/Clinic): Coordinate monthly subcutaneous injection schedule with healthcare provider.
  7. Set Renewal Reminder (Patient/Clinic): Mark calendar for reauthorization 30-45 days before current approval expires.

Required Documentation

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Must be approved before coverage Availity portal Aetna PA List
Biochemical Confirmation Elevated ALA/PBG levels (≥4x normal) Lab reports during/after attacks AHP Testing Guidelines
Step Therapy Trial/failure of hemin therapy Medical records, hospital notes PA Requirements
Genetic Testing AHP subtype confirmation Gene panel results (HMBS, CPOX, PPOX) Invitae AHP Panel
Specialist Prescriber Often required for approval Hepatologist, hematologist, or geneticist Varies by plan

Clinician Corner: Medical Necessity Letter Checklist

Your medical necessity letter should include:

Clinical Problem:

  • Confirmed acute hepatic porphyria diagnosis with genetic testing results
  • Attack frequency and severity (hospitalizations, ER visits)
  • Elevated urinary ALA and PBG levels (include specific values and dates)

Prior Treatments and Outcomes:

  • Hemin (Panhematin) trial with documented failure or intolerance
  • Trigger avoidance measures attempted
  • Healthcare utilization despite current management

Clinical Rationale:

Monitoring Plan:

  • Monthly liver function tests for first 6 months
  • Renal function monitoring
  • Attack frequency tracking
  • Weight-based dosing calculations (2.5 mg/kg monthly)

Step Therapy Requirements

Hemin Documentation Required

Aetna CVS Health typically requires documented failure or intolerance of hemin (Panhematin) before approving Givlaari. Acceptable documentation includes:

  • Treatment Records: Hospital or infusion center records showing hemin administration
  • Failure Evidence: Continued attacks despite hemin therapy, inadequate attack reduction
  • Intolerance Documentation: Adverse reactions, difficulty with IV access, iron accumulation concerns
  • Contraindications: Medical reasons preventing hemin use (vascular access issues, iron overload)
Note: Once approved for Givlaari, patients cannot receive concomitant prophylactic hemin but may still receive hemin for breakthrough acute attacks.

Timing and Deadlines

Prior Authorization Timeline

  • Standard Review: 30 days maximum, most decisions within 24-72 hours when complete
  • Expedited Review: 72 hours for urgent medical situations
  • Incomplete Submissions: Additional 14 days for missing information

Appeal Deadlines in Pennsylvania

  • Internal Appeal: 180 days from denial notice
  • External Review: 4 months from Final Adverse Benefit Determination letter
  • Expedited Appeals: 72 hours for urgent situations

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documents
Missing biochemical confirmation Submit elevated ALA/PBG lab results Urine porphyrin studies showing ≥4x elevation
Insufficient attack history Document qualifying attacks in past 6-12 months Hospital records, ER visits, hemin use
No step therapy trial Provide hemin failure/intolerance evidence Treatment records, adverse event documentation
Non-specialist prescriber Transfer to appropriate specialist Hepatologist, hematologist, or geneticist
"Experimental/investigational" Cite FDA approval and clinical evidence FDA label, published studies, guidelines

Appeals Process in Pennsylvania

Pennsylvania's External Review Advantage

Pennsylvania launched its Independent External Review Program in January 2024, providing a powerful tool for overturning Aetna denials. Key statistics: 50% of external reviews are decided in favor of patients, with 259 successful appeals in the program's first year.

Internal Appeal Process (Required First Step)

  1. File Within 180 Days: Submit appeal through Aetna member portal or by phone
  2. Include New Evidence: Additional clinical documentation, peer-reviewed studies, specialist letters
  3. Request Peer-to-Peer: Ask for physician-to-physician review if clinical complexity warrants
  4. Timeline: Standard appeals decided within 30 days, expedited within 72 hours

Pennsylvania External Review Process

After receiving your Final Adverse Benefit Determination:

  1. Submit Request: File through Pennsylvania Insurance Department website within 4 months
  2. Independent Review: Third-party physicians review your case within 45 days
  3. Additional Evidence: You have 15 days after assignment to submit supporting information
  4. Binding Decision: If overturned, Aetna must provide coverage immediately, including retroactive coverage
Pennsylvania Advantage: Contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388 for free guidance through the external review process.

Costs and Financial Assistance

Alnylam Assist Program

Commercial Insurance Patients (including Aetna CVS Health) may qualify for:

  • Copay Program: Reduce out-of-pocket costs to as low as $0
  • Enrollment: Call 1-833-256-2748 or have provider submit Start Form
  • Eligibility: Must not have Medicare, Medicaid, or government insurance

Uninsured/Underinsured Patients:

  • Patient Assistance Program: May provide Givlaari at no cost based on financial criteria
  • Application: Through healthcare provider and Alnylam Assist

Coverage Through CVS Specialty

Once approved, Givlaari is typically dispensed through:

  • CVS Specialty Pharmacy (preferred)
  • Other Aetna-contracted specialty pharmacies
  • Prior authorization transfers automatically with prescription

Renewal Requirements

Annual Reauthorization

Submit renewal 30-45 days before expiration with:

  • Updated Clinical Response: Attack frequency reduction data
  • Current Weight: For accurate dosing calculations
  • Liver Function Tests: Recent results (monthly monitoring required)
  • Adherence Documentation: ≥85% adherence to monthly dosing
  • Specialist Attestation: Continued medical necessity

Specialty Pharmacy Transfer

Why Prescriptions Are Transferred

Givlaari requires specialty pharmacy handling due to:

  • Cold storage requirements
  • Patient education needs
  • Injection training support
  • Insurance coordination complexity

What to Expect

  • Automatic Transfer: Upon PA approval, prescription moves to CVS Specialty
  • Patient Contact: Specialty pharmacy will call to coordinate delivery
  • Injection Training: Healthcare provider administration required
  • Ongoing Support: Monthly refill coordination and clinical monitoring

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Pennsylvania? Most complete submissions are approved within 24-72 hours. Standard timeline allows up to 30 days, with expedited review available for urgent situations within 72 hours.

What if Givlaari is non-formulary on my plan? Request a formulary exception through the same prior authorization process. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I request an expedited appeal in Pennsylvania? Yes, expedited appeals are available for urgent medical situations. Both Aetna internal appeals (72 hours) and Pennsylvania external reviews (72 hours for urgent cases) offer expedited timelines.

Does step therapy apply if I failed hemin outside Pennsylvania? Yes, documented hemin failure from any location is acceptable. Include complete medical records showing trial, outcomes, and reasons for discontinuation.

What happens if I'm already on Givlaari and switch to Aetna? Submit prior authorization immediately upon plan change. Include current treatment response data, attack reduction documentation, and specialist attestation of ongoing medical necessity.

How much will Givlaari cost with Aetna CVS Health? Costs vary by plan design. With commercial insurance and Alnylam Assist copay program, out-of-pocket costs may be reduced to $0. Contact Alnylam Assist at 1-833-256-2748 for specific assistance.

From our advocates: "We've seen Pennsylvania patients successfully overturn Givlaari denials by combining thorough biochemical documentation with the state's new external review process. One key tip: don't wait for internal appeals to finish—start gathering additional clinical evidence immediately, as you can submit new information during external review. The 50% success rate reflects the power of independent medical review when cases are well-documented."

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-backed, payer-specific strategies. Our platform analyzes denial letters and plan policies to create targeted rebuttals that address specific coverage criteria, helping streamline the prior authorization and appeals process for complex medications like Givlaari.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Prior authorization requirements and appeal processes may change. Always consult with your healthcare provider and insurance plan for current requirements and personalized guidance.

Sources & Further Reading

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