By Counterforce Health Team in Givlaari (givosiran) —

Aetna CVS Health Coverage for Givlaari (Givosiran) in Virginia: Medical Necessity Criteria and Appeals Guide

Quick Answer: Getting Givlaari (Givosiran) Covered by Aetna CVS Health in Virginia

Aetna requires prior authorization for Givlaari through CVS Specialty Pharmacy. Key requirements: confirmed acute hepatic porphyria with elevated ALA/PBG levels, 4+ attacks per year or active symptoms requiring hospitalization/hemin, age 18+, and specialist prescriber. Submit via CVS Caremark Specialty at 866-814-5506 with attack documentation and lab results. If denied, Virginia offers external review through the State Corporation Commission within 120 days. Start today: Contact your specialist to gather attack logs and recent lab results showing elevated porphobilinogen or ALA levels.

Table of Contents

  1. Policy Overview: How Aetna CVS Health Covers Givlaari
  2. Indication Requirements: What Qualifies as Medical Necessity
  3. Step Therapy & Exceptions: Prior Treatment Documentation
  4. Required Diagnostics: Lab Values and Timing
  5. Specialty Pharmacy Requirements
  6. Evidence to Support Medical Necessity
  7. Sample Medical Necessity Narrative
  8. Common Denial Reasons & Solutions
  9. Virginia Appeals Process
  10. Costs & Patient Support
  11. FAQ

Policy Overview: How Aetna CVS Health Covers Givlaari

Aetna requires precertification for all Givlaari requests across HMO, PPO, and POS plans. The drug is handled through CVS Specialty Pharmacy with specific clinical criteria that must be met before approval.

Plan Types and Coverage

  • Commercial plans: Standard prior authorization through CVS Caremark
  • Medicare Advantage: May have additional CMS requirements
  • Medicaid managed care: Subject to state formulary restrictions
Note: Self-funded employer plans may have different criteria. Check your specific plan documents or contact member services at the number on your insurance card.

Indication Requirements: What Qualifies as Medical Necessity

Aetna's clinical policy considers Givlaari medically necessary for acute hepatic porphyria when all criteria are met:

FDA-Approved Indication

  • Primary indication: Acute hepatic porphyria in adults to reduce attack frequency
  • Age requirement: 18 years or older
  • Subtypes covered: All AHP variants (AIP, HCP, VP, ADP)

Clinical Activity Requirements

Patients must demonstrate active disease through either:

  • 4 or more porphyria attacks per year, OR
  • Currently symptomatic with attacks requiring:
    • Hospitalization
    • Urgent healthcare visits
    • Intravenous hemin administration

Step Therapy & Exceptions: Prior Treatment Documentation

Hemin Trial Requirements

Most Aetna policies require documentation of:

  • Previous hemin use (Panhematin) for acute attacks
  • Inadequate response or intolerance to hemin therapy
  • Contraindications to continued hemin use

Medical Exception Pathways

Step therapy can be bypassed with documentation of:

  • Hemin contraindications (venous access issues, iron overload)
  • Previous adverse reactions to hemin
  • Clinical deterioration despite hemin therapy
Tip: Maintain detailed records of all hemin administrations, including dates, doses, and clinical outcomes.

Required Diagnostics: Lab Values and Timing

Biochemical Confirmation

Elevated levels required (documented within past 12 months):

  • Urinary porphobilinogen (PBG), OR
  • Urinary aminolevulinic acid (ALA), OR
  • Plasma porphyrin levels

Timing Considerations

  • Optimal sampling: During or immediately after acute attacks
  • Reference ranges: Must be provided with all lab results
  • Specimen type: Specify urine (preferred) or plasma collection

Attack Documentation

Maintain a detailed log including:

  • Dates and duration of each attack
  • Symptoms: Abdominal pain, neuropathy, psychiatric symptoms
  • Healthcare utilization: ER visits, hospitalizations, hemin treatments
  • Functional impact: Work/school absences, quality of life measures

Specialty Pharmacy Requirements

Prescriber Requirements

  • Specialist involvement: Hematologist, hepatologist, gastroenterologist, or porphyria specialist
  • Consultation acceptable: Primary care with specialist consultation documented

Submission Process

Contact CVS Caremark Specialty: 866-814-5506

Dosing Requirements

  • FDA-approved dosing: 2.5 mg/kg subcutaneously monthly
  • Weight-based calculations: Must align with patient's current weight
  • Administration: Healthcare provider supervised

Evidence to Support Medical Necessity

Clinical Guidelines

Reference these authoritative sources in medical necessity letters:

  • FDA prescribing information for Givlaari
  • American Porphyria Foundation treatment guidelines
  • European Porphyria Network recommendations

Peer-Reviewed Evidence

Key studies to reference:

  • ENVISION Phase 3 trial data (New England Journal of Medicine)
  • Long-term safety and efficacy studies
  • Real-world evidence publications

Documentation Best Practices

Include:

  • Patient-specific clinical history
  • Attack frequency trends
  • Previous treatment failures
  • Expected outcomes with Givlaari

Sample Medical Necessity Narrative

Clinician Corner: Use this template structure for medical necessity letters:

"[Patient name] is an [age]-year-old with confirmed acute intermittent porphyria (ICD-10: E80.21) documented by elevated urinary PBG levels of [value] (normal <2.0 mg/L) obtained on [date]. The patient has experienced [number] documented attacks in the past [timeframe], requiring [hospitalizations/hemin treatments]. Previous treatment with hemin has been [inadequate/contraindicated] due to [specific reasons]. Given the frequency and severity of attacks impacting quality of life and functional status, Givlaari is medically necessary to reduce attack frequency and prevent long-term neurological complications."

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Insufficient attack documentation Provide detailed attack log Hospital records, ER visits, hemin administration logs
Missing biochemical confirmation Submit recent lab results Elevated ALA/PBG levels with reference ranges
Step therapy not met Document hemin trial/failure Treatment records showing inadequate response
Non-specialist prescriber Obtain specialist consultation Letter from hematologist or hepatologist
Experimental/investigational Reference FDA approval FDA prescribing information, clinical guidelines

Virginia Appeals Process

Internal Appeals with Aetna

  • Timeline: Submit within 180 days of denial
  • Standard review: 30-45 days for decision
  • Expedited appeals: 72 hours for urgent requests

Virginia External Review

If internal appeals fail, Virginia law provides independent review through the State Corporation Commission Bureau of Insurance:

Timeline: Submit Form 216-A within 120 days of final denial

Process:

  1. Submit request via email ([email protected]), fax (804-371-9915), or mail
  2. Preliminary review within 7 business days
  3. Independent review decision within 45 days (72 hours if expedited)
  4. Binding decision on Aetna

Required documents:

  • Completed Form 216-A
  • Insurance card copy
  • Final denial letter
  • All internal appeal records
  • Additional clinical documentation
Virginia residents benefit from one of the nation's most consumer-friendly external review processes, with no fees and binding decisions that insurers must honor.

Costs & Patient Support

Manufacturer Support

Alnylam Assist offers:

  • Prior authorization support
  • Appeals assistance
  • Financial assistance programs
  • Copay support for eligible patients

Virginia Resources

  • Virginia Poverty Law Center: Health assistance for coverage appeals
  • SCC Consumer Services: 1-877-310-6560 for insurance questions

Counterforce Health Support

When navigating complex prior authorization requirements for specialty medications like Givlaari, many patients and providers benefit from expert appeals assistance. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements.

FAQ

How long does Aetna prior authorization take for Givlaari in Virginia? Standard reviews typically take 30-45 days. Expedited reviews for urgent medical necessity are decided within 72 hours.

What if Givlaari is non-formulary on my Aetna plan? Submit a formulary exception request with medical necessity documentation. Non-formulary status doesn't prevent coverage if medically necessary.

Can I request an expedited appeal if my attacks are frequent? Yes, if your physician certifies that waiting for standard review could seriously jeopardize your health or ability to regain function.

Does step therapy apply if I've never tried hemin? Most policies require documented hemin trial unless contraindicated. Work with your specialist to document any contraindications.

What happens if Virginia external review upholds the denial? The decision is binding, but you retain rights to pursue legal action if you believe the law was violated.

How much does Givlaari cost without insurance? The wholesale acquisition cost is approximately $41,375 per vial, with total annual costs varying based on patient weight.

From our advocates: "We've seen many Givlaari appeals succeed when patients work closely with their specialists to document attack frequency and previous treatment failures. The key is comprehensive documentation that directly addresses Aetna's specific clinical criteria. One patient's appeal was initially denied for 'insufficient attack documentation' but was approved after submitting detailed hospital records and a specialist letter explaining the attack pattern and functional impact."

When to Contact Counterforce Health

For complex denials or appeals requiring detailed policy analysis and evidence compilation, consider working with specialists who understand payer-specific requirements. Counterforce Health helps patients, clinicians, and specialty pharmacies navigate the appeals process by identifying denial basis and crafting targeted rebuttals with appropriate clinical evidence and regulatory citations.

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with Aetna and consult with your healthcare provider and insurance representative for plan-specific guidance.

Sources & Further Reading

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.