By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Aetna (CVS Health) in Illinois: Prior Authorization Guide and Appeal Process

Answer Box: Getting Givlaari Covered by Aetna in Illinois

Aetna (CVS Health) requires prior authorization for Givlaari (givosiran) with documentation of at least 4 acute hepatic porphyria attacks per year and elevated urine ALA/PBG levels. Submit requests via phone (855-582-2025), fax (855-330-1716), or mail to Aetna PA, 1300 E. Campbell Rd., Richardson, TX 75081. Standard decisions take 72 hours; expedited reviews take 24 hours. If denied, you have 180 days to appeal internally, then 30 days for Illinois external review through the Department of Insurance. Start by gathering attack documentation, lab results, and having your specialist complete the medical necessity letter.

Table of Contents

  1. When Givlaari Makes Sense vs. Alternatives
  2. Typical Formulary Alternatives
  3. Coverage Requirements at a Glance
  4. Step-by-Step: Fastest Path to Approval
  5. Common Denial Reasons & How to Fix Them
  6. Appeals Process in Illinois
  7. Exception Strategy for Non-Formulary Status
  8. Switching Logistics
  9. Re-trying for Givlaari Later
  10. FAQ

When Givlaari Makes Sense vs. Alternatives

Givlaari (givosiran) is the only FDA-approved medication specifically designed to prevent recurrent acute hepatic porphyria (AHP) attacks. Unlike IV hemin (Panhematin), which treats acute attacks, Givlaari works as a monthly subcutaneous injection to reduce the frequency of attacks by suppressing hepatic ALAS1.

Givlaari is typically appropriate when:

  • You're experiencing 4 or more acute attacks per year requiring hospitalization or urgent care
  • You have elevated urine porphobilinogen (PBG) or aminolevulinic acid (ALA) levels
  • You're currently using prophylactic hemin infusions
  • Standard trigger avoidance isn't sufficient to control symptoms

Key advantages over alternatives:

  • Only chronic prevention therapy approved by FDA
  • Monthly self-injection vs. frequent IV infusions
  • Clinical trials showed 70% reduction in attack frequency
  • 96% reduction in hemin use in long-term studies

Typical Formulary Alternatives

Aetna's formulary includes limited options for AHP management, as Givlaari represents the first targeted therapy for this rare condition.

Primary Alternative: IV Hemin (Panhematin)

Coverage status: Covered for acute attacks; prophylactic use requires prior authorization Mechanism: Provides exogenous heme to suppress ALA synthase Administration: IV infusion, typically 3-4 mg/kg/day for 4 days during attacks Pros: Established therapy, effective for acute management Cons: Requires IV access, iron accumulation risk, not FDA-approved for prevention

Supportive Care Options

Glucose administration: IV dextrose for mild attacks Symptom management: Pain control, antiemetics, electrolyte correction Trigger avoidance: Medication review, dietary counseling Coverage: Generally covered as standard medical care

Note: No other medications match Givlaari's mechanism or FDA indication for AHP prevention. Step therapy typically requires documented failure or intolerance of hemin before Givlaari approval.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Givlaari prescriptions Aetna provider portal or PA forms Aetna PA Process
Specialist Prescriber Hematologist, hepatologist, or gastroenterologist Provider directory CVS Specialty Network
Attack Documentation ≥4 attacks/year with hospitalization or urgent care Medical records, discharge summaries Clinical documentation
Laboratory Evidence Elevated urine ALA/PBG (≥4x upper normal) Lab reports from attacks Porphyria diagnostic testing
Step Therapy Trial/failure of hemin or contraindication Prior therapy records Medical necessity letter
Quantity Limits 2.5 mg/kg monthly dosing Prescription details FDA prescribing information

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient + Clinic)

Timeline: 1-2 weeks before submission

  • Insurance card and member ID
  • Complete attack history with dates, treatments, hospitalizations
  • Laboratory results showing elevated ALA/PBG during attacks
  • Records of prior hemin use or contraindications
  • Current weight for dosing calculation

2. Specialist Evaluation and Prescription (Clinic)

Timeline: 1-2 clinic visits

  • Porphyria specialist consultation (required by Aetna)
  • Medical necessity letter detailing attack frequency, severity, and treatment failures
  • Prescription with appropriate ICD-10 codes (E80.21 for acute intermittent porphyria)

3. Submit Prior Authorization Request (Clinic)

Timeline: Same day as prescription

  • Phone: 855-582-2025 (fastest for urgent cases)
  • Fax: 855-330-1716
  • Mail: Aetna PA, 1300 E. Campbell Rd., Richardson, TX 75081
  • Include all supporting documentation with initial submission

4. Follow Up and Track Status (Patient + Clinic)

Timeline: 72 hours for standard, 24 hours for expedited

  • Call Aetna member services to confirm receipt
  • Request expedited review if health may be jeopardized by delay
  • Document all communications with reference numbers

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Insufficient attack frequency Provide detailed attack log with dates, symptoms, treatments Hospital records, ER visits, hemin administration logs
Missing laboratory evidence Submit ALA/PBG results from acute episodes Lab reports showing ≥4x elevation during attacks
Non-specialist prescriber Transfer care or obtain co-signature Referral to hematologist/hepatologist/gastroenterologist
Lack of step therapy Document hemin trial/failure or contraindication Treatment records, adverse event documentation
"Experimental" designation Cite FDA approval and clinical guidelines FDA prescribing information, porphyria society guidelines
From Our Advocates: We've seen cases where patients were initially denied because their attack documentation was scattered across multiple hospitals. Creating a comprehensive chronological summary with all ER visits, admissions, and treatments in one document significantly improved approval rates. Don't assume the insurance company will piece together your medical history from separate records.

Appeals Process in Illinois

Illinois provides strong patient protections with specific timelines that are shorter than many states, so prompt action is essential.

Internal Appeal (First Level)

Deadline: 180 days from denial date Timeline: 15 business days for standard, 24 hours for expedited How to file: Written request to Aetna with additional medical evidence Required: Original denial letter, new supporting documentation, clinical rationale

External Review (Final Level)

Deadline: 30 days from final internal denial (shorter than most states) Timeline: 5 business days once IRO receives all materials Authority: Illinois Department of Insurance Process: Independent physician reviewer with porphyria expertise Binding: Yes, Aetna must comply with favorable decisions Cost: Free to patients

Illinois Department of Insurance Contact:

Additional Illinois Resources

  • Attorney General Health Care Helpline: 877-305-5145
  • Citizen Action/Illinois: Advocacy support for complex cases

Exception Strategy for Non-Formulary Status

If Givlaari isn't on your specific Aetna formulary, you can request a formulary exception based on medical necessity.

When to Request an Exception

  • No formulary alternatives are effective for your condition
  • You're stable on Givlaari and switching would jeopardize your health
  • Covered alternatives cause unacceptable side effects

Evidence That Helps

Clinical documentation:

  • Detailed porphyria attack history
  • Failed trials of hemin or contraindications
  • Quality of life impact assessments
  • Specialist recommendation letter

Supporting literature:

  • FDA prescribing information
  • Clinical trial data showing efficacy
  • Porphyria society treatment guidelines
  • Peer-reviewed studies on attack prevention

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned with payer policies. Their platform helps identify the specific denial basis and pulls the right clinical evidence to support your case.

Switching Logistics

Coordination with Your Care Team

Before starting Givlaari:

  • Confirm baseline liver and kidney function tests
  • Review all medications for CYP1A2/CYP2D6 interactions
  • Establish monitoring schedule with specialist
  • Arrange specialty pharmacy delivery

Pharmacy Coordination

CVS Specialty Pharmacy typically handles Givlaari:

  • Verify network coverage and copay structure
  • Arrange delivery schedule for monthly injections
  • Confirm proper storage requirements (refrigerated)
  • Set up injection training if needed

Important Restriction

You cannot receive prophylactic hemin while on Givlaari. However, hemin remains available for treating breakthrough acute attacks.

Monitoring Requirements

  • Regular liver function tests
  • Kidney function monitoring
  • Homocysteine levels (may increase with treatment)
  • Attack frequency and severity tracking

Re-trying for Givlaari Later

If initially denied, you can reapply for Givlaari coverage when your clinical situation changes or with additional evidence.

What to Document During Alternative Therapy

  • Attack frequency and severity on current treatment
  • Side effects or complications from hemin
  • Quality of life impacts
  • Healthcare utilization (ER visits, hospitalizations)
  • Work/school absences due to attacks

When to Reapply

  • After 4+ documented attacks on alternative therapy
  • If hemin becomes contraindicated or causes complications
  • When new clinical evidence supports your case
  • After formulary changes or policy updates

Strengthening Your Case

  • Maintain detailed attack diary with dates, symptoms, treatments
  • Document all healthcare encounters related to porphyria
  • Track medication adherence and response to alternatives
  • Obtain updated specialist recommendations

FAQ

How long does Aetna prior authorization take in Illinois? Standard requests: 72 hours after receiving complete documentation. Expedited requests: 24 hours if delay could jeopardize your health.

What if Givlaari is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. The process is similar to prior authorization but requires additional justification for why covered alternatives aren't suitable.

Can I request an expedited appeal in Illinois? Yes, if waiting for standard review could seriously harm your health. Both internal appeals and external reviews have expedited options with faster timelines.

Does step therapy apply if I've tried hemin outside Illinois? Yes, documentation of prior therapy from any location counts toward step therapy requirements. Ensure you have complete records of treatments and outcomes.

What's the average cost of Givlaari with Aetna coverage? This varies significantly by plan. The list price is approximately $575,000 annually, but your out-of-pocket cost depends on your specific benefits. Alnylam Assist offers copay support programs for eligible patients.

How often do Givlaari appeals succeed? While specific statistics aren't published, appeals with comprehensive medical documentation and specialist support have higher success rates. Illinois's external review process provides an additional layer of protection with binding decisions.

Can my primary care doctor prescribe Givlaari? Aetna requires prescribing by or consultation with a specialist experienced in porphyria management (hematologist, hepatologist, or gastroenterologist).

What happens if I have a breakthrough attack on Givlaari? Hemin remains available for treating acute attacks even while on Givlaari. Contact your specialist immediately for acute attack management.

Clinician Corner: Medical Necessity Letter Checklist

Essential elements for Aetna approval:

  • Patient demographics and insurance information
  • Confirmed AHP diagnosis with genetic testing or biochemical evidence
  • Complete attack history: dates, severity, treatments, hospitalizations
  • Laboratory evidence: elevated ALA/PBG levels during attacks
  • Prior therapy documentation: hemin use, outcomes, side effects
  • Clinical rationale for Givlaari: prevention of recurrent attacks
  • Dosing justification: 2.5 mg/kg monthly based on current weight
  • Monitoring plan: liver function, kidney function, attack frequency
  • Contraindications to alternatives or treatment failures
  • Quality of life impact and functional limitations

Key guideline references:

  • FDA prescribing information for Givlaari (givosiran)
  • American Porphyria Foundation treatment guidelines
  • Clinical trial data from ENVISION study

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for the most current coverage policies and medical recommendations specific to your situation.

Sources & Further Reading:

For personalized assistance with insurance appeals and prior authorization requests, Counterforce Health helps patients and clinicians navigate complex coverage decisions by analyzing denial patterns and crafting evidence-based appeals tailored to specific payer requirements.

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