By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Aetna (CVS Health) in New York: Prior Authorization Forms, Appeal Process & Success Strategies

Answer Box: Getting Givlaari (givosiran) Covered by Aetna (CVS Health) in New York

Fastest Path to Approval: Submit prior authorization through CVS Specialty with: (1) elevated urine PBG/ALA lab results, (2) documented ≥4 attacks per year requiring hospitalization or hemin, and (3) specialist prescriber letter. Timeline: 30-45 days for standard review, 72 hours expedited. If denied: File internal appeal within 180 days, then external review through NY Department of Financial Services within 4 months. Start today: Call CVS Specialty at 1-800-237-2767 to initiate prior authorization.

Table of Contents

  1. When Alternatives Make Sense
  2. Typical Alternatives to Givlaari
  3. Pros & Cons Overview
  4. Exception Strategy for Givlaari
  5. Switching Logistics
  6. Re-trying for Givlaari Later
  7. Appeals Playbook for Aetna (CVS Health) in New York
  8. Common Denial Reasons & Fixes
  9. FAQ

When Alternatives Make Sense

If Aetna (CVS Health) denies Givlaari (givosiran) for your acute hepatic porphyria (AHP), you might wonder about alternatives. The reality is stark: there are virtually no equivalent alternatives to Givlaari for chronic AHP prevention.

Givlaari is the only FDA-approved medication specifically designed to prevent AHP attacks through monthly injections. According to Aetna's medical policy, the primary alternative remains IV hemin (Panhematin), but this presents significant limitations for long-term use.

When alternatives might be appropriate:

  • You're experiencing frequent but manageable attacks (fewer than 4 per year)
  • Givlaari's monthly injection schedule isn't feasible for your lifestyle
  • You're waiting for prior authorization approval and need interim management
  • Cost considerations make alternatives necessary while appealing

Contraindications to consider:

  • Chronic hemin use carries risks of iron overload and venous access complications
  • Some patients develop tolerance to hemin over time
  • Trigger avoidance alone rarely prevents severe, recurrent attacks

Typical Alternatives to Givlaari

Primary Alternative: IV Hemin (Panhematin)

Mechanism: Provides exogenous heme to suppress ALAS1 enzyme activity, reducing toxic porphyrin precursor accumulation.

Usage patterns:

  • Acute treatment: 3-4 mg/kg daily for 3-4 days during attacks
  • Prophylactic use: Some specialists prescribe weekly or bi-weekly infusions for patients with frequent attacks, though this is off-label

Access considerations: Usually covered by Aetna for acute episodes; prophylactic use may require prior authorization and specialist justification.

Supportive Measures

Trigger avoidance:

  • Medication screening (avoiding porphyrinogenic drugs)
  • Nutritional counseling (maintaining adequate carbohydrate intake)
  • Stress management and sleep hygiene

Symptom management:

  • Pain control during acute episodes
  • Anti-nausea medications
  • IV glucose for mild attacks
Note: These supportive measures are essential regardless of which primary therapy you use, but they're insufficient alone for patients with severe, recurrent AHP.

Pros & Cons Overview

Treatment Option Access/Coverage Monitoring Requirements Effectiveness
Givlaari Prior auth required; specialty pharmacy Monthly liver/kidney function, homocysteine Reduces attacks by ~70% in clinical trials
IV Hemin (acute) Usually covered for episodes Basic labs during treatment Effective for acute episodes
IV Hemin (prophylactic) May require prior auth Iron studies, venous access monitoring Variable; some patients develop tolerance
Supportive care only Generally covered None specific Limited effectiveness for severe AHP

Access considerations for New York patients:

  • Specialty pharmacies must coordinate with Aetna's CVS Caremark network
  • Home infusion services for hemin require network provider verification
  • New York's external appeal process provides additional coverage options if initial denials occur

Exception Strategy for Givlaari

Even if Givlaari isn't immediately approved, you can build a strong case for a formulary exception. Here's when and how to request coverage:

When to Request an Exception

Immediate scenarios:

  • You've tried hemin prophylaxis with inadequate response or intolerable side effects
  • Frequent hospitalizations demonstrate inadequate control with standard therapies
  • Quality of life significantly impacted despite optimal supportive care

Documentation requirements:

  • Detailed attack diary with dates, symptoms, and healthcare utilization
  • Lab results showing elevated ALA/PBG levels during symptomatic periods
  • Records of hemin treatments and their effectiveness/tolerability

Evidence That Helps

Clinical documentation:

  • Specialist letter detailing attack frequency and severity
  • Hospital discharge summaries from AHP-related admissions
  • Emergency department records showing recurrent presentations
  • Failed medication trials (if applicable)

Literature support:

  • FDA prescribing information demonstrating Givlaari's approved indication
  • Clinical trial data showing efficacy in reducing attack frequency
  • Professional society guidelines supporting use in severe AHP
From our advocates: "We've seen strongest success when patients document every healthcare interaction related to AHP for at least 6 months before requesting coverage. Emergency room visits, specialist appointments, even urgent care—it all builds the case that standard treatments aren't sufficient."

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to identify specific coverage criteria, then drafting point-by-point rebuttals that align with the insurer's own rules.

Switching Logistics

If you're currently using hemin and want to transition to Givlaari, coordination is essential:

Pre-Switch Preparation

  1. Insurance verification: Confirm Givlaari coverage and any step therapy requirements
  2. Specialty pharmacy enrollment: CVS Specialty typically handles Givlaari distribution
  3. Baseline monitoring: Complete liver function tests, kidney function, and homocysteine levels
  4. Provider coordination: Ensure your specialist can administer monthly injections

Transition Timeline

Weeks 1-2: Submit prior authorization with complete documentation Weeks 3-4: Await determination; prepare appeal materials if needed Week 5+: If approved, schedule first injection and establish monitoring schedule

Monitoring Requirements

According to the FDA prescribing information, patients require:

  • Monthly liver function tests for first 6 months
  • Annual kidney function assessment
  • Periodic homocysteine monitoring
  • Regular specialist follow-up

Re-trying for Givlaari Later

If your initial request is denied, document everything during your trial of alternatives:

What to track:

  • Attack frequency and severity while on alternative therapy
  • Healthcare utilization (ER visits, hospitalizations, specialist appointments)
  • Side effects or complications from hemin or other treatments
  • Impact on work, school, and daily activities

When to resubmit:

  • After 6-12 months of documented inadequate response to alternatives
  • Following any significant change in attack pattern or severity
  • If new clinical evidence becomes available supporting Givlaari use

Strengthening your case:

  • Maintain detailed symptom diary
  • Collect all medical records from AHP-related healthcare encounters
  • Work with your specialist to document treatment failures objectively

Appeals Playbook for Aetna (CVS Health) in New York

Internal Appeals Process

Timeline: 180 days from denial to file internal appeal Method: Submit through Aetna member portal or mail to address on denial letter Required documents: Original denial letter, prescriber statement, supporting medical records

External Review Through New York DFS

If Aetna upholds the denial after internal appeal, New York residents have robust external review rights:

Timeline: 4 months from final adverse determination Cost: $25 fee (waived for Medicaid or financial hardship) Process: Submit application to NY Department of Financial Services Decision timeline: 30 days standard, 72 hours expedited (24 hours for non-formulary drugs)

Expedited review criteria:

  • Delay could seriously harm your health
  • You're currently hospitalized
  • Undergoing active treatment that could be interrupted
Tip: New York's external review decisions are binding on Aetna and include reimbursement of your appeal fee if the denial is overturned.

Common Denial Reasons & Fixes

Denial Reason How to Overturn
Insufficient attack documentation Submit detailed attack diary with specific dates, symptoms, and healthcare utilization records
Missing biochemical confirmation Provide urine ALA/PBG levels during symptomatic periods with reference ranges
Non-specialist prescriber Transfer care to hematologist, hepatologist, or gastroenterologist familiar with porphyria
Experimental/investigational Cite FDA approval for AHP and submit clinical trial efficacy data
Step therapy not completed Document hemin trials with specific dates, doses, and reasons for discontinuation

For complex appeals, platforms like Counterforce Health can help identify specific denial reasons and craft targeted rebuttals using the insurer's own policy language and clinical evidence requirements.

FAQ

How long does Aetna (CVS Health) prior authorization take in New York? Standard review takes 30-45 days. Expedited review (for urgent medical needs) takes 72 hours. Submit through CVS Specialty at 1-800-237-2767.

What if Givlaari is non-formulary on my plan? Request a formulary exception with detailed medical necessity documentation. If denied, appeal through Aetna's internal process, then New York's external review system.

Can I request an expedited appeal in New York? Yes. If waiting for standard appeal timeline could harm your health, request expedited review. New York DFS provides decisions within 72 hours (24 hours for drug denials).

Does step therapy apply if I've failed treatments outside New York? Medical records from any state are valid. Document previous treatment failures with specific dates, medications tried, and reasons for discontinuation.

What counts as adequate attack documentation? Aetna typically requires ≥4 attacks per year with specific dates, each requiring hospitalization, emergency care, or hemin administration. Generic statements aren't sufficient.

How much does Givlaari cost without insurance? List price is approximately $575,000 annually. Alnylam offers patient assistance programs - check alnylamassist.com for eligibility.

Can my primary care doctor prescribe Givlaari? Aetna requires specialist prescribers (hematology, hepatology, gastroenterology) familiar with porphyria management and monitoring requirements.

What happens if external review overturns Aetna's denial? Aetna must cover the treatment and reimburse your $25 appeal fee. The decision is legally binding and cannot be appealed by the insurer.

Disclaimer: This information is for educational purposes only and is not medical advice. Coverage policies vary by specific plan and may change. Always verify current requirements with Aetna (CVS Health) and consult your healthcare provider for medical decisions.

Need help with your appeal? Contact Community Health Advocates at 888-614-5400 for free assistance with New York insurance appeals, or visit the NY Department of Financial Services for external review information.

Sources & Further Reading

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