By Counterforce Health Team in Amvuttra (vutrisiran) —

How to Get Amvuttra (Vutrisiran) Covered by Aetna CVS Health in New York: Complete PA Guide with Appeals Process

Answer Box: Getting Amvuttra (Vutrisiran) Covered by Aetna CVS Health in New York

Fastest path to approval: Submit Aetna's Amvuttra precertification form with genetic testing (for hATTR-PN) or heart failure documentation (for ATTR-CM), plus evidence of contraindications to preferred alternatives like Onpattro or tafamidis. First step today: Verify your formulary tier and step therapy requirements by calling Aetna at (866) 752-7021. If denied, New York provides external appeal rights through the Department of Financial Services within 4 months, with binding decisions in 24-72 hours for urgent drug requests.

Table of Contents

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all requests Aetna PA form Aetna Policy
Formulary Status Non-preferred specialty drug 2025 Drug Guide Aetna Formulary
Step Therapy Must try Onpattro (PN) or tafamidis (CM) first Medical Policy 0939 Aetna Clinical
Age Requirement 18 years or older Medical Policy 0939 Aetna Clinical
Genetic Testing TTR mutation required for hATTR-PN Medical Policy 0939 Aetna Clinical
Appeals Deadline 180 days (standard); 4 months (external) NY DFS Appeals NY State Law

Step-by-Step: Fastest Path to Approval

1. Verify Your Coverage Status

Who does it: Patient or clinic staff
Action: Call Aetna at (866) 752-7021 to confirm formulary tier and step therapy requirements
Timeline: Same day
Tip: Ask specifically about medical exceptions to step therapy

2. Gather Required Documentation

Who does it: Healthcare team
Documents needed:

  • TTR genetic testing report (for hATTR-PN)
  • Heart failure hospitalization records or NYHA class documentation (for ATTR-CM)
  • Prior treatment history with Onpattro, tafamidis, or other ATTR therapies
  • Current lab values (sTTR, NT-proBNP if applicable)
  • Specialist evaluation (neurologist, cardiologist, or geneticist)

3. Complete the Prior Authorization Form

Who does it: Prescribing physician
Form: Amvuttra Precertification Request
Key sections: Patient demographics, ICD codes, treatment history, clinical justification
Timeline: Allow 1-2 hours for completion

4. Submit the Request

How to submit:

  • Fax: (888) 267-3277
  • Phone: (866) 752-7021 Timeline: 30-45 days for standard review; 72 hours for urgent requests

5. Monitor Decision Status

Who does it: Clinic staff
Action: Follow up if no response within expected timeline
Escalation: Request peer-to-peer review if initial denial

6. If Denied: File Internal Appeal

Timeline: Within 180 days of denial
Method: Aetna Provider Portal or mail
Decision time: 45 business days (standard); 72 hours (expedited)

7. If Still Denied: External Appeal in New York

Timeline: Within 4 months of final internal denial
Method: NY DFS External Appeal
Decision time: 24-72 hours for drug appeals

Tip: Submit your PA request 60 days before you need to start treatment to allow time for potential appeals.

Required Forms and Submission Methods

Primary Prior Authorization Form

Aetna requires the Amvuttra Precertification Request form for all initial and continuation requests. The form must include:

  • Complete patient demographics and insurance information
  • Primary and secondary ICD-10 diagnosis codes
  • Documentation of polyneuropathy manifestations (for hATTR-PN) or heart failure symptoms (for ATTR-CM)
  • Prescriber specialty confirmation (neurologist, cardiologist, geneticist, or amyloidosis specialist)
  • Prior treatment history with related medications

Submission Options

Phone: (866) 752-7021 (standard processing)
Fax: (888) 267-3277
Online: Through Aetna's provider portal (verify current link with customer service)

Required Supporting Documents

  • TTR genetic testing report
  • Specialist consultation notes
  • Prior medication trial documentation
  • Current laboratory results
  • Imaging studies (echocardiogram for ATTR-CM)

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Step therapy not completed" Document contraindications or failures with preferred drugs Prior authorization denial letters, allergy records, treatment failure notes
"Not medically necessary" Provide specialist evaluation and guideline support Neurologist/cardiologist letter, FDA label excerpts
"Experimental/investigational" Cite FDA approval and clinical evidence FDA approval letter, peer-reviewed studies, specialty society guidelines
"Missing genetic confirmation" Submit TTR gene sequencing results Genetic testing report with specific mutation identified
"Inadequate documentation" Provide comprehensive clinical records Complete medical history, staging assessments, functional evaluations

Appeals Process for New York Patients

Internal Appeal with Aetna

Deadline: 180 days from denial notice
Method: Provider appeals portal or mail to:

Aetna Better Health of New York
Appeals & Complaints
PO Box 81040
Cleveland, OH 44181

Timeline: 45 business days (standard); 72 hours (expedited)

Expedited Appeals

Available when delay could jeopardize patient health. Decisions within 36-72 hours depending on appeal level.

External Review (New York State)

New York provides independent external review through the Department of Financial Services.

Eligibility: Final adverse determination from internal appeal
Deadline: 4 months from final internal denial
Timeline: 24 hours (expedited drug appeals); 72 hours (standard drug appeals)
Cost: $25 maximum (waived for financial hardship)

Submit to:
New York State Department of Financial Services
99 Washington Avenue, Box 177
Albany, NY 12210
Fax: (800) 332-2729

Note: External review decisions are binding on both patient and insurer. If overturned, Aetna must cover the medication and refund the appeal fee.

Specialty Pharmacy Setup

Amvuttra requires specialty pharmacy dispensing through CVS Specialty or other approved networks.

Enrollment Process

  1. Start with Alnylam Assist: Complete the Start Form
  2. Fax to: 1-833-256-2747 (pages 1-2 only)
  3. Online option: Alnylam webform

CVS Specialty Coordination

An Alnylam Case Manager will coordinate with CVS Specialty for:

  • Benefit verification (within 2 business days)
  • Prior authorization status tracking
  • Delivery scheduling
  • Financial assistance enrollment

Administration Requirements

Amvuttra must be administered by a healthcare professional as a subcutaneous injection every 3 months. The medication comes as a prefilled syringe and requires proper storage and handling protocols.

Financial Assistance Options

Alnylam Assist Programs

Copay Program: Reduces out-of-pocket costs for insured patients
Patient Assistance Program: Free medication for uninsured patients meeting income criteria
Information: Visit alnylamassist.com or call 1-833-256-9526

Additional Resources

  • State pharmaceutical assistance programs
  • Foundation grants for rare diseases
  • Hospital charity care programs
From our advocates: "We've seen cases where patients initially denied for Amvuttra were approved after providing comprehensive documentation of heart failure hospitalizations and demonstrating contraindications to tafamidis. The key is thorough clinical documentation and persistence through the appeals process."

When to Escalate to State Regulators

Contact New York regulators if:

  • Aetna fails to meet appeal deadlines
  • Requests for medical records are excessive or inappropriate
  • Coverage decisions appear to violate state insurance laws

New York Department of Financial Services
Consumer Hotline: 1-800-342-3736
File a complaint online

Community Health Advocates (free assistance)
Phone: 888-614-5400
Provides free counseling on insurance denials and appeals

FAQ

How long does Aetna prior authorization take for Amvuttra in New York?
Standard requests: 30-45 days. Urgent requests: 72 hours. Submit 60 days early for complex cases to allow appeal time.

What if Amvuttra is non-formulary on my plan?
You can request a formulary exception through the standard PA process. If denied, New York's external appeal process provides independent review with binding decisions.

Can I request an expedited appeal if my doctor says treatment is urgent?
Yes. Expedited appeals are available when delay could jeopardize your health. Decisions are made within 36-72 hours.

Does step therapy apply if I tried preferred drugs in another state?
Yes, if you have documentation of prior trials and failures. Include medical records and pharmacy claims from your previous state.

What happens if my external appeal is approved?
Aetna must cover the medication immediately and refund your appeal filing fee. The decision is legally binding.

How much does Amvuttra cost without insurance?
Approximately $476,000 annually (four quarterly injections at ~$119,000 each). Financial assistance programs may significantly reduce costs.

Do I need a specialist to prescribe Amvuttra?
Aetna typically requires prescription by a neurologist, cardiologist, geneticist, or amyloidosis specialist for PA approval.

Can my pharmacy help with the prior authorization?
Yes, CVS Specialty and other specialty pharmacies often assist with PA submissions and appeals as part of their clinical services.

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeals processes for specialty medications like Amvuttra. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that align with payer-specific requirements and procedural deadlines. Learn more at counterforcehealth.org.

For comprehensive support with your Amvuttra coverage journey, Counterforce Health provides tools and expertise to turn insurance denials into successful approvals through systematic, evidence-based appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

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