By Counterforce Health Team in Amvuttra (vutrisiran) —

How to Get Amvuttra (Vutrisiran) Covered by Aetna CVS Health in New Jersey: Prior Authorization Guide and Appeal Process

Answer Box: Fast Track to Amvuttra Coverage

Aetna CVS Health requires prior authorization for Amvuttra (vutrisiran) in New Jersey with step therapy after Onpattro unless contraindicated. Submit PA with confirmed hATTR-PN or ATTR-CM diagnosis, genetic testing (TTR mutation), specialist evaluation, and documented failure/intolerance to preferred alternatives. Appeals follow a 180-day internal process, then external review through CMS-contracted Independent Review Entity. Start today: Call Aetna member services (number on your insurance card) to verify active coverage and request PA forms.

Table of Contents

Policy Overview

Aetna CVS Health covers Amvuttra (vutrisiran) under the medical benefit for hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN) and ATTR cardiomyopathy (ATTR-CM) in adults. The medication requires prior authorization across all Aetna plan types in New Jersey, including commercial HMO/PPO, Medicare Advantage, and Medicaid plans.

Key Policy Details:

  • Non-preferred formulary status requiring step therapy
  • 12-month approval periods for initial and renewal requests
  • CVS Specialty Pharmacy typically handles dispensing
  • Quarterly subcutaneous injection administered by healthcare provider

Find current Aetna precertification requirements and verify your specific plan's formulary through the member portal.

Indication Requirements

FDA-Approved Uses

Amvuttra is approved for:

  1. hATTR-PN: Hereditary transthyretin-mediated amyloidosis with polyneuropathy in adults
  2. ATTR-CM: ATTR cardiomyopathy (wild-type or hereditary) to reduce cardiovascular death, hospitalizations, and urgent heart failure visits

Documentation Needed

  • ICD-10 codes for amyloidosis (E85.1 for hereditary, E85.4 for organ-limited)
  • Specialist consultation from neurologist, cardiologist, or amyloidosis specialist
  • Genetic testing report confirming pathogenic TTR variant (for hATTR cases)
  • Cardiac imaging (echo, MRI) and bone scintigraphy (for ATTR-CM)

Step Therapy & Exceptions

Aetna typically requires trial of Onpattro (patisiran) before approving Amvuttra for hATTR-PN. Step therapy exceptions are granted for:

Medical Contraindications

  • Infusion-related reactions to Onpattro
  • Venous access issues preventing IV administration
  • Scheduling conflicts with every-3-week infusions

Documentation for Exceptions

Submit records showing:

  • Previous treatment attempts and outcomes
  • Specific adverse events or contraindications
  • Clinical rationale for Amvuttra's quarterly dosing advantage

Contact CVS Specialty Pharmacy to verify current step therapy requirements for your specific plan.

Required Diagnostics

For hATTR-PN

  • TTR genetic testing: Pathogenic variant confirmation
  • Nerve conduction studies: Documenting polyneuropathy
  • NIS+7 score: Baseline neurological assessment
  • Vitamin A levels: Safety monitoring requirement

For ATTR-CM

  • Echocardiogram: Left ventricular wall thickness >12mm
  • Bone scintigraphy: Grade 2-3 myocardial uptake (99mTc-PYP/DPD)
  • Serum free light chains: Normal ratio to exclude AL amyloidosis
  • NT-proBNP: Elevated levels indicating heart failure
  • NYHA class: Functional status assessment
Tip: Schedule all required tests before PA submission to avoid delays. Most labs must be within 6 months of the request.

Site of Care Requirements

Amvuttra administration typically occurs in:

  • Physician offices with injection capability
  • Outpatient infusion centers
  • Hospital outpatient departments (may require justification)
  • Specialty clinics focused on amyloidosis care

Aetna may restrict coverage to lower-cost sites. Use the AMVUTTRA Treatment Center Directory to find approved locations in New Jersey.

Evidence to Support Medical Necessity

Clinical Guidelines

  • FDA labeling: Primary source for approved indications
  • AHA/ACC guidelines: ATTR-CM management recommendations
  • Peripheral Nerve Society: hATTR-PN treatment standards

Required Clinical Evidence

  1. Diagnosis confirmation with appropriate testing
  2. Disease progression documentation
  3. Treatment goals aligned with FDA-approved outcomes
  4. Monitoring plan for efficacy and safety

Reference the Aetna clinical policy bulletin for detailed medical necessity criteria.

Sample Medical Necessity Letter

Paragraph 1: Patient & Diagnosis "[Patient name], DOB [date], member ID [number], has confirmed hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN) based on genetic testing showing [specific TTR mutation] and clinical polyneuropathy with NIS+7 score of [value]."

Paragraph 2: Treatment History "Patient previously tried [prior treatments] with [specific outcomes/adverse events]. Onpattro is contraindicated due to [specific reason] documented on [date]."

Paragraph 3: Clinical Rationale "Amvuttra is FDA-approved for hATTR-PN and offers quarterly dosing advantage with demonstrated efficacy in reducing disease progression as measured by [specific endpoints]."

Paragraph 4: Monitoring Plan "Patient will be monitored every 3 months with [specific assessments] to evaluate treatment response and safety, consistent with FDA labeling recommendations."

Common Denial Reasons & Fixes

Denial Reason How to Overturn
Missing genetic testing Submit complete TTR sequencing report with pathogenic variant
Step therapy not met Document contraindications to Onpattro with clinical notes
Insufficient specialist input Obtain consultation from neurologist or amyloidosis specialist
Incomplete diagnosis proof Provide nerve conduction studies, biopsy results, or cardiac imaging
Non-formulary status Request formulary exception with medical necessity documentation

New Jersey Appeal Process

Internal Appeals (Level 1 & 2)

  • Filing deadline: 180 calendar days from denial notice
  • Level 1 timeline: 30 calendar days for authorization decisions
  • Level 2 deadline: 60 calendar days from Level 1 denial
  • Expedited appeals: 72 hours for urgent cases

Submit appeals through the Availity provider website or call 1-844-362-0934.

External Review

After completing internal appeals, request external review through a CMS-contracted Independent Review Entity (IRE):

  • Filing deadline: 60 calendar days from Level 2 denial
  • Standard timeline: 30-45 days for decision
  • Binding decision: IRE ruling is final and enforceable
Note: New Jersey residents with state-regulated plans may also access the Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services for additional review options.

For detailed appeal procedures, review Aetna's New Jersey provider appeal process.

Costs & Patient Assistance

Alnylam Assist Program

  • Benefit verification: Within 2 business days
  • Copay assistance: For commercially insured patients
  • Patient assistance program: For uninsured/underinsured
  • Contact: 1-833-256-2748

Estimated Costs

  • Wholesale price: ~$119,351 per quarterly dose
  • Annual cost: ~$476,000 before insurance
  • Patient responsibility: Varies by plan deductible and coinsurance

Counterforce Health helps patients navigate complex prior authorization requirements and turn insurance denials into targeted, evidence-backed appeals for specialty medications like Amvuttra.

Additional Resources

  • New Jersey Department of Banking and Insurance: 1-800-446-7467
  • Medicare beneficiaries: 1-800-MEDICARE
  • State Health Insurance Assistance Program (SHIP): Free counseling for Medicare questions

FAQ

How long does Aetna prior authorization take for Amvuttra in New Jersey? Standard PA decisions take 30-45 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Amvuttra is non-formulary on my Aetna plan? Request a formulary exception by submitting medical necessity documentation showing why preferred alternatives are inappropriate.

Can I appeal if I'm denied coverage for Amvuttra? Yes. You have 180 days to file an internal appeal, followed by external review options through independent entities.

Does step therapy apply if I tried other treatments outside New Jersey? Yes, documented treatment failures from any location count toward step therapy requirements if properly documented.

What happens if my doctor isn't an amyloidosis specialist? Aetna may require consultation with or referral to a neurologist, cardiologist, or amyloidosis specialist for approval.

How often do I need to renew Amvuttra coverage? Typically annually (12 months), with documentation of continued medical necessity and treatment response.

From our advocates: We've seen cases where patients received approval after initially being denied when their physician provided more detailed documentation of why the quarterly Amvuttra dosing was medically preferable to more frequent alternatives. The key was clearly explaining the patient's specific circumstances that made other options less suitable.

Important: This information is for educational purposes only and does not constitute medical advice. Coverage policies change frequently. Always verify current requirements with Aetna directly and consult your healthcare provider for medical decisions.

For additional assistance with insurance appeals and prior authorization challenges, Counterforce Health specializes in helping patients and clinicians navigate complex coverage requirements for specialty medications.

Sources & Further Reading

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