By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (Patisiran) Covered by Aetna CVS Health in Virginia: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Onpattro (Patisiran) Covered by Aetna CVS Health in Virginia

Aetna CVS Health covers Onpattro (patisiran) as a preferred specialty medication but requires prior authorization. To get approved: (1) Have your neurologist confirm hATTR polyneuropathy with genetic testing and document mNIS+7/6MWT scores, (2) Submit PA through CVS Specialty Pharmacy at (866) 752-7021, and (3) If denied, appeal within 180 days using Virginia's Form 216-A external review process. Processing takes 5-10 business days for complete submissions.

First step today: Contact your neurologist to schedule genetic testing (free through Alnylam Act program) and baseline functional assessments.

Table of Contents

Understanding Your Aetna Coverage

Onpattro (patisiran) is the first FDA-approved treatment for polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR-PN). At approximately $450,000-$500,000 annually, this life-changing therapy requires careful navigation of Aetna's coverage policies.

Coverage Basics:

  • Formulary Status: Preferred specialty medication across all Aetna plan types
  • Pharmacy Benefit: Must be dispensed through CVS Specialty Pharmacy
  • Site of Care: Home infusion, physician offices, or independent infusion centers preferred
  • Prior Authorization: Required before first dose
Note: Hospital administration is only covered for first dose, re-initiation after 6+ months, or patients with severe adverse events.

Prior Authorization Requirements

Aetna requires comprehensive documentation to approve Onpattro coverage. Here's what your healthcare team needs to provide:

Medical Necessity Criteria

Requirement Documentation Needed Source
Diagnosis Confirmed hATTR-PN (ICD-10 E85.1), age 18+ Aetna Policy
Genetic Testing Pathogenic TTR variant with ACMG classification Aetna Policy
Specialist Evaluation Neurologist assessment with examination findings Aetna Policy
Functional Assessment mNIS+7 score and 6-Minute Walk Test results Aetna Policy
Baseline Labs Liver function, vitamin A levels Aetna Policy

Required Baseline Assessments

mNIS+7 (Modified Neuropathy Impairment Score plus 7 tests):

  • Must be performed by qualified neurologist
  • Numeric score with detailed findings required
  • Measures motor, sensory, and autonomic function

6-Minute Walk Test (6MWT):

  • Distance in meters
  • Assistance level (1-7 scale)
  • Assistive device documentation
  • Baseline vital signs and oxygen saturation
  • Must follow American Thoracic Society guidelines

Step-by-Step: Fastest Path to Approval

1. Genetic Testing Confirmation

Who: Patient with neurologist order
Timeline: 2-3 weeks
Cost: Free through Alnylam Act program
What to do: Contact qualified provider to order TTR gene sequencing

2. Specialist Evaluation

Who: Neurologist or amyloidosis specialist
Timeline: 1-2 weeks
Documents: Complete neurological examination, mNIS+7 assessment, 6MWT
What to do: Schedule comprehensive evaluation with functional testing

3. Prior Authorization Submission

Who: Prescriber or CVS Specialty Pharmacy
Timeline: 5-10 business days
Contact: (866) 752-7021 or fax (888) 267-3277
What to submit: PA form, genetic test results, specialist notes, lab work

4. Coverage Determination

Timeline: 5-10 business days for complete submissions
Possible outcomes: Approved, denied, or request for additional information
Next steps: If approved, coordinate with CVS Specialty; if denied, begin appeal process

Reading Your Denial Letter

Common Aetna denial codes for Onpattro include:

  • No genetic confirmation: Missing pathogenic TTR variant documentation
  • Insufficient specialist evaluation: Neurologist assessment incomplete
  • Missing functional assessments: mNIS+7 or 6MWT not provided
  • Non-FDA labeled use: Request for cardiac amyloidosis (not FDA-approved)
  • Incomplete baseline documentation: Missing required lab work or imaging

Extract key information from your denial:

  • Denial reason code
  • Appeal deadline (typically 180 days)
  • Required documentation for reconsideration
  • Contact information for appeals

First-Level Appeal Process

Aetna Internal Appeal Timeline

  • Filing deadline: 180 days from denial notice
  • Decision timeline: 45 business days (may extend to 60 days for specialty review)
  • Expedited appeals: 72 hours for urgent cases

Required Appeal Documentation

  1. Original denial letter and EOB
  2. Complete medical records supporting medical necessity
  3. Updated specialist evaluation addressing denial reasons
  4. Peer-reviewed literature supporting Onpattro use
  5. Letter of medical necessity (see template below)

Submission Options

  • Preferred: Availity provider portal (auto-generates forms)
  • Alternative: Mail or fax appeal form from Aetna's professional forms page
  • Include: Clear statement of disagreement and request for peer-to-peer review

Peer-to-Peer Review Strategy

Request a peer-to-peer review as part of your provider appeal. This allows your neurologist to speak directly with Aetna's medical director.

Preparation Checklist:

  • Review FDA labeling for Onpattro
  • Prepare patient-specific clinical rationale
  • Have genetic test results and functional assessments ready
  • Document prior treatment failures if applicable
  • Reference APOLLO trial data (mNIS+7 improvement -6.0 vs. placebo)

Key Talking Points:

  • FDA approval for hATTR polyneuropathy
  • Progressive nature without treatment
  • Patient-specific functional decline (mNIS+7/6MWT scores)
  • Lack of effective alternatives for confirmed genetic variant

Virginia External Review Rights

If Aetna upholds the denial, Virginia residents have strong external review rights through the State Corporation Commission Bureau of Insurance.

Virginia External Review Process

Eligibility: Final adverse determination after internal appeals
Timeline: File within 120 days of final denial
Form: Form 216-A External Review Request
Cost: Free

Submit to: SCC Bureau of Insurance – External Review
P.O. Box 1157
Richmond, VA 23218
Phone: (877) 310-6560

Review Timelines

Review Type Timeline Requirements
Standard IRO decision promptly after commission notification Post-internal appeal
Expedited 72 hours (24 hours if exigent) Physician certifies urgency

Required Documents:

  • All denial correspondence
  • Medical records release form
  • Insurance policy details
  • Clinical evidence (diagnosis, genetic testing, functional assessments)
Virginia Advantage: The state's External Review process has successfully overturned specialty drug denials, and the Independent Review Organization's decision is binding on Aetna.

Medical Necessity Letter Template

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to create compelling medical necessity arguments. Here's a template based on successful Onpattro approvals:

[Date]
RE: [Patient Name], Policy #[Number], Onpattro (patisiran) Appeal
Diagnosis: hATTR Polyneuropathy (ICD-10 E85.1)

[Medical Director]
[Aetna Address]

Dear Medical Director,

I am writing to appeal the denial of ONPATTRO (patisiran) for my patient with hereditary transthyretin-mediated amyloidosis polyneuropathy.

**FDA Approval & Medical Necessity:**
Onpattro is FDA-approved specifically for polyneuropathy of hATTR amyloidosis in adults. This patient meets all criteria with confirmed genetic testing and progressive symptoms.

**Patient-Specific Clinical Evidence:**
- Confirmed pathogenic TTR variant: [specify variant]
- Baseline mNIS+7 score: [insert score] indicating significant neuropathy
- 6MWT distance: [insert meters] demonstrating functional impairment
- Progressive symptoms: [describe motor/sensory deficits]

**Treatment Rationale:**
Without Onpattro, this patient faces progressive, irreversible neuropathy. The APOLLO trial demonstrated significant improvement in neuropathy scores (mNIS+7 least-squares mean difference -6.0 vs. placebo, p<0.0001).

**Monitoring Plan:**
- Pre-infusion labs and vitamin A supplementation
- Quarterly functional assessments
- Infusion every 3 weeks at [approved site]

Onpattro is medically necessary and appropriate. I request immediate approval.

Sincerely,
[Neurologist Name, Credentials]
[Phone number]

Attachments: Genetic testing, mNIS+7 results, 6MWT, lab work, FDA labeling

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
No genetic confirmation Submit pathogenic TTR variant test ACMG classification, HGVS nomenclature
Insufficient specialist evaluation Comprehensive neurologist assessment Complete examination, mNIS+7, 6MWT
Missing functional measures Baseline and monitoring assessments Numeric scores with detailed findings
Non-formulary status Formulary exception request Medical necessity, lack of alternatives
Experimental/investigational FDA approval documentation Label indication, clinical trial data

Cost Support Options

Alnylam Assist Program:

  • Prior authorization support
  • Free genetic testing
  • Copay assistance (up to $10,000/year for eligible patients)
  • Patient navigation services

Additional Resources:

  • Patient Advocate Foundation copay relief
  • HealthWell Foundation rare disease fund
  • Virginia Medicaid (if eligible after 2019 expansion)

For patients navigating complex coverage challenges, Counterforce Health provides specialized support in creating evidence-backed appeals that align with payer-specific requirements and improve approval rates.

FAQ

How long does Aetna prior authorization take for Onpattro in Virginia? 5-10 business days for complete submissions. Expedited reviews available for urgent cases (72 hours).

What if Onpattro isn't on my Aetna formulary? Request a formulary exception with medical necessity documentation. Non-formulary status doesn't prevent coverage with proper justification.

Can I request an expedited appeal in Virginia? Yes, if your physician certifies that waiting could jeopardize your health. Virginia expedited external reviews are decided within 72 hours.

Does step therapy apply to Onpattro? Aetna typically considers Onpattro first-line for hATTR polyneuropathy, but policies vary by plan. Check your specific coverage.

What happens if my appeal is denied? You can request Virginia external review using Form 216-A within 120 days. The Independent Review Organization's decision is binding on Aetna.

How much does genetic testing cost? Free through the Alnylam Act program for eligible patients with suspected hATTR amyloidosis.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits and medical circumstances. Consult your healthcare provider and insurance plan documents for specific guidance. Virginia residents should contact the State Corporation Commission Bureau of Insurance for official appeals guidance.

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