By Counterforce Health Team in Onpattro (patisiran) —

Work With Your Doctor to Get Onpattro (patisiran) Approved by Aetna CVS Health in California

Answer Box: Getting Started Today

Onpattro (patisiran) requires prior authorization from Aetna CVS Health for hereditary transthyretin amyloidosis polyneuropathy (hATTR-PN). Your fastest path: schedule a neurologist visit to confirm genetic testing (TTR variant), baseline mNIS+7 score, and 6-minute walk test. Submit Aetna's precertification form with complete documentation. If denied, California's Independent Medical Review (IMR) overturns 55-68% of specialty drug denials for free. First step today: Call your doctor's office to request your TTR genetic test results and schedule a neurologist consultation if you haven't had one yet.

Table of Contents

  1. Set Your Goal: What Approval Requires
  2. Visit Prep: Essential Information to Gather
  3. Evidence Kit: Building Your Case
  4. Letter of Medical Necessity Structure
  5. Supporting Your Doctor's Peer-to-Peer Call
  6. After-Visit Summary
  7. Respectful Persistence and Appeals
  8. California Appeals Process
  9. FAQ

Set Your Goal: What Approval Requires

Working with your doctor to get Onpattro covered by Aetna CVS Health means understanding exactly what the insurance company needs to see. This isn't just about having the right diagnosis—it's about presenting a complete, well-documented case that meets their specific criteria.

Aetna CVS Health Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must be approved before treatment Aetna Precertification List
Genetic Testing Pathogenic TTR variant confirmed Lab report with HGVS nomenclature
Neurologist Evaluation Specialist confirms hATTR-PN diagnosis Neurology consultation notes
Baseline Assessments mNIS+7 score and 6-minute walk test Recent test results (within 6 months)
ICD-10 Code E85.1 (hATTR amyloidosis) Medical records

Your partnership with your doctor is crucial because they'll need to provide the clinical evidence and submit the prior authorization request. Counterforce Health helps patients and clinicians navigate these complex approval processes by turning insurance denials into targeted, evidence-backed appeals.

Tip: Aetna processes complete submissions within 5-10 business days. Incomplete submissions can delay approval by weeks.

Visit Prep: Essential Information to Gather

Before your appointment, gather everything your doctor will need to build a strong case. This preparation can make the difference between approval and denial.

Symptom Timeline Documentation

Write down:

  • When symptoms first appeared
  • How they've progressed (walking difficulty, numbness, weakness)
  • Family history of similar symptoms
  • Impact on daily activities (work, mobility, self-care)

Previous Treatments and Outcomes

Document every treatment you've tried:

  • Medications (names, doses, duration)
  • Why each treatment was stopped (ineffective, side effects, contraindications)
  • Physical therapy or other interventions
  • Dates and healthcare providers involved

Current Functional Status

Note specific examples:

  • Walking distance before fatigue
  • Difficulty with fine motor tasks (buttoning clothes, writing)
  • Balance problems or falls
  • Autonomic symptoms (digestive issues, blood pressure changes)

Evidence Kit: Building Your Case

Your doctor needs specific documentation to meet Aetna's medical necessity criteria. Help them gather this evidence systematically.

Required Laboratory Evidence

  • TTR genetic testing results showing pathogenic variant
  • Baseline blood work (complete metabolic panel, liver function)
  • Vitamin A levels (important for monitoring during treatment)

Imaging and Specialized Tests

  • Nerve conduction studies and EMG results
  • Echocardiogram if cardiac involvement suspected
  • Bone scintigraphy (if performed to rule out cardiac amyloidosis)

Clinical Assessment Scores

Your neurologist must document:

  • mNIS+7 score (modified Neuropathy Impairment Score plus 7 tests)
  • 6-minute walk test results
  • Polyneuropathy Disability (PND) score (should be ≤ IIIb for Onpattro)
Note: California has specialized amyloidosis centers at Stanford, UCSF, and Cedars-Sinai that can perform these assessments if your local neurologist needs support.

Letter of Medical Necessity Structure

Your doctor's letter of medical necessity is the cornerstone of your approval request. Here's what should be included, based on Alnylam's sample template:

Opening Section

  • Patient identification and insurance information
  • Clear statement: "I request ONPATTRO for [patient name] with FDA-approved hATTR polyneuropathy"
  • Date of diagnosis and confirming physician

Clinical History

  • Genetic confirmation: Specific TTR variant (e.g., "Patient carries the p.V142I pathogenic variant")
  • Symptom progression: Timeline with specific functional decline
  • Baseline scores: Current mNIS+7, 6MWT, and PND scores
  • Prior treatments: What was tried, for how long, and why it failed

Medical Rationale

  • Reference to FDA approval for hATTR-PN
  • Citation of APOLLO trial efficacy data
  • Explanation of why Onpattro is appropriate for this patient's stage of disease
  • Dosing request: 0.3 mg/kg IV every 3 weeks

Supporting Documentation

Your doctor should attach:

  • Genetic testing report
  • Recent neurologist consultation notes
  • Baseline assessment scores
  • Prior treatment documentation

Supporting Your Doctor's Peer-to-Peer Call

If Aetna requests a peer-to-peer review, you can help your doctor prepare for this crucial conversation.

Key Points to Emphasize

  1. Genetic confirmation: Lead with the specific TTR variant
  2. Progressive decline: Quantify changes in mNIS+7 or functional status
  3. FDA indication match: Emphasize polyneuropathy (not cardiac) indication
  4. Treatment urgency: Explain risks of disease progression without treatment

Preparation Checklist

Offer to help your doctor by:

  • Providing a one-page summary of your case
  • Confirming your availability for any follow-up questions
  • Gathering additional documentation if requested
From our advocates: We've seen cases where patients who prepared a concise timeline of their symptoms and treatment failures helped their doctors present more compelling peer-to-peer calls, leading to faster approvals.

After-Visit Summary

After your appointment, make sure you understand next steps and have copies of important documents.

What to Request

  • Copy of the prior authorization submission
  • Timeline for expected response
  • Contact information for follow-up
  • Plan if the initial request is denied

Patient Portal Communication

Use your doctor's patient portal to:

  • Confirm submission details
  • Ask for updates on approval status
  • Request copies of any correspondence with Aetna

Respectful Persistence and Appeals

If your initial request is denied, don't give up. Work with your doctor on a systematic appeal strategy.

Internal Appeal Timeline

  • File within: 180 days of denial
  • Standard review: 30 days
  • Expedited review: 72 hours for urgent cases
  • Required documents: Original denial letter, additional clinical evidence

When to Escalate

Contact your doctor if:

  • No response after stated timeline
  • Request for additional information seems unreasonable
  • Denial reasons don't match your clinical situation

Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting targeted rebuttals with the right clinical evidence.

California Appeals Process

California offers robust patient protections through the Department of Managed Health Care (DMHC) Independent Medical Review process.

California IMR Success Rates

  • Overall success rate: 55-68% for medical necessity denials
  • Specialty drugs: 50-70% success with strong documentation
  • Cost to patients: Free

IMR Process Steps

  1. Exhaust internal appeals with Aetna first
  2. File IMR application within 6 months of final denial
  3. Submit via DMHC website or call 888-466-2219
  4. Include complete documentation: All medical records, denial letters, supporting evidence

Timeline for Resolution

Review Type Decision Time Implementation
Standard IMR 30-45 days 5 business days
Expedited IMR 7 days 5 business days
California advantage: The DMHC recently fined UnitedHealthcare $475,000 for delays in implementing IMR decisions, showing strong enforcement of patient rights.

FAQ

How long does Aetna CVS Health prior authorization take for Onpattro in California? Standard processing is 5-10 business days for complete submissions. Expedited reviews for urgent cases are completed within 72 hours.

What if Onpattro is not on Aetna's formulary? You can request a formulary exception with documentation of medical necessity. If denied, California's IMR process can override formulary restrictions for medically necessary treatments.

Can I request an expedited appeal if my condition is worsening? Yes. Document rapid progression with your neurologist and request expedited review, which must be completed within 72 hours under California law.

What genetic testing labs are available in California? Ambry Genetics (Aliso Viejo) offers comprehensive TTR sequencing. UCSF also provides genetic testing services. Most commercial labs can perform TTR variant analysis.

Does step therapy apply if I've failed treatments outside California? Treatment failures from any state should be documented and submitted. Aetna typically accepts prior treatment history regardless of where it occurred.

What if my neurologist isn't familiar with hATTR-PN? California has specialized amyloidosis centers at Stanford, UCSF, and Cedars-Sinai. Request a referral for consultation and baseline assessments.

How much does Onpattro cost without insurance? The wholesale acquisition cost is approximately $9,785 per vial, with annual treatment costs typically $450,000-$500,000+ depending on patient weight and dosing requirements.

Can I appeal to the state if Aetna denies my claim? Yes. California's DMHC Independent Medical Review is free and has a 55-68% success rate for overturning denials of specialty medications like Onpattro.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For assistance with California insurance complaints or appeals, contact the DMHC Help Center at 888-466-2219 or visit healthhelp.ca.gov.

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