By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (patisiran) Covered by Aetna CVS Health in Pennsylvania: Complete Prior Authorization & Appeals Guide

Answer Box: Getting Onpattro (patisiran) Covered by Aetna CVS Health in Pennsylvania

Aetna CVS Health requires prior authorization for Onpattro (patisiran) in Pennsylvania. You'll need confirmed hATTR polyneuropathy with genetic testing, neurologist evaluation, and baseline functional scores (mNIS+7, 6MWT). First step today: Contact your neurologist to order TTR genetic testing and schedule functional assessments. Submit the complete Aetna Onpattro precertification form via CVS Specialty at (866) 752-7021. If denied, Pennsylvania's new external review program overturns about 50% of appeals.

Table of Contents

  1. Aetna CVS Health Plan Types & Coverage Implications
  2. Onpattro Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. CVS Specialty Pharmacy Setup Process
  5. Cost-Share Basics (Educational Overview)
  6. Submission Process & Required Forms
  7. Common Approval Patterns
  8. Appeals Process in Pennsylvania
  9. FAQ: Onpattro Coverage by Aetna CVS Health
  10. Sources & Further Reading

Plan Types & Coverage Implications

Aetna CVS Health offers multiple plan types in Pennsylvania, each with distinct coverage rules for specialty medications like Onpattro:

Commercial Plans (HMO/PPO/EPO)

  • Prior authorization required across all commercial products
  • Specialist referrals may be needed for HMO plans before neurologist evaluation
  • Network requirements apply for infusion sites

Medicare Advantage

  • Enhanced appeal rights under Medicare regulations
  • Expedited appeals available within 72 hours for urgent cases
  • Coverage decisions follow Medicare Part B guidelines for infused medications

Medicaid (Aetna Better Health)

  • State-specific formulary may apply
  • Additional documentation requirements possible
  • Coordination with Pennsylvania Medicaid policies
Note: Self-funded employer plans may have modified coverage criteria. Verify your specific plan details through the Aetna member portal or member services.

Onpattro Formulary Status & Tier Placement

Onpattro (patisiran) is classified as a preferred specialty medication on Aetna's formulary, requiring prior authorization regardless of plan type.

Coverage Details

  • Formulary Status: Preferred specialty tier
  • Prior Authorization: Required for all plans
  • Step Therapy: Not required (Onpattro is first-line therapy)
  • Quantity Limits: Weight-based dosing per FDA labeling
  • Site of Care: Preferred administration through approved infusion centers

Alternative Treatments

If Onpattro is denied, alternative hATTR therapies include:

  • Amvuttra (vutrisiran) - subcutaneous every 3 months
  • Wainua (eplontersen) - subcutaneous every 4 weeks
  • Tegsedi (inotersen) - subcutaneous weekly
  • Supportive care measures

Prior Authorization Requirements

Aetna CVS Health requires comprehensive documentation for Onpattro approval:

Coverage at a Glance

Requirement What It Means Where to Find It
Diagnosis Confirmed hATTR polyneuropathy (ICD-10 E85.1), age 18+ Neurologist consultation notes
Genetic Testing Pathogenic TTR variant (ACMG classified) Lab report with HGVS nomenclature
Specialist Evaluation Neurologist or amyloidosis specialist assessment Clinical examination findings
Baseline Scores mNIS+7 and 6-minute walk test (6MWT) Functional assessment documentation
Laboratory Results Liver function tests, vitamin A levels Recent lab reports

Medical Necessity Criteria

Required Documentation:

  1. Genetic Confirmation: Pathogenic or likely pathogenic TTR gene variant
  2. Clinical Assessment: Progressive sensorimotor and/or autonomic neuropathy
  3. Functional Measures: Baseline mNIS+7 score and 6MWT distance
  4. Exclusions: No concurrent hATTR therapies without documented failure
Clinician Corner: Free genetic testing is available through Alnylam's Act program for eligible patients. Results typically available in 2-3 weeks.

CVS Specialty Pharmacy Setup Process

Onpattro must be dispensed through CVS Specialty Pharmacy for Aetna members.

Step-by-Step Setup Process

  1. Provider Enrollment (1-2 business days)
    • Complete CVS Specialty enrollment forms
    • Verify DEA and NPI information
    • Contact: (866) 752-7021
  2. Patient Registration (Same day)
  3. Prior Authorization Submission (5-10 business days)
    • Submit complete documentation package
    • Include all required clinical assessments
    • Fax: (888) 267-3277
  4. Infusion Site Coordination
    • Home infusion (preferred)
    • Physician office with infusion capability
    • Independent infusion center
    • Hospital outpatient (limited circumstances)

Cost-Share Basics (Educational Overview)

Understanding your potential out-of-pocket costs can help with financial planning:

Typical Cost Structure:

  • Annual list price: ~$450,000-$500,000+ (weight-dependent)
  • Specialty tier copay/coinsurance applies
  • Deductible may apply before coverage begins

Financial Assistance Options:

Important: This is educational information only. Consult your plan documents or member services for specific cost-sharing details.

Submission Process & Required Forms

Fastest Path to Approval

  1. Genetic Testing (Patient/Provider - 2-3 weeks)
    • Order TTR gene sequencing through neurologist
    • Request ACMG classification in results
    • Use Alnylam Act program if eligible
  2. Functional Assessments (Provider - 1 week)
    • Complete mNIS+7 scoring
    • Perform 6-minute walk test per ATS guidelines
    • Document baseline neurological examination
  3. Form Completion (Provider - 1 day)
  4. Submission (Provider - Same day)
    • Submit via CVS Specialty: (866) 752-7021
    • Fax backup: (888) 267-3277
    • Track submission confirmation
  5. Follow-up (Provider - 5-10 business days)
    • Monitor for approval notification
    • Prepare for potential peer-to-peer review
    • Ready appeal documentation if needed

Common Approval Patterns

Strong submissions typically include:

Documentation Checklist

  • Completed Aetna precertification form
  • TTR genetic testing results with pathogenic variant
  • Neurologist consultation notes
  • Baseline mNIS+7 and 6MWT scores
  • Recent laboratory results (liver function, vitamin A)
  • Insurance verification and patient demographics

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Missing genetic testing Submit lab report with pathogenic TTR variant
Insufficient neurological evaluation Provide detailed specialist consultation notes
Incomplete functional assessments Include properly scored mNIS+7 and 6MWT results
Non-formulary status Request formulary exception with medical necessity

Appeals Process in Pennsylvania

Pennsylvania strengthened its appeals system in 2024 with a new state-run external review program.

Internal Appeals (First Level)

  • Deadline: 180 days from denial
  • Timeline: 30-45 days for standard review
  • Expedited: 72 hours for urgent cases
  • Contact: Aetna member services or provider portal

Pennsylvania External Review (Second Level)

Pennsylvania launched its Independent External Review Program in January 2024, providing enhanced consumer protections:

  • Eligibility: After receiving Final Adverse Benefit Determination
  • Deadline: 4 months to request external review
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Success Rate: Approximately 50% of appeals overturned in first year
  • Submission: Online via PA Insurance Department portal or mail/fax

Appeal Documentation

Include with your appeal:

  • Original denial letter and Final Adverse Benefit Determination
  • Complete medical records supporting medical necessity
  • FDA prescribing information for Onpattro
  • Published clinical evidence (APOLLO trial data)
  • Updated functional assessments if available
From Our Advocates: "We've seen Pennsylvania's new external review process make a real difference. One patient's Onpattro denial was overturned within 30 days after the independent reviewers examined the genetic testing and neurologist's detailed assessment. The key was submitting organized, complete documentation that clearly demonstrated medical necessity."

FAQ: Onpattro Coverage by Aetna CVS Health

Q: How long does Aetna prior authorization take for Onpattro in Pennsylvania? A: Standard processing takes 5-10 business days with complete documentation. Expedited reviews for urgent cases are available within 72 hours.

Q: What if Onpattro is denied as "not medically necessary"? A: Request an internal appeal within 180 days, including updated clinical documentation and medical necessity letter. If denied again, use Pennsylvania's external review program.

Q: Does Aetna require step therapy before approving Onpattro? A: No, Aetna does not require step therapy for hATTR polyneuropathy. Onpattro is typically considered first-line therapy.

Q: Can I get Onpattro covered if I don't have genetic testing results? A: No, confirmed pathogenic TTR variant is required for approval. Free testing is available through Alnylam's Act program.

Q: What if my infusion site isn't in Aetna's network? A: Contact member services to request a network exception. Document medical necessity for the specific site if alternatives aren't available.

Q: How often do I need reauthorization for Onpattro? A: Typically annually, with updated functional assessments (mNIS+7, 6MWT) demonstrating continued benefit or stability.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's requirements. For complex cases like Onpattro appeals, we pull the right clinical evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weave them into appeals that meet procedural requirements while tracking deadlines and required documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or insurance advice. Coverage policies and requirements may vary by plan and change over time. Always verify current requirements with your insurance provider and consult healthcare professionals for medical decisions. For personalized assistance with appeals and prior authorizations, consider consulting Counterforce Health or similar advocacy services.

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