How to Get Onpattro (patisiran) Covered by Aetna CVS Health in Washington: Complete Prior Authorization and Appeal Guide
Answer Box: Your Fastest Path to Onpattro Coverage
To get Onpattro (patisiran) covered by Aetna CVS Health in Washington: Submit the Onpattro precertification form with genetic testing confirming hATTR-PN, baseline mNIS+7 scores, and neurologist evaluation. Aetna typically decides within 5-10 business days. If denied, file internal appeal within 180 days, then request external review through Washington's IRO process (82% overturn rate for specialty drugs). Start today by verifying your plan covers Onpattro and requesting the precert form from your prescriber.
Table of Contents
- What This Guide Covers
- Before You Start: Verify Your Coverage
- Gather Required Documentation
- Submit Your Prior Authorization Request
- Follow-Up and Timeline Expectations
- If You Need More Information
- If Your Request is Denied
- Renewal and Reauthorization
- Printable Checklist
- FAQ
What This Guide Covers
This comprehensive guide helps Washington residents get Onpattro (patisiran) approved by Aetna CVS Health for hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN). Whether you're a patient, caregiver, or clinician, you'll find step-by-step instructions, required forms, and proven appeal strategies.
Who this helps:
- Patients diagnosed with hATTR-PN needing Onpattro coverage
- Caregivers navigating the prior authorization process
- Healthcare providers submitting requests for their patients
- Anyone facing an Aetna denial who needs appeal guidance
Quick outcome preview: With proper documentation, most Onpattro requests get approved within 7-10 business days. If initially denied, Washington's strong external review process has an 82% success rate for overturning specialty drug denials.
Before You Start: Verify Your Coverage
Step 1: Confirm Your Plan Type
Check your insurance card or member portal to identify:
- Commercial Aetna plan (employer-sponsored or individual)
- Aetna Medicare Advantage
- Aetna Better Health (Medicaid managed care)
Note: Self-funded employer plans may have different appeal rights. Contact your HR department to confirm if your plan is self-funded (ERISA) or fully insured.
Step 2: Verify Onpattro is on Formulary
Log into your Aetna member portal and search for "patisiran" or "Onpattro." Look for:
- Formulary tier (typically Tier 5 specialty)
- Prior authorization requirement (yes for most plans)
- Step therapy requirements (Onpattro is first-line; alternatives require Onpattro failure)
- Quantity limits (weight-based dosing)
Step 3: Confirm Network Status
Onpattro requires infusion at an approved site. Verify your infusion center is in-network through Aetna's provider directory. Aetna's site-of-care policy prefers home or office infusion over hospital outpatient when medically appropriate.
Gather Required Documentation
Core Clinical Requirements
Genetic Testing Results:
- Pathogenic or likely pathogenic TTR gene variant
- Lab report with HGVS nomenclature and ACMG classification
- Must confirm hereditary (not wild-type) ATTR
Specialist Evaluation:
- Neurologist, geneticist, or amyloidosis specialist consultation
- Confirmed hATTR-PN diagnosis (ICD-10: E85.1)
- Baseline neurologic assessment
Objective Outcome Measures:
- mNIS+7 score (Modified Neuropathy Impairment Score +7)
- 6-minute walk test (6MWT) results
- Polyneuropathy disability (PND) stage documentation
Supporting Documentation
Medical History:
- Prior therapy trials and outcomes
- Contraindications to alternative treatments
- Current medications and allergies
- Relevant lab results and imaging
Insurance Information:
- Member ID and policy details
- Previous authorization attempts
- Any prior denials with reason codes
Submit Your Prior Authorization Request
Step 1: Obtain the Correct Form
Use Aetna's Onpattro Injectable Medication Precertification Request form. This drug-specific form includes all required clinical fields.
Step 2: Complete All Required Sections
Patient Information:
- Full name, date of birth, member ID
- Primary and secondary insurance details
- Contact information
Prescriber Information:
- Provider name, NPI, specialty
- Confirmation of neurologist/specialist involvement
- Office contact details
Clinical Information:
- Primary diagnosis: hATTR-PN (E85.1)
- Baseline mNIS+7 score and date
- 6MWT distance and date
- Weight for dosing calculations
- Site of care justification
Step 3: Submit Through Preferred Channel
Online (Fastest):
- Availity/Novologix provider portal
- Typical processing: 3-5 business days
Fax:
- Use fax number on the Onpattro precert form
- Include cover sheet with member ID
- Request fax confirmation
Phone:
- Call (866) 752-7021 for urgent cases
- Have all documentation ready
- Request reference number
Follow-Up and Timeline Expectations
Washington-Specific Timelines
Standard Prior Authorization:
- 5-10 business days for complete submissions
- 72 hours for expedited/urgent requests
- 24-48 hours for life-threatening situations
Required Decision Timeframes:
- Pre-service: 15 calendar days maximum
- Post-service: 30 calendar days maximum
- Expedited: 72 hours maximum
Sample Follow-Up Script
"Hi, I'm calling to check on the status of a prior authorization for Onpattro (patisiran) for member [ID]. The request was submitted on [date] with reference number [if available]. Can you provide an update on the review timeline and let me know if any additional information is needed?"
What to Document:
- Date and time of call
- Representative name and reference number
- Status update received
- Any additional requirements mentioned
If You Need More Information
Common Information Requests
Medical Necessity Questions:
- Detailed treatment history
- Why alternatives aren't appropriate
- Expected clinical outcomes
- Monitoring plan
Documentation Requests:
- Updated clinical notes
- Additional lab results
- Specialist consultation reports
- Literature supporting off-label use (if applicable)
Strengthening Your Request
When Counterforce Health assists patients with complex prior authorizations like Onpattro, we often see requests strengthened by including peer-reviewed literature citations, FDA labeling excerpts, and detailed clinical rationales that directly address the plan's coverage criteria. This evidence-backed approach significantly improves approval rates.
Key Clinical References:
- FDA Onpattro labeling
- APOLLO trial primary endpoint data
- Current hATTR treatment guidelines
If Your Request is Denied
Understanding Denial Reasons
Common Denial Codes:
- Not medically necessary: Missing baseline scores or specialist evaluation
- Non-formulary: Step therapy or formulary exception needed
- Experimental/investigational: Off-label use concerns
- Site of care: Hospital setting not justified
Washington Appeals Process
Level 1: Internal Appeal with Aetna
- Deadline: 180 days from denial notice
- Decision timeline: 30 days standard, 72 hours expedited
- How to file: Written request to address on denial letter
Level 2: External Review (IRO)
- Deadline: 180 days from final internal denial
- Decision timeline: 30 days standard, 72 hours expedited
- How to request: Contact Washington Office of Insurance Commissioner at 1-800-562-6900
Appeal Documentation Checklist
✓ Copy of original denial letter ✓ Updated clinical notes addressing denial reasons ✓ Peer-reviewed literature supporting medical necessity ✓ Specialist letter of medical necessity ✓ Patient impact statement ✓ Any new test results or clinical findings
From our advocates: We've seen Washington external reviews overturn Aetna specialty drug denials when the appeal includes a detailed neurologist letter explaining why the specific patient needs Onpattro over alternatives, with objective measures like mNIS+7 progression data. The key is addressing each denial reason point-by-point with clinical evidence.
Renewal and Reauthorization
When to Start Renewal Process
Begin reauthorization 30-45 days before your current approval expires. Aetna typically requires renewal every 6-12 months for Onpattro.
Required Renewal Documentation
Clinical Response Data:
- Updated mNIS+7 scores showing stability or improvement
- Current 6MWT results
- Neurologic examination findings
- Quality of life assessments
Continued Medical Necessity:
- Demonstration of clinical benefit
- Absence of significant adverse events
- Ongoing appropriate indication
- Plan for continued monitoring
Renewal Success Factors:
- Objective evidence of treatment benefit
- No serious safety concerns
- Continued specialist oversight
- Clear documentation of response
Printable Checklist
Before Submission
□ Verify Onpattro is on formulary □ Confirm in-network infusion site □ Obtain Aetna Onpattro precert form □ Gather genetic testing results □ Schedule specialist evaluation □ Complete baseline mNIS+7 and 6MWT
Submission Package
□ Completed precert form □ TTR genetic test report □ Specialist consultation note □ Baseline outcome measures □ Prior therapy documentation □ Site of care justification
After Submission
□ Request confirmation receipt □ Calendar follow-up date □ Prepare for potential questions □ Document all communications □ Plan renewal timeline
FAQ
How long does Aetna CVS Health prior authorization take in Washington? Standard requests: 5-10 business days. Expedited requests: 72 hours. Washington law requires decisions within 15 calendar days for pre-service requests.
What if Onpattro is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Aetna must cover medically necessary treatments even if non-formulary, especially for rare diseases with limited alternatives.
Can I request an expedited appeal in Washington? Yes. If delay could seriously jeopardize your health, request expedited review. Aetna must decide within 72 hours, and Washington IRO expedited reviews are completed within 72 hours.
Does step therapy apply if I tried other treatments outside Washington? Yes. Document any prior hATTR treatments (tafamidis, inotersen, etc.) with dates, doses, and reasons for discontinuation. This supports medical necessity for Onpattro.
What if my employer plan is self-funded? Self-funded ERISA plans aren't subject to Washington state appeals laws. However, you can still appeal through the plan's internal process and may have federal ERISA appeal rights.
How much will Onpattro cost with Aetna coverage? Costs vary by plan. Specialty tier copays typically range from $100-500+ per infusion. Check the Alnylam Assist program for potential copay assistance.
What happens if I miss a renewal deadline? Contact Aetna immediately to request retroactive coverage or expedited renewal. You may need to restart the prior authorization process, potentially causing treatment delays.
Can I switch infusion sites after approval? Yes, but notify Aetna if changing from your approved site. Some site changes may require updated prior authorization, especially if moving from office to hospital setting.
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Onpattro. Our platform helps patients, clinicians, and specialty pharmacies navigate the prior authorization process by identifying denial reasons and crafting point-by-point rebuttals aligned with each plan's specific requirements.
Sources & Further Reading
- Aetna Onpattro Precertification Form (PDF)
- Aetna ATTR Amyloidosis Clinical Policy
- Washington Insurance Commissioner Appeals Process
- Aetna Site of Care Policy
- FDA Onpattro Prescribing Information
- Alnylam Assist Patient Support Program
Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For additional help with appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900.
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