By Counterforce Health Team in Onpattro (patisiran) —

How to Get Onpattro (Patisiran) Covered by Cigna in North Carolina: Complete Timeline, Forms & Appeal Guide

Answer Box: Getting Onpattro (Patisiran) Covered by Cigna in North Carolina

Eligibility: Adults with hereditary transthyretin amyloidosis polyneuropathy (hATTR-PN) confirmed by genetic testing and neurologist evaluation.

Fastest Path: Submit complete prior authorization through Cigna's provider portal with genetic test results, neurologist consultation notes, and mNIS+7 scores. Standard approval takes 5 business days with complete documentation.

Start Today: Gather your genetic testing results, schedule a neurologist consultation if needed, and have your doctor begin the prior authorization process through Cigna's provider portal.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Age 18+ Patient must be adult Medical records Cigna Policy
Genetic Testing Pathogenic TTR mutation confirmed CLIA-certified lab report Cigna Policy
Neurologist Evaluation Specialist consultation required Neurology consultation notes Cigna Policy
Polyneuropathy Documentation Symptomatic nerve damage mNIS+7 score or clinical notes Cigna Policy
Prior Authorization Required before coverage Submit via provider portal Cigna Precertification
Appeals Deadline 180 days for internal appeals Denial letter date Cigna Appeals
External Review 120 days after final denial Smart NC application NC DOI External Review

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis (Patient + Doctor)

What you need: Genetic testing from a CLIA-certified lab showing a pathogenic TTR mutation Timeline: If not done, allow 2-4 weeks for testing and results Submit via: Include with prior authorization packet

2. Schedule Neurologist Consultation (Patient)

What you need: Evaluation by neurologist, geneticist, or amyloidosis specialist Timeline: 1-4 weeks depending on availability Document: mNIS+7 score, polyneuropathy staging, treatment plan

3. Gather Clinical Documentation (Doctor's Office)

What you need:

  • Complete medical history
  • Prior treatment attempts and outcomes
  • Baseline functional assessments
  • Exclusion of other neuropathy causes Timeline: 1-2 days to compile existing records

4. Submit Prior Authorization (Doctor's Office)

Submit via: Cigna provider portal or CoverMyMeds Timeline: Same day electronic submission Include: All documentation from steps 1-3

5. Track Your Request (Patient + Doctor)

Standard timeline: 5 business days for complete requests Expedited timeline: 72 hours for urgent cases Follow up: Call Cigna if no response within timeline

6. If Approved: Coordinate Specialty Pharmacy (Patient)

Next step: Work with Accredo or designated specialty pharmacy Timeline: 1-2 weeks for first infusion scheduling Prepare: Insurance cards, copay assistance enrollment

7. If Denied: Begin Appeals Process (Patient + Doctor)

Timeline: File within 180 days of denial First step: Internal appeal with additional documentation Backup plan: External review through Smart NC if internal appeal fails

What Affects Your Timeline

Documentation Completeness

The most common cause of delays is incomplete documentation. Cigna requires:

  • Genetic testing confirmation: Must show pathogenic TTR variant
  • Specialist involvement: Neurologist consultation notes
  • Functional assessment: mNIS+7 scores or equivalent staging
  • Medical necessity: Clear documentation of symptomatic polyneuropathy

Submission Method

  • Electronic submission: Fastest processing through provider portals
  • Fax/mail: May add 1-3 days to processing time
  • Incomplete forms: Can restart the review clock

Plan Type and Coverage

  • Commercial plans: Standard 5-day timeline
  • Medicare Advantage: May have additional step therapy requirements
  • Prior authorization history: Previous approvals may expedite renewals
From Our Advocates: We've seen cases where patients waited months for approval simply because the genetic testing report was missing one key detail—the specific pathogenic variant. Always request a complete genetic counselor summary that explicitly states "pathogenic TTR mutation confirmed" rather than just lab values.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"No genetic confirmation" Submit complete genetic testing CLIA-certified lab report with pathogenic variant identified
"Lack of specialist evaluation" Obtain neurologist consultation Consultation notes confirming hATTR-PN diagnosis and treatment plan
"Insufficient polyneuropathy documentation" Provide functional assessments mNIS+7 scores, nerve conduction studies, or clinical staging
"Not medically necessary" Submit comprehensive medical necessity letter Prior treatments tried, contraindications to alternatives, treatment goals
"Step therapy not completed" Request step therapy exception Documentation of contraindications or prior failures of required medications

Clinician Corner: Medical Necessity Letter Checklist

When appealing a denial, your medical necessity letter should include:

  • Problem statement: Clear diagnosis of hATTR-PN with genetic confirmation
  • Prior treatments: Document any previous therapies and their outcomes
  • Clinical rationale: Why Onpattro is the appropriate choice
  • Guideline support: Reference FDA labeling and treatment guidelines
  • Monitoring plan: How you'll assess treatment response

Appeals Process in North Carolina

Internal Appeals with Cigna

Timeline: Must file within 180 days of denial Process:

  1. Submit appeal letter with additional documentation
  2. Request peer-to-peer review if available
  3. Cigna has 60 days to respond (72 hours for urgent)

Submit to: Cigna appeals department (verify current address)

External Review through Smart NC

If Cigna's internal appeals are exhausted:

Eligibility:

  • State-regulated plan (not self-funded ERISA)
  • Medical necessity denial
  • Internal appeals completed

Timeline:

  • File within: 120 days of final internal denial
  • Standard decision: 45 days
  • Expedited decision: 72 hours for urgent cases

Process:

  1. Complete NC DOI external review form
  2. Include denial letters, medical records, insurance card
  3. Submit to Smart NC (no cost to you)

Contact Smart NC: 1-855-408-1212 for free advocacy support

Note: Smart NC's decision is binding on Cigna. If they overturn the denial, Cigna must provide coverage within 3 business days.

Cost Savings & Patient Support

Manufacturer Support Programs

  • Alnylam Assist: Copay assistance and patient support services
  • Eligibility: Commercial insurance patients may qualify for $0 copays
  • Apply: alnylamassist.com or call 1-877-256-9526

Foundation Grants

  • Patient Access Network (PAN) Foundation: Grants for rare disease medications
  • HealthWell Foundation: Financial assistance for specialty drugs
  • Good Days: Copay and premium assistance programs

State Resources

  • North Carolina SHIP: Medicare beneficiaries can get free counseling
  • NC Department of Insurance: Consumer assistance for insurance issues

FAQ: Most Asked Questions

Q: How long does Cigna prior authorization take in North Carolina? A: Standard requests are processed within 5 business days once complete documentation is received. Urgent requests are handled within 72 hours.

Q: What if Onpattro isn't on my formulary? A: You can request a formulary exception through Cigna's appeals process. Your doctor will need to provide medical necessity documentation.

Q: Can I get an expedited review if my condition is worsening? A: Yes, both Cigna and Smart NC offer expedited reviews for urgent medical situations. Document the urgency in your request.

Q: What genetic testing is required? A: You need genetic testing from a CLIA-certified laboratory that confirms a pathogenic TTR gene mutation causing hATTR amyloidosis.

Q: Does step therapy apply to Onpattro? A: Some Cigna plans may require trying other treatments first. Your doctor can request a step therapy exception if other medications are contraindicated.

Q: What if I've been getting Onpattro in another state? A: Provide documentation of your current treatment and response. This may help expedite approval in North Carolina.

Q: How often do I need reauthorization? A: Most plans require annual reauthorization. Start the renewal process 30-45 days before your current authorization expires.

Q: What should I do if my authorization is delayed? A: Contact Cigna immediately to request a bridge supply or temporary authorization while your case is being reviewed.

When to Contact Smart NC

Contact Smart NC at 1-855-408-1212 if:

  • Cigna has denied your internal appeals
  • You need help understanding the external review process
  • Your case involves urgent medical circumstances
  • You need assistance gathering documentation for your appeal

Smart NC provides free advocacy and can help you navigate North Carolina's external review system.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and payer policies to create targeted, evidence-backed appeals that align with each plan's specific requirements, improving approval rates for complex medications like Onpattro.

For additional support with your Onpattro coverage journey, Counterforce Health can help you understand your denial reasons and develop a comprehensive appeal strategy based on Cigna's specific policies and North Carolina's regulatory environment.

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 the most current coverage policies and medical guidance. Coverage requirements may vary by specific plan and individual circumstances.

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