By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by UnitedHealthcare in North Carolina: Complete Guide with Forms and Appeal Scripts

Answer Box: Getting Tegsedi Covered by UnitedHealthcare in North Carolina

Eligibility: Adults with confirmed hATTR polyneuropathy and documented TTR gene mutation. Fastest path: Complete REMS enrollment, document step therapy failure (typically Onpattro), and submit comprehensive prior authorization through UnitedHealthcare Provider Portal. First step today: Contact your neurologist to verify genetic testing results and begin REMS program enrollment. If denied, North Carolina's Smart NC external review offers strong success rates for well-documented rare disease appeals.

Table of Contents

  1. Understanding Tegsedi Coverage Requirements
  2. Pre-Authorization Preparation
  3. Step-by-Step Submission Process
  4. Common Denial Reasons & Solutions
  5. Appeals Process in North Carolina
  6. Costs & Patient Assistance
  7. When to Escalate
  8. FAQ

Understanding Tegsedi Coverage Requirements

Tegsedi (inotersen) is a weekly subcutaneous injection approved by the FDA for adults with hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy. UnitedHealthcare requires prior authorization for this specialty medication through OptumRx, with specific clinical and safety requirements.

Coverage at a Glance

Requirement What it means Where to find it
Prior Authorization Required before dispensing UnitedHealthcare Provider Portal
REMS Enrollment Mandatory safety program FDA-required before treatment
Step Therapy Trial of Onpattro typically required Plan formulary documents
Lab Monitoring Plan Regular platelet/kidney function tests Every 2 weeks during treatment
Genetic Confirmation TTR gene mutation documentation Molecular genetic testing report

Pre-Authorization Preparation

Before submitting your prior authorization request, gather comprehensive documentation to maximize approval chances.

Essential Documentation Checklist

Clinical Requirements:

  • Confirmed hATTR polyneuropathy diagnosis with genetic testing showing pathogenic TTR mutation
  • Neurological evaluation with mNIS+7 or similar neuropathy assessment
  • Documentation of progressive sensorimotor and/or autonomic polyneuropathy symptoms
  • ICD-10 codes: E85.1 (Neuropathic heredofamilial amyloidosis)

Step Therapy Documentation: UnitedHealthcare typically requires trial and failure of Onpattro (patisiran) before approving Tegsedi. Document:

  • Previous trial of first-line agent (usually Onpattro)
  • Inadequate response, intolerance, or contraindication to preferred therapy
  • Specific reasons why alternatives are inappropriate

Safety Requirements:

  • REMS program enrollment confirmation for both prescriber and patient
  • Baseline laboratory values (platelet count, serum creatinine, urine protein)
  • Detailed lab monitoring plan (every 2 weeks)
Tip: Start REMS enrollment immediately after diagnosis confirmation. This process can take several days and is required before any prior authorization approval.

Step-by-Step Submission Process

Step 1: Complete REMS Enrollment

Who does it: Prescribing physician and patient Timeline: 3-5 business days How: Visit the Tegsedi REMS website (verify with prescriber)

Step 2: Gather Clinical Documentation

Who does it: Clinical team Timeline: 1-2 weeks Documents needed:

  • Genetic testing report confirming TTR mutation
  • Comprehensive neurological evaluation
  • Prior therapy documentation
  • Lab monitoring plan

Step 3: Submit Prior Authorization

Who does it: Prescriber or authorized staff How: UnitedHealthcare Provider Portal or OptumRx system Timeline: Submit 2-3 weeks before needed start date Required elements:

  • Completed prior authorization form
  • Clinical documentation package
  • REMS enrollment verification
  • Step therapy exception request (if applicable)

Step 4: Follow Up

Timeline: Decision typically within 15 business days Action: Monitor portal for status updates and respond promptly to any requests for additional information

Common Denial Reasons & Solutions

Denial Reason How to Overturn
No REMS enrollment documented Submit REMS enrollment confirmation; include both prescriber and patient enrollment
Step therapy not completed Provide detailed documentation of Onpattro trial/failure or contraindication
Insufficient genetic documentation Submit complete genetic testing report with pathogenic TTR variant identification
Missing lab monitoring plan Include detailed every-2-week monitoring schedule with specific lab parameters
"Not medically necessary" Submit peer-reviewed literature, FDA labeling, and clinical guidelines supporting use

Clinician Corner: Medical Necessity Letter Elements

When drafting your medical necessity letter, include:

  1. Patient presentation: Progressive polyneuropathy symptoms with confirmed hATTR diagnosis
  2. Genetic confirmation: Specific TTR mutation (e.g., Val30Met) with pathogenicity assessment
  3. Prior treatments: Document trial and failure/intolerance of step therapy requirements
  4. Clinical rationale: Reference FDA approval for hATTR polyneuropathy and clinical trial data
  5. Monitoring plan: Detailed REMS compliance and lab monitoring schedule
  6. Treatment goals: Slowing neuropathy progression and improving quality of life

Appeals Process in North Carolina

If your initial prior authorization is denied, North Carolina offers robust appeal rights through both UnitedHealthcare's internal process and the state's Smart NC external review program.

Internal Appeals with UnitedHealthcare

Timeline: Must file within 180 days of denial Process:

  1. Standard Appeal: 15-30 days for decision
  2. Urgent Appeal: 72 hours for decision (if delay would jeopardize health)
  3. Submit via: UnitedHealthcare member portal, mail, or fax

Required documentation:

  • Original denial letter
  • Additional clinical evidence
  • Peer-to-peer review request (if appropriate)
  • Updated medical necessity letter

Smart NC External Review

North Carolina's external review program offers particularly strong success rates for specialty and orphan drug appeals. After exhausting UnitedHealthcare's internal appeals:

Eligibility: State-regulated plans (not self-funded employer plans) Timeline: 45 days for standard review, 72 hours for expedited How to file: Contact Smart NC at 1-855-408-1212 or visit NCDOI website Success factors: Well-documented medical necessity appeals for specialty drugs may succeed in up to 80% of cases with thorough documentation

Note: Smart NC provides free advocacy assistance and can help gather supporting documentation for your external review.

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeals processes by analyzing denial letters, identifying specific coverage criteria, and drafting targeted appeals with evidence-backed medical necessity arguments. Their platform specializes in turning insurance denials into successful approvals through payer-specific workflows and comprehensive documentation strategies.

Peer-to-Peer Review Talking Points

If UnitedHealthcare requests a peer-to-peer review, focus on:

Clinical Evidence:

  • NEURO-TTR Phase 3 trial showed significant reduction in neuropathy progression (mNIS+7 improvement)
  • Quality of life improvements demonstrated in Norfolk QOL-DN scores
  • FDA approval based on robust clinical evidence for hATTR polyneuropathy

Safety Monitoring:

  • Comprehensive REMS program addresses thrombocytopenia and glomerulonephritis risks
  • Regular lab monitoring every 2 weeks ensures patient safety
  • Established protocols for dose modifications or discontinuation if needed

Medical Necessity:

  • Progressive, life-limiting disease without treatment
  • Limited therapeutic alternatives for hATTR polyneuropathy
  • Disease-modifying therapy addressing root cause (TTR protein reduction)

Costs & Patient Assistance

Manufacturer Support Programs

  • Tegsedi TouchRx: Patient support program offering copay assistance and prior authorization support
  • Eligibility: Commercial insurance patients may qualify for significant copay reductions
  • Contact: Verify current program details with prescribing physician

Additional Resources

  • Patient Access Network (PAN) Foundation: Grants for rare disease medications
  • HealthWell Foundation: Copay assistance for eligible patients
  • State pharmaceutical assistance programs: North Carolina residents may qualify for additional support

When to Escalate

If standard appeals fail, consider these escalation options:

North Carolina Department of Insurance

Contact: Smart NC Consumer Assistance Program Phone: 1-855-408-1212 When to contact: After internal appeal denial, before or during external review Services: Free advocacy, appeal assistance, complaint filing

State Regulatory Complaints

For broader coverage issues or potential bad faith denials:

  • File complaint with NC Department of Insurance
  • Document all communication attempts and denials
  • Include clinical evidence and appeal history

FAQ

How long does UnitedHealthcare prior authorization take for Tegsedi in North Carolina? Standard prior authorization decisions take up to 15 business days. Urgent requests (when delay would jeopardize health) must be decided within 72 hours.

What if Tegsedi is not on my UnitedHealthcare formulary? Non-formulary medications require additional documentation but can be approved through medical necessity exceptions. Focus on documenting why formulary alternatives are inappropriate.

Can I request an expedited appeal in North Carolina? Yes, both UnitedHealthcare internal appeals and Smart NC external reviews offer expedited processes for urgent medical situations, typically decided within 72 hours.

Does step therapy apply if I tried Onpattro in another state? Yes, documented trial and failure of step therapy requirements from other states should satisfy UnitedHealthcare's requirements. Ensure complete documentation transfer.

What happens if I'm on a self-funded employer plan? Self-funded plans are not eligible for Smart NC external review. These plans must offer federal external review rights, though the process may be less favorable for specialty drugs.

How can I continue treatment during appeals? Request bridge supplies from specialty pharmacies and manufacturer patient assistance programs. Many offer temporary supplies during active appeals processes.

What documentation do I need for genetic testing coverage? Clinical suspicion of hATTR amyloidosis plus family or personal history suggestive of hereditary amyloidosis. Include pre-test genetic counseling documentation and clear medical necessity for testing.

Are there any North Carolina-specific protections for rare disease coverage? North Carolina's external review program and Smart NC advocacy services provide particularly strong protections for specialty and orphan drug appeals compared to many other states.

When navigating complex coverage challenges, Counterforce Health offers specialized expertise in transforming insurance denials into successful approvals through evidence-based appeals and comprehensive understanding of payer-specific requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your insurance provider and consult your healthcare team for medical decisions. For official North Carolina insurance assistance, contact Smart NC at 1-855-408-1212.

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