By Counterforce Health Team in Tegsedi (inotersen) —

The Requirements Checklist to Get Tegsedi (inotersen) Covered by Cigna in New Jersey

Quick Answer for New Jersey Patients: Tegsedi (inotersen) requires Cigna prior authorization with mandatory REMS enrollment and strict lab monitoring. You'll need genetic confirmation of hATTR, specialist prescribing, and weekly platelet/kidney function tests. If denied, New Jersey's IHCAP external review program through Maximus gives you a strong second chance—about 40-60% of external appeals succeed for specialty drugs. Start by confirming your Cigna plan covers specialty drugs through Accredo, then have your neurologist submit the PA with complete REMS documentation.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: Tracking Your Request
  9. Common Denial Prevention Tips
  10. Appeals Process in New Jersey
  11. Quick Reference Checklist

Who Should Use This Checklist

This guide is for New Jersey patients with hereditary transthyretin amyloidosis (hATTR) polyneuropathy and their healthcare teams seeking Cigna coverage for Tegsedi (inotersen). Use this checklist if:

  • You've been diagnosed with hATTR polyneuropathy and your neurologist recommends Tegsedi
  • Your Cigna plan requires prior authorization for specialty medications
  • You've received a denial and need to understand the appeal process
  • You're preparing your initial prior authorization submission

Expected outcome: Following this checklist increases your chances of first-time approval and helps you navigate New Jersey's external appeal system if needed.

Note: Tegsedi was discontinued by the manufacturer in September 2024, but existing patients may continue therapy through 2026 under legacy coverage policies.

Member & Plan Basics

Active Coverage Requirements

✓ Verify active Cigna coverage through your member portal or by calling the number on your insurance card

✓ Confirm specialty drug benefits are included in your plan—most Cigna plans route specialty medications through Accredo specialty pharmacy

✓ Check your deductible status as Tegsedi may be subject to your annual deductible before copay assistance applies

✓ Identify your plan type:

  • Commercial/employer plans: Follow standard PA process
  • Medicare Advantage: May have additional step therapy requirements
  • Medicaid managed care: Different approval pathways may apply

Authorization Requirements

All Cigna plans require prior authorization for Tegsedi. According to Cigna's coverage policy, approval is only granted for FDA-approved indications with specialist involvement.

Clinical Criteria Requirements

FDA-Approved Indication

✓ hATTR polyneuropathy in adults - Tegsedi is only covered for this specific indication

Genetic Testing Documentation

✓ Confirmed TTR pathogenic variant through genetic testing results ✓ Symptomatic polyneuropathy documented by clinical exam, patient history, or nerve conduction studies

Prescriber Requirements

✓ Specialist involvement required:

  • Neurologist
  • Geneticist
  • Physician specializing in amyloidosis

✓ Age restriction: Patient must be ≥18 years old ✓ No liver transplant history (contraindication)

REMS Program Enrollment

This is the most critical requirement. Tegsedi has a Risk Evaluation and Mitigation Strategy (REMS) due to serious risks:

✓ Patient enrolled in Tegsedi REMS program before dispensing ✓ Prescriber certified in REMS program ✓ Pharmacy enrolled and certified to dispense

Lab Monitoring Requirements

Test Frequency Action Level
Platelet count Weekly × 2 months, then every 2 weeks Discontinue if <50,000/µL
Urinalysis (proteinuria) Weekly × 2 months, then every 2 weeks 24-hour urine if ≥1+ protein
24-hour urine protein If proteinuria detected Discontinue if ≥0.5 g/24 hours
Liver function tests Periodic monitoring As clinically indicated

Coding and Billing Information

HCPCS Codes

Since Tegsedi lacks a specific J-code, use:

  • J3490: Unclassified drugs (specify "Tegsedi (inotersen)")
  • C9399: Unclassified drugs or biologicals (hospital outpatient use)

Diagnosis Coding

✓ Primary ICD-10: E85.1 (Neuropathic heredofamilial amyloidosis)

NDC Information

✓ Report the exact NDC from the dispensed vial packaging ✓ Common format: 72126-0120-01 (verify current lot information)

Documentation Packet Essentials

Provider Note Elements

Your neurologist's clinical note should include:

✓ Confirmed hATTR diagnosis with genetic testing results ✓ Current neurological symptoms and functional impact ✓ Prior treatment history and outcomes ✓ Contraindications to alternative treatments (if applicable) ✓ Treatment goals and expected outcomes ✓ REMS enrollment confirmation

Medical Necessity Letter Components

A strong letter of medical necessity should address:

  1. Clinical rationale for Tegsedi specifically
  2. FDA labeling alignment for hATTR polyneuropathy
  3. Patient-specific factors supporting the choice
  4. Monitoring plan per REMS requirements
  5. Expected clinical outcomes

Required Attachments

✓ Genetic testing report confirming TTR mutation ✓ Neurological evaluation with symptom documentation ✓ Lab results showing baseline platelet count and kidney function ✓ REMS enrollment confirmation ✓ Prior therapy documentation (if step therapy applies)

Submission Process

Electronic Submission Options

CoverMyMeds (Recommended):

Evicore by Evernorth:

MyAccredoPatients.com:

  • Use "Electronic Referral" or iAssist feature
  • Allows simultaneous PA and referral submission

Required Fields That Commonly Cause Rejections

✓ Complete patient demographics matching insurance card exactly ✓ Correct prescriber NPI and taxonomy codes ✓ Specific drug name: "Tegsedi (inotersen)" ✓ Accurate ICD-10 diagnosis code: E85.1 ✓ REMS enrollment confirmation number ✓ Specialist prescriber credentials

Specialty Pharmacy Coordination

Accredo Integration

Most Cigna plans route Tegsedi through Accredo specialty pharmacy:

✓ Verify Accredo is in-network for your specific plan ✓ Coordinate PA submission - Accredo can help facilitate if referral is submitted ✓ Confirm shipping address and preferred delivery schedule ✓ Set up patient portal access for order tracking

Transfer Process

If switching from another specialty pharmacy:

  1. Request prescription transfer to Accredo
  2. Provide previous pharmacy with Accredo contact information
  3. Confirm remaining refills transfer correctly
  4. Verify insurance coverage transfers with prescription

After Submission: Tracking Your Request

Confirmation Numbers

✓ Save PA reference number from submission portal ✓ Document submission date for appeal deadline tracking ✓ Record contact information for follow-up

Status Check Schedule

  • Day 3: Verify receipt and completeness
  • Day 7: Check for additional information requests
  • Day 14: Follow up if no decision received
  • Day 21: Consider peer-to-peer review request

What to Record

✓ All communication dates and reference numbers ✓ Names of representatives spoken with ✓ Requests for additional information ✓ Decision notifications and reasons

Common Denial Prevention Tips

Five Pitfalls to Avoid

  1. Incomplete REMS documentation - Ensure all REMS requirements are clearly documented
  2. Missing specialist involvement - Non-neurologist prescribers often face automatic denials
  3. Inadequate genetic testing documentation - Submit complete genetic testing report, not just a summary
  4. Incorrect coding - Use J3490 with specific drug identification, not generic codes
  5. Insufficient monitoring plan - Detail the specific lab monitoring schedule per REMS requirements

Success Strategies

From our advocates: We've seen the highest approval rates when prescribers submit a comprehensive packet upfront rather than responding to information requests. One composite case involved a patient whose neurologist included genetic testing, baseline labs, REMS enrollment confirmation, and a detailed monitoring plan in the initial submission—approved within 5 business days without additional requests.

Appeals Process in New Jersey

If your initial request is denied, New Jersey offers robust appeal rights:

Internal Appeals with Cigna

✓ First-level appeal: Submit within 180 days of denial ✓ Second-level appeal: Available if first appeal is denied ✓ Expedited appeals: Available for urgent cases

External Review Through IHCAP

New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review:

✓ Eligibility: After completing Cigna's internal appeals ✓ Timeline: Submit within 4 months (180 days) of final internal denial ✓ Process: Managed by Maximus Federal Services as the independent review organization ✓ Decision deadline: 45 calendar days for standard review ✓ Cost: Free to patients (insurers pay all costs)

External Review Success Rates

Research indicates external appeals for specialty drugs with strong medical evidence succeed in approximately 40-60% of cases. Success rates increase significantly when appeals directly address the insurer's specific denial reasons with clinical evidence.

Contact Information

  • IHCAP Hotline: 1-888-393-1062
  • NJ Department of Banking and Insurance: 1-800-446-7467
  • Consumer assistance: Available for process questions and guidance

Quick Reference Checklist

Before Starting

□ Active Cigna coverage confirmed □ Specialty drug benefits verified
□ Neurologist or amyloidosis specialist identified □ Genetic testing completed and documented

Clinical Requirements

□ hATTR polyneuropathy diagnosis confirmed □ TTR pathogenic variant documented □ Patient ≥18 years old □ No liver transplant history □ Baseline labs obtained (platelets, kidney function)

REMS Requirements

□ Patient enrolled in Tegsedi REMS □ Prescriber REMS-certified □ Dispensing pharmacy REMS-enrolled □ Monitoring plan established

Submission Essentials

□ Prior authorization form completed □ Medical necessity letter prepared □ All supporting documentation attached □ Correct coding used (J3490, E85.1) □ Electronic submission via preferred portal

Post-Submission

□ Confirmation number saved □ Status tracking system established □ Appeal deadlines noted □ Contact information documented

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical guidelines to create compelling appeals that align with payer-specific workflows and procedural requirements.

For patients facing Tegsedi coverage challenges, having the right documentation and understanding New Jersey's appeal process can make the difference between approval and denial. The state's IHCAP program provides a valuable safety net when initial requests don't succeed.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider about treatment options and work with your insurance company directly for coverage determinations. For questions about New Jersey insurance regulations, contact the NJ Department of Banking and Insurance at 1-800-446-7467.

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