By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Cigna in Georgia: Complete Prior Authorization and Appeals Guide

Quick Answer: To get Tegsedi (inotersen) covered by Cigna in Georgia, you need: (1) genetic confirmation of hATTR polyneuropathy, (2) REMS enrollment for prescriber and patient, (3) prior authorization with baseline labs and monitoring plan, and (4) specialty pharmacy routing through Accredo. If denied, Georgia law gives you 60 days to request external review through the Georgia Department of Insurance. Start by calling Cigna at 1-800-882-4462 to verify your plan's specific requirements.

Table of Contents

  1. Cigna's Coverage Policy for Tegsedi
  2. Medical Necessity Requirements
  3. REMS Program and Safety Monitoring
  4. Step Therapy and Alternative Treatments
  5. Quantity Limits and Dosing
  6. Specialty Pharmacy Requirements
  7. Prior Authorization Process
  8. Appeals Process in Georgia
  9. Common Denial Reasons and Solutions
  10. Cost Support and Patient Assistance
  11. When to Escalate

Cigna's Coverage Policy for Tegsedi

Cigna covers Tegsedi (inotersen) for hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy under strict prior authorization requirements. The drug is classified as a specialty medication, typically placed on the highest formulary tier with significant cost-sharing.

Plan Types and Coverage:

  • Commercial plans: Prior authorization required across all product lines
  • Medicare Advantage: Covered under Part D with additional step therapy requirements
  • Express Scripts management: Most Cigna plans route specialty drugs through Express Scripts/Accredo

The current Cigna policy requires documented hATTR polyneuropathy, REMS enrollment, and specialist management.

Medical Necessity Requirements

Cigna's medical necessity criteria align with FDA labeling but include additional documentation requirements:

Core Diagnostic Requirements

  • Genetic confirmation: Pathogenic TTR gene mutation documented by genetic testing
  • Polyneuropathy symptoms: Progressive sensorimotor neuropathy with functional impairment
  • Age restriction: Must be 18 years or older
  • Specialist management: Neurologist, geneticist, or amyloidosis specialist involvement required

Required Documentation

Document Type Specific Requirements Source
Genetic test report Pathogenic TTR variant confirmation Laboratory report with variant classification
Neurologic evaluation PND/NIS scores, ambulatory status, symptom progression Specialist consultation note
Baseline labs Platelets ≥100,000/µL, normal renal function Complete blood count, comprehensive metabolic panel
Prior treatments Documentation of previous therapies and outcomes Medical records

Contraindications that trigger denial:

  • Prior liver transplant
  • Severe thrombocytopenia (platelets <100,000/µL)
  • Severe renal impairment (eGFR <45 mL/min)
  • Non-hATTR amyloidosis types

REMS Program and Safety Monitoring

Tegsedi requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program due to risks of severe thrombocytopenia and glomerulonephritis. Cigna will not approve coverage without documented REMS compliance.

REMS Enrollment Steps

  1. Prescriber certification: Complete training at TegsediREMS.com
  2. Patient enrollment: Sign acknowledgment forms and safety monitoring agreement
  3. Pharmacy certification: Ensure specialty pharmacy is REMS-certified

Mandatory Monitoring Schedule

Timeframe Required Tests Action Thresholds
Baseline Platelets, CBC, creatinine, eGFR, urinalysis Platelets ≥100,000/µL required
Weekly (first 2 months) Platelet count, urinalysis Hold if platelets <75,000/µL
Every 2 weeks (ongoing) Platelet count, urinalysis Discontinue if severe thrombocytopenia
Every 3 months Comprehensive metabolic panel Monitor renal function
Critical: Submit a written monitoring protocol with your prior authorization. Include specific platelet count thresholds for holding or discontinuing therapy.

Step Therapy and Alternative Treatments

Cigna may require trial of alternative hATTR treatments before approving Tegsedi, depending on your specific plan:

Common Step Therapy Requirements

  • Onpattro (patisiran): IV infusion every 3 weeks
  • Vyndamax/Vyndaqel (tafamidis): Oral daily for mixed cardiomyopathy cases
  • Amvuttra (vutrisiran): Subcutaneous injection every 6 months

Medical Exception Criteria

Document any of the following to bypass step therapy:

  • Infusion intolerance: Severe reactions or inability to tolerate IV therapy
  • Access barriers: Distance to infusion center, transportation issues, caregiver constraints
  • Contraindications: Medical reasons why alternatives are inappropriate
  • Prior failure: Previous trial with inadequate response or intolerance
From our advocates: "We've seen step therapy exceptions approved when patients document that traveling 2+ hours each way for Onpattro infusions would significantly impact their quality of life and medication adherence."

Quantity Limits and Dosing

Cigna covers Tegsedi at the FDA-approved dose only:

Approved Dosing:

  • 284 mg subcutaneous injection once weekly
  • Maximum: 4 syringes per 28-day period
  • No dose escalation or increased frequency allowed

NDC and Coding:

  • NDC: 72126-0007-02 (284 mg/1.5 mL prefilled syringe)
  • HCPCS: J3490 (unclassified injection) for medical benefit claims
  • ICD-10: E85.1 (neuropathic heredofamilial amyloidosis)

Specialty Pharmacy Requirements

Cigna mandates specialty pharmacy dispensing through their contracted network:

Required Pharmacy

Accredo Specialty Pharmacy is Cigna's primary specialty pharmacy partner for Tegsedi:

  • Phone: 1-800-835-3784
  • Website: myaccredo.com
  • REMS-certified for Tegsedi dispensing

Dispensing Process

  1. Prior authorization approval required first
  2. Prescriber submits prescription to Accredo
  3. Patient enrollment and benefit verification
  4. REMS compliance verification
  5. Home delivery coordination

Important: Retail pharmacies cannot dispense Tegsedi due to REMS requirements and Cigna's specialty pharmacy mandate.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify coverage (Patient): Call Cigna at 1-800-882-4462 to confirm Tegsedi is covered under your plan
  2. Complete REMS enrollment (Prescriber): Obtain certification and enroll patient in REMS program
  3. Gather documentation (Clinic): Collect genetic test, specialist notes, baseline labs, monitoring plan
  4. Submit PA electronically (Prescriber): Use CoverMyMeds or Express Scripts provider portal
  5. Follow up within 48 hours (Clinic): Check status and provide additional information if requested
  6. Coordinate with Accredo (Patient): Complete specialty pharmacy enrollment once approved
  7. Schedule monitoring (Patient): Arrange weekly lab draws and follow-up appointments

Required Documentation Checklist

  • Completed Cigna prior authorization form
  • Genetic testing report confirming pathogenic TTR variant
  • Neurologist consultation note with PND/NIS scores
  • Baseline laboratory results (CBC, CMP, urinalysis)
  • REMS enrollment confirmations (prescriber and patient)
  • Written laboratory monitoring protocol
  • Documentation of prior treatments and outcomes
  • Insurance card and member ID

Appeals Process in Georgia

If Cigna denies your Tegsedi prior authorization, Georgia law provides multiple appeal levels:

Internal Appeals (Required First Step)

Timeline: Must file within 180 days of denial Process:

  • Submit appeal through Cigna member portal or mail
  • Include additional clinical documentation
  • Request peer-to-peer review with prescribing physician
  • Decision within 30 days (15 days for expedited)

External Review (Georgia DOI)

Timeline: Must file within 60 days of final internal denial Process:

  1. Complete Georgia external review application
  2. Submit to Georgia Office of Commissioner of Insurance
  3. Independent physician review of medical necessity
  4. Decision within 30 business days (72 hours if expedited)
  5. Binding on Cigna if approved

Georgia Consumer Services: 1-800-656-2298

Note: Georgia's external review is free for consumers and has strong legal backing. Many wrongful denials are overturned at this level.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
REMS enrollment incomplete Complete all REMS steps Prescriber certification ID, patient enrollment confirmation
Insufficient genetic documentation Submit complete genetic test Full laboratory report with variant classification
Missing monitoring plan Provide detailed protocol Written schedule with specific thresholds and actions
Step therapy not met Request medical exception Prior treatment documentation or contraindication rationale
Non-specialty pharmacy Transfer to Accredo Coordinate prescription transfer
Baseline labs inadequate Repeat with acceptable values Platelets ≥100,000/µL, normal renal function

Medical Necessity Letter Template

When appealing, include a letter addressing:

  • Clinical presentation: Progressive hATTR polyneuropathy symptoms and functional decline
  • Diagnostic confirmation: Genetic testing results and amyloid deposition evidence
  • Treatment rationale: Why Tegsedi is medically necessary and appropriate
  • Safety monitoring: Detailed REMS compliance and monitoring plan
  • Alternative therapy considerations: Why other options are not suitable

Cost Support and Patient Assistance

Manufacturer Support:

  • AKCEA CONNECT: Patient support program
  • Copay assistance for eligible commercial insurance patients
  • Prior authorization support and appeals assistance

Financial Assistance Options:

  • Patient Access Network (PAN) Foundation
  • HealthWell Foundation
  • State pharmaceutical assistance programs
  • Hospital charity care programs

Contact the manufacturer's patient support program first, as they often provide comprehensive assistance with both coverage and affordability.

When to Escalate

Consider escalation if:

  • Multiple internal appeals have been denied
  • Cigna fails to meet Georgia appeal deadlines
  • You suspect discriminatory coverage practices
  • Medical urgency requires immediate treatment

Escalation Resources:

  • Georgia Department of Insurance: File complaint at oci.ga.gov
  • Georgians for a Healthy Future: Consumer assistance organization
  • Georgia Legal Services Program: Free legal assistance for low-income patients
  • Healthcare appeals attorney: For complex cases with significant financial impact

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

FAQ

How long does Cigna prior authorization take for Tegsedi? Electronic submissions typically receive decisions within 24-48 hours. Complex cases may take up to 15 days.

What if Tegsedi is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Georgia law requires coverage for medically necessary treatments even if non-formulary.

Can I request expedited review? Yes, if delays pose serious risk to health. Both internal and external reviews offer expedited pathways (15 days and 72 hours, respectively).

Does step therapy apply if I failed treatments in another state? Yes, document all prior treatments regardless of location. Include medical records showing inadequate response or intolerance.

What happens if I move between Georgia and another state? Appeal rights follow state of residence. Notify Cigna of address changes and verify new state requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations change frequently. Always verify current requirements with Cigna and consult healthcare providers for medical decisions.

For additional support with insurance appeals and coverage challenges, Counterforce Health offers specialized assistance in developing evidence-based appeals that meet payer-specific requirements.

Sources & Further Reading

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