How to Get Tegsedi (inotersen) Covered by Cigna in California: Complete Guide with Forms, Appeals, and IMR Process
Answer Box: Your Fastest Path to Tegsedi Coverage
Tegsedi (inotersen) requires prior authorization through Cigna in California. Your prescriber must submit a PA request via the EviCore portal or call 1-800-882-4462 with genetic testing confirmation, REMS enrollment proof, and specialist prescription. If denied, file an internal appeal within 180 days, then request an Independent Medical Review (IMR) through California's DMHC—which overturns ~73% of specialty drug denials.
First step today: Confirm your Cigna plan covers specialty drugs through Accredo and have your neurologist begin REMS enrollment at TEGSEDIREMS.com.
Table of Contents
- Verify Your Cigna Plan Coverage
- Required Forms and Documentation
- REMS Enrollment Process
- Submission Portals and Methods
- Accredo Specialty Pharmacy Setup
- Appeals Process: Internal to IMR
- Support Lines and Resources
- California Regulatory Assistance
- FAQ
Verify Your Cigna Plan Coverage
Before starting your Tegsedi prior authorization, confirm your specific plan's requirements. Cigna typically manages specialty drugs like Tegsedi through Express Scripts/Accredo specialty pharmacy networks.
Coverage Requirements at a Glance:
| Requirement | Details | Where to Verify |
|---|---|---|
| Prior Authorization | Required for all plans | Cigna Coverage Policies |
| Specialty Pharmacy | Usually requires Accredo | Your member portal or ID card |
| Age Requirement | 18+ years | Cigna policy document |
| Prescriber Type | Neurologist, geneticist, or amyloidosis specialist | PA form requirements |
| Genetic Testing | TTR gene mutation confirmed | Medical records |
Tip: California law requires Cigna to respond to PA requests within 72 hours (non-urgent) or 24 hours (urgent). No response means automatic approval.
Required Forms and Documentation
Core Prior Authorization Package
Your prescriber needs to gather these documents before submitting:
- Cigna Prior Authorization Form - Available through the EviCore portal
- Genetic Test Results - Confirming TTR pathogenic variant
- Clinical Notes - Documenting symptomatic polyneuropathy
- REMS Enrollment Confirmation - Both patient and prescriber certificates
- Baseline Laboratory Results - Platelet count, kidney function (creatinine, eGFR)
- Specialist Credentials - Prescriber's specialty certification
Medical Necessity Documentation
Clinician Corner: Essential Elements for Your Letter
Your medical necessity letter should include:
- Patient's confirmed TTR gene mutation with lab report
- Clinical presentation of polyneuropathy symptoms
- Prior treatment failures or contraindications (if applicable)
- Baseline laboratory values and monitoring plan
- REMS program enrollment status
- Treatment goals and expected outcomes
Include references to the FDA label and relevant neurological guidelines when available.
REMS Enrollment Process
Tegsedi requires mandatory REMS enrollment before any prescription can be filled. This FDA requirement exists due to risks of severe thrombocytopenia and glomerulonephritis.
Step-by-Step REMS Enrollment
- Visit TEGSEDIREMS.com or call 1-844-483-4736
- Prescriber Enrollment (1-2 business days):
- Complete prescriber training module
- Attest to monitoring requirements
- Receive enrollment confirmation
- Patient Enrollment (same day):
- Review patient education materials
- Complete enrollment form
- Receive patient enrollment card
- Pharmacy Verification - Only REMS-certified pharmacies can dispense
Important: Submit REMS confirmation documents with your PA request. Missing REMS enrollment is a common denial reason.
Laboratory Monitoring Requirements
The REMS program mandates specific lab monitoring:
- Baseline: Complete blood count with platelets, comprehensive metabolic panel
- Ongoing: Platelet counts and kidney function per protocol schedule
- Documentation: Include monitoring plan and baseline results in PA submission
Submission Portals and Methods
Primary Submission Routes
EviCore Portal (Preferred Method):
- Access: Cigna Provider Portal
- Upload: All documents in PDF format
- Tracking: Real-time status updates
- Timeline: 72 hours for standard requests
Phone Submission:
- Number: 1-800-882-4462
- Hours: Business hours (verify current times)
- Have ready: All documentation, patient ID, prescriber NPI
Fax Submission:
- Confirm current fax number through provider portal
- Use cover sheet with patient ID and "URGENT" if applicable
- Request fax confirmation receipt
Accredo Specialty Pharmacy Setup
Most Cigna plans require Tegsedi to be dispensed through Accredo specialty pharmacy. Here's how to enroll:
Enrollment Process
- Patient Portal Setup:
- Create account at MyAccredoPatients.com
- Link to your Cigna member ID
- Upload insurance card and PA approval
- Prescription Transfer:
- Download Accredo Referral Form
- Complete all sections (prescriber signature required)
- Submit via fax (866-759-1557) or portal upload
- Delivery Coordination:
- Phone: 877-826-7657
- Hours: Mon-Fri 7am-10pm, Sat 7am-4pm CST
- Schedule delivery to home or clinic
Note: Accredo coordinates with REMS-certified dispensing and provides 24/7 pharmacist support.
Appeals Process: Internal to IMR
If your Tegsedi PA is denied, California provides robust appeal rights with high success rates for specialty drugs.
Step-by-Step Appeals Timeline
Level 1: Internal Appeal with Cigna
- Deadline: 180 days from denial notice
- Submit via: Cigna member portal, phone (1-800-882-4462), or mail
- Decision timeline: 30 days (15 for urgent)
- Include: Denial letter, medical records, physician statement
Level 2: Second Internal Appeal
- Automatic: If Level 1 denied
- Deadline: 60 days from Level 1 decision
- Review: Different clinician reviews case
- Decision timeline: 30 days (15 for urgent)
Level 3: Independent Medical Review (IMR)
- Eligibility: After internal appeals exhausted
- Deadline: 30 days from final internal denial
- File with: California DMHC at dmhc.ca.gov
- Cost: Free to patients
- Timeline: 45 days standard, 7 days expedited
- Success rate: ~73% overturn rate for specialty drug denials
Common Denial Reasons & Solutions
| Denial Reason | How to Address |
|---|---|
| Missing REMS enrollment | Submit confirmation certificates |
| Insufficient lab monitoring plan | Provide detailed monitoring schedule |
| Non-specialist prescriber | Transfer to neurologist or geneticist |
| Incomplete genetic testing | Include full TTR mutation report |
| Missing clinical documentation | Add polyneuropathy assessment notes |
Support Lines and Resources
Cigna Contact Information
Member Services:
- Phone: Number on your ID card
- Portal: myCigna.com
- For PA status checks and appeals
Provider Services:
- Phone: 1-800-882-4462
- EviCore portal support
- Peer-to-peer review requests
Accredo Specialty Pharmacy:
- Patient line: 877-826-7657
- Physician service: 844-516-3319
- 24/7 pharmacist consultation available
What to Ask When You Call
For PA Status:
- "What's the current status of PA request #[number]?"
- "What additional documentation is needed?"
- "Can we schedule a peer-to-peer review?"
For Appeals:
- "I need to file an internal appeal for denial #[number]"
- "What's the fastest way to submit appeal documents?"
- "Can this be processed as expedited due to medical urgency?"
California Regulatory Assistance
California offers exceptional consumer protection for insurance denials:
DMHC Resources (For HMO/Most PPO Plans)
Contact Information:
- Phone: 1-888-466-2219
- Website: healthhelp.ca.gov
- Online complaint filing available
Services Provided:
- IMR application assistance
- Complaint investigation
- Enforcement of appeal timelines
- Multilingual support
Additional Consumer Help
Health Consumer Alliance:
- Nonprofit assistance for complex appeals
- Free consultation for rare disease cases
- Help with documentation preparation
Legal Aid Organizations:
- Available for cases involving discrimination or bad faith denials
- Search "legal aid California health insurance" for local resources
FAQ
How long does Cigna PA approval take in California? Cigna must respond within 72 hours for non-urgent requests, 24 hours for urgent requests. No response equals automatic approval under California law.
What if Tegsedi isn't on my formulary? Request a formulary exception through the same PA process. Include medical necessity documentation and alternative drug contraindications or failures.
Can I get expedited processing? Yes, if your doctor certifies that delay would seriously jeopardize your health. Mark all submissions "URGENT" and include clinical justification.
Does step therapy apply if I tried alternatives in another state? Yes, California's AB 347 law recognizes out-of-state prior therapy failures. Include documentation from previous providers.
What happens if DMHC IMR approves my case? Cigna must authorize coverage within 5 business days. Failure to comply can result in state fines and enforcement action.
How much does Tegsedi cost with Cigna coverage? Costs depend on your specific plan's specialty tier copay or coinsurance. Contact member services for your exact out-of-pocket amount.
Can I use manufacturer assistance with Cigna? Yes, Ionis offers patient assistance programs. Check eligibility requirements and coordinate with Accredo for processing.
What if I need help with the appeals process? Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients and clinicians navigate complex prior authorization requirements and craft compelling medical necessity arguments using payer-specific workflows and clinical evidence.
Counterforce Health transforms the insurance appeals process by analyzing denial letters, plan policies, and clinical notes to create targeted rebuttals aligned with each payer's specific requirements. For patients facing Tegsedi denials, their evidence-based approach combines FDA labeling, peer-reviewed studies, and specialty guidelines with the precise clinical documentation that payers expect—helping turn denials into approvals through systematic, professional advocacy.
Sources & Further Reading
- Cigna Tegsedi Coverage Policy (PDF)
- California DMHC Independent Medical Review
- Cigna Prior Authorization Process
- Tegsedi REMS Program
- Accredo Specialty Pharmacy
- California Health Help Center
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Appeal processes and requirements may change—verify current procedures with official sources.
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