By Counterforce Health Team in Tegsedi (inotersen) —

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

Quick Answer: Getting Tegsedi (Inotersen) Approved by Cigna in Washington

Cigna requires prior authorization for Tegsedi (inotersen) with strict criteria: confirmed hATTR polyneuropathy, TTR gene mutation, REMS enrollment, and detailed lab monitoring plan. In Washington, you have 72 hours for standard PA decisions and strong appeal rights including independent external review. First step: Have your neurologist gather genetic testing, baseline labs, and complete the Cigna PA form through their provider portal or CoverMyMeds.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. If Additional Information Is Requested
  7. If Your Request Is Denied
  8. Appeals Process in Washington
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist
  11. Frequently Asked Questions

What This Guide Covers

This comprehensive guide helps patients with hereditary transthyretin-mediated (hATTR) amyloidosis and their healthcare providers navigate Cigna's approval process for Tegsedi (inotersen) in Washington State. Whether you're facing an initial prior authorization or appealing a denial, this guide provides step-by-step instructions, required forms, and Washington-specific protections.

Tegsedi is a weekly subcutaneous injection that can slow progression of hATTR polyneuropathy, but requires careful safety monitoring and strict adherence to the REMS program. Understanding Cigna's requirements upfront significantly improves your chances of approval.

Before You Start: Verify Your Coverage

Check Your Plan Type and Formulary Status

  1. Log into myCigna or call member services (1-800-244-6224) to confirm:
    • Your plan covers specialty medications
    • Tegsedi's formulary tier (typically Specialty Tier 4 or 5)
    • Whether Express Scripts manages your pharmacy benefits
  2. Verify Network Status
    • Ensure your neurologist or amyloidosis specialist is in-network
    • Confirm which specialty pharmacy is preferred (usually Accredo)
  3. Understand Your Benefits
    • Specialty tier coinsurance (often 25-40%)
    • Annual out-of-pocket maximum
    • Whether manufacturer copay assistance is allowed
Tip: Washington residents with Cigna plans purchased through Washington Healthplanfinder have additional consumer protections under state insurance law.

Gather Required Documentation

Core Clinical Requirements

Genetic Testing Results

  • Laboratory report confirming pathogenic TTR gene mutation
  • Must be from a CLIA-certified laboratory
  • Include full gene sequencing results, not just targeted testing

Neurological Documentation

  • Specialist consultation notes documenting:
    • Confirmed hATTR polyneuropathy diagnosis
    • Disease stage and functional status
    • Neurologic exam findings
    • PND stage or NIS+7 scores (if available)

Baseline Laboratory Results

  • Complete blood count with platelets (≥100,000/µL required)
  • Comprehensive metabolic panel including creatinine and eGFR
  • Urinalysis with protein/creatinine ratio
  • Liver function tests

Treatment History Documentation

Document all prior therapies with:

  • Medication names, doses, and duration of treatment
  • Clinical response or lack thereof
  • Reasons for discontinuation (ineffective, intolerance, contraindications)
  • Specific side effects or adverse reactions

Common alternatives that may need to be addressed:

  • Onpattro (patisiran)
  • Amvuttra (vutrisiran)
  • Wainua (eplontersen)
  • Tafamidis (Vyndaqel/Vyndamax)

REMS Program Requirements

Tegsedi is only available through the Tegsedi REMS program due to risks of severe thrombocytopenia and glomerulonephritis:

  • Prescriber REMS certification and ID number
  • Patient REMS enrollment confirmation
  • Detailed monitoring plan including:
    • Weekly platelet count schedule
    • Quarterly renal function monitoring
    • Specific thresholds for dose holds or discontinuation

Submit Your Prior Authorization Request

Fastest Submission Methods

  1. Electronic Submission (Preferred)
  2. Alternative Methods
    • Fax: Express Scripts prior authorization fax line (verify current number with plan)
    • Phone: Cigna provider services line

Complete Request Packet Checklist

✅ Cigna/Express Scripts PA form (completed in full)
✅ Prescriber letter addressing medical necessity
✅ Genetic testing report with pathogenic TTR mutation
✅ Neurologist consultation notes with diagnosis and staging
✅ Baseline laboratory results (CBC, CMP, urinalysis)
✅ Prior treatment history with outcomes
✅ REMS enrollment confirmations (prescriber and patient)
✅ Detailed monitoring protocol with specific schedules and thresholds

Note: Incomplete submissions are a leading cause of delays. Include all supporting documentation with your initial request.

Follow-Up and Timeline Expectations

Washington State Requirements

Under Washington law, Cigna must respond to prior authorization requests:

  • Standard requests: Within 72 hours of receiving complete information
  • Expedited/urgent requests: Within 24 hours when delay could seriously jeopardize health

Day 1-2: Confirm receipt and completeness of submission
Day 3: Check status if no response received
Day 5: Escalate if still pending (request expedited review if clinically appropriate)

Sample Status Check Script

"I'm calling to check the status of a prior authorization for Tegsedi (inotersen) for [patient name], member ID [number], submitted on [date]. The reference number is [PA number]. Can you tell me the current status and whether any additional information is needed?"

Document all call reference numbers and representative names for your records.

If Additional Information Is Requested

Common Requests and Responses

"Need more details on medical necessity"

  • Submit peer-reviewed literature supporting Tegsedi use in hATTR
  • Include FDA labeling information
  • Reference relevant treatment guidelines from neurology societies

"Insufficient prior therapy documentation"

  • Provide detailed timeline of all previous treatments
  • Include specific reasons each therapy was discontinued
  • Document contraindications to preferred alternatives

"Monitoring plan unclear"

  • Submit written protocol with specific lab schedules
  • Include contact information for monitoring laboratory
  • Define exact platelet thresholds for dose modifications

Peer-to-Peer Review Strategy

If Cigna requests a peer-to-peer discussion:

  1. Prepare key talking points:
    • Patient's specific clinical presentation
    • Why alternatives are inappropriate or have failed
    • Expected benefits and monitoring plan
  2. Have documentation ready:
    • Genetic test results
    • Current functional status
    • Safety monitoring protocol
  3. Request appropriate reviewer:
    • Neurologist or amyloidosis specialist preferred
    • General internist may not be familiar with hATTR

If Your Request Is Denied

Common Denial Reasons and Solutions

Denial Reason Solution
Missing REMS documentation Submit prescriber certification and patient enrollment confirmations
Inadequate monitoring plan Provide detailed weekly platelet and quarterly renal monitoring schedule
Step therapy not met Document failure/contraindication to required alternatives
Insufficient genetic evidence Ensure complete TTR sequencing report is included
Baseline labs abnormal Repeat labs when stable; ensure platelets ≥100,000/µL

Immediate Next Steps

  1. Request detailed denial rationale in writing
  2. Review appeal rights included in denial letter
  3. Gather additional supporting evidence addressing specific concerns
  4. File internal appeal within 180 days of denial date

Appeals Process in Washington

Internal Appeals with Cigna

Level 1 Internal Appeal

  • Deadline: 180 days from denial date
  • Cigna response time: 30-45 days for standard; expedited available for urgent cases
  • Required: Written appeal with clinical documentation

Level 2 Internal Appeal

  • Available for some plan types
  • Cigna response time: 60 days
  • Strategy: Include any new clinical evidence or treatment failures

Washington External Review (IRO)

After exhausting internal appeals, Washington residents can request Independent Review Organization (IRO) review:

Eligibility: Medical necessity denials, experimental/investigational determinations
Deadline: 120 days from final internal denial
Timeline: 20 days for standard review, 72 hours for expedited
Cost: Free to patient
Outcome: Binding on Cigna if overturned

How to Request External Review:

  1. Contact Cigna member services to initiate
  2. Or call Washington Office of Insurance Commissioner: 1-800-562-6900
  3. Submit request with denial letters and clinical documentation
Washington Advantage: The state's external review process has independent medical experts who can override insurer determinations when treatment is medically necessary.

When to Request Expedited Review

Request expedited appeals when:

  • Rapid disease progression is occurring
  • Delay would result in irreversible neurologic decline
  • Current symptoms significantly impact daily functioning

Renewal and Re-Authorization

Annual Re-Authorization Requirements

Cigna typically requires annual renewal for Tegsedi with updated documentation:

Clinical Updates Needed:

  • Current neurologic status and functional assessment
  • Recent laboratory results showing stable monitoring parameters
  • Documentation of treatment response or disease stabilization
  • Updated safety monitoring plan

Timing Strategy:

  • Submit renewal request 30-45 days before current authorization expires
  • Include letter documenting clinical benefit or disease stabilization
  • Highlight continued adherence to REMS requirements

Evidence of Treatment Benefit

Document ongoing treatment value with:

  • Stable or improved neurologic function scores
  • Maintained independence in activities of daily living
  • Absence of significant adverse events
  • Patient/family reported quality of life improvements

Quick Reference Checklist

Before Submitting PA Request

  • Verify Cigna formulary status for patient's specific plan
  • Confirm neurologist is in-network
  • Complete prescriber and patient REMS enrollment
  • Obtain baseline labs (CBC, CMP, urinalysis)
  • Document genetic testing results
  • Gather prior treatment history

During PA Process

  • Submit complete packet electronically
  • Follow up within 72 hours
  • Document all reference numbers and contacts
  • Respond promptly to information requests
  • Request peer-to-peer if denied

If Appealing

  • File within 180 days of denial
  • Address each specific denial reason
  • Include updated clinical documentation
  • Consider expedited review if urgent
  • Know Washington external review rights

For Renewal

  • Submit 30-45 days before expiration
  • Document treatment benefit or stabilization
  • Include current lab monitoring results
  • Update safety monitoring plan

Frequently Asked Questions

Q: How long does Cigna prior authorization take in Washington? A: Washington law requires decisions within 72 hours for standard requests and 24 hours for expedited requests when Cigna has complete information.

Q: What if Tegsedi is non-formulary on my Cigna plan? A: You can request a formulary exception by documenting why formulary alternatives are not clinically appropriate. Your neurologist must provide detailed medical justification.

Q: Can I request an expedited appeal in Washington? A: Yes, both internal appeals and external reviews can be expedited when delay would seriously jeopardize your health or ability to regain function.

Q: Does step therapy apply if I've tried treatments outside Washington? A: Treatment history from any location counts toward step therapy requirements. Ensure your neurologist documents all prior therapies with specific outcomes.

Q: What happens if I miss my weekly lab draws? A: REMS requires strict adherence to platelet monitoring. Missing labs could result in automatic treatment holds and may affect continued authorization.

Q: How much will Tegsedi cost with Cigna coverage? A: As a specialty tier medication, you'll typically pay 25-40% coinsurance. Manufacturer copay assistance may help reduce costs if you're eligible.

Q: Can my family doctor prescribe Tegsedi? A: Cigna typically requires prescribing by or consultation with a neurologist or amyloidosis specialist due to the complexity of hATTR management.

Q: What if Cigna misses the 72-hour deadline in Washington? A: Contact the Washington Office of Insurance Commissioner at 1-800-562-6900 to file a complaint about missed statutory deadlines.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-based strategies. Our platform analyzes denial letters and plan policies to create targeted rebuttals that align with each payer's specific requirements, helping families access life-changing medications like Tegsedi.

This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and review your specific insurance plan documents. For assistance with insurance appeals in Washington, contact the Office of the Insurance Commissioner at 1-800-562-6900 or visit insurance.wa.gov.

Sources & Further Reading

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