By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Humana in Washington: Prior Authorization, Appeals, and Cost Assistance

Answer Box: Getting Tegsedi (Inotersen) Covered by Humana in Washington

Note: Tegsedi was discontinued in September 2024 - verify current availability before proceeding.

Getting Tegsedi covered by Humana requires prior authorization with specific documentation: genetic confirmation of hATTR polyneuropathy, specialist prescription, REMS enrollment, and baseline labs. In Washington, if denied, you have 65 days to appeal internally, then 180 days for external review through an Independent Review Organization (IRO).

First step today: Contact your prescribing specialist to initiate the prior authorization process through Humana's provider portal, ensuring all genetic testing and REMS requirements are documented.

Table of Contents

Understanding Tegsedi Coverage Requirements

Tegsedi (inotersen) is a specialty medication that requires prior authorization for all Humana Medicare Advantage plans. The drug targets hereditary transthyretin-mediated amyloidosis (hATTR) polyneuropathy, a rare genetic condition affecting the nervous system.

Coverage at a Glance

Requirement What It Means Documentation Needed
Prior Authorization Mandatory approval before coverage Completed PA form with clinical rationale
REMS Program Risk mitigation for safety monitoring Patient, prescriber, and pharmacy certification
Genetic Testing Confirmed TTR gene mutation Lab report showing specific mutation
Specialist Prescription Neurologist or geneticist required Provider credentials and specialty verification
Baseline Labs Safety monitoring requirements Platelet count ≥100k, eGFR ≥45

The medication carries significant costs, typically placing it in specialty tier categories. Humana's CenterWell Specialty Pharmacy handles distribution for most specialty medications, providing clinical support and coordination.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Genetic Confirmation (Patient/Clinic)
    • Obtain TTR genetic testing results showing specific mutation
    • Timeline: 2-4 weeks for testing
    • Submit: Lab report with mutation details
  2. REMS Enrollment (All Parties)
    • Patient, prescriber, and dispensing pharmacy must complete certification
    • Timeline: 1-2 weeks
    • Submit: REMS completion certificates
  3. Clinical Documentation (Prescriber)
    • Compile diagnosis codes (ICD-10 E85.1), symptom progression, prior therapies
    • Timeline: 1 week to gather
    • Submit: Medical necessity letter with supporting notes
  4. PA Submission (Prescriber)
    • Submit through Humana provider portal
    • Timeline: 30 days standard, 72 hours expedited
    • Required: All documentation above plus prescription

Medical Necessity Documentation

Your specialist needs to address these key points in the prior authorization:

  • Diagnosis: Confirmed hATTR polyneuropathy with genetic testing
  • Disease Stage: Mild to moderate neuropathy (PND score ≤ IIIb)
  • Prior Treatments: Document any previous therapies, outcomes, or contraindications
  • Clinical Rationale: FDA approval basis, symptom progression, functional impact
  • Monitoring Plan: Regular platelet and kidney function testing schedule
Clinician Corner: Include specific neuropathy scores (NIS, PND, FAP staging) with dates to demonstrate disease progression. Reference the NEURO-TTR study data showing efficacy in patients with NIS scores 10-130.

Cost Factors and Assistance Options

Understanding Your Costs

Tegsedi's cost depends on several factors:

  • Formulary Tier: Specialty tier placement affects copayments
  • Deductible: Whether you've met your annual deductible
  • Coverage Gap: Medicare Part D "donut hole" considerations
  • Site of Care: Specialty pharmacy vs. retail differences

Manufacturer Support

Ionis Every Step patient support program provides assistance regardless of insurance type:

  • Call 1-844-444-4315 (Mon-Fri, 8 AM-8 PM ET)
  • Financial assistance evaluation
  • Insurance navigation support
  • Educational resources and injection training

The program evaluates copay assistance on a case-by-case basis. Medicare patients may have different options due to federal regulations on copay cards.

Additional Financial Resources

  • Patient advocacy organizations: Many rare disease foundations offer grants
  • State programs: Washington may have additional assistance through Apple Health (Medicaid)
  • Hospital charity care: If receiving care at a major medical center

Appeals Process in Washington

Washington provides strong consumer protections for insurance denials. The state requires multiple levels of appeal before external review.

Internal Appeals Timeline

  1. First Internal Appeal: 65 days from denial notice
    • Submit: Written appeal with additional documentation
    • Timeline: 30 days for standard, 72 hours for urgent
    • Contact: Humana member services number on ID card
  2. Second Internal Appeal (if available): 65 days from first denial
    • Submit: New evidence or peer-to-peer review request
    • Timeline: 30 days for determination

External Review Process

If internal appeals fail, Washington's Independent Review Organization (IRO) process provides an independent evaluation:

  • Deadline: 180 days from final internal denial
  • Process: Submit request to Washington Office of Insurance Commissioner
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Cost: Free to consumers
  • Binding: Decision is binding on Humana if overturned

Contact the Washington Insurance Commissioner's Consumer Advocacy line at 1-800-562-6900 for assistance with appeals.

When to Request Expedited Review

Request expedited appeals if:

  • Disease progression could worsen without treatment
  • Current symptoms significantly impact daily function
  • Delay could cause irreversible neurological damage

Pharmacy Network Requirements

CenterWell Specialty Pharmacy

Humana's preferred specialty pharmacy handles Tegsedi distribution:

  • Services: Prior authorization coordination, REMS compliance, injection training
  • Delivery: 3-5 business days after approval
  • Support: Clinical pharmacist consultation, refill reminders

Retail Pharmacy Options

Limited retail access available:

  • Transition supply: 30-day supply during first 90 days of coverage
  • Requirements: REMS-certified pharmacy only
  • Coverage: May apply to deductible differently than specialty pharmacy
Note: Most ongoing Tegsedi therapy must go through specialty pharmacy for full coverage benefits.

Renewal and Annual Changes

Annual Formulary Updates

Humana's formulary changes occur primarily January 1st each year:

  • Notification: 30 days advance notice for mid-year changes
  • Review: Check 2026 formulary updates during open enrollment
  • Transition: Temporary coverage may be available if removed from formulary

Monitoring Your Coverage

  • Review: Annual Evidence of Coverage (EOC) documents
  • Track: Prior authorization renewal dates (typically 6-12 months)
  • Plan: Budget for potential tier changes or new requirements

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Incomplete REMS Submit certification proof REMS completion certificates for all parties
Missing genetic testing Provide mutation confirmation TTR gene test results with specific variant
Inadequate specialist Verify provider credentials Board certification in neurology/genetics
Insufficient disease severity Document progression Neuropathy scores, functional assessments
Missing prior therapy Show treatment history Records of previous medications tried/failed

Scripts for Key Conversations

Calling Humana Member Services

"I need to check the prior authorization status for Tegsedi, spelled T-E-G-S-E-D-I, generic name inotersen. My member ID is [number]. Can you tell me what documentation is still needed and the expected timeline for determination?"

Requesting Peer-to-Peer Review

"We'd like to request a peer-to-peer review for our Tegsedi prior authorization. The patient has confirmed hATTR polyneuropathy with [specific mutation] and meets all FDA approval criteria. When can we schedule the clinical discussion?"

Escalating to Supervisor

"I need to speak with a supervisor about our Tegsedi appeal. We've provided all required documentation including genetic testing and REMS enrollment, but the denial reason doesn't align with the clinical evidence submitted."

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, payer-specific documentation. Our platform helps patients, clinicians, and pharmacies navigate complex prior authorization requirements for specialty medications like Tegsedi, ensuring appeals address the specific criteria each insurer uses for approval decisions.

When facing a Tegsedi denial from Humana, having the right documentation strategy can make the difference between approval and continued delays. Counterforce Health's platform analyzes denial letters and creates targeted appeals that speak directly to Humana's specific requirements, increasing your chances of a successful outcome.

Frequently Asked Questions

How long does Humana's prior authorization take for Tegsedi? Standard prior authorization takes up to 30 days, with expedited reviews completed within 72 hours for urgent cases. Complete documentation speeds the process.

What if Tegsedi isn't on Humana's formulary? Request a formulary exception by demonstrating medical necessity and that preferred alternatives are inappropriate or ineffective for your condition.

Can I appeal if I live in Washington but have an employer plan? Self-funded employer plans may not follow Washington state appeal rights. Contact the U.S. Department of Labor for ERISA plan appeals, though many employers voluntarily use external review.

Does step therapy apply to Tegsedi? Yes, Humana requires trying preferred medications first unless contraindicated. Document why alternatives aren't suitable in your prior authorization.

What happens if my appeal is denied? In Washington, you can request external review through an Independent Review Organization within 180 days of the final internal denial.

Sources & Further Reading

This article provides general information about insurance coverage and appeals processes. It is not medical advice. Consult your healthcare provider for medical decisions and your insurance company for specific coverage details. For assistance with Washington insurance issues, contact the Office of the Insurance Commissioner at 1-800-562-6900.

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