By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (Inotersen) Covered by Humana in Ohio: Prior Authorization, Appeals, and REMS Requirements

Answer Box: Get Tegsedi (Inotersen) Covered by Humana in Ohio

Humana requires prior authorization for Tegsedi (inotersen) for hATTR polyneuropathy in Ohio. Your fastest path to approval: 1) Ensure REMS program enrollment (both prescriber and patient), 2) Submit complete PA request with genetic testing confirmation and lab monitoring plan, 3) Include medical necessity letter citing FDA approval and treatment failure documentation. Most requests are decided within one business day when complete. If denied, you have 65 days to appeal and can request external review through Ohio Department of Insurance within 180 days of final denial.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before dispensing Humana PA Portal Humana PA Lists
REMS Enrollment Mandatory safety program www.tegsedirems.com FDA REMS
Genetic Testing TTR gene mutation confirmed Lab report or genetic counselor Clinical Documentation
Laboratory Monitoring Weekly platelets, monthly kidney function Ongoing lab plan required FDA Label
Formulary Status Specialty tier coverage Plan-specific formulary Member Portal
Age Restriction Adults only (18+) FDA indication FDA Approval

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Genetic Testing

Who does it: Your neurologist or geneticist
Documents needed: TTR gene sequencing results showing pathogenic mutation
Timeline: If not done, allow 10-21 days for results
Source: Genetic testing is covered by most insurance when clinical criteria are met

2. Complete REMS Enrollment

Who does it: Prescriber and patient (separately)
Where: www.tegsedirems.com
Timeline: Must be completed before prescribing
Required: Prescriber certification, patient agreement, pharmacy verification

3. Establish Baseline Laboratory Values

Who does it: Prescriber orders, patient completes
Tests needed: Complete blood count (platelets), comprehensive metabolic panel, urinalysis, liver function tests
Timeline: Must be current (within 30 days)
Ongoing: Weekly platelet monitoring throughout treatment

4. Submit Prior Authorization Request

Who does it: Prescriber or clinic staff
How to submit: Humana provider portal or fax
Documents to include: Medical necessity letter, genetic testing, baseline labs, REMS enrollment confirmation
Timeline: Decision typically within 1 business day for complete submissions

5. Arrange Specialty Pharmacy

Who does it: Patient with clinic coordination
Requirements: Must use REMS-certified specialty pharmacy
Popular options: CenterWell Specialty Pharmacy (Humana's preferred)
Timeline: Allow 3-5 business days for initial setup

6. Monitor for Approval and Begin Treatment

Timeline: If approved, treatment can begin immediately
Ongoing requirements: Maintain lab monitoring schedule, document compliance
If denied: Proceed to appeals process (see section below)

REMS Enrollment Requirements

Tegsedi requires participation in a Risk Evaluation and Mitigation Strategy (REMS) program due to risks of severe thrombocytopenia and glomerulonephritis.

Prescriber Requirements:

  • Complete training at www.tegsedirems.com
  • Maintain certification throughout patient treatment
  • Document patient counseling on risks and monitoring

Patient Requirements:

  • Enroll in REMS program before first dose
  • Agree to required laboratory monitoring schedule
  • Understand risks and symptoms to report

Pharmacy Requirements:

  • Only REMS-certified pharmacies may dispense
  • Verify enrollment before each prescription
  • Provide patient counseling materials
Important Update: Tegsedi commercial availability in the US is scheduled to be discontinued as of September 27, 2024. Patients currently on therapy should work with their healthcare team to transition to alternative treatments like Amvuttra (vutrisiran) or Onpattro (patisiran).

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
No REMS enrollment Submit proof of completion REMS enrollment confirmations
Insufficient diagnosis documentation Provide genetic testing results TTR gene sequencing report
Missing lab monitoring plan Submit detailed monitoring schedule Lab protocols, baseline values
Off-label use Clarify FDA-approved indication Medical necessity letter
Quantity limits exceeded Justify dosing rationale Clinical guidelines, weight-based dosing
Step therapy not met Document prior treatment failures Treatment history, intolerance records

Appeals Playbook for Humana in Ohio

Level 1: Internal Appeal (Redetermination)

Deadline: 65 days from denial notice
Timeline: Humana responds within 7 calendar days
How to file: Member exceptions and appeals page
Expedited option: 72 hours if delay could jeopardize health

Level 2: External Review (Ohio)

Deadline: 180 days from final internal denial
Process: File with your health plan, who notifies Ohio Department of Insurance
Timeline: 30 days standard, 72 hours expedited
Contact: Ohio Department of Insurance Consumer Services: 1-800-686-1526

Required Documents for Appeals

  • Original denial letter
  • Medical necessity letter from prescriber
  • Clinical documentation supporting diagnosis
  • Evidence of prior treatment failures (if applicable)
  • REMS enrollment proof
  • Current laboratory values

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps identify denial reasons and drafts point-by-point rebuttals aligned to payer policies, potentially saving weeks in the appeals process.

Medical Necessity Letter Checklist

Your prescriber's medical necessity letter should include:

Patient Information:

  • Confirmed hATTR polyneuropathy diagnosis
  • ICD-10 code: E85.1 (Neuropathic heredofamilial amyloidosis)
  • TTR gene mutation details

Clinical Justification:

  • Progressive polyneuropathy symptoms
  • Functional impairment documentation
  • Prior treatments tried and outcomes
  • Contraindications to alternatives

Treatment Plan:

  • Tegsedi dosing schedule (284 mg weekly subcutaneous)
  • Laboratory monitoring protocol
  • REMS compliance confirmation
  • Expected treatment outcomes

Supporting Evidence:

  • FDA approval for hATTR polyneuropathy
  • Clinical trial data (NEURO-TTR study)
  • Treatment guidelines from neurology societies

Costs & Patient Assistance Options

Manufacturer Support:

  • Ionis/Akcea patient assistance programs (verify current availability given discontinuation)
  • Copay assistance for eligible patients
  • Free drug programs for qualifying uninsured patients

Foundation Grants:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Resources:

  • Ohio Medicaid may provide coverage for eligible patients
  • OSHIIP (Ohio Senior Health Insurance Information Program) for Medicare questions

FAQ: Tegsedi Coverage by Humana

Q: How long does Humana prior authorization take in Ohio? A: Typically 1 business day for complete electronic submissions. Standard mail/fax requests may take up to 14 days.

Q: What if Tegsedi is not on Humana's formulary? A: You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are inappropriate.

Q: Can I get expedited approval if my condition is worsening? A: Yes, if waiting could seriously jeopardize your health, request expedited review (72-hour timeline).

Q: Does Ohio have special protections for rare disease drugs? A: Ohio's external review process provides independent medical review, which is often favorable for rare disease treatments when medical necessity is clear.

Q: What happens if I move from Ohio to another state? A: Appeal rights vary by state. Contact your new state's insurance department for external review procedures.

Q: Are there alternatives if Tegsedi is denied? A: Yes, other FDA-approved treatments for hATTR polyneuropathy include Onpattro (patisiran) and Amvuttra (vutrisiran), which may have different coverage criteria.

When to Contact Ohio Regulators

Contact the Ohio Department of Insurance if:

  • Humana improperly denies your external review request
  • Appeal deadlines are not being met
  • You need help understanding your coverage rights
  • The insurer is not following Ohio insurance laws

Ohio Department of Insurance Consumer Services:

  • Phone: 1-800-686-1526
  • Website: insurance.ohio.gov
  • External Review Request Form available online

For Medicare-specific issues, also contact:

  • Ohio SHIP (State Health Insurance Assistance Program)
  • Medicare.gov complaint system
  • 1-800-MEDICARE (1-800-633-4227)
From our advocates: We've seen patients successfully overturn Tegsedi denials by ensuring their genetic testing clearly documents a pathogenic TTR mutation and that their prescriber emphasizes the progressive nature of hATTR polyneuropathy. The key is often demonstrating that this isn't just any peripheral neuropathy—it's a specific genetic condition with FDA-approved treatment options.

When navigating insurance coverage for rare disease treatments, having expert support can make the difference between approval and denial. Counterforce Health helps patients and clinicians transform complex medical cases into compelling coverage requests that speak directly to payer policies and requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your insurance plan and consult with your healthcare provider for medical decisions. For personalized assistance with insurance appeals in Ohio, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

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