By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (inotersen) Covered by Humana in California: A Complete Prior Authorization Guide

Answer Box: Getting Tegsedi (inotersen) Covered by Humana in California

Important Update: Tegsedi (inotersen) was discontinued in the US as of September 27, 2024. Patients should work with their doctors to transition to alternatives like Amvuttra (vutrisiran) or Onpattro (patisiran).

For existing patients or those with remaining supply, Humana requires: (1) Confirmed TTR gene mutation and hATTR polyneuropathy diagnosis, (2) REMS program enrollment before first dose, (3) Baseline labs within 30 days, and (4) prescription from a neurologist or amyloidosis specialist. Submit via Humana's provider portal with complete documentation. If denied, California residents can appeal through Humana's internal process, then request an Independent Medical Review (IMR) through the DMHC.

Table of Contents

Patient Profile: Who Qualifies for Tegsedi

Tegsedi (inotersen) was approved for hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN) in adults. To qualify for Humana coverage, patients typically need:

Medical Criteria:

  • Age 18 or older
  • Confirmed TTR gene mutation via genetic testing
  • Documented polyneuropathy (often measured by mNIS+7 score ≥5 or Norfolk QoL-DN ≥80)
  • Prescription from a neurologist, geneticist, or amyloidosis specialist
  • ICD-10 diagnosis code E85.1 (Neuropathic heredofamilial amyloidosis)

Required Documentation:

  • TTR gene sequencing report showing pathogenic variant
  • Nerve conduction studies or EMG confirming peripheral neuropathy
  • Baseline laboratory values (within 30 days)
  • Medical necessity letter from prescribing physician
Note: Given the drug's discontinuation, focus discussions with your doctor on transitioning to available alternatives rather than initiating new Tegsedi therapy.

Pre-Authorization Preparation

Success with Humana's prior authorization process depends on thorough preparation. Here's what to gather before submitting:

Essential Documents Checklist

  • Humana member ID and policy information
  • TTR genetic testing results
  • Baseline lab work (CBC with platelets, comprehensive metabolic panel, urinalysis with UPCR, liver function tests)
  • Nerve conduction study or EMG results
  • Documentation of prior therapy failures (if applicable)
  • REMS enrollment confirmation
  • Prescriber's medical necessity letter

Medical Necessity Letter Components

Your doctor's letter should address:

  1. Clinical presentation: Symptoms, functional impact, disease progression
  2. Diagnostic confirmation: TTR mutation details, neuropathy evidence
  3. Treatment rationale: Why Tegsedi is medically necessary
  4. Monitoring plan: Lab schedule, safety protocols
  5. Alternative considerations: Why other treatments aren't suitable

Submission Process

Humana processes Tegsedi prior authorizations through their specialty pharmacy network, typically CenterWell Specialty Pharmacy.

Step-by-Step Submission

  1. Prescriber completes PA request via Humana provider portal or fax
  2. Include all supporting documentation from the checklist above
  3. Verify REMS enrollment is complete and documented
  4. Submit to CenterWell Specialty as Humana's preferred REMS-certified pharmacy
  5. Track status through provider portal or by calling 800-867-6601

Timeline: Humana typically responds within 1 business day for complete packets. Incomplete submissions may take 7-14 days while additional information is requested.

Common Denial Scenarios

Understanding common denial reasons helps you prepare stronger initial submissions and appeals.

Denial Reason How to Address Required Documentation
No REMS enrollment Submit proof of enrollment REMS confirmation letter
Insufficient diagnosis Provide genetic testing TTR sequencing report
Missing lab monitoring plan Include detailed protocol Baseline labs + monitoring schedule
Lack of specialist prescription Transfer to qualified prescriber Neurologist/geneticist letter
Alternative therapy not tried Document contraindications or failures Prior treatment records

Strengthening Your Case

  • Ensure genetic testing clearly identifies a pathogenic TTR variant
  • Document functional impairment using standardized scales
  • Include peer-reviewed literature supporting treatment choice
  • Provide detailed monitoring protocols per REMS requirements

California Appeals Process

California offers robust patient protections for insurance denials, including specialized external review processes.

Internal Appeal with Humana

If initially denied, you have 65 days from the denial notice to request a redetermination:

  1. Complete Humana's redetermination form (available on member portal)
  2. Include additional medical evidence not in original submission
  3. Request peer-to-peer review by calling 800-867-6601
  4. Submit within deadline via portal, fax, or mail

Timeline: Humana must decide within 7 calendar days (72 hours for expedited requests).

California Independent Medical Review (IMR)

If Humana upholds the denial, California residents can request an Independent Medical Review through the Department of Managed Health Care (DMHC):

Eligibility: Available for denials based on medical necessity, experimental/investigational determinations, or coverage disputes.

Process:

  1. File IMR application at healthhelp.ca.gov or call 888-466-2219
  2. Submit within 6 months of final internal denial
  3. Include all medical records and denial correspondence
  4. DMHC assigns independent reviewer specializing in relevant medical area

Timeline: Standard IMR decisions within 45 days; expedited reviews within 7 days for urgent cases.

Success Rates: California IMRs overturn approximately 50-60% of specialty drug denials when medical necessity is well-documented.

Tip: The IMR process is free to patients, and insurers must abide by the independent reviewer's decision.

REMS Program Requirements

The Tegsedi Risk Evaluation and Mitigation Strategy (REMS) program is mandatory due to risks of thrombocytopenia and glomerulonephritis.

Enrollment Steps

For Prescribers:

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

For Patients:

  • Enroll at www.tegsedirems.com before first dose
  • Complete safety attestation every 90 days
  • Agree to required laboratory monitoring

For Pharmacies:

  • Must be REMS-certified to dispense
  • Verify patient/prescriber enrollment per prescription
  • CenterWell Specialty Pharmacy is Humana's preferred option

Monitoring Requirements

  • Baseline labs (within 30 days): Platelets, kidney function, liver tests, urinalysis
  • Ongoing monitoring: Weekly platelets for 3 months, then every 2 weeks; monthly kidney function
  • Discontinuation triggers: Platelets <75,000, protein/creatinine ratio ≥1000 mg/g, or significant kidney function decline

Cost and Assistance Options

Even with insurance coverage, specialty medications can involve significant out-of-pocket costs.

Financial Assistance Programs

  • Manufacturer support: Check with Ionis Pharmaceuticals for any remaining patient assistance programs
  • State programs: California residents may qualify for additional support through Medi-Cal or state pharmaceutical assistance programs
  • Nonprofit foundations: Organizations like the HealthWell Foundation or Patient Access Network Foundation may provide grants

Insurance Considerations

  • Formulary tier: Specialty drugs typically fall on Tier 4 or 5, with higher cost-sharing
  • Step therapy: Some plans require trying less expensive alternatives first
  • Quantity limits: May restrict monthly supply or require frequent reauthorizations

Frequently Asked Questions

Q: How long does Humana's prior authorization process take? A: Complete submissions typically receive decisions within 1 business day. Incomplete packets may take 7-14 days while additional information is requested.

Q: Can I request an expedited review? A: Yes, if delay in treatment could seriously jeopardize your health. Call Humana at 800-867-6601 and specify the urgent nature of your request.

Q: What if Tegsedi isn't on Humana's formulary? A: You can request a formulary exception through the same prior authorization process, providing medical justification for why covered alternatives aren't suitable.

Q: Do I need to be enrolled in REMS before submitting the PA? A: Yes, REMS enrollment is typically required before Humana will approve coverage. Complete enrollment at www.tegsedirems.com first.

Q: Can I appeal if my doctor isn't a specialist? A: Humana may require prescriptions from neurologists or amyloidosis specialists. Consider transferring care or obtaining a specialist consultation.

Q: What's the difference between Humana's internal appeal and California's IMR? A: Internal appeals are handled by Humana directly. IMR involves independent medical experts outside the insurance company and has higher overturn rates for medically justified requests.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific requirements, improving approval rates for specialty medications like those used in rare disease treatment.

For additional support with your Tegsedi prior authorization or appeal, Counterforce Health can help analyze your specific denial and create a customized response strategy.

Sources & Further Reading

This guide is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. For assistance with insurance appeals or complaints in California, contact the DMHC Help Center at 888-466-2219.

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