By Counterforce Health Team in Hetlioz (tasimelteon) —

Getting Hetlioz (Tasimelteon) Covered by Cigna in Ohio: Complete PA Guide and Appeals Process

Quick Answer: Getting Hetlioz (Tasimelteon) Covered by Cigna in Ohio

Cigna requires prior authorization for Hetlioz (tasimelteon) for both Non-24-Hour Sleep-Wake Disorder and Smith-Magenis Syndrome. The fastest path to approval: (1) Ensure your sleep specialist documents diagnosis with ICD-10 code G47.24, (2) Complete step therapy with ramelteon and a preferred sleep medication, and (3) Submit PA request through Cigna's provider portal with clinical notes showing prior therapy failures. If denied, Ohio residents have 60 days to request external review through the Ohio Department of Insurance. Start by calling Cigna at the number on your insurance card to verify current PA requirements.

Table of Contents

  1. Coverage Basics: Is Hetlioz Covered by Cigna?
  2. Prior Authorization Process: Who Submits and How
  3. Timing: How Long Does PA Take?
  4. Coverage Criteria: What Cigna Requires
  5. Costs and Financial Assistance
  6. Denials and Appeals in Ohio
  7. Renewal Requirements
  8. Specialty Pharmacy: Accredo Dispensing
  9. Common Issues and Troubleshooting
  10. Frequently Asked Questions

Coverage Basics: Is Hetlioz Covered by Cigna?

Hetlioz (tasimelteon) is a specialty medication that requires prior authorization from Cigna for all covered indications. The drug is typically managed through Express Scripts/Accredo specialty pharmacy and may not appear on standard formularies without approval.

FDA-Approved Uses:

  • Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
  • Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) - capsules for ages 16+, oral suspension (Hetlioz LQ) for ages 3-15

Coverage Status: Hetlioz requires medical necessity review and step therapy completion before approval. Cigna's coverage policy outlines specific criteria that must be met.

Prior Authorization Process: Who Submits and How

Your physician must initiate the prior authorization request - patients cannot submit directly. Here's the step-by-step process:

Step-by-Step: Fastest Path to Approval

  1. Sleep Specialist Consultation (Required)
    • Schedule with board-certified sleep medicine physician
    • Obtain clinical evaluation and diagnosis confirmation
    • Timeline: 1-2 weeks for appointment
  2. Complete Step Therapy Requirements
    • Try ramelteon (Rozerem) first - document failure or intolerance
    • Trial one preferred sedative/hypnotic non-benzodiazepine
    • Timeline: 4-8 weeks per medication trial
  3. Gather Required Documentation
    • ICD-10 diagnosis code G47.24 (Circadian rhythm sleep disorder, free running type)
    • Clinical notes showing functional impairment
    • Prior therapy documentation with outcomes
    • Timeline: 1-2 days
  4. Physician Submits PA Request
    • Use Cigna provider portal or fax
    • Include sleep specialist attestation and clinical rationale
    • Timeline: Same day submission
  5. Cigna Review Process
    • Standard review: up to 72 hours
    • May request peer-to-peer consultation
    • Timeline: 1-3 business days
  6. If Approved: Specialty Pharmacy Setup
    • Prescription routed to Accredo automatically
    • Patient enrollment in HETLIOZSolutions support program
    • Timeline: 3-5 business days for first shipment
  7. If Denied: Appeal Process
    • Internal appeal within 180 days
    • External review through Ohio Department of Insurance within 60 days
    • Timeline: 30 days for external review decision

Timing: How Long Does PA Take?

Standard Timeline:

  • Initial PA review: 72 hours (3 business days)
  • Expedited review: 24 hours (if health is in serious jeopardy)
  • Internal appeal: 30 days for standard, 72 hours for expedited
  • External review in Ohio: 30 days standard, 72 hours expedited

When to Request Expedited Review:

  • Severe sleep disruption affecting safety (driving, work hazards)
  • Hospitalization risk due to sleep deprivation
  • Existing therapy discontinuation would cause immediate harm

Contact Cigna member services at the number on your insurance card to request expedited processing.

Coverage Criteria: What Cigna Requires

For Non-24-Hour Sleep-Wake Disorder

Required Documentation:

  • Patient age 18 or older
  • Total blindness with no light perception (key requirement)
  • ICD-10 code G47.24 documented
  • Sleep specialist evaluation and attestation
  • Analysis of circadian markers or documented clinical evaluation

Step Therapy Requirements:

  • Trial and documented failure with ramelteon (Rozerem)
  • Trial and documented failure with at least one preferred sedative/hypnotic non-benzodiazepine agent (e.g., zolpidem, eszopiclone)

For Smith-Magenis Syndrome

Important Note: Cigna's policy states that Hetlioz LQ is "not recommended for approval due to insufficient clinical efficacy data" for SMS, which may require appeal.

If Attempting Coverage:

  • Genetic confirmation of deletion 17p11.2 or RAI1 gene mutation
  • Documentation of nighttime sleep disturbances
  • Trial and failure with at least one other sleep medication
  • Sleep specialist consultation required

Medical Necessity Documentation

Your physician must provide:

  • Clinical rationale for Hetlioz over alternatives
  • Functional impairment documentation
  • Treatment goals and expected outcomes
  • Contraindications to step therapy medications (if applicable)

Costs and Financial Assistance

Typical Costs:

  • Hetlioz capsules: approximately $5,895 for 30×20mg
  • Hetlioz LQ: approximately $24,678 per bottle
  • Insurance coverage varies significantly

Financial Assistance Options:

HETLIOZSolutions Patient Support Program:

Limitations:

  • Not available for Medicare, Medicaid, or other government insurance
  • Income and insurance type restrictions may apply

When navigating complex insurance approvals, services like Counterforce Health specialize in turning denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to craft point-by-point rebuttals aligned with payer requirements.

Denials and Appeals in Ohio

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Age/diagnosis not documented Submit sleep specialist attestation ICD-10 G47.24, clinical evaluation
Step therapy not completed Document prior trials and failures Pharmacy records, clinical notes
"Not medically necessary" Provide functional impairment evidence Sleep studies, quality of life measures
Non-formulary status Request formulary exception Medical necessity letter

Ohio Appeals Process

Internal Appeals with Cigna:

  1. First Level Internal Appeal
    • Deadline: 180 days from denial
    • Decision timeframe: 30 days standard, 72 hours expedited
    • Submit via Cigna member portal or mail
  2. Second Level Internal Appeal
    • Available after first-level denial
    • Same timeframes as first level
    • May include peer-to-peer physician review

External Review through Ohio Department of Insurance:

  • Eligibility: Must complete Cigna's internal appeals first
  • Deadline: 60 days from final internal denial
  • Timeline: 30 days for decision (72 hours if expedited)
  • Cost: Free to patient (Cigna pays IRO fees)
  • Decision: Binding on Cigna

How to File External Review:

  1. Contact Ohio Department of Insurance: 800-686-1526
  2. Submit external review request form
  3. Include all denial letters and medical records
  4. IRO assigned randomly based on specialty needed
From Our Advocates: We've seen cases where patients initially denied for Hetlioz successfully obtained coverage through external review by providing comprehensive sleep study data and documenting the functional impact of Non-24 on daily activities. The key was showing that standard sleep medications had been tried at appropriate doses and durations before concluding they were ineffective.

Renewal Requirements

Initial Authorization: Up to 6 months if criteria met

Reauthorization Requirements:

  • Documented clinical benefit (increased nighttime sleep, decreased daytime sleep, improved entrainment)
  • Continued medical necessity
  • No significant adverse effects
  • Ongoing sleep specialist oversight

Continued Authorization: Up to 12 months after initial period with documented benefit

What to Track:

  • Sleep diary or actigraphy data
  • Functional improvement measures
  • Quality of life assessments
  • Any adverse effects

Specialty Pharmacy: Accredo Dispensing

Hetlioz is dispensed exclusively through Accredo Specialty Pharmacy, part of Express Scripts. Once approved, your prescription will automatically be transferred.

Accredo Contact Information:

  • Prescriber fax: 1-844-364-2424
  • Prescriber phone: 1-844-438-5469
  • Patient portal: MyAccredoPatients.com

What to Expect:

  • Initial enrollment call from Accredo pharmacist
  • Medication shipped in temperature-controlled packaging
  • Refill reminders and adherence support
  • Direct communication with your prescriber for any issues

Required Forms:

Common Issues and Troubleshooting

Portal Access Problems:

  • Reset password through Cigna member portal
  • Call member services for technical support
  • Use alternative submission methods (fax, phone)

Missing Documentation:

  • Contact prescriber's office for complete medical records
  • Request sleep study reports if applicable
  • Obtain pharmacy records showing prior medication trials

Communication Gaps:

  • Establish single point of contact at prescriber's office
  • Keep detailed log of all calls and submissions
  • Request confirmation numbers for all submissions

Peer-to-Peer Requests: If Cigna requests physician-to-physician consultation, ensure your sleep specialist is available and prepared with:

  • Complete clinical history
  • Rationale for Hetlioz over alternatives
  • Treatment goals and monitoring plan

Frequently Asked Questions

Q: How long does Cigna prior authorization take for Hetlioz in Ohio? A: Standard PA review takes up to 72 hours. Expedited review (for urgent medical needs) takes up to 24 hours.

Q: What if Hetlioz is non-formulary on my Cigna plan? A: Your physician can request a formulary exception by providing medical necessity documentation and evidence that formulary alternatives are unsuitable.

Q: Can I request an expedited appeal in Ohio? A: Yes, both internal appeals with Cigna and external reviews through Ohio Department of Insurance offer expedited processing for urgent medical situations.

Q: Does step therapy apply if I tried medications outside Ohio? A: Yes, documented trials from any location count toward step therapy requirements, provided you have pharmacy records and clinical notes.

Q: What happens if the external review denies coverage? A: The IRO decision is binding, but you retain rights to other remedies such as regulatory complaints or legal action if appropriate.

Q: Is there copay assistance for Hetlioz? A: Yes, the HETLIOZSolutions program offers copay assistance for eligible commercially insured patients. Medicare and Medicaid patients are not eligible.

Q: Who can help me navigate the appeals process in Ohio? A: Contact Ohio Department of Insurance Consumer Services at 800-686-1526, or consider services like Counterforce Health that specialize in insurance appeals for complex medications.

Q: What if my sleep specialist isn't available for peer-to-peer review? A: Ensure your specialist's office has clear procedures for responding to P2P requests. Consider identifying a backup sleep medicine physician who can review your case if needed.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current requirements with Cigna and consult with your healthcare provider for medical decisions.

Sources & Further Reading

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