By Counterforce Health Team in Hetlioz (tasimelteon) —

How to Get Hetlioz (Tasimelteon) Covered by Cigna in New York: Complete Prior Authorization Guide and Appeals Process

Answer Box: Getting Hetlioz Covered by Cigna in New York

Cigna requires prior authorization for Hetlioz (tasimelteon) with documented failure of 6 months of daily melatonin therapy for Non-24-hour sleep-wake disorder in totally blind adults. The fastest path to approval: (1) Gather sleep logs showing irregular patterns and melatonin trial records, (2) Submit PA through your prescriber via CoverMyMeds or Express Scripts portal with specialist attestation, (3) If denied, file internal appeal within 180 days, then external review through New York Department of Financial Services within 4 months. Standard review takes 72 hours; expedited available for urgent needs.

First step today: Call Cigna member services at the number on your card to confirm your plan's formulary status and request PA forms.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Documentation Requirements
  5. Submission Process
  6. Specialty Pharmacy Coordination
  7. Appeals Process in New York
  8. Common Denial Reasons & Solutions
  9. Cost Savings Options
  10. FAQ

Who Should Use This Guide

This guide helps Cigna members in New York get Hetlioz (tasimelteon) covered for:

  • Non-24-hour sleep-wake disorder in totally blind adults (≥18 years)
  • Smith-Magenis syndrome sleep disturbances (Hetlioz LQ suspension for ages 3-15)

Expected outcome: With proper documentation, most medically appropriate Hetlioz requests receive approval. If initially denied, New York's external appeal process has successfully overturned Hetlioz denials when clinical evidence supports medical necessity.

You'll need a sleep specialist or neurologist to attest to your diagnosis and coordinate the prior authorization process.

Member & Plan Basics

Coverage Verification

Before starting, confirm these basics with Cigna member services:

  • Active coverage with current member ID
  • Formulary tier for Hetlioz (typically Tier 5 specialty)
  • Deductible status and specialty pharmacy copay
  • Prior authorization requirements specific to your plan

Plan Types

Hetlioz coverage applies across Cigna plan types:

  • Commercial employer plans
  • Individual marketplace plans
  • Medicare Part D (Secure/Premier plans mirror commercial PA requirements)

Note: Medicaid managed care plans may have different criteria—verify with your specific plan.

Clinical Criteria for Approval

Coverage at a Glance

Requirement Details Documentation Needed
Diagnosis Non-24-hour sleep-wake disorder (ICD-10 G47.24) Sleep specialist evaluation
Patient Status Totally blind (no light perception) Ophthalmology records
Age ≥18 years for capsules; 3-15 years for LQ suspension Date of birth verification
Prior Therapy 6 months continuous daily melatonin failure Sleep logs, pharmacy records
Sleep Documentation ≥14 days showing irregular patterns Sleep diary, actigraphy
Specialist Attestation Board-certified sleep medicine or neurology Provider letter with credentials

Step Therapy Requirements

Cigna's sedative hypnotics policy requires trial of Step 1 products before approving advanced sleep medications. For Non-24-hour sleep-wake disorder:

Required prior therapy: 6 consecutive months of daily melatonin therapy with documented inadequate response or intolerance.

Acceptable alternatives: Ramelteon (melatonin receptor agonist) may substitute for melatonin in some cases—verify with your prescriber.

Exclusions

Cigna will not cover Hetlioz for:

  • Off-label sleep disorders (delayed sleep phase, general insomnia)
  • Concurrent use with ramelteon or melatonin
  • Sighted patients without documented Non-24 diagnosis

Documentation Requirements

Medical Necessity Letter Components

Your prescriber's letter should include:

  1. Patient identification: Name, DOB, Cigna member ID
  2. Diagnosis: Non-24-hour sleep-wake disorder with ICD-10 code G47.24
  3. Visual status: Total blindness with no light perception
  4. Prior therapy: Specific melatonin doses, duration (≥6 months), and reasons for failure
  5. Sleep pattern documentation: Summary of sleep logs showing progressive daily delays
  6. Treatment goals: Expected outcomes with tasimelteon therapy
  7. Prescriber credentials: Board certification in sleep medicine or neurology

Required Attachments

  • Sleep diary or actigraphy data (≥14 days)
  • Ophthalmology records confirming total blindness
  • Pharmacy records showing melatonin trial
  • Previous sleep study results (if available)
  • Specialist consultation notes
Clinician Corner: The FDA label specifies Hetlioz is indicated for Non-24-hour sleep-wake disorder in totally blind individuals. Emphasize the circadian rhythm disruption specific to blindness and inability to entrain to light cues in your medical necessity letter.

Submission Process

Step-by-Step: Fastest Path to Approval

  1. Prescriber initiates PA (Day 1)
    • Submit via CoverMyMeds, Cigna provider portal, or Express Scripts ePA
    • Include all documentation upfront to avoid delays
  2. Cigna reviews (72 hours standard, 24 hours expedited)
    • Clinical pharmacist evaluates against coverage criteria
    • May request additional information
  3. Approval notification (Day 3-4)
    • Cigna notifies prescriber and patient
    • Prescription automatically routes to Accredo specialty pharmacy
  4. Accredo enrollment (Day 4-5)
    • Pharmacy contacts patient within 24 hours
    • Coordinates first shipment and ongoing refills
  5. First shipment (Day 7-10)
    • Temperature-controlled delivery
    • Patient selects delivery date and time

Submission Portals

  • CoverMyMeds: Most efficient for PA submissions
  • Cigna Provider Portal: Direct submission with real-time status
  • Express Scripts ePA: Alternative electronic option
  • Fax: Use only if electronic options unavailable

Specialty Pharmacy Coordination

Accredo Enrollment Process

Cigna routes approved Hetlioz prescriptions exclusively to Accredo specialty pharmacy. The enrollment process includes:

  1. Automatic enrollment upon PA approval
  2. Patient contact within 24 hours for delivery coordination
  3. HETLIOZSolutions program enrollment (optional patient support)
  4. Temperature-controlled shipping in 3-5 business days

Prescription Transfer Steps

If transferring from another pharmacy:

  • Prescriber faxes Accredo referral form to 888-302-1028
  • Include Cigna member information and "transfer to Accredo" notation
  • Call Accredo at 800-803-2523 to expedite if not auto-routed

Appeals Process in New York

New York provides robust appeal rights through multiple levels of review.

Internal Appeals (First Step)

Timeline: File within 180 days of denial Process:

  • Submit appeal letter with additional clinical documentation
  • Include specialist support and medical literature
  • Cigna has 30 days to respond (expedited: 72 hours)

External Review (New York DFS)

Timeline: File within 4 months of final internal denial Authority: New York Department of Financial Services Process:

  • Independent medical expert review
  • Decision timeline: 30 days standard, 72 hours expedited
  • Binding decision on the insurer
  • No cost to patient (filing fee waived)
New York Advantage: DFS has documented precedent overturning Hetlioz denials for sleep disorders when medical necessity is clearly established. Cases 202107-139959 and 202103-136666 provide examples of successful appeals.

When to Escalate

Contact Community Health Advocates at 888-614-5400 for free assistance with:

  • Understanding denial reasons
  • Preparing appeal documentation
  • Filing external reviews
  • Navigating the appeals process

Common Denial Reasons & Solutions

Denial Reason Solution
Insufficient melatonin trial Provide pharmacy records showing ≥6 months daily use with specific doses and failure documentation
Lack of specialist attestation Obtain letter from board-certified sleep medicine physician or neurologist
Incomplete sleep documentation Submit ≥14 days of sleep logs showing progressive daily delays characteristic of Non-24
Age/diagnosis mismatch Verify ICD-10 G47.24 coding and confirm total blindness documentation
Step therapy not completed Document melatonin trial failure or request exception based on clinical contraindications

Cost Savings Options

Manufacturer Support

HETLIOZSolutions: Patient support program offering:

  • Copay assistance (eligibility restrictions apply)
  • Prior authorization support
  • Adherence counseling
  • Call 1-844-HETLIOZ (1-844-438-5469)

Financial Assistance

  • Vanda Pharmaceuticals Patient Assistance Program: For uninsured or underinsured patients
  • Foundation grants: Organizations like Patient Access Network Foundation may provide copay assistance
  • New York State programs: Essential Plan for lower-income residents not eligible for Medicaid

FAQ

How long does Cigna prior authorization take in New York? Standard review: 72 hours. Expedited review: 24 hours for urgent medical needs. Submit complete documentation upfront to avoid delays.

What if Hetlioz is non-formulary on my plan? Request formulary exception through your prescriber with medical necessity documentation. Cigna must respond within 72 hours for standard requests.

Can I request an expedited appeal in New York? Yes. Both Cigna internal appeals and New York DFS external appeals offer expedited review for urgent medical situations.

Does step therapy apply if I tried melatonin outside New York? Yes. Cigna accepts documented melatonin trials from any location, provided you have pharmacy records and clinical notes showing the 6-month requirement.

What happens if my external appeal is approved? The decision is binding on Cigna. They must cover the treatment and may refund your appeal costs. Approval typically includes retroactive coverage from the original request date.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals using FDA labeling, peer-reviewed studies, and payer-specific requirements. We've helped numerous patients navigate complex prior authorization requirements for specialty medications like Hetlioz, ensuring proper documentation and appeal strategies that align with each payer's specific criteria.

For additional support with your Hetlioz prior authorization or appeal, visit www.counterforcehealth.org to learn how our platform can help streamline your approval process and improve your chances of coverage.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual circumstances, plan benefits, and clinical factors. Always consult your healthcare provider for medical decisions and verify current coverage details with your insurance plan. For additional help with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

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