By Counterforce Health Team in Hetlioz (tasimelteon) —

Getting Hetlioz (Tasimelteon) Covered by Humana in New Jersey: PA Guide, Appeals, and Cost Assistance

Answer Box: Fast Track to Hetlioz (Tasimelteon) Coverage

Hetlioz (tasimelteon) requires prior authorization from Humana for both Non-24-hour sleep-wake disorder and Smith-Magenis syndrome. Start by calling Humana at the number on your ID card to confirm your plan's formulary status and PA requirements. Submit complete documentation including diagnosis codes (G47.24 for Non-24, Q93.82 for SMS), sleep studies, failed alternative treatments, and specialist letters. If denied, you have 65 days for internal appeals and 180 days for New Jersey's free external review through IHCAP.

First step today: Call Humana to verify coverage and request PA forms, then gather sleep diary records and prior treatment documentation.

Table of Contents

  1. Understanding Hetlioz Coverage Basics
  2. Prior Authorization Requirements
  3. Step-by-Step Approval Process
  4. Cost and Financial Assistance
  5. When Prior Authorization Gets Denied
  6. Appeals Process in New Jersey
  7. Specialty Pharmacy Requirements
  8. Renewal and Annual Changes
  9. Conversation Scripts
  10. FAQ

Understanding Hetlioz Coverage Basics

Hetlioz (tasimelteon) is a melatonin receptor agonist approved for two specific conditions: Non-24-hour sleep-wake disorder in adults and nighttime sleep disturbances in Smith-Magenis syndrome. The medication comes in two forms—capsules for patients 16 and older, and Hetlioz LQ oral suspension for ages 3-15.

Coverage at a Glance

Requirement Details Where to Verify Source
Prior Authorization Required for all Humana plans Member portal or 1-800-281-6918 Humana PA Resources
Formulary Tier Specialty tier (varies by plan) Drug list lookup tool Humana Drug Lists
Specialty Pharmacy CenterWell Specialty required Provider portal CenterWell Specialty
Age Restrictions Capsules ≥16 years, LQ 3-15 years FDA labeling FDA Access Data
Diagnosis Codes G47.24 (Non-24), Q93.82 (SMS) Clinical documentation Counterforce Health

Humana typically covers Hetlioz under their specialty pharmacy benefit, which means retail pharmacies cannot dispense it. The medication requires special handling, including refrigerated storage and precise weight-based dosing for pediatric patients.

Prior Authorization Requirements

Humana's prior authorization process for Hetlioz focuses on confirming the diagnosis and documenting that less expensive alternatives have been tried and failed. The specific requirements vary slightly between Non-24-hour sleep-wake disorder and Smith-Magenis syndrome.

For Non-24-Hour Sleep-Wake Disorder

Required Documentation:

  • Sleep diary showing progressive sleep phase delay (minimum 2-4 weeks)
  • Actigraphy data confirming non-24-hour sleep pattern
  • Documentation of blindness or severe visual impairment (when applicable)
  • Evidence of failed trials with melatonin or other sleep aids
  • Sleep study results or specialist evaluation
  • ICD-10 code G47.24

For Smith-Magenis Syndrome

Required Documentation:

  • Genetic testing confirming SMS diagnosis (chromosome 17p11.2 deletion)
  • Documentation of sleep disturbances despite behavioral interventions
  • Evidence of failed melatonin trials
  • Weight-based dosing calculations for LQ formulation
  • ICD-10 codes Q93.82 (SMS) and G47.0 (insomnia)
Clinician Corner: Your medical necessity letter should address why Hetlioz is specifically needed over alternatives. Include duration and dosing of failed treatments, contraindications to other options, and how sleep disturbances impact daily functioning. Reference the FDA prescribing information for approved indications and dosing.

Step-by-Step Approval Process

1. Verify Coverage (Day 1)

  • Call Humana member services at the number on your ID card
  • Confirm Hetlioz is on your plan's formulary
  • Ask about specific PA requirements for your plan
  • Request PA forms if not available online

2. Gather Documentation (Days 2-7)

  • Collect sleep studies, genetic testing, or specialist evaluations
  • Document prior treatment failures with dates and outcomes
  • Obtain current prescription from sleep specialist or neurologist
  • Calculate weight-based dosing for pediatric patients (LQ formulation)

3. Submit PA Request (Day 8)

  • Complete via Humana provider portal (preferred) or fax 1-877-486-2621
  • Include all supporting documentation
  • Request expedited review if clinically urgent (72-hour timeline)
  • Standard decisions typically within 7-30 days

4. Follow Up (Days 10-14)

  • Check status via provider portal or member services
  • Respond promptly to requests for additional information
  • Schedule peer-to-peer review if requested by Humana

5. Receive Decision (Days 14-30)

  • Approval: Prescription forwarded to CenterWell Specialty Pharmacy
  • Denial: Begin appeal process within 65 days

Cost and Financial Assistance

Hetlioz carries significant costs—capsules typically run around $5,895 for a 30-day supply, while Hetlioz LQ can cost approximately $24,678 per bottle. However, several assistance programs can dramatically reduce out-of-pocket expenses.

Manufacturer Support

Hetlioz Solutions Patient Copay Assistance Program provides the medication at little to no cost for eligible patients with commercial insurance. The program covers up to 12 fills per year for US and Puerto Rico residents.

Eligibility Requirements:

  • Commercial insurance (not Medicare or Medicaid)
  • Valid prescription for approved indication
  • Enrollment via signed form faxed to 1-844-364-2424

To Enroll:

  1. Call Hetlioz Solutions at 1-844-438-5469 (9AM-8PM ET)
  2. Complete benefits investigation with Patient Care Coordinator
  3. Submit signed enrollment form with prescriber
  4. Coordinate with specialty pharmacy for delivery
Note: Medicare patients are not eligible for the copay assistance program but may qualify for Vanda's separate Patient Assistance Program for uninsured/underinsured individuals.

Foundation Grants

Several foundations provide grants for sleep disorder medications:

  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)
  • HealthWell Foundation

Contact these organizations directly to check current availability for Hetlioz coverage.

Humana Cost-Sharing Reductions

If Hetlioz is placed on a high specialty tier, you may request a formulary exception to move it to a lower tier with reduced cost-sharing. This requires demonstrating medical necessity and that preferred alternatives are unsuitable.

When Prior Authorization Gets Denied

Common denial reasons for Hetlioz include insufficient diagnostic documentation, lack of evidence for failed alternative treatments, or questions about medical necessity. Counterforce Health helps patients and clinicians turn these denials into targeted, evidence-backed appeals by analyzing the specific denial basis and crafting point-by-point rebuttals.

Most Frequent Denial Reasons

Denial Reason How to Address
Insufficient diagnostic evidence Submit sleep studies, actigraphy, specialist evaluation
No documented trial failures Provide detailed records of melatonin or other sleep aid attempts
Age/indication mismatch Confirm genetic testing for SMS or blindness documentation for Non-24
Quantity/dosing questions Include weight-based calculations and specialist dosing rationale

Immediate Steps After Denial

  1. Read the denial letter carefully to identify specific objections
  2. Gather additional evidence addressing each denial reason
  3. Contact the prescribing physician to discuss appeal strategy
  4. File internal appeal within 65 days of denial notice
  5. Consider peer-to-peer review if offered by Humana

Appeals Process in New Jersey

New Jersey provides excellent protections for patients through a comprehensive appeals system. If Humana denies your Hetlioz coverage, you have multiple levels of review available.

Internal Appeals (Level 1)

Timeline: File within 65 days of denial Process: Submit "Request for Redetermination" via Humana member portal, fax, or mail Decision: 7 days standard, 72 hours expedited Required: Additional documentation addressing denial reasons

External Review (IHCAP)

New Jersey's Independent Health Care Appeals Program (IHCAP) provides free, binding external review after you complete Humana's internal appeals.

Key Details:

  • Timeline: 180 days (4 months) from final internal denial
  • Administrator: Maximus Federal Services
  • Cost: Free to patients
  • Decision: Binding on Humana per N.J.S.A. 26:2S-11
  • Hotline: 1-888-393-1062

External Review Process:

  1. Complete all internal appeals first
  2. Submit request directly to Maximus (not NJ DOBI)
  3. Include medical records, prescriber letters, denial notices
  4. Physician panel reviews within 45 days (expedited available)
  5. Humana must comply with favorable decisions

Consumer Support

  • NJ Department of Banking and Insurance: 1-800-446-7467
  • IHCAP Hotline: 1-888-393-1062
  • Managed Care Ombudsman: Available for State Health Benefits Plan issues

Specialty Pharmacy Requirements

Humana requires Hetlioz to be dispensed through their specialty pharmacy network, primarily CenterWell Specialty Pharmacy. This ensures proper handling of the medication's storage requirements and provides additional patient support services.

CenterWell Specialty Pharmacy

Contact: 1-800-486-2668 Services:

  • Refrigerated shipping and storage
  • Weight-based dosing calculations
  • Oral syringe provision for LQ formulation
  • Adherence monitoring and refill coordination
  • Insurance verification and prior authorization tracking

Setup Process:

  1. Humana forwards approved prescription to CenterWell
  2. CenterWell contacts patient within 2-3 business days
  3. Verify insurance benefits and delivery preferences
  4. Schedule initial shipment with signature required
  5. Set up automatic refill schedule

Storage and Handling

Hetlioz LQ requires refrigerated storage (36-46°F) and has specific discard timelines. CenterWell provides detailed storage instructions and monitors adherence through regular check-ins.

Renewal and Annual Changes

Hetlioz prior authorizations typically require annual renewal. Start the renewal process 30-60 days before your current authorization expires to avoid treatment gaps.

Annual Renewal Requirements

  • Updated treatment response documentation
  • Continued medical necessity attestation
  • Current weight and dosing (for pediatric patients)
  • Any new sleep studies or specialist evaluations

Plan Year Changes

Humana formularies can change annually. Key dates to monitor:

October: New formulary announcements for following year January 1: New plan year begins February-March: Transition policies for existing prescriptions

If Hetlioz moves to a higher tier or requires new restrictions, you may qualify for a transition fill while appealing the change.

Conversation Scripts

Calling Humana Member Services

"Hi, I'm calling to check prior authorization requirements for Hetlioz, generic name tasimelteon, for my [condition]. Can you tell me if this medication is on my formulary, what tier it's placed on, and what documentation is needed for prior authorization? I'd also like to know the timeline for PA decisions and how to submit the request."

Requesting Peer-to-Peer Review

"We received a denial for Hetlioz for our patient with [Non-24-hour sleep-wake disorder/Smith-Magenis syndrome]. We'd like to request a peer-to-peer review to discuss the medical necessity. The patient has tried [list prior treatments] without success, and Hetlioz is specifically indicated for this condition. When can we schedule this review?"

Pharmacy Coordination

"I have a Hetlioz prescription that was approved by Humana. Can you confirm this will be filled through CenterWell Specialty Pharmacy? I need to coordinate delivery and understand the storage requirements for the LQ formulation."

FAQ

How long does Humana prior authorization take for Hetlioz in New Jersey? Standard PA decisions typically take 7-30 days. Expedited reviews for urgent cases are completed within 72 hours. You can track status through Humana's member portal or by calling member services.

What if Hetlioz is non-formulary on my Humana plan? You can request a formulary exception by demonstrating medical necessity and that formulary alternatives are inappropriate. Submit the same documentation required for PA along with a detailed explanation of why Hetlioz is specifically needed.

Can I request an expedited appeal if Humana denies Hetlioz? Yes, if a delay in treatment would cause serious harm to your health. Expedited appeals are decided within 72 hours. Include documentation of clinical urgency from your prescribing physician.

Does step therapy apply if I've tried treatments outside New Jersey? Yes, documented treatment failures from any state count toward step therapy requirements. Provide complete records including medication names, dosing, duration, and reasons for discontinuation.

What happens if I miss the 65-day appeal deadline? Contact Humana immediately to discuss options. In some cases, they may accept late appeals if you have good cause for the delay. New Jersey's external review deadline is 180 days from the final internal denial.

Are there alternatives if Hetlioz isn't covered? Alternatives include melatonin receptor agonist ramelteon, over-the-counter melatonin, or other sleep medications as clinically appropriate. However, Hetlioz is specifically FDA-approved for Non-24 and SMS, making it the preferred treatment for these conditions.

From our advocates: "We've seen success when families gather comprehensive sleep diary data before starting the PA process. One family documented their child's sleep patterns for six weeks, showing the clear non-24-hour cycle. This thorough documentation helped get approval on the first submission, avoiding delays in treatment."

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional support with prior authorizations and appeals, Counterforce Health provides specialized assistance in turning insurance denials into evidence-backed appeals.

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