By Counterforce Health Team in Hetlioz (tasimelteon) —

How to Get Hetlioz (Tasimelteon) Covered by Aetna (CVS Health) in Pennsylvania: Complete Guide with Appeals Process and Forms

Answer Box: Getting Hetlioz (Tasimelteon) Covered by Aetna (CVS Health) in Pennsylvania

Fastest Path to Approval: 1) Have your sleep specialist document Non-24-Hour Sleep-Wake Disorder or Smith-Magenis syndrome with sleep logs/actigraphy, 2) Submit prior authorization through Aetna's provider portal with documented melatonin trial failure, 3) If denied, file internal appeal within 180 days, then Pennsylvania external review within 4 months. Start today: Call Aetna member services at the number on your ID card to verify your plan's exact PA requirements and formulary tier for Hetlioz.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process for Pennsylvania
  5. Medical Necessity Letter Requirements
  6. Costs and Financial Assistance
  7. When to Escalate to State Regulators
  8. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Must get approval before filling prescription Aetna provider portal or member ID card Aetna PA Guidelines
Specialty Pharmacy Must use CVS Specialty or approved network CVS Specialty Drug List CVS Specialty
Formulary Tier Typically Tier 5 (highest cost-sharing) Plan formulary document Medicare Coverage Guide
Step Therapy Melatonin trial required first Aetna clinical policy Sample PA Criteria
Specialist Requirement Sleep medicine or neurology prescription PA form requirements Aetna Precertification
Age Restrictions Capsules ≥16 years; LQ suspension 3-15 years FDA labeling FDA Access Data

Step-by-Step: Fastest Path to Approval

1. Verify Your Coverage (Patient/Clinic Staff)

Call the member services number on your Aetna ID card and ask:

  • Is Hetlioz (tasimelteon) on my plan's formulary?
  • What tier is it placed on?
  • What prior authorization requirements apply?
  • Must I use CVS Specialty pharmacy?

Timeline: 10-15 minutes
Source: Aetna Member Services

2. Gather Required Documentation (Prescriber)

Your sleep specialist or neurologist must collect:

  • Diagnosis confirmation: Sleep logs showing non-24-hour pattern for ≥6 weeks
  • Specialist attestation: Board-certified sleep medicine or neurology consultation
  • Prior treatment failure: Documented melatonin trial with dose, duration, and outcome
  • Genetic confirmation: For Smith-Magenis syndrome cases, include genetic testing results

Timeline: 1-2 weeks
Source: Typical PA Requirements

3. Submit Prior Authorization (Prescriber)

Submit through:

  • Aetna provider portal (preferred method)
  • CVS Caremark PA system
  • Fax: Use number on provider materials (verify current number)

Include complete medical necessity letter addressing all criteria.

Timeline: Submit at least 2 weeks before needed
Source: Aetna Provider Guidelines

4. Monitor Decision (Patient/Clinic)

Aetna reports >95% of PAs are decided within 24 hours for complete submissions.

  • Standard review: Up to 15 business days
  • Expedited review: 72 hours (if urgent medical need)

Timeline: 1-15 business days
Source: Aetna PA Performance

5. If Approved: Fill at Specialty Pharmacy

Contact CVS Specialty at 1-800-237-2767 or use the pharmacy specified in your approval letter.

6. If Denied: File Internal Appeal

Submit within 180 days with enhanced medical necessity documentation.

7. External Review Option

Pennsylvania residents can request independent external review within 4 months of final internal denial.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"Diagnosis not documented" Submit sleep specialist consultation with ICD-10 G47.24 Sleep logs, actigraphy reports, specialist letter
"Step therapy not met" Document melatonin trial failure or contraindication Prescription records, clinical notes on outcomes
"Non-formulary drug" Request formulary exception with medical necessity Comparative effectiveness data, intolerance documentation
"Not prescribed by specialist" Get sleep medicine or neurology consultation Board certification verification, consultation notes
"Age requirements not met" Verify FDA-approved age ranges for formulation Prescription for age-appropriate formulation

Source: Pennsylvania External Review Data

Appeals Process for Pennsylvania

Internal Appeal (Required First Step)

  • Deadline: 180 days from denial date
  • Submit to: Aetna appeals department (address on denial letter)
  • Include: Enhanced medical necessity letter, additional clinical evidence
  • Timeline: Aetna must respond within 30-45 days

Pennsylvania External Review (After Internal Denial)

Pennsylvania launched its Independent External Review program in January 2024, with a 50% success rate for overturning denials.

  • Deadline: 4 months from final internal denial
  • Submit to: Pennsylvania Insurance Department
  • Cost: Free to patients
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Decision: Binding on Aetna

Expedited Review Available if:

  • Life or health at serious risk without treatment
  • Waiting would jeopardize ability to regain maximum function

Source: PA Insurance Department External Review

Medical Necessity Letter Requirements

Essential Elements for Sleep Specialist Letter

1. Patient & Diagnosis Information

  • Full name, DOB, Aetna member ID
  • ICD-10 code G47.24 (Non-24-Hour Sleep-Wake Disorder)
  • Clear diagnosis statement with syndrome specification

2. Clinical Documentation

  • Sleep pattern documentation (≥6 weeks of logs/actigraphy)
  • Functional impairment description
  • Safety concerns or quality of life impacts

3. Prior Treatment History

  • Melatonin: specific dose, duration, adherence, outcome
  • Other sleep medications tried and failed
  • Behavioral interventions attempted

4. Medical Necessity Justification

  • Why Hetlioz is specifically needed over alternatives
  • Risk of not treating with targeted therapy
  • Expected clinical outcomes

5. Specialist Credentials

  • Board certification in sleep medicine or neurology
  • Clinical experience with circadian rhythm disorders
Clinician Corner: Key Documentation Tips

When drafting medical necessity letters, address each specific denial reason point-by-point. Reference Aetna's clinical criteria directly and explain how your patient meets or exceeds each requirement. Include objective sleep data whenever possible—actigraphy plots and sleep diary summaries carry significant weight in appeals.

Source: Medical Necessity Guidelines

Costs and Financial Assistance

Typical Costs

  • Hetlioz capsules: Approximately $5,895 for 30×20mg
  • Hetlioz LQ: Around $24,678 for common bottle size
  • Insurance varies: Tier 5 placement typically means 25-50% coinsurance

Financial Assistance Options

  • HETLIOZSolutions: Manufacturer patient assistance program
    • Phone: 1-844-438-5469
    • Fax: 1-844-364-2424
    • Provides benefits investigation and copay support
  • Foundation grants: Check with patient advocacy organizations
  • State programs: Pennsylvania may have additional assistance for rare disease medications

Source: HETLIOZSolutions Program

When to Escalate to State Regulators

Contact the Pennsylvania Insurance Department if:

  • Aetna fails to respond to appeals within required timeframes
  • You believe your external review was improperly handled
  • You need help understanding your appeal rights

Pennsylvania Insurance Department Consumer Services

Frequently Asked Questions

Q: How long does Aetna prior authorization take in Pennsylvania? A: Aetna reports >95% of complete PAs are approved within 24 hours. Standard reviews can take up to 15 business days, while expedited reviews are completed within 72 hours.

Q: What if Hetlioz is non-formulary on my plan? A: Request a formulary exception by submitting a medical necessity letter explaining why formulary alternatives are inappropriate. Pennsylvania's external review process has a 50% success rate for overturning such denials.

Q: Can I request an expedited appeal? A: Yes, if your health is at serious risk or waiting would jeopardize your ability to regain maximum function. Your doctor must certify the urgent need.

Q: Does step therapy apply if I failed melatonin in another state? A: Yes, documented melatonin failure from any location should satisfy step therapy requirements. Ensure your medical records clearly document the trial and outcome.

Q: What happens if my external review is successful? A: Aetna must immediately provide coverage for Hetlioz and may need to reimburse you for any out-of-pocket costs incurred during the appeal process.

Q: How do I know if my plan is subject to Pennsylvania's external review? A: Most fully-insured commercial plans are covered. Self-funded ERISA plans may use federal external review instead. Call the Pennsylvania Insurance Department to confirm eligibility.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based advocacy. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical guidelines to create targeted, point-by-point rebuttals that align with each insurer's specific criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department or consider working with a qualified patient advocacy service like Counterforce Health.

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