By Counterforce Health Team in Xyrem (sodium oxybate) —

Getting Xyrem (Sodium Oxybate) Covered by Cigna in Washington: Complete Prior Authorization Guide

Answer Box: Getting Xyrem Covered by Cigna in Washington

Eligibility: Cigna requires prior authorization for Xyrem (sodium oxybate) with documented narcolepsy, sleep study results, and failed stimulant therapy. Fastest path: Have your sleep specialist complete Cigna's PA form with PSG/MSLT results and dextroamphetamine trial documentation. Start today: Contact the XYWAV and XYREM REMS program at 1-866-997-3688 to begin prescriber and patient enrollment while gathering your sleep study records. Washington residents have strong appeal rights through the Office of the Insurance Commissioner if initially denied.

Table of Contents

  1. Coverage Overview: How Cigna Handles Xyrem
  2. Medical Necessity Requirements
  3. Step Therapy and Exceptions
  4. Quantity Limits and Dosing Rules
  5. Required Diagnostics and Documentation
  6. REMS Program and Specialty Pharmacy
  7. Appeals Process in Washington
  8. Common Denial Reasons and Solutions
  9. Cost-Saving Options
  10. FAQ

Coverage Overview: How Cigna Handles Xyrem

Xyrem (sodium oxybate) is classified as a specialty medication requiring prior authorization across all Cigna plans. The drug carries a retail cash price of approximately $18,968 per three-month supply, making insurance coverage essential for most patients.

Plan Types and Coverage

Commercial Plans: Xyrem typically appears on Tier 3 or 4 (specialty tier) with prior authorization requirements and step therapy protocols.

Medicare Part D: Listed with prior authorization, quantity limits, and often requires trial of preferred wake-promoting agents first.

Medicaid (Apple Health in Washington): Covered with PA requirements similar to commercial plans, following state Medicaid guidelines.

Note: Self-funded employer plans follow federal ERISA rules rather than Washington state insurance law for appeals.

Medical Necessity Requirements

Core Eligibility Criteria

Cigna's 2024 national policy for oxybate products requires all of the following:

  1. Age: Patient must be ≥7 years old
  2. Confirmed narcolepsy diagnosis based on clinical evaluation
  3. Objective sleep testing: Both polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) completed
  4. Specialist prescriber: Sleep medicine physician or neurologist
  5. Prior stimulant trial: Documented use of dextroamphetamine OR contraindication/intolerance

FDA-Approved Indications Covered

  • Narcolepsy with cataplexy (≥7 years)
  • Narcolepsy with excessive daytime sleepiness (≥7 years)

Not typically covered: Off-label uses like idiopathic hypersomnia (Xywav is preferred), depression, or chronic pain.

Step Therapy and Exceptions

Required Prior Therapies

Primary Step: Documentation of dextroamphetamine trial or valid contraindication such as:

  • Substance use disorder history
  • Advanced arteriosclerosis
  • Symptomatic cardiovascular disease
  • Moderate to severe hypertension
  • Hyperthyroidism
  • Glaucoma

Preferred Product Step (effective April 2024): Cigna may require trial of generic sodium oxybate before covering brand Xyrem.

Medical Exception Pathways

If standard step therapy isn't appropriate, document:

  • Contraindications with specific medical reasons
  • Prior failures with dates, doses, duration, and adverse effects
  • Intolerance with detailed symptom descriptions
Tip: Include prescriber attestation of why the preferred agent cannot be used rather than just listing "failed trial."

Quantity Limits and Dosing Rules

Maximum Allowable Doses

  • Adults: Up to 9 grams per night (4.5g + 4.5g doses)
  • Pediatric weight-based limits:
    • 20-<30 kg: Maximum 6g/night
    • 30-<45 kg: Maximum 7.5g/night
    • ≥45 kg: Maximum 9g/night

Titration Schedule

Standard Protocol:

  • Start: 4.5g/night (2.25g twice nightly)
  • Increase: 1.5g/night per week
  • Target: 6-9g/night based on response

Coverage Duration: Typically 6-12 months per authorization cycle.

Required Diagnostics and Documentation

Sleep Study Requirements

Polysomnography (PSG): Must demonstrate sleep architecture abnormalities consistent with narcolepsy

Multiple Sleep Latency Test (MSLT): Required to confirm excessive daytime sleepiness with:

  • Mean sleep latency ≤8 minutes
  • ≥2 sleep-onset REM periods (if cataplexy absent)

Clinical Documentation Checklist

  • ICD-10 codes (G47.411 for narcolepsy with cataplexy, G47.419 without)
  • Cataplexy frequency and triggers (if present)
  • Epworth Sleepiness Scale scores
  • Prior medication trials with specific outcomes
  • Current functional impairment details
  • Weight and dosing calculations for pediatric patients

REMS Program and Specialty Pharmacy

Mandatory REMS Enrollment

Before Cigna will cover Xyrem, both prescriber and patient must enroll in the XYWAV and XYREM REMS program:

Prescriber Requirements:

  • Complete REMS Prescriber Enrollment Form
  • Review prescriber brochure and full prescribing information
  • Attest to patient counseling obligations

Patient Requirements:

  • Complete Patient Enrollment Form with prescriber
  • Receive counseling on risks and safe use
  • Agree to pharmacy counseling checklist

Dispensing Restrictions

Xyrem can only be dispensed through the REMS-certified central pharmacy, not through:

  • Retail pharmacies
  • Accredo or other specialty pharmacies
  • Hospital pharmacies

Contact: XYWAV and XYREM REMS at 1-866-997-3688

Appeals Process in Washington

Washington residents have robust appeal rights when Cigna denies Xyrem coverage.

Internal Appeals Timeline

  1. File internal appeal: Within 180 days of denial
  2. Cigna decision: Required within specific timeframes based on urgency
  3. Final internal denial: Triggers external review eligibility

External Review (IRO Process)

For Washington state-regulated plans:

Standard Review:

  • Request deadline: 180 days from final internal denial
  • IRO decision: Within 30-45 days
  • Required documents: All medical records sent within 3 business days

Expedited Review:

  • Decision timeline: Within 72 hours
  • Criteria: Serious jeopardy to health or ability to regain maximum function

Contact: Washington Office of the Insurance Commissioner at 1-800-562-6900

Important: Self-funded employer plans follow federal external review rules instead of Washington state IRO process.

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
No REMS enrollment Complete enrollment first REMS confirmation
Insufficient sleep studies Provide PSG + MSLT results Sleep lab reports
No stimulant trial Document dextroamphetamine use or contraindication Medication history, adverse effects
Exceeds quantity limits Justify dosing within FDA limits Weight-based calculations, titration schedule
Non-formulary status Request formulary exception Medical necessity letter

Peer-to-Peer Review Strategy

When requesting peer review with Cigna:

  • Emphasize functional impairment from narcolepsy
  • Reference FDA labeling for approved indications
  • Highlight safety of REMS-restricted distribution
  • Document improvement in cataplexy or sleepiness metrics

Cost-Saving Options

Manufacturer Support Programs

JazzCares: Patient assistance program offering:

  • Copay assistance for eligible commercial patients
  • Free drug program for uninsured patients meeting income criteria
  • Prior authorization support services

Eligibility: Varies by program; typically excludes Medicare and Medicaid patients from copay assistance.

State and Federal Programs

Washington Apple Health: Medicaid expansion covering adults up to 138% of federal poverty level

Medicare Extra Help: Low-income subsidy program reducing Part D costs

FAQ

How long does Cigna prior authorization take in Washington? Standard PA decisions are required within 3 calendar days for electronic submissions under Washington's 2024 prior authorization modernization law. Urgent requests must be decided within 1 calendar day.

What if Xyrem is non-formulary on my plan? Request a formulary exception by submitting a medical necessity letter documenting why formulary alternatives are inappropriate. Include specialist recommendation and clinical guidelines supporting Xyrem use.

Can I request an expedited appeal? Yes, if delay in treatment would seriously jeopardize your health. Your prescriber must certify the urgent medical need, and the IRO must decide within 72 hours.

Does step therapy apply if I've used stimulants outside Washington? Yes, prior therapy documentation from any location typically satisfies step therapy requirements. Ensure you have records showing medication names, doses, duration, and outcomes.

What happens if my employer plan is self-funded? Self-funded ERISA plans follow federal external review rules instead of Washington's IRO process. Check your plan documents or contact the U.S. Department of Labor for guidance.

How much does Xyrem cost without insurance? Retail prices typically exceed $18,000 per three-month supply. The JazzCares program may provide assistance for eligible uninsured patients.

From Our Advocates

We've seen Washington patients successfully overturn initial Xyrem denials by submitting comprehensive sleep study documentation alongside detailed medical necessity letters from their specialists. The key is often demonstrating functional impairment and documenting why standard wake-promoting agents haven't provided adequate symptom control. While outcomes vary by individual circumstances, thorough documentation significantly improves approval chances.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific basis for denial. The platform then drafts targeted, evidence-backed rebuttals that align with each payer's own rules and procedural requirements. For complex cases like Xyrem approvals, having the right clinical evidence and regulatory citations can make the difference between approval and denial.

When facing a Cigna denial for Xyrem in Washington, remember that you have strong consumer protections through the state's external review process. The Washington Office of the Insurance Commissioner provides robust support for residents navigating insurance appeals, and many specialty drug denials are overturned when proper clinical evidence is presented to independent review organizations.

For personalized assistance with your specific situation, Counterforce Health can help analyze your denial and develop a targeted appeal strategy based on Cigna's specific policy requirements and Washington's regulatory framework.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with qualified healthcare providers regarding your specific medical condition and treatment options. Insurance coverage decisions depend on individual plan terms and medical circumstances.

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