By Counterforce Health Team in Xyrem (sodium oxybate) —

How to Get Xyrem (Sodium Oxybate) Covered by Cigna in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Xyrem Covered by Cigna in North Carolina

To get Xyrem (sodium oxybate) covered by Cigna in North Carolina, you need:

  1. REMS enrollment (prescriber and patient) through xywavxyremrems.com
  2. Prior authorization with PSG/MSLT results and documented step therapy failure (dextroamphetamine or Wakix)
  3. Prescription through sleep specialist or neurologist

First step today: Call 1-866-997-3688 to start REMS enrollment while gathering sleep study documentation. If denied, North Carolina's Smart NC external review overturns ~50% of specialty drug denials within 45 days.

Table of Contents

Cigna's Coverage Criteria Overview

Cigna covers Xyrem (sodium oxybate) as a Tier 3/4 specialty medication requiring prior authorization across commercial, Medicare Part D, and Medicaid plans. The drug is dispensed exclusively through Accredo specialty pharmacy under FDA-mandated REMS restrictions.

Coverage at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plan types PA form with clinical rationale Cigna Policy CNF-643
Age Requirement ≥7 years old Birth certificate or medical record FDA Label
Diagnosis Narcolepsy with cataplexy/EDS PSG + MSLT results Cigna Policy IP-0103
Prescriber Sleep specialist or neurologist DEA certification Cigna PA Form
Step Therapy Dextroamphetamine OR Wakix failure Trial documentation with dates/doses Cigna Policy CNF-643
REMS Enrollment Mandatory before dispensing Enrollment confirmation letter REMS Website

Step-by-Step: Fastest Path to Approval

1. Enroll in REMS Program (Week 1)

Who: Prescriber and patient
Action: Complete enrollment forms at xywavxyremrems.com
Timeline: 3-5 business days for confirmation
Documents: Prescriber enrollment form, patient enrollment form

2. Gather Sleep Study Documentation

Who: Patient/clinic staff
Documents needed:

  • Polysomnography (PSG) report showing sleep-onset REM periods
  • Multiple Sleep Latency Test (MSLT) with mean sleep latency ≤8 minutes
  • At least 2 SOREMPs documented

3. Document Step Therapy Trials

Required trials (choose one):

  • Dextroamphetamine: Minimum 4-week trial at therapeutic dose with documented failure/intolerance
  • Wakix (pitolisant): Trial with inadequate efficacy (for patients ≥18 years)
  • Medical contraindication: Document specific contraindications (cardiovascular disease, substance abuse history, etc.)

4. Submit Prior Authorization

Who: Prescriber
Method: Cigna provider portal or fax
Timeline: 5 business days for standard review, 24 hours for urgent
Include: PA form, sleep studies, step therapy documentation, REMS confirmation

5. Follow Up and Track

Action: Call Cigna at member services number on insurance card
Timeline: Check status after 3 business days
Backup: If no response by day 5, consider filing grievance

Medical Necessity Requirements

Clinician Corner: Your medical necessity letter should address each of these criteria with specific documentation.

Core Eligibility Criteria

  1. Confirmed narcolepsy diagnosis with PSG/MSLT results consistent with narcolepsy per prescriber assessment
  2. Age ≥7 years with appropriate weight-based dosing calculations
  3. Specialist prescription from sleep medicine or neurology provider
  4. Step therapy completion or documented medical contraindication
  5. REMS program enrollment for both prescriber and patient

Required Clinical Documentation

  • ICD-10 codes: G47.411 (narcolepsy without cataplexy) or G47.419 (narcolepsy with cataplexy)
  • Sleep study timeline: PSG and MSLT performed within 2 years of request
  • Prior therapy details: Specific medications, doses, duration, and reasons for discontinuation
  • Dosing rationale: Starting dose (typically 4.5g nightly) with titration plan
  • Monitoring plan: 3-month follow-up schedule per REMS requirements

When navigating complex prior authorization requirements, many patients and providers turn to specialized services. Counterforce Health helps streamline this process by analyzing denial letters, identifying specific coverage gaps, and drafting targeted appeals that address payer-specific criteria with clinical evidence.

Appeals Process in North Carolina

North Carolina provides robust consumer protections through Smart NC, which offers free advocacy and binding external review for specialty drug denials.

Internal Appeals with Cigna

Timeline: File within 180 days of denial
Response time: 15 business days for pre-service appeals
Method: Submit through Cigna member portal or mail to address on denial letter

Smart NC External Review

When to use: After exhausting Cigna's internal appeals
Timeline: Request within 120 days of final Cigna denial
Success rate: Approximately 50% of specialty drug denials are overturned
Contact: 855-408-1212 or NC Department of Insurance

From our advocates: We've seen Xyrem appeals succeed when families provide comprehensive sleep study documentation and clearly demonstrate how stimulant alternatives failed due to side effects or insufficient symptom control. The key is showing that standard treatments don't address both the excessive daytime sleepiness and cataplexy episodes that significantly impact daily functioning.

Expedited Review Process

Eligibility: Physician certifies delay would seriously jeopardize health
Timeline: 72 hours for binding decision
Documentation: Medical urgency certification per North Carolina General Statute 58-50-61

Common Denial Reasons & Solutions

Denial Reason How to Fix Required Documentation
No REMS enrollment Complete enrollment immediately REMS confirmation letter
Missing sleep studies Submit PSG/MSLT reports Official sleep lab results with interpretation
Insufficient step therapy Document adequate trials Pharmacy records, clinic notes with dates/doses
Non-formulary status Request formulary exception Exception form with medical necessity
Quantity limits exceeded Justify dosing requirements Weight-based calculations, titration schedule
Wrong prescriber type Transfer to sleep specialist New prescription from qualified provider

Medical Necessity Letter Template

When submitting appeals, include these key elements:

  • Patient demographics: Age, weight, diagnosis with ICD-10 codes
  • Sleep study results: Specific MSLT/PSG findings supporting narcolepsy diagnosis
  • Prior therapy failures: Detailed trial history with outcomes and side effects
  • Clinical rationale: Why Xyrem is medically necessary vs. alternatives
  • Monitoring plan: Safety assessments and follow-up schedule

Cost Assistance Options

Manufacturer Support

  • JazzCares Patient Advocate Program: Financial assistance and insurance navigation
  • Contact: Visit jazzcares.com or call patient support line
  • Eligibility: Income-based assistance available for qualifying patients

North Carolina State Resources

  • Smart NC: Free insurance advocacy at 855-408-1212
  • NC Health Insurance Smart Guide: Sample appeal letters and coverage tips
  • Medicaid expansion: Effective 2024, expanding coverage options for low-income adults

For complex cases involving multiple denials or unique clinical circumstances, services like Counterforce Health can provide targeted appeal strategies that address specific payer criteria while incorporating the latest clinical evidence and guidelines.

FAQ

How long does Cigna prior authorization take in North Carolina?
Standard PA requests: 5 business days. Urgent requests with physician certification: 24 hours. Track status through Cigna member portal.

What if Xyrem is non-formulary on my plan?
Submit a formulary exception request using Cigna's exception form with clinical rationale for medical necessity.

Can I get expedited review if my health is at risk?
Yes. Both Cigna and Smart NC offer expedited reviews when physician certifies that delay would seriously jeopardize health or ability to function.

Does step therapy apply if I failed treatments in another state?
Yes, documented failures from out-of-state providers count toward step therapy requirements. Include complete medical records with dates and outcomes.

What happens if Smart NC denies my external review?
Smart NC decisions are binding on insurers. If denied, consult with healthcare attorney about potential legal options, though administrative remedies are typically exhausted.

How much does Xyrem cost without insurance?
Retail cash price examples show approximately $18,968 per 3×180 mL supply. Manufacturer assistance programs may significantly reduce out-of-pocket costs.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Consult with your healthcare provider for medical decisions and verify current coverage policies with your specific Cigna plan. Coverage criteria and appeal procedures may vary by plan type and can change over time.

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