By Counterforce Health Team in Xyrem (sodium oxybate) —

Xyrem (Sodium Oxybate) Approval with UnitedHealthcare in Georgia: Answers to the Most Common Questions

Answer Box: Getting Xyrem Covered by UnitedHealthcare in Georgia

UnitedHealthcare requires prior authorization for Xyrem (sodium oxybate) in Georgia, with strict step-therapy requirements including trials of modafinil, armodafinil, and other wake-promoting agents. The fastest path: (1) Complete REMS enrollment at XywavXyremREMS.com, (2) Submit PA via UnitedHealthcare provider portal with sleep study documentation and detailed prior therapy failures, (3) If denied, file internal appeal within 60-180 days, then Georgia external review within 60 days of final denial through the Georgia Department of Insurance (1-800-656-2298).

Table of Contents

Coverage Basics

Is Xyrem covered by UnitedHealthcare in Georgia?

UnitedHealthcare typically covers Xyrem (sodium oxybate) under the specialty pharmacy benefit, but with significant restrictions. According to UnitedHealthcare's clinical policy, Xyrem brand and Amneal-manufactured authorized generics are often excluded from coverage, with preference given to Lumryz, Hikma sodium oxybate, or Xywav.

Which UnitedHealthcare plans cover Xyrem?

Coverage varies by plan type:

  • Commercial plans: Prior authorization required through OptumRx
  • Medicare Advantage: Specialty tier with PA requirements
  • Medicaid managed care: Subject to state formulary restrictions
  • Employer self-funded: Depends on specific benefit design

Always verify coverage through your specific plan's formulary or by calling the member services number on your insurance card.

Prior Authorization Process

Who submits the prior authorization?

Your prescribing physician (typically a sleep specialist or neurologist) must submit the PA request. Patients cannot submit directly, but you can help gather required documentation.

How to check PA status

  • UnitedHealthcare Provider Portal: Real-time status updates
  • OptumRx PA phone line: Number provided on denial letters
  • Member services: Call the number on your insurance card

Required documentation includes:

  • Confirmed narcolepsy diagnosis with ICD-10 codes (G47.411 for narcolepsy with cataplexy)
  • Polysomnography and Multiple Sleep Latency Test results
  • Documentation of failed trials with modafinil, armodafinil, and other required medications
  • Completed REMS enrollment for both prescriber and patient
  • Letter of medical necessity addressing functional impairment and safety concerns

Timing and Urgency

Standard processing times

According to Counterforce Health's analysis, UnitedHealthcare PA decisions typically take:

  • Electronic submission: 1-3 business days
  • Fax submission: 3-7 business days
  • Mail submission: Up to 15 business days

Expedited/urgent requests

For urgent cases where delay may seriously jeopardize health, request expedited prior authorization:

  • Decision typically within 72 hours
  • Requires clinical justification of urgency
  • Submit through provider portal marked as "urgent"

Step Therapy Requirements

What medications must be tried first?

UnitedHealthcare's step therapy policy typically requires documented failure, intolerance, or contraindication to three of the following:

  • Lumryz
  • Sodium oxybate AG (Hikma)
  • Xywav
  • Wakix (pitolisant)

Additionally, trials of standard wake-promoting agents are usually required:

  • Modafinil
  • Armodafinil
  • Other stimulants (methylphenidate, amphetamines)
  • Solriamfetol

Step therapy exceptions

Exceptions may be granted if:

  • Previous medications caused serious adverse effects
  • Medical contraindications exist
  • Patient has documented positive response to Xyrem specifically
  • Formulary alternatives are clinically inappropriate

Costs and Financial Assistance

Typical costs with UnitedHealthcare

Xyrem is typically placed on the specialty tier (Tier 4 or 5), resulting in:

  • Higher coinsurance (often 25-40% of drug cost)
  • Retail cash price approximately $18,968 per 3×180 mL supply
  • Annual out-of-pocket costs can reach thousands of dollars

Financial assistance options

  • JazzCares Patient Assistance Program: Income-based assistance for eligible patients
  • Copay assistance: May be available for commercial insurance (not Medicare)
  • Georgia pharmaceutical assistance programs: Contact Georgia Department of Community Health

When dealing with insurance challenges, Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to draft point-by-point rebuttals.

Denials and Appeals

Common denial reasons

Denial Reason How to Address
Insufficient step therapy Document specific medications tried, doses, durations, and outcomes
Medical necessity not established Provide sleep study results, functional impact documentation
REMS enrollment incomplete Complete enrollment at XywavXyremREMS.com
Concurrent CNS depressants Document discontinuation or medical necessity
Non-formulary status Request formulary exception or consider covered alternatives

Georgia appeals process

Internal Appeals with UnitedHealthcare:

  • Deadline: Typically 180 days for commercial plans, 60 days for Medicare Advantage
  • Submission: Provider portal, fax, or mail to address on denial letter
  • Documentation: Include medical necessity letter, clinical records, prior therapy documentation

Georgia External Review: After exhausting internal appeals, Georgia residents have powerful protection through the state's external review process:

  • Deadline: 60 days from final internal denial letter
  • Cost: Free to patients
  • Process: Independent medical review by specialists
  • Contact: Georgia Department of Insurance at 1-800-656-2298
  • Timeline: Standard decisions within 30 business days, urgent cases within 72 hours
  • Binding: If approved, UnitedHealthcare must provide coverage
Important: Georgia's 60-day external review deadline is firm. Missing this window typically forfeits your right to independent review.

Medical necessity letter template

Your sleep specialist should include:

  • Confirmed narcolepsy diagnosis with objective sleep study findings
  • Detailed history of prior medication failures with specific reasons
  • Current symptom severity and functional impairment
  • Safety concerns (fall risk, driving impairment, occupational hazards)
  • Clinical rationale for Xyrem specifically versus alternatives

Renewals and Reauthorization

When is reauthorization needed?

Initial Xyrem approvals are typically granted for 12 months. Reauthorization requires:

  • Documented clinical benefit (reduced excessive daytime sleepiness and cataplexy frequency)
  • Continued medical necessity
  • Updated safety screening
  • Ongoing REMS compliance

What changes trigger new PA?

  • Dose increases beyond approved limits
  • Changes in diagnosis or indication
  • Addition of contraindicated medications
  • Insurance plan changes

REMS and Specialty Pharmacy

Why was my prescription transferred?

Xyrem is subject to FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) requirements:

  • Can only be dispensed through REMS-certified specialty pharmacy
  • Both prescriber and patient must be enrolled in XYWAV and XYREM REMS program
  • Home delivery only - no retail pickup available

REMS enrollment process

For Prescribers:

  1. Complete Prescriber Enrollment Form at XywavXyremREMS.com
  2. Review prescriber brochure and safety materials
  3. Attest to understanding of risks and monitoring requirements

For Patients:

  1. Complete Patient Enrollment Form (one-time)
  2. Provide insurance and contact information
  3. Acknowledge counseling on safe use conditions
  4. Designate caregiver if under 18

REMS pharmacy contact

  • Phone: 1-866-997-3688
  • Fax: 1-866-470-1744
  • Address: XYWAV and XYREM REMS, PO Box 66589, St. Louis, MO 63166-6589

Troubleshooting Common Issues

Provider portal problems

If the UnitedHealthcare provider portal is down:

  • Use backup fax numbers provided on denial letters
  • Call provider services for alternative submission methods
  • Document submission attempts for appeal purposes

Missing forms or documentation

  • Contact prescriber's office for complete medical records
  • Request sleep study reports directly from sleep center
  • Obtain prior medication history from previous pharmacies
  • Use patient portal to access historical claims information

Communication gaps

Patient script for calling UnitedHealthcare: "I'm calling about prior authorization status for Xyrem for narcolepsy. My member ID is [ID], and the PA was submitted on [date]. Can you provide the current status and any additional requirements?"

Clinic script for peer-to-peer request: "I'm requesting a peer-to-peer review for a Xyrem prior authorization denial. The patient has documented narcolepsy with cataplexy and has failed multiple formulary alternatives. I'd like to discuss the medical necessity with a sleep medicine specialist."

Key Terms Glossary

  • PA (Prior Authorization): Insurance approval required before coverage begins
  • QL (Quantity Limits): Restrictions on amount of medication covered per time period
  • ST (Step Therapy): Requirement to try preferred medications before covering alternatives
  • P2P (Peer-to-Peer): Discussion between prescriber and insurance medical director
  • LMN (Letter of Medical Necessity): Detailed clinical justification for coverage
  • REMS: Risk Evaluation and Mitigation Strategy - FDA safety program
  • EOB (Explanation of Benefits): Insurance statement showing coverage decisions
  • Formulary: List of covered medications under insurance plan
  • External Review: Independent review of insurance denials by state-assigned experts
From our advocates: One Georgia patient's Xyrem approval was initially denied due to "insufficient step therapy documentation." By working with their sleep specialist to create a detailed timeline showing specific dates, doses, and adverse effects from five prior medications, plus emphasizing fall risks from uncontrolled cataplexy, they successfully overturned the denial on internal appeal within two weeks. The key was demonstrating not just that alternatives were tried, but why each was inadequate or unsafe for their specific situation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may vary by plan and change over time. Always consult your healthcare provider for medical decisions and verify current requirements with UnitedHealthcare and the Georgia Department of Insurance.

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