CurrentCignaPolicy N/A

Xyrem (sodium oxybate) prior authorization — coverage criteria

This form and policy govern prior authorization requests for Xyrem (sodium oxybate) for treatment of narcolepsy and other hypersomnolence disorders for Cigna members; it describes required clinical documentation and criteria to support coverage decisions.

Policy Summary

PayerCigna

PolicyXyrem (sodium oxybate) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete prior authorization form and attach required supportive documentation including sleep study results and prior medication trial information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

v080120document version

1drug covered (Xyrem)

Coverage / Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met (grouped by narcolepsy type):

General requirements: Requested drug is prescribed by or in consultation with a neurologist, pulmonologist, or sleep specialist; supportive documentation (chart notes, sleep study, etc.) is attached; completed form information and prescriber attestation/signature provided.

Prescriber must attest information is accurate and include signature and date.

Diagnosis: Documented diagnosis indicating narcolepsy type 1 OR narcolepsy type 2 OR narcolepsy type unknown.

Form includes checkbox for type and requires supporting documentation.

Narcolepsy Type 1 specific: Patient has cataplexy OR low CSF hypocretin-1 AND has daily irrepressible sleepiness for at least 3 months; nocturnal PSG and MSLT performed with MSLT mean sleep latency ≤ 8 minutes OR ≥ 2 SOREMPs OR a SOREMP on PSG. Additionally, documentation of failure, inadequate response, intolerance, contraindication, or patient is not a candidate for ONE of: a tricyclic antidepressant (TCA), a selective serotonin reuptake inhibitor (SSRI), or venlafaxine.

Policy Summary

PayerCigna

PolicyXyrem (sodium oxybate) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete prior authorization form and attach required supportive documentation including sleep study results and prior medication trial information.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Codes and Key Clinical Thresholds

Covered/Referenced Codesmixed

N/A	Form and policy reference for Xyrem (sodium oxybate) prior authorization; no specific CPT/HCPCS/ICD codes listed on form.

inv-05: Mean sleep latency on MSLT

ThresholdMean sleep latency on MSLT ≤ 8 minutes

Form questionDid your patient have a multiple sleep latency test (MSLT) that showed a mean sleep latency of 8 minutes or less? (Yes/No)

Role in diagnosisMSLT mean sleep latency ≤8 min supports narcolepsy type 1 when combined with clinical features and/or SOREMPs

inv-06: CSF hypocretin-1 concentration

ThresholdCSF hypocretin-1 concentration ≤ 110 pg/mL OR less than one third of mean values obtained in normal subjects with the same standardized assay

Form question — measuredDid your patient undergo a measurement of hypocretin-1 levels in their cerebrospinal fluid (CSF)? (Yes/No)

Form question — result optionsIf yes: 110 pg/mL OR less; 111 pg/mL or higher; less than one third of mean values with same assay; more than one third of mean values with same assay

Provider Requirements and Prior Authorization Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required for Xyrem. Submit a completed prior authorization form and attach all required supportive documentation (chart notes, sleep study reports, CSF testing results, medication trial history). Incomplete submissions or missing documentation may lead to denial or delay of the request.

Medication: Xyrem (sodium oxybate)
Submit via CoverMyMeds or SureScripts, or include completed form with request
Attach: PSG report, MSLT results, CSF hypocretin-1 if performed, clinic notes documenting symptoms and duration

Documentation Required

Supportive Documentation Required

All of the following supportive documentation must be attached to the request: sleep study (nocturnal PSG) to rule out other causes of hypersomnolence, MSLT results including mean sleep latency and number of SOREMPs, CSF hypocretin-1 concentration if tested, clinic notes documenting daily irrepressible sleepiness for ≥3 months and cataplexy status, and documentation of reductions in symptoms if continuing therapy.

Nocturnal polysomnography (PSG) report
Multiple sleep latency test (MSLT) report with mean sleep latency and SOREMP count
CSF hypocretin-1 level and assay interpretation (if performed)
Clinic/chart notes documenting symptom duration (≥3 months), frequency, and cataplexy
Documentation of concomitant sedative/hypnotic use (yes/no) and rationale

Step Therapy

Required Prior Medication Trials

Required prior medication trials must be documented before approval: for type 1 narcolepsy, trial or contraindication/intolerance to at least one TCA, SSRI, or venlafaxine; for type 2 narcolepsy or idiopathic hypersomnolence, documented failure/intolerance/contraindication or ineligibility for modafinil or armodafinil and for stimulant therapy (amphetamine, dextroamphetamine, or methylphenidate) as applicable.

Type 1: trial or documented contraindication/intolerance to one TCA (eg, amitriptyline, desipramine, imipramine), one SSRI (eg, fluoxetine, sertraline, paroxetine) or venlafaxine
Type 2: trial or documented contraindication/intolerance to modafinil or armodafinil
Type 2: trial or documented contraindication/intolerance to a stimulant (amphetamine, dextroamphetamine, or methylphenidate)

Documentation Required

Completed Form Fields — Patient and Prescriber Information Required

Completed form fields are required for all asterisked items. Ensure the prescriber and patient information is fully completed: physician name, specialty, DEA/NPI/TIN, office contact, patient name, Cigna ID, date of birth, patient address/phone, urgency, medication requested, directions, quantity, ICD-10, and prescriber signature. Missing these fields may prevent processing.

Prescriber: name, specialty, DEA/NPI/TIN, office contact, phone, fax, address
Patient: name, Cigna ID, date of birth, address, phone
Request details: urgency, medication requested, directions, quantity, ICD-10, dosing rationale
Prescriber signature and date

Denial Risk

Missing Documentation / Unconfirmed Diagnosis — Potential Denial or Delay

Missing required documentation or unconfirmed diagnostic testing (eg, absence of PSG/MSLT results or CSF hypocretin-1 when indicated) may result in denial or request for additional information. If diagnostic criteria are not met or prior trials are not documented, the request will be subject to medical necessity review and may be denied.

Denial risk if PSG or MSLT reports are not provided when required
Denial or delay if prior medication trials (or documented contraindications) are not included
Provide clear documentation if diagnosis is unconfirmed or alternative causes of hypersomnolence were not excluded

Background

Sodium oxybate (Xyrem) is indicated for management of narcolepsy symptoms including cataplexy and excessive daytime sleepiness. The form emphasizes that diagnosis typically relies on clinical history plus objective sleep testing: a nocturnal polysomnography (PSG) to exclude other causes of hypersomnolence, and a multiple sleep latency test (MSLT) reporting mean sleep latency and presence/number of SOREMPs. The form also captures CSF hypocretin-1 measurement when performed, with explicit thresholds (for example, 110 pg/mL or less or less than one third of mean values on the same assay) that support narcolepsy type 1. Complete documentation of these test results and clinical history is required with the prior authorization request.

Key Definitions

inv-14: Cataplexy definition and form question

DefinitionCataplexy: sudden loss of muscle tone associated with narcolepsy (form asks whether patient has cataplexy).

Form questionDoes your patient have cataplexy? (Yes/No)

RelevancePresence of cataplexy is a criterion supporting narcolepsy type 1 when combined with excessive daytime sleepiness and appropriate testing

inv-15: SOREMP — definition and how form captures SOREMPs

DefinitionSOREMP: sleep-onset rapid eye movement period occurring during the MSLT (or within 15 minutes of sleep onset on nocturnal PSG).

Form capture — MSLTDid your patient have any sleep-onset rapid eye movement periods (SOREMPs) during the MSLT? Options: Yes, 2 or more SOREMPs; Yes, only 1 SOREMP; No or Unknown.

Form capture — PSGDid your patient have a SOREMP within 15 minutes of sleep onset during the nocturnal PSG? (Yes/No)