Prior Authorization Required

Prior authorization is required for agents in this policy. Providers must submit required clinical documentation to support medical necessity, and approval durations vary by agent (see policy criteria).

• Prior authorization required for Xyrem and Xywav and related agents (REMS enrollment required where noted).
• Approval durations per drug listed in policy (typically 12–24 months).

REMS Requirement for Xywav/Xyrem

Xywav and Xyrem are available only through the Xyrem/Xywav REMS program. For Xywav, the prescribing physician and patient must be enrolled in the Xywav REMS Program; for Xyrem (and when Xyrem is used), the patient and physician must be enrolled in the Xyrem/Xywav REMS Program. Documentation of REMS enrollment must be provided with the prior authorization request.

• REMS enrollment required prior to approval for Xyrem or Xywav.
• REMS documentation must be included with initial and continuation requests.

Xywav — Sodium‑Restriction and Prior Therapy Documentation

For Xywav (and Xyrem when Xywav is requested), the prescriber must document a clinical reason to restrict sodium intake (e.g., renal impairment, heart failure, or hypertension) AND document failure of Xyrem due to sodium-related clinical worsening despite dietary sodium restriction. Failure must be attributed to the high sodium content of Xyrem (e.g., worsening renal function, reduced cardiac output, or increased blood pressure) and not to other causes.

• Clinical reason to restrict sodium intake must be clearly documented.
• Documentation that Xyrem was tried and produced sodium-related clinical worsening despite sodium restriction (details of lab changes, vitals, or cardiac metrics).

Not Medically Necessary if Criteria Unmet

Failure to document required trials, REMS enrollment, diagnostic confirmation, or other specified criteria will result in the request being considered not medically necessary and may be denied.

• Lack of documentation of required stimulant/wake‑promoting trials.
• Missing REMS enrollment evidence for Xyrem/Xywav.
• Absent sleep study, MSLT, CSF hypocretin, or other diagnostic documentation where required.

Required Diagnostic and REMS Documentation

Required diagnostic documentation must be submitted with the request where specified in the criteria (e.g., sleep study/polysomnography, MSLT results, CSF hypocretin-1 levels when applicable). For narcolepsy, idiopathic hypersomnia, and OSA indications, clinical documentation such as chart notes, sleep study reports, and MSLT or CSF results are required. For Xyrem/Xywav, REMS enrollment confirmation must also be included.

• Polysomnography and MSLT reports where required.
• CSF hypocretin-1 concentration when indicated.
• Clinical chart notes documenting symptom frequency/duration.
• REMS enrollment documentation for Xyrem/Xywav.

Required Clinical Documentation and REMS Enrollment for Continuation

Continuation requests for Xyrem or Xywav require clinical documentation demonstrating a positive response to therapy (e.g., reduction in excessive daytime sleepiness or decreased cataplexy frequency) in addition to maintaining REMS enrollment.

• Clinical outcome documentation (e.g., ESS scores, cataplexy frequency) for continuation.
• REMS enrollment must be maintained and evidence submitted with renewal requests.

Step Therapy / Required Trials

Step therapy is required where specified: many long‑acting stimulants and related agents require trials and documented failure of immediate‑acting formulary alternatives or of specified stimulant/wake‑promoting agents before approval of brand/long‑acting products.

• Most long‑acting stimulants: trial and failure of at least TWO immediate‑acting formulary alternatives unless exceptions apply (e.g., age/school administration constraints).
• Vyvanse: trial and failure of at least TWO immediate‑acting stimulants with different active ingredients unless exception applies.
• Daytrana/Xelstrym: trial and failure of TWO appropriately dosed long‑acting stimulants (one being an oral formulation) unless exception applies.

Required Trials of Stimulant and Wake‑Promoting Agents

For indications of excessive sleepiness or narcolepsy, prior therapy trials must be documented: at least one stimulant AND at least one wake‑promoting agent (e.g., modafinil/armodafinil) should have been tried and shown inadequate response or intolerance unless the patient currently has a positive therapeutic outcome on the requested agent through health insurance.

• Documentation of prior stimulant and wake‑promoting agent trials and outcomes (ineffective, not tolerated, or contraindicated).
• Exceptions allowed if patient is currently benefiting from requested medication under insurance coverage.

CPAP Requirement and Documentation for OSA

For patients with obstructive sleep apnea (OSA), CPAP is the gold standard and a maximal effort to treat with CPAP must be attempted and used. Modafinil and armodafinil should be adjunctive to CPAP and not used as monotherapy. Prior to initiating modafinil or armodafinil for residual sleepiness, providers must document CPAP treatment efforts and periodic assessment of CPAP adherence.

• Documentation that CPAP therapy was attempted and the patient is adherent with CPAP where required (e.g., for OSA indications for modafinil/armodafinil or Sunosi).
• Modafinil/armodafinil or other wake‑promoting agents should be prescribed as adjunctive therapy to CPAP, not as sole therapy for OSA.
• Periodic assessments of CPAP adherence should be included in the clinical record.