ModifiedBlue Cross Blue Shield - IowaPolicy 05.01.82

ADHD and Narcolepsy Prior Authorization (drug therapy)

Defines prior authorization criteria for stimulant and wakefulness‑promoting medications for ADHD, narcolepsy, hypersomnia, and related sleep disorders for Wellmark/Blue Cross Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyADHD and Narcolepsy Prior Authorization (drug therapy)

Policy CodePolicy 05.01.82

Change TypeRevised

Effective DateOctober 8, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document required trials, diagnostic sleep study results, and REMS enrollment for oxybate products.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and revised in August 2025 with current effective date of October 8, 2025.

24 monthstypical approval duration (long-acting stimulants)

12 monthstypical approval duration (sleep/specialty agents)

9 gm/dayXyrem/Xywav max

RequiredREMS enrollment

6 yrsminimum age for some agents

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Coverage Criteria

Initial and Ongoing Coverage Criteria

Initial and continuation therapy are covered when the following criteria are met. Approval durations noted with each group.

Initial therapy - long-acting stimulants (narcolepsy/hypersomnia)

Diagnosis of narcolepsy or idiopathic hypersomnia confirmed by appropriate sleep testing (e.g., nocturnal polysomnography and multiple sleep latency test [MSLT]) as documented in chart notes or sleep study reports.
Prescribing physician is a board certified sleep medicine specialist or neurologist (when indicated by specific agent criteria).
Patient is not being treated with sedative-hypnotic agents (e.g., benzodiazepines, barbiturates, zolpidem) where specified by agent-specific criteria.
Approval duration: 24 months for long-acting stimulant agents used for narcolepsy or hypersomnia, unless otherwise specified by agent-specific criteria.

Initial therapy - long-acting stimulants (ADHD)

Diagnosis of ADHD documented in the medical record.
For patients 19 years of age or younger who attend school that limits in-school medication administration, long-acting stimulants may be considered when once-daily dosing is necessary.
Patient has tried and failed at least TWO immediate‑acting formulary stimulant alternatives (different active ingredients) unless the patient is currently receiving a positive therapeutic outcome on the requested long‑acting agent through health insurance (excludes samples and manufacturer patient assistance programs). Treatment failure cannot be due to noncompliance or unwillingness to take immediate‑acting options.
Approval duration: generally 24 months for long-acting stimulants for ADHD unless otherwise specified for specific formulations (see agent-specific groups).

Agent‑specific initial therapy examples

Vyvanse/Arynta (ADHD): Patient must have tried and failed at least TWO immediate‑acting stimulants with different active ingredients unless already receiving benefit on Vyvanse through coverage. If Arynta (oral solution) is requested, patient must be unable to swallow oral solid dosage forms (age, dysphagia, enteral feeding tube, oral-motor difficulties). Approval: 24 months.
Vyvanse (Binge Eating Disorder): Diagnosis of moderate to severe binge eating disorder per DSM-5 and tried/failed or contraindication to at least one prerequisite agent (e.g., SSRIs, topiramate, zonisamide) unless currently benefiting under coverage. If Arynta requested, same swallowing restrictions as above. Approval: 24 months.
Transdermal/patch (Daytrana) and Xelstrym: Patient has medical condition preventing oral therapy OR tried and failed TWO appropriately dosed long‑acting stimulants (one must be an oral long‑acting formulation of the corresponding active moiety) unless currently benefiting under coverage. Approval: 24 months for Daytrana/Xelstrym is specified as 24 months in source for some agents and 12 months for others—verify agent-specific duration at time of authorization.
Nonstimulant (Qelbree): Patient ≥ 6 years; tried and failed at least TWO stimulant medications with different active ingredients OR has history of substance abuse/dependence OR tried and failed atomoxetine or has contraindication/intolerance to atomoxetine OR has FDA‑labeled contraindication to all stimulant medications. Approval: 12 months.

Initial therapy - wakefulness promoting agents (modafinil/armodafinil, solriamfetol, pitolisant)

Diagnosis confirmed by appropriate testing and clinical documentation (e.g., sleep study) relevant to the indication: narcolepsy, OSA (with adherence to CPAP when indicated), shift work disorder, idiopathic hypersomnia, or EDS associated with MS or Parkinson's disease as applicable.
For OSA: documentation of use of and adherence with CPAP therapy (when indicated).
Patient has experienced inadequate response, intolerance, or contraindication to at least one CNS stimulant (e.g., amphetamine or methylphenidate) AND one CNS promoting wakefulness drug (e.g., modafinil or armodafinil) when required by agent-specific criteria, unless currently receiving positive therapeutic outcome on the requested medication through coverage.
Prescribing physician is a board certified sleep medicine specialist or neurologist when required by agent-specific criteria (specified for many wakefulness agents).
Patients must not have unmanaged conditions contributing to excessive sleepiness (e.g., untreated OSA, insufficient sleep, substance effects).

Initial therapy - oxybate products (Xyrem, Xywav)

Diagnosis of narcolepsy with cataplexy, narcolepsy without cataplexy (EDS), or idiopathic hypersomnia as specified by the particular indication with required diagnostic documentation (sleep study results, MSLT, CSF hypocretin when indicated).
Prescribing physician and patient must be enrolled in the Xyrem/Xywav REMS program (REMS enrollment required).
Patient has experienced inadequate response, intolerance, or has contraindication to at least one CNS stimulant AND one CNS promoting wakefulness drug when required by indication, unless currently benefiting under coverage.
Other causes of sleepiness must be ruled out or treated (e.g., OSA, insufficient sleep, shift work, medication/substance effects).
Patient must not be treated with sedative‑hypnotic agents where specified by agent criteria.

Continuation therapy

Wakix (pitolisant): continuation may be approved when ALL initial authorization criteria are met AND documentation shows positive clinical response (improvement in EDS or reduction in cataplexy compared to baseline). Approval: 24 months for continuation of Wakix per source.
Xyrem/Xywav: continuation may be approved when ALL initial authorization criteria are met AND documentation shows positive clinical response (improvement in EDS or decrease in cataplexy episodes compared to baseline). Approval: 12 months for continuation of Xyrem/Xywav per source.
All other agents: continuation requests (including new patients requesting continuation) must meet ALL initial authorization criteria and provide clinical documentation of continued benefit. Approval durations follow agent-specific guidance (commonly 12–24 months).

Not medically necessary / exclusions

Agents in this policy are not medically necessary for patients who do not meet the criteria set forth in the corresponding initial or continuation sections.
Coverage will be denied if required diagnostic testing, REMS enrollment, prescriber specialty, prior trial requirements, or dose/age limits are not met.

Dose and pediatric limitations

Dose limits above studied ranges are not supported (e.g., oxybate products > 9 g/day not recommended; modafinil/armodafinil doses above recommended ranges lack consistent evidence of additional benefit).
Modafinil and armodafinil are not indicated for pediatric patients under specified ages (modafinil: <16 years; armodafinil: <17 years) and serious rash has been reported in children; pediatric use is limited as noted in product labeling.

Operational notes

Therapeutic trial failures cited as prior therapy must exclude lack of compliance or unwillingness to take alternatives and exclude samples or manufacturer's patient assistance program supplies when assessing prior use.
When formulations for swallowing difficulties are requested (oral suspension, chewable, ODT, or solution), documentation must support inability to swallow intact solids (age, dysphagia, oral‑motor dysfunction, enteral tube) and prior attempts with alternate preparation methods where required by product-specific rules.

Initial Therapy Criteria

Initial therapy — stimulants

Initial approval requirements for long‑acting stimulants

General long-acting stimulants initial criteria: Patient age and required prior trials are as specified by product: for ADHD formulations, patients ≤19 years in school limiting multiple daily dosing qualify; and patients must have tried and failed at least TWO immediate-acting formulary alternatives unless currently receiving a positive therapeutic outcome on the requested medication through insurance (samples/PAP excluded). Treatment failure cannot be due to noncompliance or unwillingness to take alternatives.

From chunks 4 and 5.

Initial therapy - oxybates

Initial authorization requirements for oxybate agents

Initial - Xywav for narcolepsy with cataplexy: Patient and physician enrolled in REMS; prescriber is a board-certified sleep medicine specialist or neurologist; diagnostic confirmation (clinical documentation, MSLT and/or CSF hypocretin as applicable); patient experiences ≥14 cataplexy episodes in a typical 2-week period; patient is not being treated with barbiturates or zolpidem; approval duration: 12 months.

Continuation and Renewal Criteria

Continuation therapy nodes

Continuation requirements per agent

Vyvanse/Arynta continuation: Continuation is considered medically necessary when initial authorization criteria are met; for binge eating disorder, documentation of meaningful reduction in binge episodes/days or symptom improvement is required; approval 24 months.

Wakix continuation: Continuation is considered medically necessary when initial authorization criteria are met AND clinical documentation demonstrates a positive response to therapy (e.g., improvement in EDS or reduction in cataplexy); approval 24 months.

Xyrem/Xywav continuation: Continuation is considered medically necessary when initial authorization criteria are met AND clinical documentation demonstrates a positive response to therapy (e.g., improvement in EDS or reduction in cataplexy); approval 12 months.

Step Therapy Requirements

Requirement	Details
Failure of immediate‑acting alternatives
Patient must have tried and failed at least TWO immediate‑acting formulary alternatives (or two immediate‑acting stimulants with different active ingredients) prior to approval of many long‑acting agents; samples and manufacturer patient assistance program supplies do not count. Treatment failure cannot be due to noncompliance or unwillingness to take the alternative.

Requirement	Details
Xyrem trial required before Xywav for sodium‑restricted patients
For patients requiring sodium restriction (e.g., renal impairment, heart failure, hypertension), Xywav may be considered only after documented failure of Xyrem despite dietary sodium limitation. Failure must be attributed to Xyrem's sodium content (worsening renal function, cardiac output, or blood pressure) and documented.

Requirement	Details
Prior trial of stimulant and modafinil/armodafinil
Patient must have experienced inadequate response, intolerance, or have a contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate) AND one wakefulness‑promoting agent (modafinil or armodafinil), unless currently receiving a positive therapeutic outcome on the requested medication through health insurance. Samples and manufacturer assistance program supplies do not count.

Requirement

Details

Prior trial of stimulant and modafinil/armodafinil

Patient must have experienced inadequate response, intolerance, or have a contraindication to at least one CNS stimulant (e.g., amphetamine, dextroamphetamine, methylphenidate) AND one wakefulness‑promoting agent (modafinil or armodafinil), unless currently receiving a positive therapeutic outcome on the requested medication through health insurance. Samples and manufacturer assistance program supplies do not count.

Requirement	Details
Trial of established agents may be required
Where applicable, providers may be expected to document a therapeutic trial of more established wake‑promoting agents (for example, modafinil) and demonstrate lack of clinical benefit or intolerable adverse effects before coverage of alternative or less‑established agents per plan step therapy rules.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization and REMS Enrollment

Prior authorization is required for many agents referenced in this policy. For Xyrem/Xywav (oxybates), enrollment of both the prescriber and patient in the applicable REMS program (Xyrem REMS or Xywav/Xyrem REMS) is required prior to coverage. Submit documentation of REMS enrollment with the prior authorization request.

Prior authorization required for oxybates (Xyrem, Xywav) and REMS enrollment must be verified.
Include REMS enrollment documentation with the PA request.

Prior Authorization

Prior Authorization for Oxybates

Xyrem and Xywav are available only through their REMS programs; failure to confirm patient and prescriber REMS enrollment may result in denial of the request. For oxybates specifically, ensure the prescriber is a board-certified sleep medicine specialist or neurologist and REMS enrollment is current.

Xyrem/Xywav REMS enrollment required for patient and prescriber.
Prescriber specialty requirement: board certified sleep medicine specialist or neurologist.

Procedures, Codes, and Key Metrics

Procedures and billing guidancemixed

No codes listed

Xyrem/Xywav maximum daily dose

Maximum daily dose (all oxybates)9 grams per day

Policy quantity limit (Xyrem)9 gm (18 mL) per day

Policy quantity limit (Xywav)9 gm (18 mL) per day

Narcolepsy cataplexy frequency threshold

Required cataplexy frequency for narcolepsy criteria>= 14 episodes in a typical 2-week period

Episode descriptionEpisodes generally brief (<2 minutes), usually bilaterally symmetrical, sudden loss of muscle tone with retained consciousness

Quantity Limits

Xyrem quantity limit

Xyrem quantity limit9 gm (18 mL) per day

Maximum daily dose referenced9 grams per day (policy maximum)

Authorization durationApprovals typically issued for 12 months for oxybates

Xywav quantity limit

Xywav quantity limit9 gm (18 mL) per day

Recommended nightly dose range6–9 grams per night divided into two doses (per product labeling)

REMS and lower-sodium rationale

Site of Care and Dispensing

Billing Rule

Oxybate REMS-controlled distribution and dispensing constraints

Xywav and Xyrem are controlled‑distribution oxybate products available only under a REMS; dispensing and monitoring processes may limit dispensing to specialty pharmacy channels consistent with REMS distribution controls.

Xywav is available only through the Xywav/Xyrem REMS because of CNS depression and abuse/misuse risks
Dispensing and monitoring processes under REMS may restrict site of dispensing to specialty pharmacy rather than standard retail pharmacy

Definitions

Prior Authorization (PA) definition

DefinitionPrior Authorization (PA) is a program to ensure therapy selection aligns with FDA labeling, clinical guidelines, and cost‑effectiveness

PurposeUsed to confirm diagnostic criteria, required prior trials, dosing within labeling, and specialist prescriber when applicable

Typical approval durationsApprovals commonly issued for defined durations (e.g., 12 or 24 months) when criteria are met

Cataplexy definition

Cataplexy definitionBrief (<2 minutes), usually bilaterally symmetrical, sudden loss of muscle tone with retained consciousness

Diagnostic threshold used in policyAt least 14 cataplexy episodes in a typical 2‑week period required for narcolepsy with cataplexy criteria

Background

This policy aims to ensure appropriate selection and use of stimulant and wakefulness‑promoting therapies in alignment with FDA labeling and clinical practice guidance. It prioritizes use of formulary and lower‑cost alternatives where clinically appropriate, requires objective diagnostic confirmation (for example, sleep study documentation for narcolepsy), and enforces step‑therapy and prior‑authorization safeguards — including required trials of immediate‑acting stimulants or wake‑promoting agents, specialist prescriber requirements, and REMS enrollment for oxybate products — to promote safe, effective, and cost‑effective therapy selection.

Revision History

2015-08creation

Policy created (Policy #05.01.82).

2025-08reviewed

Policy reviewed (administrative and clinical review documented).

2025-08revisedLatest

Policy revised with updates reflected in the current effective date of October 8, 2025.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyADHD and Narcolepsy Prior Authorization (drug therapy)

Policy CodePolicy 05.01.82

Change TypeRevised

Effective DateOctober 8, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document required trials, diagnostic sleep study results, and REMS enrollment for oxybate products.

SourceLink

On This Page

Oral suspension/chewable/ODT formulations (e.g., Quillivant XR, QuilliChew ER, Cotempla XR, Adzenys XR‑ODT, Dyanavel XR): Patient ≥ 6 years (agent dependent); unable to swallow intact tablet/capsule AND tried and failed or has medical reason preventing use of contents of immediate‑acting alternatives when crushed/sprinkled and/or tried and failed one long‑acting capsule when contents are sprinkled without crushing, unless currently benefiting under coverage or patient is ≤19 in school limiting administration. Approval: typically 12–24 months depending on product.

Approval duration: typically 12 months for these agents; see agent-specific criteria for exceptions.

Xywav-specific: for patients with clinical reasons to restrict sodium (e.g., renal impairment, heart failure, hypertension) who have failed Xyrem despite dietary sodium limitation — documentation required; failure defined as clinically attributable worsening attributable to Xyrem sodium content.

Dose limits: oxybate dose should not exceed 9 g/day (6–9 g/night typical). Approval duration: 12 months unless otherwise specified.

Initial - Xyrem/Xywav for idiopathic hypersomnia: Patient and physician enrolled in REMS; prescriber is a board-certified sleep medicine specialist or neurologist; recurrent irrepressible sleep/napping ≥3 times/week for ≥3 months; MSLT mean latency <8 minutes; documentation of ≥660 minutes average daily sleep time; <2 SOREMPs on MSLT (or none if PSG REM latency ≤15 minutes); no cataplexy and no known hypocretin deficiency; patient not treated with sedative-hypnotics; dose ≤9 g/day; approval duration: 12 months.

Initial therapy dosing

Initial dosing and titration guidance per product labeling

Modafinil dosing: Recommended dose of modafinil is 200 mg once daily for narcolepsy and OSA (take in morning) and approximately 1 hour before shift for SWSD; doses up to 400 mg/day have been tolerated but provide no consistent additional benefit. Not indicated for children <16 years.

From chunk 36

Armodafinil dosing: Recommended armodafinil dose is 150 mg (typical) given once daily in the morning; doses up to 250 mg/day have been tolerated without consistent additional benefit. Not indicated for children <17 years.

From chunk 36

Pitolisant (Wakix) dosing: Titrate pitolisant starting at 8.9 mg once daily to 17.8 mg after 1 week and may increase to 35.6 mg once daily after another week; lower initiation and maximum (17.8 mg) recommended in moderate hepatic impairment or moderate-severe renal impairment; dosage adjustments for CYP2D6 inhibitors specified in labeling.

From chunk 37

Xyrem/Xywav dosing: Xyrem recommended dose is 9 g per night divided into two equal doses. Xywav recommended dose is 6–9 g per night divided into two equal doses; doses >9 g/night have not been studied and ordinarily should not be administered. REMS program required for both products.

From chunks 37 and 38

Other agents continuation: All patients requesting continuation of other agents in this policy must meet ALL initial authorization criteria (including new patients).

Oxybate continuation

Continuation after stabilization

Stabilized oxybate therapy: Patients stabilized on Xyrem or Xywav with documented benefit and monitoring may continue therapy under REMS requirements; effectiveness in pediatric patients for Xywav is based on Xyrem studies plus pharmacokinetic data.

From chunk 38

Step Therapy

Step Therapy / Required Trials

Step therapy requires documented trials and failures of specified immediate‑release or alternative long‑acting stimulant agents before coverage for many branded long‑acting stimulants. Trials must be adequately dosed and administered and failures cannot be due to non‑adherence or inability to obtain formulary products only as samples or via manufacturer assistance.

Many long‑acting stimulants require trial and failure of at least TWO immediate‑acting formulary alternatives (different active ingredients for some products).
Vyvanse/Arynta require failure of two generically available immediate acting stimulants with different active ingredients (unless already receiving via benefit).
Daytrana/Xelstrym require failure of two appropriately dosed long‑acting stimulants with one trial of a long‑acting oral formulation of the requested drug class.
Trials must not be counted if failure was due to noncompliance or only because patient refused therapy.

Step Therapy

Step Requirements for Sodium‑Restricted Patients

When a patient has a clinical reason to restrict sodium (e.g., renal impairment, heart failure, hypertension), Xywav may be preferred over Xyrem. For sodium‑restricted patients requesting Xywav, document prior failure of Xyrem despite sodium‑limited diet, including objective evidence that worsening renal function, cardiac output, or blood pressure was attributable to Xyrem's sodium content.

Clinical reason to restrict sodium must be documented (renal impairment, heart failure, hypertension).
Documentation of Xyrem failure despite sodium restriction is required and must attribute adverse effects to sodium content.
Dose for sodium‑restricted patients must not exceed 9 g/day.

Step Therapy

Trial Requirements for Stimulants

For stimulant products used to treat ADHD or narcolepsy, require documented trials of immediate‑acting stimulants unless the patient is currently receiving the requested medication through their health plan. Trials must be of two medications with different active ingredients for certain agents (e.g., Vyvanse). For patients unable to take oral formulations, document the clinical reason (e.g., dysphagia, feeding tube).

Qelbree requires failure of at least TWO stimulant medications with different active ingredients prior to approval.
Vyvanse requires failure of two immediate‑acting stimulants with different active ingredients unless currently covered through the benefit.
If Arynta (oral solution) is requested, document inability to swallow oral solids (age in school limiting dosing, dysphagia, feeding tube, oral motor difficulties).

Documentation Required

Sleep Study / Specialist Documentation

When specialist input or sleep testing is required by the criteria (for example, narcolepsy, OSA, idiopathic hypersomnia, or cataplexy), include the required sleep study reports and/or documentation from a board‑certified sleep medicine specialist or neurologist with the PA request.

Narcolepsy and many oxybate indications require diagnosis confirmation by sleep study (MSLT and/or polysomnogram) — include full reports.
Prescriber must be a board‑certified sleep medicine specialist or neurologist when required by the criteria.
Include documentation of MSLT findings (mean latency, SOREMPs) or CSF hypocretin results where specified.

Documentation Required

Required Clinical Documentation

Provide clear clinical documentation with any PA: diagnosis, relevant sleep study reports (polysomnography, MSLT), prior medication trials (drug, dose, duration, reason for failure), REMS enrollment verification for oxybates, and objective measures of response for continuation requests (e.g., reduced ESS score, fewer cataplexy episodes).

Diagnosis and supporting clinical notes.
Complete sleep study reports (polysomnography, MSLT) when required.
Details of prior therapy trials: agent, dose, duration, outcome, and reason for failure.
REMS enrollment documentation for Xyrem/Xywav.
Objective clinical response for continuation (improvement in EDS, reduction in cataplexy frequency).

Denial Risk

REMS‑Related Denial Risk and Other Denial Conditions

Denials may occur if REMS enrollment is not verified, required sleep studies or specialist documentation are missing, step‑therapy trials are not adequately documented, trials failed due to nonadherence, or oxybate dosing exceeds recommended limits. For oxybates, failure to document REMS compliance creates particular denial risk.

Missing REMS enrollment or noncompliant REMS documentation may lead to denial.
Requests lacking required sleep study/MSLT reports or prescriber specialty documentation are at risk for denial.
Insufficient documentation of prior trials (including dose/duration and reason for failure) may result in denial.
Oxybate doses above studied limits (greater than 9 g/day) are not supported.

Associated enrollment requirement

Patient and physician must be enrolled in the Xywav REMS Program

MSLT mean sleep latency threshold

MSLT mean sleep latency threshold< 8 minutes

SOREMP requirement for narcolepsy>= 2 SOREMPs on MSLT (a SOREMP on preceding PSG may replace one MSLT SOREMP)

Idiopathic hypersomnia MSLT pattern< 8 minutes mean latency with <2 SOREMPs (or no SOREMPs if PSG REM latency <=15 minutes)

Documentation of average daily sleep time for idiopathic hypersomnia

Minimum documented average daily sleep time (IH)>= 660 minutes

Supporting documentationClinical documentation (chart notes, study results) required to support diagnosis of idiopathic hypersomnia

Other required MSLT findingMean sleep latency < 8 minutes

Xywav nightly dose

Recommended nightly dose range (Xywav)6 to 9 grams per night, divided into two equal doses

Upper dose limitDoses higher than 9 grams per night have not been studied and ordinarily should not be administered

REMS statusXywav available only through REMS due to CNS depression and abuse/misuse risk

Xyrem recommended dose

Recommended nightly dose (Xyrem)9 grams per night divided into two equal doses

Efficacy/safety ceilingEfficacy and safety at doses higher than 9 grams per day have not been evaluated

Policy quantity limit (Xyrem)9 gm (18 mL) per day

Xywav contains 92% less sodium than Xyrem and is available only through REMS

Multiple ADHD agents (examples listed)

Examples of multiple ADHD agents subject to quantity rulesAdzenys XR-ODT, Azstarys, Daytrana, Dyanavel XR, Qelbree

Quantity limits vary by productEach listed ADHD product has a product‑specific daily quantity limit per policy

FDA recommended maximum doses notedPolicy references FDA recommended maximum dose per 24 hours for many listed products

Associated requirementsClinical documentation confirming diagnosis and REMS enrollment required for oxybate coverage

MSLT / SOREMPs definition

MSLT / SOREMPs definitionMSLT mean sleep latency < 8 minutes; >=2 sleep‑onset REM periods (SOREMPs) consistent with narcolepsy

PSG substitutionA SOREMP on the preceding nocturnal polysomnogram may replace one MSLT SOREMP

Idiopathic hypersomnia distinctionFor idiopathic hypersomnia, mean latency <8 minutes with <2 SOREMPs on MSLT (or no SOREMPs if PSG REM latency <=15 minutes)

REMS definition

REMS meaningRisk Evaluation and Mitigation Strategy — restricted program for Xyrem and Xywav due to risks of CNS depression and abuse/misuse

Program requirementPatient and prescribing physician must be enrolled in the Xyrem/Xywav REMS Program for oxybate prescribing

Impact on dispensingREMS distribution and monitoring limit dispensing and require specialty handling (controlled substance processes)

ESS definition

ESS definitionEpworth Sleepiness Scale — a measure used as a key secondary endpoint in oxybate randomized‑withdrawal trials to assess reduction in excessive daytime sleepiness

Clinical roleUsed to quantify change in EDS (policy cites ESS change as trial endpoint for Xywav studies)

ContextESS employed in clinical trials supporting oxybate effectiveness (e.g., Xywav randomized‑withdrawal study)