mhn Modafinil (Provigil) Coverage Update | OpenPayer

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mhn Modafinil (Provigil) Coverage Update | OpenPayer

Coverage Criteria

Initial Therapy — Narcolepsy

Covered when ALL of the following are met

Narcolepsy initial criteria: 1. Diagnosis of narcolepsy; 2. Prescribed by or in consultation with a neurologist or sleep medicine specialist; 3. Age ≥ 17 years; 4. Failure of a 1-month trial of one of the following generic central nervous system stimulant-containing agents at up to maximally indicated doses unless contraindicated or intolerant: amphetamine, dextroamphetamine, or methylphenidate; 5. Failure of a 1-month trial of armodafinil at up to maximally indicated doses unless contraindicated or intolerant; 6. For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395; 7. If request is for brand Provigil, member must use generic modafinil unless contraindicated or clinically significant adverse effects are experienced; 8. Dose does not exceed both of the following: (a) 400 mg per day; and (b) 2 tablets per day.

Initial Therapy — OSA

Covered when ALL of the following are met

OSA initial criteria: 1. Diagnosis of obstructive sleep apnea (OSA); 2. Age ≥ 17 years; 3. Documented evidence of residual sleepiness despite compliant positive airway pressure therapy (e.g., CPAP, BiPAP) used as monotherapy; 4. Modafinil (Provigil) is prescribed concurrently with continued use of positive airway pressure therapy (e.g., CPAP or BiPAP); 5. Failure of a 1-month trial of armodafinil at up to maximally indicated doses unless contraindicated or intolerant; 6. For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395; 7. If request is for brand Provigil, member must use generic modafinil unless contraindicated or clinically significant adverse effects are experienced; 8. Dose does not exceed both of the following: (a) 400 mg per day; and (b) 2 tablets per day.

Initial Therapy — Shift Work Disorder

Covered when ALL of the following are met

SWD initial criteria: 1. Diagnosis of shift work disorder (SWD); 2. Age ≥ 17 years; 3. Failure of a 1-month trial of armodafinil at up to maximally indicated doses unless contraindicated or intolerant; 4. If request is for brand Provigil, member must use generic modafinil unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed both of the following: (a) 200 mg per day; and (b) 1 tablet per day.

Initial Therapy — MS-associated fatigue (off-label)

Covered when ALL of the following are met

MS fatigue initial criteria: 1. Diagnosis of multiple sclerosis (MS)-associated fatigue; 2. Age ≥ 17 years; 3. Failure of 200 mg/day of amantadine and ≥ 10 mg/day of methylphenidate unless contraindicated or intolerant; 4. Failure of a 1-month trial of armodafinil at up to maximally indicated doses unless contraindicated or intolerant; 5. If request is for brand Provigil, member must use generic modafinil unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed both of the following: (a) 400 mg per day; and (b) 2 tablets per day.

Continued Therapy

Covered when ALL of the following are met

Continued therapy criteria: 1. Member currently receiving medication via Centene benefit or member has previously met initial approval criteria, or member is receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. For members with OSA, modafinil (Provigil) is prescribed concurrently with continued use of positive airway pressure therapy (e.g., CPAP, BiPAP); 4. If request is for brand Provigil, member must use generic modafinil unless contraindicated or clinically significant adverse effects are experienced; 5. If request is for a dose increase, the new dose does not exceed indication-specific maximums: (a) Narcolepsy, OSA, and MS-associated fatigue — 400 mg per day and 2 tablets per day; (b) SWD — 200 mg per day and 1 tablet per day.

OSA concurrent positive airway pressure therapy requirement

Covered when ALL of the following are met

OSA concurrent therapy: Modafinil (Provigil) is prescribed concurrently with continued use of positive airway pressure therapy (e.g., CPAP or BiPAP)

Added in 2Q 2026 review

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (see HIM.PA.154 for marketplace/ICHRA and CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

When there is a conflict between this clinical policy and state Medicaid coverage provisions, the state Medicaid requirements take precedence and will be applied for affected members and lines of business.

Modafinil is indicated in obstructive sleep apnea (OSA) to treat residual excessive sleepiness only and is not an acceptable treatment for the underlying anatomic obstruction. A maximal effort to treat the airway obstruction with continuous positive airway pressure (CPAP) or other positive airway pressure therapy should be made prior to and during treatment with modafinil.

Use of modafinil as therapy for the underlying obstruction in OSA (in place of positive airway pressure therapy) is not an accepted indication; modafinil is limited to treatment of residual sleepiness. Non‑FDA uses not addressed in this policy require supporting documentation per applicable off‑label policies and may be denied if such documentation is not provided.

Coding and Drug Strengths

Tablet strengths — 100 mg, 200 mg

Available strengthsTablets in 100 mg and 200 mg strengths.

Dosing formulationsOral tablet formulation only as listed in product availability.

Maximum tablets/day (narcolepsy/OSA/MS fatigue)Limit of 2 tablets per day corresponds to 400 mg/day maximum dose.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Approval is granted only when the member meets the diagnosis-specific criteria and any applicable step therapy requirements described in the policy.

Applies to all indications covered by this policy (narcolepsy, OSA, SWD, MS-related fatigue)
See policy criteria for required trials, specialist involvement, age limits, dosing limits, and approval durations

Documentation Required

Documentation Required — risk of denial or delay if not provided

Provider must submit documentation (such as office chart notes, sleep study reports, device usage records, lab results, or other clinical information) that supports the member has met all approval criteria. Failure to submit adequate documentation may result in delay or denial of the prior authorization request.

Examples of acceptable documentation: office notes showing diagnosis and specialist consultation, documentation of trials and failures of required agents, CPAP/BiPAP compliance data for OSA, dosing history

Background

Modafinil (Provigil) is a wakefulness‑promoting agent indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Tablet strengths available include 100 mg and 200 mg. In OSA, the drug is indicated for residual sleepiness and should be used only after and during adequate trials of positive airway pressure therapy.

Definitions

OSA / positive airway pressure — Definitions and examples (CPAP, BiPAP)

DefinitionObstructive sleep apnea/hypopnea syndrome (OSA): disorder causing excessive sleepiness; modafinil indicated for residual sleepiness in OSA, not as treatment for the underlying obstruction.

Positive airway pressure examplesIncludes continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP).

Prior therapy expectationA maximal effort to treat with CPAP or other positive airway pressure therapy should be made prior to and during treatment with modafinil for OSA.

SWD — Shift work disorder definition and dosing note

DefinitionShift work disorder (SWD): excessive sleepiness associated with shift work (diagnosis required).

Typical dosing timing