CurrentHealth NetPolicy CP PMN.39

Clinical Policy: Modafinil (Provigil)

Defines medical necessity criteria, prior authorization and dosing limits for modafinil (Provigil) for narcolepsy, obstructive sleep apnea (OSA), shift work disorder (SWD), and off-label use for multiple sclerosis (MS)-related fatigue for Health Net/Centene lines of business (HIM, Medicaid).

Policy Summary

PayerHealth Net

PolicyClinical Policy: Modafinil (Provigil)

Policy CodePolicy CP PMN.39

Change TypeAnnual reviewadministrative and template updatesgeneric redirection added

Effective DateMay 1, 2008

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) demonstrating that member meets all approval criteria; prior authorization may be required.

SourceLink

POLICY UPDATE CHANGES

2Q 2025 annual review: no significant changes; references reviewed and updated; P&T Approval Date = 05.25

Redirect to generic modafinil if request is for brand added in 2Q 2021 annual review.

Template changes to 'other diagnoses/indications' and 'continued therapy' sections applied in 09.26.22

4Covered indications

17Min age (years)

400 mgMax dose (some)

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Coverage Summary

Scope: This policy (Reference Number: CP PMN.39) defines medical necessity criteria, prior authorization and dosing limits for modafinil (Provigil) for adults for the FDA‑approved indications of narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD), and also includes off‑label coverage criteria for fatigue associated with multiple sclerosis (MS). The coverage stance is covered_with_criteria. The policy applies to HIM and Medicaid lines of business and references marketplace/other policies for non‑covered or off‑formulary uses (see HIM.PA.33, HIMPA.103, HIM.PA.154, CP.PMN.255, CP.PMN.16 as applicable).

Key requirements summarized: provider documentation and specialty prescribing or consultation are required; minimum age is ≥ 17 years (policy sections use ≥17 or >17 depending on indication); generic modafinil use is required unless contraindicated; prior trials of specified alternatives (including defined 1‑month trials of stimulants or armodafinil) are required per indication; and dose limits are indication specific (see criteria).

Key Thresholds

Age threshold≥ 17 years (policy sections use ≥ 17 or > 17 depending on indication)

Maximum dose - narcolepsy/OSA/MS‑fatigue≤ 400 mg per day AND ≤ 2 tablets per day

Maximum dose - SWD≤ 200 mg per day AND ≤ 1 tablet per day

Prior trial duration1-month trial of alternatives (e.g., generic CNS stimulants or armodafinil) at up to maximally indicated doses

Initial Therapy Criteria

Initial Approval Criteria - General

Modafinil is medically necessary when ALL of the following are met:

ALL of the following

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria
Prescribed by or in consultation with a neurologist or sleep medicine specialist
Member age ≥ 17 years
Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced

Initial Approval Criteria - Narcolepsy

Continuation Therapy Criteria

Continued Therapy

Continued therapy is approved when ONE of the following is met and dose limits respected:

Prior receipt/continuity

Member currently receiving medication via Centene benefit or has previously met initial approval criteria
Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations

Response and dosing

Member is responding positively to therapy
Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization and documentation required

Submit office chart notes, lab results, or other clinical information showing the member meets all approval criteria. Note that prior authorization may be required for armodafinil and for CNS stimulants per plan policies.

Documentation Required

CPAP compliance documentation for OSA

For OSA approvals, document residual excessive sleepiness despite compliant CPAP use as monotherapy (evidence of CPAP compliance and persistent sleepiness must be provided).

Applicable Codes and References

Reference/Policy Identifiermixed

CP PMN.39	Reference Number (policy)
CP.PMN.255	Medicaid no coverage criteria policy (referenced)
CPP.MN.16	Non-formulary policy for Medicaid (referenced, appears as CP.PMN.16 in text)
HIM.PA.33	Marketplace no coverage criteria policy (referenced)
HIMPA.103	Marketplace non-formulary policy (referenced)
HIM.PA.154	Marketplace off-label use policy (referenced)

Clinical Evidence & References

Evidence and references: the policy cites the Provigil Prescribing Information (Teva/DailyMed) for dosing and FDA‑approved indications, and a set of clinical guideline and literature references including American Academy of Sleep Medicine reports and other guideline/consensus statements on narcolepsy, OSA, SWD and MS‑related fatigue. Specific citations listed in the policy references include the Provigil Prescribing Information (DailyMed/Teva) and guideline reports (e.g., American Academy of Sleep Medicine reports and other sleep disorder guidelines).

Review history: guideline and reference materials were reviewed and updated during the policy annual reviews, most recently in the 2Q 2025 review (P&T Approval Date = 05.25), with no significant clinical policy statement changes noted.

Background

Background: Modafinil (Provigil) is a wakefulness‑promoting agent FDA‑approved to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD). The policy also includes explicit off‑label coverage criteria for MS‑associated fatigue, requiring prior trials of other agents (e.g., amantadine 200 mg/day and methylphenidate ≥10 mg/day) and a trial of armodafinil before modafinil may be approved for that indication.

Quick Facts

ScopeDefines medical necessity criteria, prior authorization and dosing limits for modafinil (Provigil) for narcolepsy, OSA, SWD, and off‑label MS‑fatigue for HIM/Medicaid

SubjectModafinil (Provigil)

Policy numberCP PMN.39

StatusCURRENT

Revision History

05.25.2025annual_reviewLatest

2Q 2025 annual review: no significant changes; references reviewed and updated; P&T Approval Date = 05.25 (non‑material revision).

05.21.2021material_revision

2Q 2021 annual review: added redirection to generic modafinil if request is for brand; updated HIM off‑label reference to HIMPA.154 (material change).

09.26.2022administrative

Policy Summary

PayerHealth Net

PolicyClinical Policy: Modafinil (Provigil)

Policy CodePolicy CP PMN.39

Change TypeAnnual reviewadministrative and template updatesgeneric redirection added

Effective DateMay 1, 2008

Next Review Date

SourceLink

On This Page

For diagnosis of narcolepsy, ALL of the following must be met:

ALL of the following

Diagnosis of narcolepsy
Prescribed by or in consultation with a neurologist or sleep medicine specialist
Age ≥ 17 years
Failure of prior therapy (ONE of)
- Failure of a 1-month trial of one of the following generic CNS stimulant-containing agents (amphetamine, dextroamphetamine, or methylphenidate) at up to maximally indicated doses unless clinically significant adverse effects are experienced or all are contraindicated1-month trial
- Failure of a 1-month trial of armodafinil at up to maximally indicated doses unless clinically significant side effects are experienced1-month trial
Dose limit: Dose does not exceed both: 400 mg per day and 2 tablets per day<= 400 mg/day AND <= 2 tablets/day

Initial Approval Criteria - Obstructive Sleep Apnea (OSA)

For diagnosis of OSA, ALL of the following must be met:

ALL of the following

Diagnosis of obstructive sleep apnea (OSA)
Age ≥ 17 years
CPAP compliance documentation: Documented evidence of residual sleepiness despite compliant CPAP use as monotherapy
Documentation required
Failure of a 1-month trial of armodafinil at up to maximally indicated doses unless clinically significant side effects are experienced1-month trial
Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced
Dose limit: Dose does not exceed both: 400 mg per day and 2 tablets per day<= 400 mg/day AND <= 2 tablets/day

Initial Approval Criteria - Shift Work Disorder (SWD)

For diagnosis of SWD, ALL of the following must be met:

ALL of the following

Diagnosis of shift work disorder (SWD)
Age ≥ 17 years
Failure of a 1-month trial of armodafinil at up to maximally indicated doses unless clinically significant side effects are experienced1-month trial
Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced
Dose limit: Dose does not exceed both: 200 mg per day and 1 tablet per day<= 200 mg/day AND <= 1 tablet/day

Initial Approval Criteria - Fatigue Associated with Multiple Sclerosis (off-label)

For MS-associated fatigue (off-label), ALL of the following must be met:

ALL of the following

Diagnosis of MS-associated fatigue
Age > 17 years
Failure of prior therapies (ALL required per text but listed as failures):
- Failure of 200 mg/day of amantadine unless contraindicated or clinically significant adverse effects are experienced200 mg/day
- Failure of ≥ 10 mg/day of methylphenidate unless contraindicated or clinically significant adverse effects are experienced>= 10 mg/day
- Failure of a 1-month trial of armodafinil at up to maximally indicated doses unless clinically significant side effects are experienced1-month trial
Member must use generic modafinil, unless contraindicated or clinically significant adverse effects are experienced
Dose limit: Dose does not exceed both: 400 mg per day and 2 tablets per day<= 400 mg/day AND <= 2 tablets/day

Other diagnoses/indications (requests not meeting above)

If requested use is not covered above, follow applicable formulary/off-label/non-formulary policies:

ANY of the following

For drugs on formulary/PDL: follow no coverage criteria policy HIM.PA.33 (marketplace) or CP.PMN.255 (Medicaid)
For drugs NOT on formulary/PDL: follow non-formulary policies HIMPA.103 (marketplace) or CP.PMN.16 (Medicaid)
If requested use is not listed and criterion 1 above does not apply: refer to off-label use policy HIM.PA.154 (marketplace) or CP.PMN.53 (Medicaid)

Dose limits by indication (must meet both dose elements stated elsewhere):

Narcolepsy/OSA/MS-fatigue: For narcolepsy, OSA, and MS-associated fatigue: dose ≤ 400 mg per day and ≤ 2 tablets per day<= 400 mg/day AND <= 2 tablets/day
SWD: For SWD: dose ≤ 200 mg per day and ≤ 1 tablet per day<= 200 mg/day AND <= 1 tablet/day

Billing Rule

Generic substitution requirement

Members must use generic modafinil unless contraindicated or clinically significant adverse effects occur. Requests for brand product should be redirected to the generic per policy (generic substitution required unless clinical contraindication/adverse effect).

Step Therapy

Step therapy/failure trials

Step therapy requires failure trials (typically 1-month at up to maximally indicated doses) of specified alternatives (e.g., generic CNS stimulants such as amphetamine, dextroamphetamine, or methylphenidate, and armodafinil where applicable) prior to approval. Note: for Illinois HIM requests, the step therapy requirements do not apply effective 2026-01-01 per IL HB 5395.

1-month trial of one listed generic CNS stimulant (amphetamine, dextroamphetamine, or methylphenidate) for narcolepsy
1-month trial of armodafinil (where required) at maximally indicated doses
For MS-associated fatigue: failure of amantadine and methylphenidate plus 1-month armodafinil trial

Denial Risk

Not authorized for non‑FDA indications without policy exception

Non‑FDA approved indications not addressed in this policy are not authorized unless sufficient documentation is provided per the applicable off-label use policy (HIM.PA.154 for marketplace or CP.PMN.53 for Medicaid) or other evidence of coverage exception.

Template/administrative clarifications applied to 'other diagnoses/indications' and 'continued therapy' sections (09.26.22).