CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Provigil (modafinil) prior authorization and quantity limits

Prior authorization criteria, quantity limits, and duration of approval for Provigil (modafinil) for indications including narcolepsy, obstructive sleep apnea (OSA), shift work disorder (SWD), idiopathic hypersomnia, multiple sclerosis-related fatigue. Applies to initial and continuation therapy and includes prescriber specialty, diagnostic confirmation, and treatment prerequisites.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyProvigil (modafinil) prior authorization and quantity limits

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionProvigil requires prior authorization; approval contingent on meeting indication-specific diagnostic and prescriber criteria (sleep specialist involvement and diagnostic confirmation such as polysomnography, MSLT, actigraphy or sleep log as specified).

POLICY UPDATE CHANGES

Policy references and internal CVS Caremark policy identifiers (178-C, 2814-C) and UDR 04-2023 displayed throughout document.

4Covered Indications with distinct criteria (OSA, Narcolepsy, SWD, Idiopathic Hypersomnia)

60/25Max tablets per 25 days

180/75Max tablets per 75 days

Coverage Summary

Scope: This policy establishes prior authorization criteria, quantity limits, and duration of approval for Provigil (modafinil) for indications including narcolepsy, obstructive sleep apnea (OSA), shift work disorder (SWD), idiopathic hypersomnia, and compendial use for multiple sclerosis–related fatigue. It applies to both initial and continuation therapy and includes requirements for prescriber specialty and diagnostic confirmation.

Coverage stance: Provigil is covered with criteria. Coverage requires indication-specific prior authorization with documentation of diagnostic testing and prescriber involvement (sleep specialist) and enforces quantity limits of 60 tablets per 25 days (30-day fill) or 180 tablets per 75 days (90-day fill). For OSA, continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) must be maximized before and continued during use of Provigil for residual sleepiness.

Overall: Coverage Criteria by Indication

The requested drug will be covered with prior authorization when the following criteria are met:

ANY of the following

Obstructive Sleep Apnea (OSA)
- The patient has a diagnosis of obstructive sleep apnea (OSA)
- The request is NOT for continuation of therapy
  applies to initial therapy requests
- The requested drug is being prescribed by, or in consultation with, a sleep specialist
- The diagnosis has been confirmed by polysomnography
- The patient has been receiving treatment for the underlying airway obstruction (CPAP or BIPAP) for at least one month>= 1 month
- Treatment with CPAP or BIPAP will continue
OSA - Continuation of Therapy
- The request is for continuation of therapy
- The patient has achieved or maintained a positive response to treatment from baseline
  compliance required for continuation
- The patient is compliant with CPAP or BIPAP
Narcolepsy
- The patient has a diagnosis of narcolepsy
- The request is NOT for continuation of therapy
  applies to initial therapy requests
- The requested drug is being prescribed by, or in consultation with, a sleep specialist
- The diagnosis is confirmed by sleep lab evaluation
Narcolepsy - Continuation of Therapy
- The request is for continuation of therapy
- The patient has achieved or maintained a positive response to treatment from baseline
Shift Work Disorder (SWD)
- The patient has a diagnosis of shift work disorder (SWD)
- The request is NOT for continuation of therapy
  applies to initial therapy requests
- The requested drug is being prescribed by, or in consultation with, a sleep specialist
- A sleep log and actigraphy monitoring have been completed for at least 14 days and show a disrupted sleep and wake pattern>= 14 days
- Symptoms have been present for 3 or more months>= 3 months
SWD - Continuation of Therapy
- The request is for continuation of therapy
- The patient has achieved or maintained a positive response to treatment from baseline
- The patient is still a shift-worker
Idiopathic Hypersomnia
- The requested drug is being prescribed for idiopathic hypersomnia
- The request is NOT for continuation of therapy
  applies to initial therapy requests
- The requested drug is being prescribed by, or in consultation with, a sleep specialist
- The patient has experienced daytime lapses into sleep or daily irrepressible periods of need to sleep for at least 3 months>= 3 months
- Insufficient sleep syndrome has been ruled out, e.g., lack of improvement after adequate trial of increased nocturnal time in bed preferably confirmed by at least a week of sleep log with wrist actigraphy>= 7 days (sleep log/actigraphy suggested)
Idiopathic Hypersomnia - Continuation of Therapy
- The request is for continuation of therapy
- The patient has achieved or maintained positive response to treatment from baseline
Multiple Sclerosis–Related Fatigue (Compendial Use)
- The requested drug is being prescribed for multiple sclerosis-related fatigue
- The request is NOT for continuation of therapy
- The request is for continuation of therapy
- The patient has achieved or maintained a positive response to treatment from baseline

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Provigil requires prior authorization; approval is contingent on meeting indication-specific diagnostic and prescriber criteria, including involvement of a sleep specialist and diagnostic confirmation such as polysomnography, MSLT, actigraphy, or sleep logs as specified in the coverage criteria.

Documentation Required

Diagnostic confirmation required

Providers must document diagnostic testing per indication: polysomnography for obstructive sleep apnea (OSA) and narcolepsy; multiple sleep latency test (MSLT) and/or 24-hour polysomnography and sleep logs/actigraphy for idiopathic hypersomnia (including MSLT or 24-hour total sleep time criteria); and at least 14 days of sleep log and actigraphy monitoring for shift work disorder (SWD). Documentation of treatment history and response is required for continuation requests.

Billing Rule

Quantity limit enforcement

Quantity limits are enforced: 60 tablets per 25 days (used for a 30-day fill period) or 180 tablets per 75 days (used for a 90-day fill period). The policy maps duration (25 days for 30-day fills, 75 days for 90-day fills) to allow time for refill processing.

Documentation Required

CPAP/BIPAP compliance for OSA continuation

For continuation of Provigil in patients with OSA, document that the patient is compliant with CPAP or BIPAP therapy and has achieved or maintained a positive response to treatment from baseline.

Clinical Evidence & References

Evidence references cited in the policy: Provigil [package insert], Teva Pharmaceuticals; December 2022; and multiple guideline and review sources including American Academy of Sleep Medicine and other sleep disorder guidelines (2009, 2014, 2017) and a 2021 systematic review/meta-analysis.

These evidence and guideline citations are used to support the listed indications and the diagnostic and treatment confirmation requirements (for example, polysomnography, MSLT, actigraphy/sleep logs) in the prior authorization criteria.

Thresholds

Sleep log and actigraphy monitoring duration (SWD)>= 14 days

Symptoms duration (SWD / Idiopathic hypersomnia daytime lapses)>= 3 months

Multiple Sleep Latency Test mean sleep latency<= 8 minutes

24-hour total sleep time>= 660 minutes

CPAP/BIPAP trial duration prior to Provigil for OSA>= 1 month

Background

FDA approval and compendial uses: Provigil (modafinil) is FDA-approved to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD). Compendial/limited uses include treatment of fatigue related to multiple sclerosis and idiopathic hypersomnia.

CPAP/BIPAP maximization note: For OSA, Provigil is indicated to treat residual excessive sleepiness and is not a treatment for the underlying airway obstruction; a maximal effort to treat with CPAP for an adequate period should be made prior to and continued during treatment with Provigil for residual sleepiness.

Quantity limits: The policy enforces quantity limits of 60 tablets per 25 days or 180 tablets per 75 days (duration values used to allow refill processing).

Continuation of therapy: Requests for ongoing therapy after initial authorization where the patient has already been treated with Provigil.

Sleep specialist: Prescriber specialty required for initial or consultative prescribing as specified in the criteria.

OpenPayer

Provigil (modafinil) prior authorization and quantity limits

Coverage Summary

Provider Actions & Prior Authorization

Applicable Codes & Limits

Clinical Evidence & References

Background

Revision History