Narcolepsy
Authority to supply modafinil (Modavigil®) for the treatment of narcolepsy through the Pharmaceutical Benefits Scheme (PBS) under the Section 85 arrangements of the National Health Act 1953.
Schedule restriction details
Note: Modafinil® is not PBS-subsidised when used in combination with PBS-subsidised dexamphetamine sulfate.
Authority required
Initial treatment
Initial treatment, by a qualified sleep medicine practitioner or a qualified neurologist, of patients with narcolepsy where:
- therapy with dexamphetamine sulfate poses an unacceptable medical risk or
- intolerance to dexamphetamine sulfate of a severity necessitating permanent treatment withdrawal develops
The presence of any one of the following indicates treatment with dexamphetamine sulfate poses an unacceptable medical risk:
- a psychiatric disorder
- a cardiac disorder
- a history of substance abuse
- glaucoma
- any other absolute contraindication to dexamphetamine sulfate as specified in the Therapeutic Goods Administration (TGA)-approved Product Information
Patients must meet the following definition of narcolepsy:
- Excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least three months and either
- a definite history of cataplexy and a Multiple Sleep Latency Test (MSLT) with a mean sleep latency of eight minutes or less
or - a MSLT with a mean sleep latency of eight minutes or less and two or more sleep onset rapid eye movement (REM) periods
or - an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep
- a definite history of cataplexy and a Multiple Sleep Latency Test (MSLT) with a mean sleep latency of eight minutes or less
- The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least six hours
- The polysomnography and MSLT or EEG test reports must be provided with the authority application
Continuing treatment
Continuing treatment of narcolepsy, where the patient has previously been issued with an authority prescription for modafinil may be requested by the patient's general practitioner. Applications for continuing treatment may be requested by telephone. Please call 1800 700 270 and select option 2 between 8am and 5pm EST Monday to Friday.
Scheduled item details
Dose
The dose of modafinil is 200 to 400 mg/day, given as a single dose in the morning, or as two divided doses, in the morning and at noon.
Modafinil is available on the PBS in 100 mg tablet form in packs of 60.
No applications for increased maximum quantities and/or repeats will be authorised.
Patient eligibility
Patients must meet the relevant restrictions as per the criteria and be eligible to receive pharmaceutical benefits.
Lodgment procedures
Please ensure that all written applications for initial PBS authorisation include:
- a completed authority prescription form
- a completed modafinil supporting information form (form 4144)
- the relevant polysomnography and (MSLT) or (EEG ) test reports
Applications for continuing approvals may be made by calling 1800 700 270 and selecting option 2 between 8am and 5pm EST Monday to Friday. Please note that continuing treatment may be requested by the patient’s general practitioner.
Please send written applications to:
Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
GPO Box 9826
Hobart TAS 7001
For more information please call 1800 700 270 and select option 2
Application for Initial PBS subsidised treatment with Modafinil
Note that all applications by medical practitioners for continuing treatment may be made by calling 1800 700 270 and selecting option 2 between 8am and 5pm EST Monday to Friday.
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Last updated: 5 May, 2008