Authority to supply modafinil (Modavigil®) for the treatment of narcolepsy, in eligible patients, through the Pharmaceutical Benefits Scheme (PBS) under the Section 85 arrangements of the National Health Act 1953.
Note: Modafinil is not PBS subsidised when used in combination with PBS subsidised dexamphetamine sulfate.
All applications for initial treatment must be made by a qualified sleep medicine practitioner or a neurologist.
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
- a definite history of cataplexy, or
- a mean sleep latency less than or equal to 10 minutes on a Mean Sleep Latency Test (MSLT), where the MSLT was preceded by a nocturnal polysomnography and the sleep prior to the MSLT was at least six hours
- an electroencephalographic (EEG) recording showing the pathologically rapid development of Rapid Eye Movement (REM) sleep
- absence of any other medical or psychiatric disorder that could otherwise account for the hypersomnia
- therapy with dexamphetamine sulfate poses an unacceptable medical risk, as indicated by a psychiatric disorder, a cardiovascular disorder, a history of substance abuse or other absolute contraindication as specified in the Therapeutic Goods Administration (TGA) approved Product Information
- an intolerance to dexamphetamine sulfate treatment develops which necessitates treatment withdrawal.
Continuing treatment of narcolepsy, where the patient has previously been issued with an authority prescription for modafinil, can be requested by the patient's medical practitioner. Applications for continuing treatment may be requested by calling 1800 700 270** (option 2) between 8.00am and 5.00pm EST, Monday to Friday.
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. The maximum quantity which may be requested is 120 tablets and 5 repeats.
No applications for increased maximum quantities and/or repeats will be authorised.
Patients must meet the relevant criteria and be eligible to receive pharmaceutical benefits.
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** (option 2) between 8.00am and 5.00pm EST, Monday to Friday.
Important: continuing treatment may be requested by the patient’s medical practitioner.
Please send written applications to:
Prior written approval of specialised drugs
Reply paid 9826
Hobart TAS 7001
For more information please call 1800 700 270** (option 2) between 8.00am and 5.00pm EST, Monday to Friday.
- Initial PBS subsidised treatment of narcolepsy [PDF, 131Kb] (form 4144) Lodge this form for a patient starting initial PBS treatment for narcolepsy.
Important: all applications by medical practitioners for continuing treatment may be made by calling 1800 700 270** (option 2) between 8.00am and 5.00pm EST, Monday to Friday.
* Call charges apply.
** Call charges apply from mobile and pay phones only.
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Last updated: 19 March, 2010