Narcolepsy

Treatment Phase: Initial 1 - treatment of narcolepsy without cataplexy

Treatment criteria:

  • Must be treated by a qualified sleep medicine practitioner or neurologist.

Clinical criteria:

  • The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; OR

  • The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal,

AND

  • Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months,

AND

  • Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); OR

  • Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep,

AND

  • Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.

The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:

(a) a psychiatric disorder;

(b) a cardiovascular disorder;

(c) a history of substance abuse;

(d) glaucoma;

(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.

The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.

The authority application must be made in writing and must include the following:

(a) a completed authority prescription form; and

(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and

(c) details of the contraindication or intolerance to dexamfetamine sulfate; and

(d) either:

(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or

(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.

The polysomnography, MSLT or EEG test reports must be provided with the authority application.

Note

This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamfetamine sulfate or armodafinil.

Note

Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au

Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos

Or mailed to:

Services Australia

Complex Drugs

Reply Paid 9826

HOBART TAS 7001

Narcolepsy

Treatment Phase: Initial 2 - treatment of narcolepsy with cataplexy

Treatment criteria:

  • Must be treated by a qualified sleep medicine practitioner or neurologist.

Clinical criteria:

  • The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; OR

  • The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal,

AND

  • Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months,

AND

  • Patient must have a definite history of cataplexy documented in their medical records for auditing purposes,

AND

  • Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.

The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:

(a) a psychiatric disorder;

(b) a cardiovascular disorder;

(c) a history of substance abuse;

(d) glaucoma;

(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.

Note

This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamfetamine sulfate or armodafinil.

Note

Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Narcolepsy

Treatment Phase: Continuing or change of treatment

Clinical criteria:

  • Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR

  • Patient must have previously received PBS-subsidised treatment with armodafinil for this condition.

Note

This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamfetamine sulfate or armodafinil.

Note

Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).