Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Narcolepsy

Initial 1 - treatment of narcolepsy without cataplexy

Must be treated by a qualified sleep medicine practitioner or neurologist; AND

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) details of the proposed prescription; 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.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Narcolepsy

Initial 2 - treatment of narcolepsy with cataplexy

Must be treated by a qualified sleep medicine practitioner or neurologist; AND

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.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Narcolepsy

Continuing or change of treatment

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

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