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

Mild to moderately severe Alzheimer disease

Initial

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND

The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND

The treatment must be the sole PBS-subsidised therapy for this condition.

The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.

Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction.

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

Mild to moderately severe Alzheimer disease

Initial

Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND

The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND

The treatment must be the sole PBS-subsidised therapy for this condition.

A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below.

Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs.

Patients who qualify under this criterion are from 1 or more of the following groups:

(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;

(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;

(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;

(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;

(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;

(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.

Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction.