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

Severe chronic plaque psoriasis

Completion of course - treatment covering weeks 16 to 24 (Whole body)

Must be treated by a dermatologist; AND

Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND

Patient must have demonstrated an adequate response to treatment; AND

Patient must not receive more than 8 weeks of treatment with etanercept under this restriction.

An adequate response to treatment is defined as:

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The assessment of response to treatment must be documented in the patient's medical records.

The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.

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

Severe chronic plaque psoriasis

Completion of course - treatment covering weeks 16 to 24 (Face, hand, foot)

Must be treated by a dermatologist; AND

Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND

Patient must have demonstrated an adequate response to treatment; AND

Patient must not receive more than 8 weeks of treatment with etanercept under this restriction.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The assessment of response to treatment must be documented in the patient's medical records.

The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.