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

Severe chronic plaque psoriasis

First continuing treatment, Whole body

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have demonstrated an adequate response to treatment with this drug; AND

Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Must be treated by a dermatologist; AND

Patient must have been under 18 years of age at the time of initial treatment with this drug.

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.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(a) details of the proposed prescription(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.

The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.

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

Severe chronic plaque psoriasis

First continuing treatment, Face, hand, foot

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have demonstrated an adequate response to treatment with this drug; AND

Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Must be treated by a dermatologist; AND

Patient must have been under 18 years of age at the time of initial treatment with this drug.

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.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(a) details of the proposed prescription(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.

The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.