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

Severe chronic plaque psoriasis

Initial 1 treatment (Whole body) - biological medicine-naive patient

Must be treated by a dermatologist; AND

Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND

Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND

Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND

Patient must be under 18 years of age.

Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient's medical records.

Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient's medical records.

Details of the accepted toxicities including severity can be found on the Services Australia website.

The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:

(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.

A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient's medical records, each of:

(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;

(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);

(iii) the PASI score that followed each prior therapy trialled;

(iv) the date the PASI scores were determined.

Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.

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

Severe chronic plaque psoriasis

Initial 2 treatment (Whole body) - Change of treatment

Must be treated by a dermatologist; AND

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND

Patient must be under 18 years of age.

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.

In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:

(i) there is an absence of an adequate response to that treatment; or

(ii) there was an intolerance to that treatment; or

(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.

The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records.

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

Severe chronic plaque psoriasis

Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years

Must be treated by a dermatologist; AND

Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND

The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words 'whole body'; or

The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words 'face, hand, foot'; AND

Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or

The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND

Patient must be under 18 years of age.

The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.

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

Severe chronic plaque psoriasis

Balance of supply - Initial 1, 2, 3 or 4 treatment (Whole body, or, face/hand/foot)

Must be treated by a dermatologist; AND

Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 16 weeks treatment available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3, (iv) Initial 4; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

The treatment must provide no more than the balance of up to 16 weeks treatment.

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

Severe chronic plaque psoriasis

Initial 4 - Re-treatment (Whole body)

Must be treated by a dermatologist; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have a documented history of severe chronic plaque psoriasis of the whole body; AND

Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following: (i) a disease flare where the PASI score has worsened (increased) by at least 50%, (ii) the current PASI score has returned above 15; AND

Patient must not have failed more than once to achieve an adequate response with etanercept; AND

Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND

Patient must be under 18 years of age.

Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.

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

Severe chronic plaque psoriasis

Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient

Must be treated by a dermatologist; AND

Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND

Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND

Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND

Patient must be under 18 years of age.

Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient's medical records.

Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient's medical records.

Details of the accepted toxicities including severity can be found on the Services Australia website.

The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:

(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or

(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy

Provide in this authority application, and document in the patient's medical records, each of:

(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;

(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);

(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;

(iv) the dates that response assessments were determined.

Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:

(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);

(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.

Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment.

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

Severe chronic plaque psoriasis

Initial 2 treatment (Face, hand, foot) - Change of treatment

Must be treated by a dermatologist; AND

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND

Patient must be under 18 years of age.

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 pre-biological treatment baseline values; or

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

In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:

(i) there is an absence of an adequate response to that treatment; or

(ii) there was an intolerance to that treatment; or

(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.

The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records.

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

Severe chronic plaque psoriasis

Initial 4 - Re-treatment (face, hand, foot)

Must be treated by a dermatologist; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND

Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following: (i) all PASI sub-measures (redness, thickness, scaling) are rated as 'moderate' to 'severe', (ii) at least 2 of the 3 PASI sub-measures are rated as 'severe' to 'very severe', (iii) the skin area affected has increased by at least 50% since the last administered dose, (iv) the skin area affected is at least 30% of the total skin area of the face/hand/foot; AND

Patient must not have failed more than once to achieve an adequate response with etanercept; AND

Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND

Patient must be under 18 years of age.

Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.