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

Chronic severe atopic dermatitis

Initial treatment with this drug of the whole body

Patient must have a Physicians Global Assessment (PGA) (5-point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND

Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND

Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND

The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND

Patient must not have experienced an inadequate response to this therapy; AND

Must be treated by a dermatologist; or

Must be treated by a clinical immunologist; AND

Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis); AND

Patient must be 12 years of age or older.

State each of the qualifying (i) PGA, (ii) EASI and (iii) DLQI scores in the authority application.

Acceptable scores can be:

(a) current scores; or

(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.

The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient's medical records.

Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled in the patient's medical records.

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

Chronic severe atopic dermatitis

Initial treatment with this drug of the face and/or hands

The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; or

The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND

Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND

The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND

Patient must not have experienced an inadequate response to this therapy; AND

Must be treated by a dermatologist; or

Must be treated by a clinical immunologist; AND

Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis); AND

Patient must be 12 years of age or older.

State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for:

(i) erythema,

(ii) oedema/papulation,

(iii) excoriation,

(iv) lichenification

Acceptable scores can be:

(a) current scores; or

(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.

State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores.

The EASI/percentage surface area and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient's medical records.

Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled are in the patient's medical records.