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

Chronic severe atopic dermatitis

Continuing or resuming treatment with this drug of the whole body

Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the whole body; AND

Patient must have achieved an adequate response prior to this first continuing treatment authority application; or

Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; or

Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; 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).

For the purposes of this restriction, an adequate response to treatment is defined as:

(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and

(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline

Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.

State each of the current EASI and DLQI scores for this authority application.

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

Chronic severe atopic dermatitis

Continuing or resuming treatment with this drug of the face and/or hands

Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND

Patient must have achieved an adequate response prior to this first continuing treatment authority application; or

Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; or

Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; 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).

For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as:

(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or

(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and

(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline

Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.

Document each qualifying response measure in the patient's medical records for PBS compliance auditing purposes