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

Chronic severe atopic dermatitis

Initial treatment 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

The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND

Patient must not have experienced an inadequate response to this biological medicine in this PBS indication; AND

Must be treated by a dermatologist; or

Must be treated by a clinical immunologist; AND

Patient must be at least 12 years of age.

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

Continuing or resuming treatment of the whole body

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

Patient must have achieved an adequate response within the first 16 weeks of treatment; or

Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; 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

The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND

Must be treated by a dermatologist; or

Must be treated by a clinical immunologist.

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

Initial treatment 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

The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND

Patient must not have experienced an inadequate response to this biological medicine in this PBS indication; AND

Must be treated by a dermatologist; or

Must be treated by a clinical immunologist; AND

Patient must be at least 12 years of age.

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.

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

Chronic severe atopic dermatitis

Continuing or resuming treatment of the face and/or hands

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

Patient must have achieved an adequate response within the first 16 weeks of treatment; or

Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; 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

The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND

Must be treated by a dermatologist; or

Must be treated by a clinical immunologist.

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