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

Moderate to severe hidradenitis suppurativa

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated a response to treatment with this drug for this condition; AND

Must be treated by a dermatologist.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

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.

A maximum of 24 weeks treatment will be authorised under this restriction per continuing 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:

(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.

If the application is submitted through HPOS form upload or mail, it must include:

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

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

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

Moderate to severe hidradenitis suppurativa

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND

Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug for this condition; AND

Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 12 weeks of treatment if the patient has been treated with this drug for this condition for 12 weeks or longer; AND

Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or

Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or

Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND

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

Must be treated by a dermatologist.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

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.

Assessment of disease severity must not have been more than 4 weeks old at the time treatment with this drug was initiated.

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

(i) the Hurley stage grading; and

(ii) the AN count; and

(iii) the name of the antibiotic/s received; or

(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal. The name of the one course of antibiotics must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal.

(v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 12 weeks or more of treatment.

If the application is submitted through HPOS form upload or mail, it must include:

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

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

A patient may qualify for PBS-subsidised treatment under this restriction once only.

For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.