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

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 1 (new patient)

Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND

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

Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND

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

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy.

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.

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 for two separate courses each of three months; or

(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.

The name of the one course of antibiotics of three months duration 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 to two different antibiotics.

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).

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

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

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)

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 3 biological medicines for this condition within 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 receive more than 16 weeks of treatment under this restriction; AND

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

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 a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application 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 biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

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.

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.

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).

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

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

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND

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

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

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

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

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.

To demonstrate a response to treatment the application 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 biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

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.

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.

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).

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.