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

Uncontrolled severe asthma

Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)

Patient must not have received PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or

Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND

Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND

Patient must have a duration of asthma of at least 1 year; AND

Patient must have total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the last 12 months; or

Patient must have blood eosinophil count of at least 150 cells per microlitre in the last 12 months; or

Patient must have a fractional exhaled nitric oxide of at least 20 ppb in the last 12 months; AND

Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND

Patient must not receive more than 32 weeks of treatment under this restriction; AND

Patient must be under the care of the same physician for at least 6 months; AND

The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND

Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND

Patient must be aged 6 to less than 12 years.

Optimised asthma therapy includes:

(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;

AND

(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

The initial IgE assessment, blood eosinophil count or fractional exhaled nitric oxide measurement must be no more than 12 months old at the time of application.

The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:

(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),

AND

(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 28 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the last dose of biological medicine, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.

A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.

A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.

The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of dupilumab of up to 32 weeks.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) 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).

The following must be provided at the time of application and documented in the patient's medical records:

(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(c) the IgE, blood eosinophil or the fractional exhaled nitric oxide result and date; and

(d) Asthma Control Questionnaire (ACQ-5) score; or

(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

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

Uncontrolled severe asthma

Initial treatment - Initial 2 (Change of treatment)

Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or

Patient must have had a blood eosinophil count of at least 150 cells per microlitre no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or

Patient must have had a fractional exhaled nitric oxide of at least 20 ppb no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND

Patient must not receive more than 32 weeks of treatment under this restriction; AND

Patient must be under the care of the same physician for at least 6 months; AND

Patient must have received prior PBS-subsidised treatment with a biological medicine in this treatment cycle for either: (i) severe asthma, (ii) severe allergic asthma; AND

Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND

Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND

Patient must be aged 6 to less than 12 years.

An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma or severe allergic asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made no more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.

An Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.

This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine.

A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.

A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.

The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) 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).

The following must be provided at the time of application and documented in the patient's medical records:

(a) the IgE, blood eosinophil or fractional exhaled nitric oxide result and date; and

(b) Asthma Control Questionnaire (ACQ-5) score; or

(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

(d) the details of prior biological medicine treatment including the details of date and duration of treatment; and

(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).