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Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13 receptor signalling (IL-4R, IL-13R), used for allergic diseases such as atopic dermatitis (eczema), asthma and nasal polyps which result in chronic sinusitis. It is also used for the treatment of eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
Read the full article on WikipediaChronic severe atopic dermatitis Clinical criteria: Treatment Phase: 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. Treatment criteria: Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. Population criteria: 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.
Uncontrolled severe asthma Clinical criteria: Treatment Phase: Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) Treatment criteria: Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team, AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma, AND Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records, AND Patient must have a duration of asthma of at least 1 year, AND Patient must have been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation, AND Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; OR Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE, 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 The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Population criteria: Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids as outlined in the clinical criteria. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to 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 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, AND (b) while receiving optimised asthma therapy in the past 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) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug 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, 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 provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. 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 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 4 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. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. 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 (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and (b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (d) Asthma Control Questionnaire (ACQ-5) score; and (e) if applicable, the eosinophil count and date; and (f) if applicable, the IgE result and date.
“Dupilumab binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα), making it a receptor antagonist. Through blockade of IL-4Rα, dupilumab modulates signaling of both the interleukin 4 and interleukin 13 pathways.”
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