Loading
If this is the first time anyone has visited this substance, we may be fetching live data from TGA Product Information, PBS, and state framework sources — that can take up to a minute. Cached substances load in a second or two.
Benralizumab, sold under the brand name Fasenra, is a monoclonal antibody directed against the alpha chain of the interleukin-5 receptor (CD125). It was developed by MedImmune for the treatment of asthma. It is currently marketed by Astrazeneca.
Read the full article on WikipediaUncontrolled severe asthma Clinical criteria: Treatment Phase: Initial treatment - Initial 1 (New patients; 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 a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids 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 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 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. 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. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. 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 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter. 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) the eosinophil count and date; and (e) Asthma Control Questionnaire (ACQ-5) score.
Working under the parallel aged-care framework? Aged-care equivalent →