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Etanercept, sold under the brand name Enbrel among others, is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF), a soluble inflammatory cytokine, by acting as a TNF inhibitor. It has US Food and Drug Administration (FDA) approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF.
Read the full article on WikipediaSevere active rheumatoid arthritis Clinical criteria: Treatment Phase: Subsequent continuing treatment Treatment criteria: Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine, AND Patient must have demonstrated an adequate response to treatment with this drug, AND Patient must not receive more than 24 weeks of treatment under this restriction. Population criteria: Patient must be at least 18 years of age. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. 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.
Severe psoriatic arthritis Clinical criteria: Treatment Phase: Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, AND Patient must have demonstrated an adequate response to treatment with this drug, AND Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction. Population criteria: Patient must be at least 18 years of age. Treatment criteria: Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient's medical records. 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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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.
Ankylosing spondylitis Clinical criteria: Treatment Phase: First continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, AND Patient must have demonstrated an adequate response to treatment with this drug, AND Patient must not receive more than 24 weeks of treatment under this restriction. Population criteria: Patient must be at least 18 years of age. Treatment criteria: Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. 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. 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.
Severe chronic plaque psoriasis Clinical criteria: Treatment Phase: Subsequent continuing treatment, whole body Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, AND Patient must have demonstrated an adequate response to treatment with this drug, AND The treatment must be as systemic monotherapy (other than methotrexate), AND Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction. Population criteria: Patient must be at least 18 years of age. Treatment criteria: Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug. 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.
Severe active juvenile idiopathic arthritis Clinical criteria: Treatment Phase: Continuing treatment Treatment criteria: Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, AND Patient must have demonstrated an adequate response to treatment with this drug, AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or (b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or (c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or (d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or (e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease. The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. 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. A patient may re-trial this drug after a minimum of 12 months 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. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
“Etanercept reduces the effect of naturally present TNF, and hence is a TNF inhibitor, functioning as a decoy receptor that binds to TNF.”
“70–132 hours”
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