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.
Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.
Read the full article on WikipediaAcute severe ulcerative colitis Clinical criteria: Treatment criteria: Must be treated by a gastroenterologist; OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]. Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application, AND Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below, AND Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital. Population criteria: Patient must be 6 years of age or older. For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where: (i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L (ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood. For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours. At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient's medical records. Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.
Moderate to severe ulcerative colitis Clinical criteria: Treatment Phase: Initial treatment - Initial 1 (new patient) Treatment criteria: Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal, AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent, AND Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years. Population criteria: Patient must be 6 years of age or older. Application for authorisation 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), which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application. An adult patient who has previously received induction therapy with PBS-subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic scoreless than or equal to 2, with no subscore greater than 1, will not be required to demonstrate failure to prior treatment with a 5-aminosalicylate oral preparation and one of azathioprine, 6-mercaptopurine or oral steroids. A patient, aged 6 to 17 years, who has previously received induction therapy with PBS-subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a PUCAI score of less than 10 will not be required to demonstrate failure to prior treatment with a 5-aminosalicylate oral preparation and one of azathioprine, 6-mercaptopurine or oral steroids. A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided 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 and no later than 4 weeks prior the completion of this course of treatment. 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. 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. Details of the accepted toxicities including severity can be found on the Services Australia website.
Severe Crohn disease Clinical criteria: Treatment Phase: Subsequent continuing treatment Treatment criteria: Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. 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 in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction, AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient, AND Patient must not receive more than 24 weeks of treatment under this restriction. Population criteria: Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) details of the proposed prescription; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of the most recent clinical assessment. All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. 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. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.
Complex refractory Fistulising Crohn disease Clinical criteria: Treatment Phase: Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must have demonstrated an adequate response to treatment with this drug. Treatment criteria: Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. An adequate response is defined as: (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. Applications for authorisation must be made in writing and must include: (a) details of the proposed prescription; and (b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition. The most recent fistula assessment must be no more than 1 month old at the time of application. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
Moderate to severe Crohn disease 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 both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; OR Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment, AND Patient must not receive more than 24 weeks of treatment under this restriction. Treatment criteria: Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Population criteria: Patient must be aged 6 to 17 years inclusive. The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: (1) details of the proposed prescription(s); 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 assessment of response must be no more than 4 weeks old at the time of application. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. Authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction for patients who: (i) received fewer than 2 repeats at the time of application; and/or (ii) required changes to their dosing regimen during this treatment phase.
Ankylosing spondylitis Clinical criteria: Treatment Phase: Subsequent continuing treatment 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. Treatment criteria: Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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). 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. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. An application for the continuing treatment 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 treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within these timeframes, 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 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 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; OR Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing 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 under this restriction, AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. 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. The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient's medical records. These values will be used for patients who transition to subcutaneous form of infliximab. 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. If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records. 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.
Severe psoriatic 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 psoriatic arthritis. 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 aged 18 years or older. 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. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. Where the most recent course of PBS-subsidised treatment with this drug was approved under the first continuing treatment restriction, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, 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. 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 aged 18 years or older. 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. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. The authority application must be made in writing and must include: (a) details of the proposed prescription(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. The most recent PASI assessment must be no more than 1 month old at the time of application. 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. 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.
Rheumatoid arthritis Clinical criteria: Treatment Phase: Initial treatment Treatment criteria: Must be treated by a rheumatologist; OR Must be treated by a consultant physician. Population criteria: Patient must be an adult. Patient must have active rheumatoid arthritis, AND Patient must have a specific accepted war-caused or service-related disability of refractory rheumatoid arthritis, AND Patient must have a proven raised erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) level, AND Patient must have proven erosive rheumatoid arthritis without end-stage disease, AND Patient must have failed an adequate trial of methotrexate and 2 other disease modifying anti-rheumatic drugs (such as sulfasalazine, hydroxychloroquine, leflunomide or ciclosporin), unless these drugs were contraindicated or intolerance developed, AND Patient must have no history of active tuberculosis requiring treatment in the last 3 years, AND Patient must have no history of opportunistic infection in the last 2 months, AND The treatment must be in combination with methotrexate, AND The treatment must be for the reduction of signs and symptoms and prevention of structural joint damage, AND Patient must not be pregnant or breastfeeding, AND Patient must be using an effective form of contraception if female and of child-bearing age. Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Infliximab (Remicade) RPBS Authority Application - Supporting Information form (contact the VAPAC on 1800 552 580 for a copy of the form).
“9.5 days”
Working under the parallel aged-care framework? Aged-care equivalent →