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Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. It is administered by subcutaneous injection (injection under the skin). It works by inactivating tumor necrosis factor (TNF).
Read the full article on WikipediaSevere Crohn disease Clinical criteria: Treatment Phase: Balance of supply for paediatric patient Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment, AND The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; OR The treatment must provide no more than the balance of up to 24 weeks therapy available under first continuing treatment or 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)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist.
Moderate to severe ulcerative colitis Clinical criteria: Treatment Phase: Initial treatment - Initial 1 (new patient) 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. 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 6 years of age or older. The authority application must be made in writing 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), which includes: (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]. 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. 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. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. 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 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.
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.
Moderate to severe hidradenitis suppurativa 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 a response to treatment with this drug for this condition. Treatment criteria: Must be treated by a dermatologist. A response to treatment is defined as: Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.
Complex refractory Fistulising Crohn disease Clinical criteria: Treatment Phase: Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years) 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 confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, AND Patient must have an externally draining enterocutaneous or rectovaginal fistula. Applications for authorisation must be made in writing and must include: (1) two completed authority prescription forms; 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 a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 4 weeks old at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. 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.
Severe active juvenile idiopathic arthritis Clinical criteria: Treatment Phase: Initial treatment - Initial 1 (new patient) Treatment criteria: Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition, AND Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months, AND Patient must not receive more than 16 weeks of treatment under this restriction. Population criteria: Patient must be under 18 years of age. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: (a) an active joint count of at least 10 active (swollen and tender) joints; or (b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or (c) active arthritis affecting the cervical spine or temporomandibular joint; or (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or (e) development/worsening of erosive disease due to active arthritis. The assessment of response to prior treatment must be documented in the patient's medical records. The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records: (a) the date of assessment of severe active juvenile idiopathic arthritis; and (b) details of prior treatment including dose and duration of treatment. At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised. The assessment of the patient's response to the initial course of treatment 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 this 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.
Severe chronic plaque psoriasis Clinical criteria: Treatment Phase: Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis, AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition, AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, AND The treatment must be as systemic monotherapy (other than methotrexate), AND Patient must not receive more than 16 weeks of treatment under this restriction. Population criteria: Patient must be at least 18 years of age. Treatment criteria: Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing 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) which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
Severe psoriatic arthritis Clinical criteria: Treatment Phase: Initial treatment - Initial 1 (new patient) 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 not have received PBS-subsidised treatment with a biological medicine for this condition, AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months, AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, AND Patient must not receive more than 16 weeks of treatment under this restriction. Population criteria: Patient must be at least 18 years of age. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (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). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The authority application must be made in writing and must include: (1) a completed authority prescription form; 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 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.
Vision threatening non-infectious uveitis Clinical criteria: Treatment Phase: Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must demonstrated or sustained an adequate response to treatment with this drug for this condition, AND The treatment must not exceed 24 weeks under this restriction per authority application. Treatment criteria: Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion. An adequate response to treatment is defined as: (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or (b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or (c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or (d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only) The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
Enthesitis/spondylitis related juvenile idiopathic arthritis Clinical criteria: Treatment Phase: Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2026, AND Patient must have, prior to initiating treatment with this drug for this condition, a diagnosis of enthesitis/spondylitis related juvenile idiopathic arthritis defined by at least one of the following: (i) peripheral arthritis and enthesitis, (ii) inflammatory sacroiliitis on Magnetic Resonance Imaging (MRI) plus at least 3 months of inflammatory back pain, (iii) arthritis or enthesitis plus at least 2 of: (a) sacroiliac joint tenderness, (b) inflammatory back pain, (c) presence of HLA-B27 antigen, (d) acute (symptomatic) anterior uveitis, (e) history of spondyloarthritis in a first-degree relative, AND Patient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for axial disease (sacroiliitis and/or spondylitis), following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) whilst completing an appropriate exercise program, for a total period of 3 months; OR Patient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for peripheral disease (arthritis and/or enthesitis) following treatment with at least 2 NSAIDs, and either: (i) methotrexate at a dose of 15 mg per square metre (maximum 20 mg) weekly, (ii) sulfasalazine at a dose of 20 mg/kg (maximum 1 g) twice daily, whilst completing an appropriate exercise program, for a total period of 3 months, 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. Treatment criteria: Must be treated by a paediatric rheumatologist; OR Must be treated by a rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Population criteria: Patient must be under 18 years of age, prior to commencement of this drug for this condition. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If treatment with methotrexate, sulfasalazine or NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to methotrexate, sulfasalazine or NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the toxicity must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application: (a) a Juvenile Spondyloarthritis Disease Activity Index score greater than 2; or (b) persistent symptoms of axial spondylitis or sacroiliitis with prior confirmatory Magnetic Resonance Imaging (MRI) assessed by a clinician experienced with juvenile spondyloarthropathy. The following must be provided at the time of application and documented in the patient's medical records: (1) details of prior treatment including dose and duration of treatment; and (i) if applicable, a baseline Juvenile Spondyloarthritis Disease Activity Index score; or (ii) if applicable, the current Juvenile Spondyloarthritis Disease Activity Index score; or (iii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) of the MRI demonstrating inflammatory spondylitis or sacroiliitis; or (iv) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) demonstrating the presence of HLA-B27. The Juvenile Spondyloarthritis Disease Activity Index score must be assessed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. An adequate response is defined as an improvement from baseline in the Juvenile Spondyloarthritis Disease Activity Index score by at least 30% or an improvement in the persistent symptoms of axial spondylitis or sacroiliitis. 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 until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
“Adalimumab is a monoclonal antibody. It works by binding to and inhibiting Tumor necrosis factor (TNF) and inducing apoptosis in mononuclear cells expressing TNF.”
“10–20 days”
Working under the parallel aged-care framework? Aged-care equivalent →