Ankylosing spondylitis Initial PBS authority application Supporting information

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1 Ankylosing spondylitis nitial PBS authity application Suppting infmation mptant infmation This fm must be completed by a rheumatologist with expertise in the management of ankylosing spondylitis. You must lodge this fm f an adult patient starting initial PBS subsidised treatment with a Tumour Necrosis Fact alpha (TNFα) antagonist. Where the term TNFα antagonist appears it only refers to adalimumab, etanercept, golimumab infliximab. Patients are eligible f PBS subsidised treatment with only one TNFα antagonist at any time. All applications must be in writing must include sufficient infmation to determine the patient s eligibility accding to the PBS criteria. All tests assessments should be perfmed preferably whilst still on treatment, but no longer than one month following cessation of the most recent pri treatment. The lodgement of this application must be made within one month of the date of the Bath Ankylosing Spondylitis Disease Activity ndex (BASDA) assessment Erythrocyte Sedimentation Rate (ESR)/Creactive Protein (CRP) blood tests. The infmation on this fm is crect at the time of publishing is subject to change. Section 100 arrangements f infliximab This item is only available to a patient who is attending: an approved private hospital a public participating hospital a public hospital is either a day admitted patient a nonadmitted patient a patient on discharge not need to be completed when submitted with this fm. Phone approvals Under no circumstance will phone approvals be granted f complete initial authity applications, f treatment that would otherwise extend the treatment period. Applications f continuing treatment The assessment of the patient s response to an initial course of treatment must be made after a minimum of 12 weeks of treatment. Assessments befe 12 weeks of treatment have been completed will not be considered. This assessment, which will be used to determine eligibility f continuing treatment, must be submitted to Medicare Australia no later than one month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken submitted to Medicare Australia within these timeframes, the patient will be deemed to have failed to respond to treatment. Assistance f you need assistance completing this fm need me infmation call (call charges may apply) select option 2, between 8.00 am 5.00 pm EST, Monday to Friday go to > F health professionals > PBS > Specialised drugs (PBS) A > Ankylosing spondylitis Lodgement Send the completed authity application fm, a completed authity prescription fm all relevant attachments to: Medicare Australia Pri written approval of specialised drugs Reply paid 9826 Hobart TAS 7001 Print in BLOCK LETTERS Tick where applicable This is not a PBS benefit f inpatients of the hospital. The hospital provider number must be included on the application fm. Acknowledgements The patient s the prescriber s acknowledgements must be signed in front of a witness (over 18 years of age). Authity prescription fm A completed authity prescription fm must be attached to this fm. The medical indication section of the authity prescription fm does Page 1 of

2 Ankylosing spondylitis nitial PBS authity application Patient s details 1 Medicare/DVA card number 2 Mr Mrs Miss Ms Other Family name 3 First given name of birth Patient s acknowledgement 4 acknowledge that PBS subsidised treatment with TNFα antagonists f ankylosing spondylitis will stop if: Ref no. subsequent testing demonstrates that have failed to demonstrate sustain a response to treatment as detailed in the criteria have failed three TNFα antagonist treatment courses f which was eligible. My prescriber has explained the nature of the ongoing moniting testing required in der to demonstrate an adequate response to therapy. Prescriber s details 5 6 Prescriber number Family name Prescriber s acknowledgement 8 have explained: the circumstances governing PBS subsidised treatment with TNFα antagonists f ankylosing spondylitis the nature of the ongoing moniting testing required to demonstrate an adequate sustained response to therapy. believe these to be understood accepted by the patient. Witness s acknowledgement 9 have witnessed the signatures of BOTH the patient the prescriber. Witness s full name (over 18 years of age) Witness s signature TNFα antagonist details 10 Which TNFα antagonist is this application f? adalimumab etanercept F infliximab only: Patient s current weight Hospital name kg golimumab infliximab First given name Hospital provider number 7 Wk phone number ( ) Alternative phone number Fax number ( ) Conditions criteria 11 To qualify f PBS authity approval, the following conditions must be met. The patient: is an adult with severe active ankylosing spondylitis Page 2 of

3 has signed the patient s acknowledgement has documented radiographically (plain XRay) confirmed Grade bilateral sacroiliitis Grade unilateral sacroiliitis has at least two of the following: / / low back pain stiffness f three me months that is relieved by exercise but not by rest limitation of motion of the lumbar spine in the sagittal the frontal planes as determined by a sce of at least one on each of the lumbar flexion lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology ndex (BASM) limitation of chest expansion relative to nmal values f age gender has failed to achieve an adequate response following a minimum of three months of treatment, with at least two nonsteroidal antiinflammaty drugs (NSADs). Provide details of pri NSAD treatment. NSAD from to NSAD from to NSAD from to Provide details of contraindications intolerance to NSAD pri therapy including the degree of toxicity. F details of the toxicity criteria go to gov.au > F health professionals > PBS > Specialised drugs (PBS) A > Ankylosing spondylitis ntolerance must be of a severity to necessitate permanent treatment withdrawal. Contraindication toxicity grade. Current assessment of patient 12 The patient can demonstrate failure to achieve an adequate response to NSAD treatment concomitant exercise program by: / Attachments BASDA assessment sce of at least 4 on a 0 10 scale an elevated ESR greater than 25 mm/hr ESR level of test an elevated CRP greater than 10 /L CRP level of test have elected to provide only one marker at baseline will assess all applications f the continuing treatment based on this same marker. f the above requirement to demonstrate an elevated ESR CRP cannot be met, state reason why: Attach plain XRay documentation, the completed exercise self certification fm, the completed BASDA assessment a completed authity prescription fm. 13 the infmation on this fm is crect Privacy note The infmation provided on this fm will be used to assess eligibility of a nominated person to receive PBS subsidised treatment. The collection of this infmation is authised by the National Health Act This infmation may be disclosed to the Department of Health Ageing, Department of Veterans Affairs as authised required by law. has completed an appropriate concomitant exercise program Page 3 of

4 Patient s declaration Ankylosing spondylitis Exercise program self certification have undertaken a minimum exercise program, as detailed below, in conjunction with appropriate NSAD therapy, over the entire three month period immediately befe this application have perfmed stretch range of motion exercises f a minimum of five times per week either an aerobic exercise of at least 20 minutes duration on at least three different occasions per week, a group exercise class at least once per week. ndicate by ticking the relevant exercise undertaken in the following table Week commencing Stretch motion exercise (5 x per week) Aerobic activity (3 x per week) Group exercise (1x per week) Wk 1 Wk 2 Wk 3 Wk 4 Wk 5 Wk 6 Wk 7 Wk 8 Wk 9 Wk 10 Wk 11 Wk 12 either have instructed the patient in an adequate exercise program. Page 4 of

5 Bath Ankylosing Spondylitis Disease Activity ndex (BASDA) Place a mark on each line below to indicate your answer to each question as it relates to your past week. 1 How would you describe the overall level of fatigue/tiredness you have experienced? 2 How would you describe the overall level of AS neck, back hip pain you have had? 3 How would you describe the overall level of pain/swelling in joints other than your neck, back hips that you have had? 4 How would you describe the overall level of discomft you have had from any areas tender to touch pressure? 5 How would you describe the overall level of mning stiffness you have had from the time you wake up? 6 How long does your mning stiffness last from the time you wake up? Scing the BASDA 0 ½ 1hr 1½ 2hr Measure each question from to the patient s mark in centimetres. Add Q5 Q6 divide by 2 = A Add Q1, Q2, Q3 Q4 = B Add A B divide by 5 = Sce Patient s declaration 7 have completed the above six questions. did not have access to any pri BASDA assessments completed by myself. 8 as the prescriber of a TNFα antagonist f the above patient witnessed the patient complete the above questions. they had no access to any pri BASDA. BASDA prepared by the Pharmaceutical Benefits Branch, Australian Government Department of Health Ageing, 15 July Reproduced extracted from: Garrett, Sarah et al. (1994) A New Approach to Defining Disease Status in Ankylosing Spondylitis: The Bath Ankylosing Spondylitis Activity ndex. Journal of Rheumatology, 21 (12), , with the permission of the copyright holder. Page 5 of

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY APPLICANT (stamp sticker acceptable) Page 1 Fm SA1620 Etanercept INITIAL APPLICATION - juvenile idiopathic arthritis Applications only from a named specialist rheumatologist. Approvals valid f 6 months.