Guidelines for the Pharmaceutical Management of Osteoporosis in Adult WA Public Hospitals

Transcription

1 WA.DRUG EVALUATION PANEL Guidelines for the Pharmaceutical Management of Osteoporosis in Adult WA Public Hospitals Introduction Osteoporotic fracture-related hospitalisations impose a substantial financial impact in WA. Over one third of patients admitted to WA hospitals for an index fracture sustain a re-fracture requiring readmission 1. One half of fragility fractures occur in individuals with non-osteoporotic DXA bone mass density (BMD) underlining the important role of falling in the aetiology of fracture. It is therefore important to assess balance and falls propensity as well as bone structure to guide the initiation of fracture reduction measures. This document provides guidance on the role of correctable lifestyle factors and the initiation of pharmacotherapy for the management of osteoporosis. Lifestyle and non-pharmacological interventions are also recommended to be adopted for the management of osteoporosis. 2 Assessment of fracture risk is recommended utilising validated falls and fracture risk calculators. This guideline stipulates that: 1. Where the PBS criteria is met and where the agent is considered clinically indicated according to patient assessment, medications should be prescribed on the PBS 2. Where pharmacotherapy is deemed appropriate, based on fracture risk assessment and specific clinical scenarios, but PBS criteria are not met, the algorithm that follows recommends the choice of therapy, listed in order of hierarchy. Patients that may fit these criteria include those undergoing organ transplantation or breast cancer patients treated with an aromatase inhibitor. Risk Assessment Tools The patient s fracture risk can be calculated to provide a guide to fracture risk in the next 5 10 years. Both the FRAX and Garvan calculator include multiple risk factors but differ in the risk factors assessed and types of fracture risk calculated. FRAX Risk Assessment 3 The FRAX WHO fracture risk assessment tool with Australian data can be found at: Garvan Risk Calculator 4 The Garvan Institute fracture risk calculator can be found at: WADEP Pharmaceutical Management of Osteoporosis 1

2 Patient Assessment Algorithm Fracture risk assessment Clinical assessment Fasting metabolic bone study BMD-DXA scan Garvan or FRAX risk (apply KANIS risk for steroid use) calculator Management Exclusion of 2 o causes Calcium and vitamin D status Weight bearing exercise Fall risk reduction If the patient fulfils PBS Criteria Consider pharmacological management with medications via the PBS See Appendix 1 Patient <75 years &/or steroid use FRAX calculator Apply KANIS risk adjustment for steroid use See Appendix 2 Patient >75 years &/or falls risk Garvan risk calculator Low Fracture Risk Non-pharmacological management Moderate Fracture Risk FRAX 10-year major osteoporotic # risk 11 19% OR Garvan 5-year major osteoporotic # risk 5 10% Prescribe approved treatment according to moderate fracture risk in Table 1 High Fracture Risk FRAX 10-year risk of major osteoporotic # >20% OR Garvan 5-year risk of major osteoporotic # > 10% FRAX 10-year risk of hip # >3% OR Garvan 5-year risk of hip # >2% Male > 60 years or postmenopausal female 4 AND T-score <-2.5 AND one risk factor Transplant Unit patient Patient with breast Ca on aromatase inhibitor where 6 : o T score <-2.0 o T score <-1.5 with 1 or more clinical risk factor o T score <-1.0 with 2 or more clinical risk factors o Age > 75 years irrespective of BMD, or o High risk by FRAX/Garvan criteria Patients with severely damaged skeletons as a result of cushings disease, previous thyrotoxicosis, malabsorption or osteogenesis imperfecta with T score <-2.5 who are considered high risk of fracture by an endocrinologist. Prescribe approved treatment according to high fracture risk in Table 1 WADEP Pharmaceutical Management of Osteoporosis 2

3 Table 1. Medications available on the Statewide Medicines Formulary for moderate high fracture risk. The following medicines may be used when patients do not meet PBS criteria for anti-resorptive treatment and is assessed as having a moderate or high fracture risk as per the patient algorithm on page 2 of this guideline. 1 st line treatment options Moderate - High Fracture Risk Alendronate 70 mg weekly PO (+/- calcium and cholecalciferol) For general populations alendronate is the preferred agent based on equivalent efficacy and lower cost. Risedronate 35mg weekly or 150mg monthly PO (+/- calcium and cholecalciferol) Where compliance is not a concern consider prescribing separate calcium and cholecalciferol products. 2 nd line treatment options Zoledronic acid 5mg IV (Annual infusion or after 12/12 repeat NTX ratio every 6/12 and retreat if no longer suppressed or above baseline) Denosumab 60mg SC 6 monthly Indication(s): Organ transplant (zoledronic acid), or First-line oral bisphosphonates are: - not tolerated defined as persistent upper gastrointestinal (GI) disturbance despite following administration instructions correctly and is sufficiently severe to warrant discontinuation, - contraindicated by documented GI pathology (oesophageal dysmotility, erosive/ulcerative oesophagitis, inflammatory bowel disease, malabsorption), or - ineffective (patient has at least 1 symptomatic new fracture after at least 12 months continuous therapy at adequate dose). 3 rd line treatment options High Fracture Risk Only Pamidronate 30 60mg 3 monthly IV Raloxifene 60 mg daily PO Indication(s): First and second-line agents are: - contraindicated as per the TGA product information, or - ineffective (patient has at least 1 symptomatic new fracture after at least 12 months continuous therapy at adequate dose). Third-line treatments are not listed on the SMF for patients with moderate risk; all use must be via an Individual Patient Approval (IPA). WADEP Pharmaceutical Management of Osteoporosis 3

4 Table 2. Costs to WA Health for anti-resorptive medications Generic name Strength Administration Dispensing frequency Approx. cost to hospital/year 1 Alendronate 70 mg One tablet weekly Monthly $21 Alendronate/ cholecalciferol/ calcium carbonate Risedronate 70 mg/ 140 mcg/ 1.25 g One alendronate tablet weekly Calcium and vitamin D all other days Monthly $ mg One tablet weekly Monthly $285 Risedronate 150 mg One tablet monthly Monthly $67 Risedronate/ cholecalciferol/ calcium carbonate 35 mg/ 22 mcg/ 2.5 g One risedronate tablet weekly Calcium and vitamin D all other days Monthly $311 Denosumab 60 mg 6 Monthly s/c Injection 6 Monthly $510 Zoledronic acid 5 mg Yearly IV infusion Yearly $94 Pamidronate mg 3 Monthly IV infusion 3 Monthly $120 - $240 Raloxifene 60 mg One tablet daily Monthly $416 Teriparatide 600 mcg in 2.4 ml pen 20 micrograms once daily s/c SC pen lasts 28 days $4,620 Calcium carbonate 1.5 g Two tablets daily 2 monthly $27 Cholecalciferol 25 mcg One tablet daily 6 monthly $18 This is not an exhaustive list of strengths and preparations. 1 Costs are correct as of 1 April 2017; costs may vary at different hospitals, for a more accurate cost please refer to the hospital pharmacy department. WADEP Pharmaceutical Management of Osteoporosis 4

5 Appendix 1. Overview of indications for anti-resorptive medications available on the PBS Correct as of 1 April 2017 truncated, for accurate and detailed information visit Corticosteroid induced osteoporosis - Long-term 3 months and high-dose 7.5 mg/day - prednisolone or equivalent, & - BMD T-score of -1.5 alendronate +/- calcium & cholecalciferol calcitriol risedronate +/- calcium & cholecalciferol Osteoporosis - BMD T-score of -2.5, & 70 years Osteoporosis - BMD T-score of -3, & 70 years Established osteoporosis - Fracture due to minimal trauma Preservation of bone mineral density - Long-term corticosteroid therapy and high-dose 7.5 mg/day prednisolone or equivalent, & - BMD T-score of -1.0 Severe established osteoporosis - Very high risk of fracture, - BMD T-score of -3, - 2 fractures due to minimal trauma, - 1 symptomatic new fracture after 12 months continuous therapy with an antiresorptive agent at adequate doses, & - treatment must not exceed a lifetime max 18 months therapy (repat only) (repat only) zoledronic denosumab raloxifene teriparatide Postmenopausal WADEP Pharmaceutical Management of Osteoporosis 5

6 Appendix 2. KANIS risk adjustment for steroid use - Percentage FRAX adjustment for 10 year risk of hip or major osteoporotic fractures by age according to dose of glucocorticoid. 7 Prednisolone equivalent (mg/day) Hip fracture Age (years) All ages Low < Medium High > Major Osteoporotic fracture Low < Medium High > WADEP Pharmaceutical Management of Osteoporosis 6

7 References 1. A.M. Briggs, W. Sun, L. Miller, E. Geelhoed, A. Huska, C.A. Inderjeeth. Aust N Z J Public Health. (2015) Hospitalisations, admission costs and re-fracture risk related to osteoporosis in Western Australia are substantial: a 10-year review. Jun 11. doi: / [Epub ahead of print] 2. Osteoporosis [revised 2014 Jun]. In: etg complete [Internet]. Melbourne: Therapeutic Guidelines Limited; 2017 Mar. 3. FRAX WHO Fracture Risk Assessment Tool (n.d.). Retrieved from 4. Garvan Institute Bone Fracture Risk Calculator (n.d.). Retrieved from 5. R. Rizzoli, J. J. Body, A. De Censi, J. Y. Reginster, P. Piscitelli, M. L. Brandi (2012). Guidance for the prevention of bone loss and fractures in postmenopausal women treated with aromatase inhibitors for breast cancer: an ESCEO position paper. Osteoporosis International, 23 (11), P. Hadji, M. S. Aapro, J. J. Body, N. J. Bundred, A. Brufsky, R. E. Coleman, M. Gnant, T. Guise, and A. Lipton (2011). Management of aromatase inhibitor-associated bone loss in postmenopausal women with breast cancer: practical guidance for prevention and treatment.. Ann Oncol, 22 (12), J. A. Kanis, H. Johansson, A. Oden, E. V. McCloskey. Osteoporosis international (2011). Guidance for the adjustment of FRAX according to the dose of glucocorticoids, 22(3), Contacts Enquiries relating to this document or the Statewide Medicines Formulary can be directed to the WA Drug Evaluation Panel: wadep@health.wa.gov.au Acknowledgements This guideline was adapted from the Fiona Stanley Hospital Osteoporosis Management Guideline and the Royal Perth Hospital Pathway for Osteoporosis Treatment. Disclaimer The management recommendations in this guideline may not apply to all clinical scenarios. The treating clinician must apply clinical judgement in all management decisions to ensure the most appropriate therapy is prescribed taking into account available therapeutic options, the benefits and risks to the patient. This guideline does not replace expert medical opinion. Printed or personally saved electronic copies of this guideline are not controlled. Document History Version Version Date Document Owner Revision Date /2017 WA Drug Evaluation Panel (WADEP) 05/2019 WADEP Pharmaceutical Management of Osteoporosis 7