Drug treatment pathway for Osteoporosis in Postmenopausal Women

Transcription

1 Drug treatment pathway for Osteoporosis in Postmenopausal Women Version 1.0 Ratified by: East Sussex HEMC Date ratified: Job title of originator/author Gillian Ells, East Sussex HEMC Pharmacist Facilitator Name of responsible committee/individual East Sussex Health Economy Medicines Committee Date issued: 26 th January 2011 Review date: January 2013 Target audience: Provider services Page 1 of 6

2 Purpose The purpose of this policy is to outline how osteoporosis in post-menopausal women will be treated within the East Sussex local health economy in order to: provide patients with a range of effective therapeutic options; meet statutory obligations in relation to National Institute for Health and Clinical Excellence (NICE) guidance; maximise value for money. Scope This policy relates to the use of osteoporosis treatments within their licensed indication for the treatment of osteoporosis in post-menopausal women. Use of these treatments in men or for the prevention or treatment of osteoporosis associated with long-term steroid use fall outside of this policy. Whilst this is predominantly focused on primary care, it is also relevant to East Sussex Hospitals Trust, the main provider for acute services in NHS East Sussex Downs and Weald and NHS Hastings and Rother and to other NHS providers who provide services to patient in the above localities. This drug treatment pathway covers both primary and secondary prevention and is supported by the following NICE guidance: TA 160. Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women (October 2008) available at: TA 161. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (October 2008) available at: TA 204. Denosumab for the prevention of osteoporotic fractures in postmenopausal women (October 2010) available at: Supporting information Primary prevention covers the treatment of post-menopausal women who have been confirmed as osteoporotic (see below) who have not yet sustained a clinically apparent fragility fracture. Secondary prevention covers the treatment of post-menopausal women who have been confirmed as osteoporotic (see below) who have suffered at least one clinically apparent fragility fracture. Osteoporosis is defined by a T-score of 2.5 standard deviations (SD) or lower on dualenergy X-ray absorptiometry (DXA) scanning. This guidance requires that DXA scanning be undertaken in most patients to determine the severity of osteoporosis as the T-score is one of the components used to determine eligibility for certain treatments. The diagnosis can, however, be assumed in patients over the age of 75 if a clinician feels a DXA scan is clinically inappropriate or unfeasible. This guidance assumes an adequate intake of calcium and Vitamin D as standard. Patients should receive appropriate calcium and vitamin D supplementation if there is any doubt about this. Page 2 of 6

3 This pathway takes a step-wise approach to treatment based on level of risk of fracture and the cost-effectiveness of these treatments. This means that certain groups of patients will not be eligible for the next step on the treatment pathway because their level of risk is lower than what NICE has deemed cost-effective to treat. In these circumstances, calcium and vitamin D supplementation should be continued until such time as the patient qualifies for active treatment. Denosumab (Prolia ) is a novel monoclonal antibody treatment for osteoporosis recently approved By NICE. It has been given orange status within the formulary indicating that it should be initiated by an appropriate specialist but is suitable for prescribing by GPs and administering by appropriately trained practice and community nurses. Denosumab requires no special injection technique and can be administered by healthcare professionals trained to give subcutaneous injections. Adverse events associated with denosumab are constipation, UTI, URTI, pain at injection site, sciatica, cataracts and rash. Less commonly, diverticulitis and cellulitis. Patients should be encouraged to seek prompt medical attention if they develop symptoms of cellulitis. Denosumab has black triangle status hence all adverse reactions should be reported to the Commission on Human Medicines (CHM) via the yellow card scheme. For further information see the Summary of Product Characteristics at: Page 3 of 6

4 Secondary prevention Osteoporotic (T-score of 2.5 or lower) and having sustained a clinically apparent fragility fracture Alendronate 70mg weekly. Prescribe generically Risendronate 35mg weekly Prescribe generically In accordance with age, T-score and number of independent clinical risk factors (see table below). Nal riskage No. risk factors for fracture X or older Denosumab 60mg SC every 6 months on specialist recommendation. Suitable for prescribing and administration in primary care. Strontium ranelate 2g daily In accordance with age, T-score and number of independent clinical risk factors (see table below). Nal riskage No. risk factors for fracture X or older Contraindication to alendronate Intolerance to alendronate (persistent upper GI disturbance requiring discontinuation of treatment) Unable to comply with administration instructions Contraindication to alendronate and risedronate Intolerance to alendronate and risedronate (persistent upper GI disturbance requiring discontinuation of treatment) Unable to comply with administration instructions Contra-indication to alendronate, risedronate, strontium ranelate and denosumab Intolerance to alendronate and risedronate (persistent upper GI disturbance requiring discontinuation of treatment), strontium ranelate and denosumab Unsatisfactory response to previous treatment (occurrence of a fragility fracture despite adherence to treatment for 1 year plus decline in BMD below pretreatment baseline) Teriparatide only Page 4 of 6

5 Zoledronate 5mg IV every 12 months Supply and administration in secondary care only // Teriparatide 20mcg SC daily Supply via secondary care for 18 months only In accordance with age, T-score and number of fractures (see table below). Age < 2 fractures > 2 fractures X or older Primary Prevention Post-menopausal and Osteoporotic (confirmed T-score of 2.5 or lower) with no history of fragility fractures Alendronate 70mg weekly. Prescribe generically Eligibility for treatment is dependent on age and the presence of indictors for low bone mineral density (BMD) and risk factors for fracture (see below). Indicators of low BMD low body mass index (defined as less than 22 kg/m2) medical conditions such as Ankylosing spondylitis, Crohn s disease conditions that result in prolonged immobility untreated menopause Independent clinical risk factors for fracture parental history of hip fracture alcohol intake of 4 or more units per day rheumatoid arthritis Age any one from the above table Age one independent clinical risk factor for fracture Age <65 one independent clinical risk factor for fracture and one indicator of low BMD Contraindication to alendronate Intolerance to alendronate (persistent upper GI disturbance requiring discontinuation of treatment) Unable to comply with administration instructions Page 5 of 6

6 // Risendronate 35mg weekly Prescribe generically In accordance with age, T-score and number of independent clinical risk factors (see table below). Nal riskage No. risk factors for fracture X or older Contraindication to alendronate and risedronate Intolerance to alendronate and risedronate (persistent upper GI disturbance requiring discontinuation of treatment) Unable to comply with administration instructions Strontium ranelate 2g daily Denosumab 60mg SC every 6 months on specialist recommendation. Suitable for prescribing and administration in primary care. In accordance with age, T-score and number of independent clinical risk factors (see table below). Nal riskage No. risk factors for fracture X or older Page 6 of 6