1. UNIVERSITY of DERBY Implementing TA 161 and 204 in the real world Dr. Jonathan Bayly Visiting Fellow, University of Derby

2. UNIVERSITY of DERBY UNIVERSITY of DERBY Strategy Identify a clinical lead Estimate total population of post-menopausal women Estimate prevalent and incident population with fragility fracture Estimate proportion eligible for secondary prevention according to NICE TA 161 Estimate proportion likely to be eligible for treatment with denosumab according to NICE TA 204 Involve Trust pharmacists Encourage the PCT and the Acute Trust to get a shared care agreement 2

3. UNIVERSITY of DERBY UNIVERSITY of DERBY Documentation NICE TA 204 NICE denosumab costing statement – http://guidance.nice.org.uk/TA204/CostingStatement/pdf/English http://guidance.nice.org.uk/TA204/CostingStatement/pdf/English Osteoporosis - secondary prevention including strontium ranelate: costing template – http://guidance.nice.org.uk/TA161/CostingTemplate/xls/English http://guidance.nice.org.uk/TA161/CostingTemplate/xls/English Any local action planning or formulary application templates Current prescribing data Cost comparison grids 3

4. UNIVERSITY of DERBY UNIVERSITY of DERBY Current therapy area profile ProductAnnual Units Annual Market Share Month Units Month Market Share Alendronic Total 78.96576.2%6,91175.7% Actonel Total10,82610.4%97410.7% Bonviva Total 7,6007.3%7167.8% Protelos4,8844.7%4344.8% Didronel PMO 6800.7%500.5% Fosavance6950.7%490.5% Figures for Sept 09 (Primary Care) 4 Similar data for secondary care

5. UNIVERSITY of DERBY UNIVERSITY of DERBY Cost comparisons Drug 1 year’s treatment (BNF 60) Teriparatide 20mcg SC od (max. 18months)£3534 Calcitonin T spray intranasal od£438 Denosumab 60mg SC 6 monthly£366 Strontium 2g po od£334 Fosavance 1 po weekly£296 Ibandronic acid 3mg iv 3 monthly£275 Zoledronic acid 5mg iv yearly£267 Risedronate 35mg po weekly£249 Raloxifene 60mg po od£222 Alendronic acid 70mg po weekly£17 5

6. UNIVERSITY of DERBY UNIVERSITY of DERBY Assumptions The numbers eligible for primary prevention with denosumab according to NICE TA 204 are theoretically very few 6

7. UNIVERSITY of DERBY UNIVERSITY of DERBY When to use denosumab (TA 204) In secondary prevention – When bisphosphonates contra-indicated – When intolerance or failure of persistence – Cognitive impairment – When eGFR <35 In primary prevention – With the above and – With a combination age, CRFs for # (parental history of hip #, alcohol >4 and RA) and BMD

8. UNIVERSITY of DERBY UNIVERSITY of DERBY Assumptions The numbers eligible for primary prevention with denosumab according to NICE TA 204 are theoretically very few Since January it became an issue for the PCT NICE implementation team not the Formulary committee First dose given in or authorised by specialist services 25% substitution rate if failure with or contra- indication to alendronate/bisphosphonates 1 Estimates of the ‘worst case scenario’ were required 8 1. Costing statement: Denosumab for the prevention of osteoporotic fractures in postmenopausal women, NICE 2010

9. UNIVERSITY of DERBY UNIVERSITY of DERBY Baseline needs assessment data: where to look? Population (PCT, local government, DoPH report) ONS (http://www.statistics.gov.uk/hub/population/index.html)http://www.statistics.gov.uk/hub/population/index.html – Female – 50-64, 65-74 and 75 plus Local audit or NICE implementation monitoring data FLS reports or DES activity analysis Hip fracture admission rate 9

10. UNIVERSITY of DERBY UNIVERSITY of DERBY 10 NICE TA 160/161 Costing template http://guidance.nice.org.uk/TA161/CostingTemplate/xls/Englishhttp://guidance.nice.org.uk/TA161/CostingTemplate/xls/English

11. UNIVERSITY of DERBY UNIVERSITY of DERBY Calculations 16% of the over 50 year old women are estimated to have a fragility fracture 1,2 NICE has estimated that 50% of fractures occur in over 75 years, 25% in 65-74 year olds and 25% in 50-64 year olds 1,100/45,000 (2.44%) of over 65 year old population (including men) will sustain a fracture each year 2 This figure can be adjusted to exclude men (2:5) ratio and include under 65 eligible women (25%:75% ratio) Of all women with a fragility fracture – 50% are over 75 years and all eligible for Rx – 25% 65-74 years and 50% eligible for Rx 2, 3 – 25% 50-64 years and 25% eligible for Rx 3 11 1 Brankin E, Mitchell C, Munro R. Current Medical Research and Opinions 2005;21:425-82. 2. Department of Health. Prevention package for Older People. 2009 3.The Clinical and Unit: Royal College of Physicians’ London. National Clinical Audit of Falls and Bone Health 4. Glasgow FLS: Alastair McLellan, personal communication

12. UNIVERSITY of DERBY UNIVERSITY of DERBY FLS: Prevalence of Osteoporosis in Women with Fractures (18,664 fractures) n 782 874 891 946 1034 958 711 386 By kind permission of Dr. Alastair Mclellan, Western Infirmary, Glasgow 12

13. UNIVERSITY of DERBY UNIVERSITY of DERBY In Gloucestershire (pop 600,000) 1238 new fractures in over 50 year old women eligible for treatment under TA161 each year At a 25% denosumab treatment rate that would equate to 309 new prescriptions/year £113,000, roughly equivalent to the calculated first year health and social care costs of four hip fracture patients entering RNCH in 2002 3,183 prior fragility fracture eligible for treatment under TA161 patients at a cost of £1.175m Equivalent to an English cohort of just over 1m women over 50 with a fragility fracture and osteoporosis 13

14. UNIVERSITY of DERBY UNIVERSITY of DERBY Calculations based on NICE TA 160/161 costing template NICE TA 160/161 Costing template http://guidance.nice.org.uk/TA161/CostingTemplate/xls/Englishhttp://guidance.nice.org.uk/TA161/CostingTemplate/xls/English 14

15. UNIVERSITY of DERBY UNIVERSITY of DERBY Further information for commissioners Trusts served by an FLS will have a higher case- identification rate of incident fractures Nationally it is estimated 40-60% of women with prevalent fragility fracture are identified on GP databases 1 15 1. Hippisley-Cox J, Bayly J, Potter J, Fenty J, Parker C. Evaluation of standards of care for osteoporosis and falls in primary care. 2007

16. UNIVERSITY of DERBY UNIVERSITY of DERBY Estimated or measured prevalence of females ≥ 50 with prior fragility fracture years 1 Hippis;ley-Cox, J et al. (2007) Information Centre. 2 Brankin, E. et al. (2005) CMRO. 3 Eisman, J. et al. (2004) Journal of Bone and Mineral Research. 4 Leslie, W. D. et al (2007) Bone. 5 Amamra, N. et al (2004) Joint Bone Spine. 16

17. UNIVERSITY of DERBY UNIVERSITY of DERBY Further information for commissioners Trusts served by an FLS will have a higher case- identification rate of incident fractures Nationally it is estimated 40-60% of women with prevalent fragility fracture are identified on GP databases 1 As few as 25% of over 75 year old women may currently be treated and 10-20% of 65-74s may have evidence of DXA or treatment 1,2 If QOF 2013 includes indicators for delivering NICE TA 161/204 a higher proportion of eligible patients will be initiated on treatment 17 1 Hippisley-Cox J, Bayly J, Potter J, Fenty J, Parker C. Evaluation of standards of care for osteoporosis and falls in primary care. 2007 2 The Clinical Effectiveness and Evaluation Unit: Royal College of Physicians’ London. National Clinical Audit of Falls and Bone Health

18. UNIVERSITY of DERBY Thank you jonathan@bayly.org