Implementing TA 161 and 204 in the real world

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

2. 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. Documentation • NICE TA 204 • NICE denosumab costing statement • 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 • Any local action planning or formulary application templates • Current prescribing data • Cost comparison grids 3

4. Current therapy area profile Figures for Sept 09 (Primary Care) Similar data for secondary care 4

5. Cost comparisons 5

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

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

8. 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. Baseline needs assessment data: where to look? • Population (PCT, local government, DoPH report) • ONS (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. 10 NICE TA 160/161 Costing template http://guidance.nice.org.uk/TA161/CostingTemplate/xls/English

11. Calculations 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 • 16% of the over 50 year old women are estimated to have a fragility fracture1,2 • 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

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

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

15. Further information for commissioners 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 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

16. 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. Further information for commissioners 2 The Clinical Effectiveness and Evaluation Unit: Royal College of Physicians’ London. National Clinical Audit of Falls and Bone Health 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 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

18. Thank you jonathan@bayly.org