Embed Size (px)
Citation preview
UNIVERSITY of DERBY
Implementing TA 161 and 204 in the real world
Dr. Jonathan Bayly
Visiting Fellow, University of Derby
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
UNIVERSITY of DERBY
UNIVERSITY of DERBY
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
UNIVERSITY of DERBY
UNIVERSITY of DERBY
Current therapy area profile
Product Annual Units Annual Market Share
Month Units Month Market Share
Alendronic Total
78.965 76.2% 6,911 75.7%
Actonel Total
10,826 10.4% 974 10.7%
Bonviva Total
7,600 7.3% 716 7.8%
Protelos 4,884 4.7% 434 4.8%Didronel PMO
680 0.7% 50 0.5%
Fosavance 695 0.7% 49 0.5%
Figures for Sept 09 (Primary Care)
4
Similar data for secondary care
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
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
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
Age 0 1 2
65–69 N/R −4.5 −4.0
70–74 −4.5 −4.0 −3.5
75 + −4.0 −4.0 −3.0
No. independent clinical risk factors for fracture
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
81. Costing statement: Denosumab for the prevention of osteoporotic fractures in postmenopausal women, NICE 2010
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)
– 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
UNIVERSITY of DERBY
UNIVERSITY of DERBY
10NICE TA 160/161 Costing template http://guidance.nice.org.uk/TA161/CostingTemplate/xls/English
UNIVERSITY of DERBY
UNIVERSITY of DERBY
Calculations
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
111 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
UNIVERSITY of DERBY
UNIVERSITY of DERBY
FLS: Prevalence of Osteoporosis inWomen with Fractures (18,664 fractures)
0%10%20%30%40%50%60%70%80%90%
100%
50-54 55-59 60-64 65-69 70-74 75-79 80-84 85+
Osteoporosis Not
n 782 874 891 946 1034 958 711 386
By kind permission of Dr. Alastair Mclellan, Western Infirmary, Glasgow 12
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
UNIVERSITY of DERBY
UNIVERSITY of DERBY
Calculations based on NICE TA 160/161 costing template
NICE calculates 1,030,928 women in England (base population 50,542,505) with osteoporosis and a fragility fracture
Women aged 50–54 years 2.00% 30,928 Women aged 55–59 years 3.00% 49,553 Women aged 60–64 years 7.00% 96,347 Women aged 65–69 years 9.00% 103,999 Women aged 70–74 years 14.00% 144,834 Women aged 75–79 years 20.00% 184,720 Women aged 80–84 years 26.00% 193,920
Women aged 85 years or older 31.00% 226,627
Total cases of osteoporosis with a clinically apparent osteoporotic
fragility fracture
1,030,928
NICE TA 160/161 Costing template http://guidance.nice.org.uk/TA161/CostingTemplate/xls/English 14
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
151. Hippisley-Cox J, Bayly J, Potter J, Fenty J, Parker C. Evaluation of standards of care for osteoporosis and falls in primary care. 2007
UNIVERSITY of DERBY
UNIVERSITY of DERBY
Estimated or measured prevalence of females ≥ 50 with prior fragility fracture years
0
5
10
15
20
25
30
35
Qresearch (1) Lanarkshire (2) Australia (3) Canada (4) France (5)
Per
cen
tag
e
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
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
171 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
