Implementing TA 161 and
204 in the real world
Dr. Jonathan Bayly
Visiting Fellow, 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
UNIVERSITY
care agreement
of DERBY
UNIVERSITY
of DERBY
2
Documentation


NICE TA 204
NICE denosumab costing statement
–

Osteoporosis - secondary prevention
including strontium ranelate: costing template
–



http://guidance.nice.org.uk/TA204/CostingStatement/pdf/English
http://guidance.nice.org.uk/TA161/CostingTemplate/xls/English
Any local action planning or formulary
application templates
Current prescribing data
UNIVERSITY
of DERBY
Cost comparison grids
UNIVERSITY
of DERBY
3
Current therapy area profile
Figures for Sept 09 (Primary Care)
Product
Alendronic
Total
Actonel Total
Bonviva
Total
Protelos
Didronel
PMO
Fosavance
Annual Units Annual
Market
Share
78.965
76.2%
Month Units Month
Market
Share
6,911
75.7%
10,826
7,600
10.4%
7.3%
974
716
10.7%
7.8%
4,884
680
4.7%
0.7%
434
50
4.8%
0.5%
695
0.7%
49
0.5%
Similar data for secondary care
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
4
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
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
5
Assumptions

The numbers eligible for primary prevention with
denosumab according to NICE TA 204 are
theoretically very few
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
6
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
Age
No. independent clinical
risk factors for fracture
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
In secondary prevention
–
–
–
–
When bisphosphonates contra-indicated
When intolerance or failure of persistence
Cognitive impairment
UNIVERSITY
of DERBY
When eGFR <35
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 contraindication to alendronate/bisphosphonates 1
Estimates of the ‘worst case scenario’ were
required
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
1. Costing statement: Denosumab for the prevention of osteoporotic fractures in postmenopausal women, NICE 2010
8
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
UNIVERSITY
of DERBY
Hip fracture admission rate
UNIVERSITY
of DERBY
9
Selected total population of postmenopausal women (base
100,000: English population)
1446
3060
1476
50 - 54
55–59
60–64
1827
65–69
70–74
3268
75–79
80–84
> 85
2047
2286
2723
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
NICE TA 160/161 Costing template http://guidance.nice.org.uk/TA161/CostingTemplate/xls/English
10
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
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
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
11
FLS: Prevalence of Osteoporosis in
Women with Fractures (18,664 fractures)
Osteoporosis
Not
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
n
50-54
55-59
60-64
65-69
70-74
75-79
782
874
891
946
1034
958
UNIVERSITY
of DERBY85+
80-84
711
386
UNIVERSITY
of DERBY
By kind permission of Dr. Alastair Mclellan, Western Infirmary, Glasgow
12
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
UNIVERSITY
women over 50 with a fragility fracture and
of DERBY
osteoporosis
UNIVERSITY
of DERBY
13
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
Women aged 55–59 years
Women aged 60–64 years
Women aged 65–69 years
Women aged 70–74 years
Women aged 75–79 years
Women aged 80–84 years
Women aged 85 years or older
2.00%
3.00%
7.00%
9.00%
14.00%
20.00%
26.00%
31.00%
Total cases of osteoporosis with
a clinically apparent osteoporotic
fragility fracture
30,928
49,553
96,347
103,999
144,834
184,720
193,920
226,627
1,030,928
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
NICE TA 160/161 Costing template http://guidance.nice.org.uk/TA161/CostingTemplate/xls/English
14
Further information for
commissioners


Trusts served by an FLS will have a higher caseidentification rate of incident fractures
Nationally it is estimated 40-60% of women with prevalent
fragility fracture are identified on GP databases 1
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
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
15
Estimated or measured prevalence of females
≥ 50 with prior fragility fracture years
35
30
Percentage
25
20
15
10
5
UNIVERSITY
of DERBY
0
Qresearch (1)
Lanarkshire (2)
Australia (3)
Canada (4)
France (5)
UNIVERSITY
of DERBY
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
Further information for
commissioners




Trusts served by an FLS will have a higher caseidentification 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
UNIVERSITY
of DERBY
UNIVERSITY
of DERBY
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
17
Thank you
jonathan@bayly.org
UNIVERSITY
of DERBY