“URINARY INCONTINENCE IN WOMEN 2013”
NICE guidelines implementation in Primary
Care
Tony Smith
Urogynaecologist
St Mary’s Hospital
Manchester
Anson Medical Centre
Manchester
Relevance of NICE to GPs
• NICE provides the evidence base for Quality
and Outcomes Framework (QOF)
Relevance of NICE to GPs
• NICE provides the evidence base for Quality
and Outcomes Framework (QOF)
• NICE pathways define appropriate transfer of
care from GP to specialist care
Relevance of NICE to GPs
• NICE provides the evidence base for Quality
and Outcomes Framework (QOF)
• NICE pathways define appropriate transfer of
care from GP to specialist care
• NICE quality standards should form the basis
for assessing the quality of the new GP
commissioners
• Key recommendations
• Antimuscarinic drugs
• Mirabegron
NICE Key recommendations
• “At the initial assessment, the woman’s UI should be
categorised as stress UI, mixed UI, or urge UI / OAB.
Initial treatment should be started on this basis. In
mixed UI, treatment should be directed towards the
predominant symptom.”
• “expert opinion concludes that symptomatic
categorisation of UI based on reports from the
woman and history taking is sufficiently reliable to
inform initial, non-invasive treatment decisions”
Who takes the best history?
Stress only
Mixed
OAB
Not Classified
Prim Care
25
15
2
7
Sec Care Patient Q KHQ
15
7
2
32
41
45
0
0
1
-
History taking
• More detailed history may be more accurate
e-PAQ
EPAQ
•
•
•
•
Comprehensive, validated questionnaire
Provides a database of patient details
Outcome analysis
Potential for online use
• Referral from primary to secondary care
• Care integration
• triage
NICE Key recommendations
Management of OAB
•
•
•
•
•
•
Lifestyle advice / behavioural therapy
Pelvic floor physiotherapy
Drug therapies
PTNS
Botox
SNS
NICE Guideline 2006
• Drug therapies
1st
IR oxybutinin (if training ineffective)
2nd
solifenacin, tolterodine, darifenacin
etc or transdermal oxybutinin
NICE Guideline 2013
Problems with the literature on anti-muscarinic
drugs
• Most studies compare drug to placebo
NICE Guideline 2013
Problems with the literature on anti-muscarinic
drugs
• Most studies compare drug to placebo
• Outcome measures vary with different trials
NICE Guideline 2013
Problems with the literature on anti-muscarinic
drugs
• Most studies compare drug to placebo
• Outcome measures vary with different trials
• Head to head comparison difficult
NICE Guideline 2013
Problems with the literature on anti-muscarinic
drugs
• Most studies compare drug to placebo
• Outcome measures vary with different trials
• Head to head comparison difficult
• Compliance in trials vs real life
NICE Guideline 2013
Network Metanalysis of drugs
Drug A vs placebo
Drug B vs placebo
Drug C vs placebo
NICE Guideline 2013
Network Metanalysis of drugs
Robust outcome measures
Similar regimes
Adverse event / compliance
Incontinence
Higher dose
12 weeks
0.39
0.55
0.43
1.02
0.43
0.54
0.57
0.49
0.87
0.38
0.60
0.48
0.49
(0.25,0.61)
(0.33,0.89)
(0.27,0.65)
(0.52,1.97)
(0.28,0.66)
(0.23,1.31)
(0.36,0.88)
(0.26,0.91)
(0.28,2.86)
(0.22,0.69)
(0.31,1.17)
(0.26,0.89)
(0.32,0.75)
1.40
1.09
2.61
1.11
1.39
1.46
1.26
2.24
0.99
1.53
1.23
1.26
(0.95,2.06)
(0.84,1.41)
(1.23,5.53)
(0.90,1.36)
(0.66,3.07)
(1.17,1.82)
(0.76,2.07)
(0.77,6.88)
(0.64,1.53)
(0.88,2.67)
(0.76,1.99)
(1.05,1.51)
0.78
1.87
0.79
0.99
1.04
0.90
1.60
0.71
1.09
0.88
0.90
(0.54,1.13)
(0.85,4.09)
(0.56,1.12)
(0.45,2.35)
(0.72,1.52)
(0.50,1.61)
(0.53,5.13)
(0.42,1.20)
(0.58,2.07)
(0.50,1.56)
(0.63,1.29)
2.40
1.02
1.28
1.34
1.15
2.05
0.91
1.40
1.13
1.16
(1.13,5.07)
(0.80,1.29)
(0.60,2.88)
(1.04,1.73)
(0.69,1.93)
(0.70,6.35)
(0.58,1.43)
(0.80,2.48)
(0.69,1.86)
(0.93,1.45)
0.42
0.53
0.56
0.48
0.86
0.38
0.59
0.47
0.48
(0.20,0.89)
(0.19,1.56)
(0.27,1.18)
(0.20,1.14)
(0.17,0.87)
(0.24,1.45)
(0.20,1.12)
(0.23,1.00)
(0.60,2.76)
1.26
1.32
1.14
2.02
0.89
1.38
1.12
1.14
(0.60,2.76)
(1.12,1.55)
(0.70,1.84)
(0.70,6.16)
(0.59,1.35)
(0.81,2.38)
(0.70,1.77)
(1.00,1.30)
1.05
0.90
1.61
0.71
1.10
0.89
0.91
(0.48,2.20)
(0.36,2.12)
(0.44,5.95)
(0.30,1.63)
(0.43,2.68)
(0.36,2.08)
(0.41,1.87)
0.86
1.54
0.68
1.05
0.85
0.86
(0.53,1.40)
(0.53,4.69)
(0.45,1.04)
(0.61,1.81)
(0.53,1.35)
(0.75,0.99)
1.79
0.79
1.22
0.98
1.00
(0.57,5.94)
(0.43,1.45)
(0.61,2.46)
(0.52,1.87)
(0.63,1.59)
0.44
0.68
0.55
0.56
(0.14,1.35)
(0.20,2.20)
(0.17,1.72)
(0.19,1.61)
1.55
1.25
1.27
(0.80,2.96)
(0.69,2.26)
(0.86,1.88)
0.81
0.82
(0.41,1.59)
(0.49,1.39)
Oxybutynin TG
1.02
Oxybutynin IR
0.67
Solifenacin
(0.31,1.40)
0.70
1.06
Oxybutynin ER
(0.30,1.60)
(0.71,1.57)
0.93
1.38
1.31
Tolterodine IR
(0.50,1.72)
(0.65,3.12)
(0.57,3.17)
0.74
1.11
1.06
0.81
Propiverine IR
(0.24,2.32)
(0.48,2.64)
(0.42,2.67)
(0.25,2.52)
0.50
0.75
0.71
0.54
0.67
Tolterodine ER
(0.24,1.04)
(0.66,0.86)
(0.49,1.03)
(0.24,1.16)
(0.28,1.54)
0.58
0.87
0.83
0.63
0.79
1.17
Propiverine ER
(0.26,1.32)
(0.60,1.28)
(0.49,1.40)
(0.26,1.45)
(0.31,1.92)
(0.82,1.69)
0.60
0.89
0.85
0.65
0.80
1.20
1.02
Fesoterodine
(0.28,1.24)
(0.77,1.04)
(0.58,1.24)
(0.29,1.38)
(0.34,1.84)
(1.09,1.31)
(0.71,1.47)
0.72
1.08
1.02
0.78
0.97
1.44
1.23
1.20
Trospium
(0.29,1.78)
(0.63,1.88)
(0.53,1.97)
(0.30,1.97)
(0.35,2.59)
(0.85,2.49)
(0.66,2.34)
(0.71,2.09)
0.62
0.92
0.87
0.67
0.83
1.23
1.05
1.03
0.85
Oxybutynin TD
(0.20,1.93)
(0.40,2.22)
(0.35,2.27)
(0.21,2.10)
(0.25,2.72)
(0.54,2.95)
(0.43,2.68)
(0.45,2.47)
(0.32,2.37)
0.80
1.19
1.13
0.86
1.07
1.59
1.36
1.33
1.11
1.30
Darifenacin
(0.32,2.00)
(0.69,2.12)
(0.59,2.21)
(0.33,2.20)
(0.39,2.87)
(0.93,2.81)
(0.72,2.61)
(0.78,2.36)
(0.52,2.37)
(0.47,3.49)
0.80
0.99
0.94
0.72
0.89
1.33
1.13
1.11
0.92
1.08
0.83
Trospium ER
(0.32,2.00)
(0.75,1.31)
(0.60,1.48)
(0.31,1.57)
(0.37,2.09)
(1.02,1.72)
(0.74,1.72)
(0.85,1.44)
(0.51,1.64)
(0.44,2.55)
(0.45,1.48)
0.63
0.94
0.89
0.68
0.84
1.25
1.07
1.05
0.87
1.02
0.79
0.95
(0.27,1.41)
(0.65,1.36)
(0.53,1.49)
(0.28,1.56)
(0.34,2.06)
(0.88,1.80)
(0.66,1.75)
(0.74,1.50)
(0.46,1.63)
(0.40,2.50)
(0.41,1.47)
(0.62,1.44)
0.34
0.51
0.48
0.37
0.46
0.68
0.58
0.57
0.47
0.55
0.43
0.51
0.54
(0.16,0.70)
(0.44,0.58)
(0.33,0.70)
(0.17,0.78)
(0.19,1.04)
(0.61,0.75)
(0.41,0.82)
(0.51,0.63)
(0.27,0.79)
(0.23,1.26)
(0.24,0.72)
(0.40,0.65)
(0.38,0.76)
(0.65,1.59)
Placebo
NICE Guideline 2013
Anti-muscarinic drugs
Conclusions
Incontinent /dry only robust outcome
All drugs are of similar efficacy
Compliance varies from 20% to 35% at 12 months
Cost
Antimuscarinic prescriptions dispensed, quantity and cost (one month data)
(National prescribing data, March 2013)
31/06/2012
Drug name and dose
dose
items
per day
dispensed
Quantity
Net ingredient cost
Solifenacin 5mg & 10mg
1
156,797
4,964,855
£
50,312,131
Darifenacin 7.5 & 15mg
1
1,586
50,000
£
373,229
Fesoterodine 4mg & 8mg
1
16,842
537,462
£
4,948,605
Oxybutynin IR - generic - 2.5, 3 & 5 mg
1
84,460
4,673,778
£
3,506,906
Oxybutynin ER 5mg & 10mg
1
34,980
1,438,950
£
9,314,160
Tolterodine IR 1 & 2mg
1
23,912
1,213,075
£
6,504,092
Tolterodine ER 4mg
1
2,045
111,263
£
598,112
Propiverine IR 15mg
1
2,566
154,896
£
497,881
Propiverine ER
1
1,240
36,446
£
318,248
Trospium ER
1
13,308
652,283
£
2,790,039
Trospium ER
1
7,171
199,423
£
1,641,647
Anti-muscarinic drugs
• Is the additional cost of the better tolerated
drugs worth paying for?
Mirabegron
Betmiga
•
•
•
•
B adrenergic agonist
First in class
Similar efficacy to tolterodine
Adverse events
Mirabegron
Betmiga
• B adrenergic agonist
• First in class
• Similar efficacy to tolterodine
• Adverse events
“treatment-emergent adverse events (TEAEs) were similar
between the mirabegron 50 mg (26.2%) and tolterodine
groups (27.6%), the incidence of treatment related serious
adverse events (SAEs) was 1.2% in the mirabegron 50 mg
group and 0.6% in the tolterodine group and the incidence
of treatment-related TEAEs leading to study drug
discontinuation was 4.3% in the mirabegron 50 mg group
and 3.8% in the tolterodine group.”
NICE guidelines for urinary incontinence in
primary care
Conclusions
• Pathways and standards are important
• Commissioning
• Treatment choices are difficult
• GP input to NICE GDG