“urinary incontinence in women 2013” nice guidelines implementation in primary care tony smith...
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“URINARY INCONTINENCE IN WOMEN 2013”NICE guidelines implementation in Primary Care
Tony SmithUrogynaecologist
St Mary’s Hospital Anson Medical CentreManchester Manchester
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Relevance of NICE to GPs
• NICE provides the evidence base for Quality and Outcomes Framework (QOF)
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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
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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
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• Key recommendations• Antimuscarinic drugs• Mirabegron
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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”
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Who takes the best history?
Prim Care Sec Care Patient Q KHQStress only 25 15 7 2Mixed 15 32 41 45OAB 2 0 0 1Not Classified 7 - - -
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History taking
• More detailed history may be more accurate
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e-PAQ
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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
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NICE Key recommendations Management of OAB
• Lifestyle advice / behavioural therapy • Pelvic floor physiotherapy• Drug therapies• PTNS• Botox• SNS
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NICE Guideline 2006
• Drug therapies1st IR oxybutinin (if training ineffective)2nd solifenacin, tolterodine, darifenacin
etc or transdermal oxybutinin
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NICE Guideline 2013
Problems with the literature on anti-muscarinic drugs
• Most studies compare drug to placebo
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NICE Guideline 2013
Problems with the literature on anti-muscarinic drugs
• Most studies compare drug to placebo• Outcome measures vary with different trials
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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
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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
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NICE Guideline 2013
Network Metanalysis of drugs
Drug A vs placeboDrug B vs placebo
Drug C vs placebo
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NICE Guideline 2013
Network Metanalysis of drugsRobust outcome measuresSimilar regimesAdverse event / compliance
Incontinence
Higher dose12 weeks
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Oxybutynin IR
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)
0.67
Solifenacin
1.40 1.09 2.61 1.11 1.39 1.46 1.26 2.24 0.99 1.53 1.23 1.26
(0.31,1.40) (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)
0.70 1.06
Oxybutynin ER
0.78 1.87 0.79 0.99 1.04 0.90 1.60 0.71 1.09 0.88 0.90
(0.30,1.60) (0.71,1.57) (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)
0.93 1.38 1.31
Tolterodine IR
2.40 1.02 1.28 1.34 1.15 2.05 0.91 1.40 1.13 1.16
(0.50,1.72) (0.65,3.12) (0.57,3.17) (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)
0.74 1.11 1.06 0.81
Propiverine IR
0.42 0.53 0.56 0.48 0.86 0.38 0.59 0.47 0.48
(0.24,2.32) (0.48,2.64) (0.42,2.67) (0.25,2.52) (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)
0.50 0.75 0.71 0.54 0.67
Tolterodine ER
1.26 1.32 1.14 2.02 0.89 1.38 1.12 1.14
(0.24,1.04) (0.66,0.86) (0.49,1.03) (0.24,1.16) (0.28,1.54) (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)
0.58 0.87 0.83 0.63 0.79 1.17
Propiverine ER
1.05 0.90 1.61 0.71 1.10 0.89 0.91
(0.26,1.32) (0.60,1.28) (0.49,1.40) (0.26,1.45) (0.31,1.92) (0.82,1.69) (0.48,2.20) (0.36,2.12) (0.44,5.95) (0.30,1.63) (0.43,2.68) (0.36,2.08) (0.41,1.87)
0.60 0.89 0.85 0.65 0.80 1.20 1.02
Fesoterodine
0.86 1.54 0.68 1.05 0.85 0.86
(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) (0.53,1.40) (0.53,4.69) (0.45,1.04) (0.61,1.81) (0.53,1.35) (0.75,0.99)
0.72 1.08 1.02 0.78 0.97 1.44 1.23 1.20
Trospium
1.79 0.79 1.22 0.98 1.00
(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) (0.57,5.94) (0.43,1.45) (0.61,2.46) (0.52,1.87) (0.63,1.59)
0.62 0.92 0.87 0.67 0.83 1.23 1.05 1.03 0.85
Oxybutynin TD
0.44 0.68 0.55 0.56
(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) (0.14,1.35) (0.20,2.20) (0.17,1.72) (0.19,1.61)
0.80 1.19 1.13 0.86 1.07 1.59 1.36 1.33 1.11 1.30
Darifenacin
1.55 1.25 1.27
(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) (0.80,2.96) (0.69,2.26) (0.86,1.88)
0.80 0.99 0.94 0.72 0.89 1.33 1.13 1.11 0.92 1.08 0.83
Trospium ER
0.81 0.82
(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) (0.41,1.59) (0.49,1.39)
0.63 0.94 0.89 0.68 0.84 1.25 1.07 1.05 0.87 1.02 0.79 0.95 Oxybutynin TG 1.02
(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) (0.65,1.59)
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 Placebo
(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)
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NICE Guideline 2013
Anti-muscarinic drugs
ConclusionsIncontinent /dry only robust outcomeAll drugs are of similar efficacyCompliance varies from 20% to 35% at 12 months
Cost
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Antimuscarinic prescriptions dispensed, quantity and cost (one month data)
(National prescribing data, March 2013)
31/06/2012 dose items
Drug name and dose 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
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Anti-muscarinic drugs
• Is the additional cost of the better tolerated drugs worth paying for?
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MirabegronBetmiga
• B adrenergic agonist• First in class• Similar efficacy to tolterodine• Adverse events
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MirabegronBetmiga
• 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.”
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NICE guidelines for urinary incontinence in primary care
Conclusions• Pathways and standards are important• Commissioning• Treatment choices are difficult• GP input to NICE GDG