“urinary incontinence in women 2013” nice guidelines implementation in primary care

“URINARY INCONTINENCE IN WOMEN 2013”NICE guidelines implementation in Primary Care

Tony SmithUrogynaecologist

St Mary’s Hospital Anson Medical CentreManchester 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?

Prim Care Sec Care Patient Q KHQStress only 25 15 7 2Mixed 15 32 41 45OAB 2 0 0 1Not Classified 7 - - -

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 therapies1st 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 placeboDrug B vs placebo

Drug C vs placebo

NICE Guideline 2013

Network Metanalysis of drugsRobust outcome measuresSimilar regimesAdverse event / compliance

Incontinence

Higher dose12 weeks

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)

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

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

Anti-muscarinic drugs

• Is the additional cost of the better tolerated drugs worth paying for?

MirabegronBetmiga

• B adrenergic agonist• First in class• Similar efficacy to tolterodine• Adverse events

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.”

NICE guidelines for urinary incontinence in primary care

Conclusions• Pathways and standards are important• Commissioning• Treatment choices are difficult• GP input to NICE GDG