Evidence Table 53Economic evidence

Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Annemans 200517
UK

Economic analysis:
cost-effectiveness analysis

Study design
Decision analysis*

Time horizon:
6 months

Discount rates:
Costs: NA
Effects: NA
Patient group:
patients hospitalised for acute urinary retention
Intervention 1:
Alfuzosin 10mg once daily used for 3 days during the initial hospitalization followed by TWOC (mean duration 55hours).
If TWOC is successful treatment with Alfuzosin for 6 months.

Intervention 2:
Immediate inpatient prostatectomy

Intervention 3:
Placebo followed by TWOC (mean duration 55hours) and placebo if TWOC is successful.
Successful TWOC*Int 1: 62%
Int 2: NA
Int 3: 48%
p value: 0.012
Funding:
Sanofi-Aventis

Limitations:
Short follow-up.

Additional outcomes:
After successful TWOC, 17% of patients treated with Alfuzosin for 6 months require prostatectomy compared to 24% of patients treated with placebo.

Notes:
* based on the ALFAUR Study195
**based on 2002 Reference Costs inflated to 2003 (inflator 1.035)
Mean cost per patient over 6 months**
2002 GBP cost of hospitalisation, prostatectomy and TURP, drugs, unsuccessful TWOC (prostatectomy), tests.
Int 1: 2,029
Int 2: 2,378
Int 3: 2,921
p value: NR
Incremental costs over 6 months
(based on 1,000 Monte Carlo simulations)
Int 3 vs. Int 1: 349 (95% CI 64-624)
Int 2 vs. Int 1: 892 (95% CI 644-1121)
Int 2 vs. Int 3 : 543 (95% CI 228 - 776)
p value : Sig
Cost-effectiveness
cost per successful TWOC
Int 1 dominates Int 2 and 3
Sensitivity analysis
Monte Carlo simulation
If the proportion of patients having an immediate prostatectomy after a failed TWOC is higher, Alfuzosin is more cost-saving.
If surgery after successful TWOC is done in an elective setting, Alfuzosin is more cost saving.
Study detailsPatientsInterventions*Outcome measuresEffect sizeComments
DiSantostefano 2006 71
USA

Economic analysis:
Cost-utility analysis

Study design
Decision analysis

Time horizon:
20 years

Discount rates:
Costs: 3%
Effects: 3%
Patient group: men aged 65 years with moderate to severe LUTS and uncomplicated BPH, with no contraindications to any of the drugs.

Group A:
moderate symptoms (IPSS 8-19)

Group B:
severe symptoms (IPSS 20-35)
Intervention 1:
Watchful waiting (WW)

Intervention 2:
Alpha-blockers (AB)

Intervention 3:
5-Alpha reductase inhibitors (5-ARI)

Intervention 4:
High-energy transurethral microwave thermotherapy (TUMT)

Intervention 5:
Transurethral resection of the prostate (TURP)
QALYs – Group AIntervention 1: 10.68
Intervention 2: 10.76
Intervention 3: 10.71
Intervention 4: 10.69
Intervention 5: 10.63
p value: NR
Funding:
National Research Service Award Institutional Training Grant from the Institute of Aging; grant from the Agency for Healthcare Research and Quality. Conflict of Interest: the author is an employee of GlaxoSmithKline.

Limitations:
Partial applicability. The lack of long-term studies and differences between patient populations might have biased the results in favour of pharmaceuticals.

Notes:
* Combination of AB and 5-ARI was an additional intervention compared in the study but it was excluded because its effectiveness was based only on experts opinion.
** GBP calculated by using the 2008 PPP
QALYs – Group BIntervention 1: 9.79
Intervention 2: 9.88
Intervention 3: 9.83
Intervention 4: 10.30
Intervention 5: 10.47
p value: NR
Mean cost per patient** – Group A
2004 USD, cost of GP visits, tests, drugs, surgery, complications (strictures, incontinence)
Intervention 1: $ 4,419 (£ 2,793)
Intervention 2: $ 6,666 (£ 4,213)
Intervention 3: $ 8,891 (£ 5,619)
Intervention 4: $ 7,982 (£ 5,045)
Intervention 5: $ 8,599 (£ 5,435)
p value: NR
Mean cost per patient** – Group B
2004 USD, cost of GP visits, tests, drugs, surgery, complications (strictures, incontinence)
Intervention 1: $ 4,403 (£ 2,783)
Intervention 2: $ 6,664 (£ 4,212)
Intervention 3: $ 8,888 (£ 5,617)
Intervention 4: $ 7,983 (£ 5,045)
Intervention 5: $ 8,558 (£ 5,409)
p value: NR
Cost-effectiveness** – incremental cost per QALYGroup A
Int 2 vs. Int 1: $ 28,088 (£17,752)
Int 3, 4 and 5 are dominated by Int 2.
Int 6 is dominated by Int 5.
Group B
Int 2 vs. Int 1: $ 25,122 (£ 15,877)
Int 3 is dominated by Int 2.
Int 4 vs. Int 2: $ 3,140 (£ 1,984)
Int 5 vs. Int 2: $ 3,210 (£ 2,029)
Int 5 vs. Int 1: $ 6,110 (£ 3,861)
Int 5 vs. Int 4: $ 3,382 (£ 2,137)
Sensitivity analysis
One-way sensitivity analysis
If switching between treatments was not permitted, TURP would cost $30,204 (£ 19,090) more than AB for each QALY gained for moderate symptoms patients.

The overall results did not change with the age of the patient.

If effectiveness of TUMT is set equal to TURP, TUMT dominates TURP.
Probabilistic sensitivity analysisFor a willingness to pay equal to $50,000 alpha-blockers have about a 70% probability of being cost-effective for patients with moderate symptoms. For the same willingness to pay, TURP had almost a 90% probability of being cost-effective for patients with severe symptoms.
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Fader 200886
UK

Economic analysis:
Cost-effectiveness analysis

Study design
RCT (cross-over)*

Duration of follow-up:
One month

Discount rates:
Costs: NA
Effects: NA
Patient group:
moderate/heavily incontinent adults (urinary or urinary/faecal) living in the community

All patients
N: 85
IPSS: NR
Age (mean): 52.8
M/F: 49/36
Drop outs: 0
Intervention 1:
Insert

Intervention 2:
Diaper

Intervention 3:
Pull-up

Intervention 4:
T-shaped

Intervention 5:
Washables
Proportion of patients willing to buy a product used during the day if they had to bear the costInt 1: 39%
Int 2: 50%
Int 3: 43%
Int 4: 39%
Int 5: 38%
p value: NR
Funding:
commissioned by the Health Technology Assessment Programme. Some of the authors have received research grant money and travel grant money from SCA AB (absorbent pad manufacturing company)

Limitations:
The study included women and faecal incontinence as well. Not a full economic evaluation.
Effectiveness was not measured in terms of any of the clinical outcomes included in our Guideline.

Notes:
*crossover design in which each participant tested all products within their group in random order. Only trial 2a is included and reported.
** scale from 0 – 100 to assess patients' preference for a product.
*** Visual Analogue Scale score is not a clinical outcome of interest and an incremental cost-effectiveness analysis based on this outcome would not be useful.
Proportion of patients willing to buy a product used during the night if they had to bear the costInt 1: 33%
Int 2: 52%
Int 3: 39%
Int 4: 33%
Int 5: 53%
p value: NR
Mean Visual Analogue Scale score** (day use – night use)Int 1: 48 – 53
Int 2: 66 – 64
Int 3: 73 – 62
Int 4: 60 – 54
Int 5: 34 – 43
p value: NR
Mean monthly cost per patient (day – night)
2005 GBP, cost of supplying the product, assuming three products per day and one per night are used. Cost of laundering washable products is not included.
Int 1: £44 - £23
Int 2: £47 - £15
Int 3: £79 - £25
Int 4: £75 - £25
Int 5: £9 - £6
p value: NR
Cost-effectivenessNA***
Sensitivity analysisDifferent types of products within the same category have different costs and performance. The results are very sensitive to these variations.
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Fehrling200790
Sweden

Economic analysis:
Cost consequences analysis

Study design
Within group comparison

Duration of follow-up:
3 months

Discount rates:
Costs: NA
Effects: NA
Patient group: patients with an overactive bladder with or without incontinence

All patients
N: 60
IPSS:
Age: the majority was 70 or older
M/F: 31/29
Drop outs: 0
Treatment:
10 session (twice weekly for 5 weeks) of Maximal Functional Electrical Stimulation (MFES) at the highest tolerable amplitude
Number of patients with: up to 8 voids per day > 8voids per day -NRBefore treatment: 11 – 44 – 5
After treatment: 11 – 30 – 19
p value: NR
Funding:
Swedish Research Council, Sahlgrenska university Hospital, and the Martha and Gustaf Agrens research Foundation.

Limitations:
Within group study.
The outcomes are not clear-cut.
Only the cost of the intervention is considered. Mixed male and female population.

Notes:
* the total sum is 61 while N=60
**Cost of treatment for each successfully treated patient is reported (€17,000) but success is not defined.
*** calculated by using the 2008 PPP for Germany
Number of patients with the following degree of leakage:
No leakage -
Minor -
Moderate -
Severe-
NR
Before treatment*: 17 – 11 – 16 – 13 – 4
After treatment: 21 – 12 – 10 – 11 – 6
p value: NR
Mean cost per patient
2007 Euro, cost of 10 sessions.
Before treatment: NR
After treatment: €3,500 (£2,640***)
p value:
Cost-effectivenessNR**
Sensitivity analysis)NR
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Fraundorfer200197
New Zealand

Economic analysis:
Cost consequences

Study design
RCT* 104

Duration of follow-up:
1 year

Discount rates:
Costs: NA
Effects: NA
Patient group: men with urodynamically proved outflow obstruction due to BPH, AUA score of 8 or greater, independent peak urinary flow rate (Qmax) of 15 mL/s or less, and bladder outflow obstruction confirmed by pressure flow urodynamic studies (Schafer grade 2 or more).

All patients
N: 120


Group 1
N: 61
Mean (±SD) Age: 66.9±6.5

Group 2
N: 59
Mean (±SD) Age: 66.8±7.4
Group 1
Holmium laser resection (HoLRP)

Group 2
TURP
Qmax (mL/s) ± SDGroup 1: 25.2 ± 11.9
Group 2: 20.4 ± 8.5
p value: <0.05
Funding:
partially funded by Coherent Medical Group.
Clinical study authors have financial interest and/or other relationship with Lumenis, Inc.

Limitations:
Not a full economic evaluation.
Partially applicable.
In real practice HoLEP might be less successful as it requires high level of skills and experience.

Additional outcomes:
Group 1 had a shorter LOS and lower complication rate.

Notes:
* The two year follow-up study 318 was reviewed for clinical effectiveness
**calculated by using the 2008 PPP
AUA scoreGroup 1: 4.2 ± 6.0
Group 2: 4.3 ± 4.1
p value: Not Sig
Mean cost per patient
2001 NZD cost of consumables, hospital facility use, operations, clinic visits, capital equipment, and unplanned events.
Group 1: 2,012 (£857**)
Group 2: 2,663 (£1,134**)
p value: NR
Cost-effectivenessNA
Sensitivity analysisNR
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Hillman 1996117
USA

Economic analysis:
Cost consequences and cost-effectiveness

Study design
Multicentre
RCT262

Duration of follow-up:
12 months

Discount rates:
Costs: NA
Effects: NA
Patient group: men 55 years or older with a clinical diagnosis of BPH and at least moderate IPSS.

All patients
N: 2084
IPSS: 20.1
Age (mean and range): 65.7 (46 – 94)
Drop outs*: 867

Group 1
N: 1053 (1010 in economic analysis)
IPSS: 20.1
Age (mean): 65.7
Drop outs*: 396

Group 2
N: 1031 (983 in economic analysis)
IPSS: 20.1
Age (mean): 65.7
Drop outs*: 471
Group 1:
Alpha-blockers (Terazosin). 1mg daily for 3days followed by 2mg daily for the remainder of the first 4 weeks. The medication dose was titrated upward at the investigator's discretion until a satisfactory response was achieved (improvement of 35% or more of IPPS).

Group 2:
Placebo
Mean change in IPSS ± SEGroup 1: -7.6 ±0.2
Group 2: -3.7 ±0.2
p value: <0.001
Funding:
Abbott Laboratories, Abbott Park, Illinois.

Limitations:
Partial applicability.
Placebo was used instead of watchful waiting.
Short follow up.

Notes:
*Patients withdrawn because of adverse events and lack of efficacy were respectively 168 and 93 in group 1, and 114 and 220 in group 2 (p<0.001).
**Calculated by using the 2008 PPP
*** calculated by NCGC
Mean change in IPSSQuality of Life ± SEGroup 1: -3.6 ±0.1
Group 2: -1.8 ±0.1
p value: <0.001
Mean cost per patient
1992 USD, cost of visits (home, GP and urologist), inpatient care, medication.
Group 1: $2,932 (£1,865**)
Group 2: $3,404 (£2,165**)
p value: NR
Cost-effectiveness***
incremental cost per IPSS point change
Group 1 dominates Group 2
Sensitivity analysis
one-way SA
Overall results were not sensitive to outlier costs, costs assigned by patient-reported events, regional vs. satellite patients, costs of patients completing a full year of therapy, costs of improperly randomised patients.
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Johansen 2007127
Norway

Economic analysis:
cost analysis

Study design
decision analysis*

Time horizon:
4 years

Discount rates:
Costs: 5%
Effects: NA
Patient group:
men with BPH
Intervention 1:
Alpha-blockers (Tamsulosin)

Intervention 2:
5-Alpha-reductase inhibitors (Dutasteride and Finasteride)

Intervention 3:
TURP
Mean cost per patient over 4 years
2006 NOK, cost of drugs, tests, visits to GP, pre-TURP visits to urologist, TURP, surgical follow-up, prostate cancer evaluation following TURP, post-TURP antibiotics, cost of AUR.
Int 1: 16,933 (£1,219**)
Int 2***: 13,946 (£ 1,004**)
Int 3: 46,109 (£ 3,320**)
p value: NR
Funding:
NR. One of the authors was an employee of GlaxoSmithKline.

Limitations:
Risk of AUR and TURP for Tamsulosin was assumed to be equal to the placebo arm of the trials.

Notes:
*improvement rates, risk of AUR and TURP were taken from Phase-III trials1 for Dutasteride, assumed to be equal for Finasteride. Risk of AUR and TURP of Tamsulosin was assumed to be equal to the placebo arm of those trials. Improvement rate of Tamsulosin was obtained from Phase-III trials and improvement rate of TURP was based on clinical opinion.
** Calculated by using the 2008 PPP
***cost of Dutasteride. Finasteride was more costly than Dutasteride but less costly than Tamsulosin.
Cost-effectivenessNA
Sensitivity analysis
One-way and multi-way SA
The overall results were not sensitive to the following changes in one-way, two-way and multi-way SA:
-

Time-horizon increased to lifetime.

-

Decrease or increase costs of TURP and AUR by 10%.

-

Inclusion of indirect costs.

-

Probability of AUR decreased by 10% after TURP/any intervention.

-

Probability of TURP after AUR reduced by 25%.

-

Decrease symptoms improvement by 10%.

-

Change in discount rate (0-8%).

Study detailsPatientsInterventions*Outcome measuresEffect sizeComments
Johnson 1999128
UK

Economic analysis:
cost-consequences analysis

Study design
decision analysis

Time horizon:
5 years

Discount rates:
Costs: 6%
Effects: 6%
Patient group:
60 years old patients with uncomplicated moderate to severe benign prostatic hyperplasia
Intervention 1:
Watchful waiting. If ineffective it will be followed by second line (Doxazosin or Finasteride) and if necessary surgery.

Intervention 2:
Alpha-blockers (Doxazosin). If ineffective or have side effects it will be followed by second line (Finasteride or watchful waiting) and if necessary surgery.

Intervention 3:
5-alpha-reductase inhibitors (Finasteride). If ineffective or have side effects it will be followed by second line (Doxazosin or watchful waiting) and if necessary surgery.
Patients discontinuing treatment over 5 yearsInt 1: 46.0%
Int 2: 39.1%
Int 3: 42.0%
p value: NR
Funding:
Pfizer International

Limitations:
It was not clear how the response-years gained were calculated.

Notes:
* Surgery was excluded from the interventions compared as this was a mix of TURP and open prostatectomy.
** Obtained from the meta-analysis described by the American Agency for Health Care Policy and Research
Patients with improved symptoms**Int 1: 42%
Int 2: 74%
Int 3: 67%
p value: NR
Improvement in symptom score from baseline**Int 1: 32%
Int 2: 48%
Int 3: 31%
p value: NR
Response-years gainedInt 1: 0.57
Int 2: 0.81
Int 3: 0.60
p value: NR
Mean cost per patient over 5 years
1999 GBP; cost of GP and urologist consultations, laboratory procedures, examinations, medications, surgical procedures, complications.
Int 1: £791
Int 2: £1427
Int 3: £1720
p value: NR
Cost-effectivenessNR
Sensitivity analysis
One-way SA
Results not sensitive to cost of surgery, response rates, discontinuation rates, response degree, and time horizon
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Keoghane2000142
UK

Economic analysis:
cost-effectiveness analysis

Study design
RCT

Duration of follow-up:
36 months (costs only 24 months)

Discount rates:
Costs: NR
Effects: NR
Patient group: all patients presenting for TURP who had not undergone previous surgery.

All patients
N: 152 (100 for cost analysis)
Drop outs: NR

Group 1
N: 47 for cost analysis
AUA score (SD): 19.9 (7.7)

Group 2
N: 53 for cost analysis
AUA score (SD): 19.4 (6.5)
Group 1
Vaporisation using MD60 Nd:YAG (Selected Laser Technologies) with 600 μm fibre incorporating sapphire-tipped probe. Irrigation using saline.

Group 2
TURP in standard manner using Storz equipment and irrigation with glycine
Mean change in AUA 7 symptom score from baseline at 12 months (±SD)Group1: 10.9 ± 8.4 (n=44)
Group 2: 13.3 ± 7.8 (n=53)
p value: not Sig (NCGC-ACC t-test)
Funding:
Oxford Regional Health Authority

Limitations:
Surgeons had limited experience with the laser technique which may have caused the high failure rate with this treatment.

Additional outcomes:
Duration of catheterisation and complications favour Contact Laser.
Reoperation rate was 18% in Group 1 and 9% in Group 2.
Inpatient stay was 3.5 days in Group 1 and 3.9 days in Group 2.

Notes:
* In the study prices were up-rated using the NHS hospital and community price index.
Mean change in AUA 7 symptom score from baseline at 24 months (±SD)Group1: 11.7 ± 9.7 (n=35)
Group 2: 13.7 ± 7.7 (n=47)
p value: not Sig (NCGC-ACC t-test)
Mean change in AUA 7 symptom score from baseline at 36 months (±SD)Group1: 11.0 ± 9.7 (n=37)
Group 2: 12.9 ± 7.9 (n=41)
p value: not Sig (NCGC-ACC t-test)
Change in flow rate (Qmax) from baseline at 3 yearsGroup1: 1.8 ± 6.2 (n=24)
Group 2: 2.1 ± 6.9 (n=24)
p value: Not Sig (NCGC-ACC t-test)
Mean cost per patient at 2 years
1997 GBP*, cost of operation, hospitalisation, outpatient visits, GP and nurse visits, re-operation, capital costs and overheads.
Group 1: £1,252
Group 2: £971
p value: Sig
Cost-effectiveness
cost per change in AUA score
TURP is dominant
Sensitivity analysis
One way
If inpatient stay in Group 1 is reduced to 1.5 days laser becomes less costly by £50.
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Lourenco 2008174
UK

Economic analysis:
Cost-utility analysis

Study design
Decision analysis

Time horizon:
10 years

Discount rates:
Costs: 3.5%
Effects: 3.5%
Patient group:
Men at the age of 70 years with BPE, presence of LUTS with a measure of IPSS>7, no complications and TURP indicated (medical treatment either contraindicated or failed).
Mean start age 70 years.
Intervention 1:
TUVP

Intervention 2:
TUMT

Intervention 3:
HoLEP

Intervention 4:
TURP

Intervention 5:
KTP

Intervention 6:
TUVP followed by HoLEP if it fails

Intervention 7:
TUVP followed by TURP if it fails

Intervention 8:
TUVP followed by repeated TURP if it fails
QALYs*Int 1: 0.3668
Int 2: 0.3625
Int 3: 0.3679
Int 4: 0.3673
Int 5: 0.3631
Int 6: 0.3684
Int 7: 0.3684
Int 8: 0.3684
p value: NR
Funding:
NHS R&D Health Technology Assessment Programme

Limitations:
Cost of equipment was included only for some strategies.
Duration and cost of operations were equal in all the strategies.
Training costs not included.
Some interventions (TURP) are used to identify prostate cancer.
Additional diagnostic tests would be necessary of another strategy is adopted.

Additional outcomes:
Other sequences of treatments starting with TURP or TUMT were dominated.
When compared to TURP alone, only TUVP, KTP and all the strategies involving a second operation starting with TUMT are not cost-effective.

Expected value of partial perfect information was £4,187,062 for TUVP epidemiology and £1,652,886 for HoLEP epidemiology.

Notes:
* results per patient of Monte Carlo simulation with 10,000 samples where 25,000 new individuals enter the model each year.
** Int 8 vs. 6 ICER=£90,576/QALY when results are calculated per population
Mean cost per patient*
2006 GBP, cost of procedure, short-term complications (acute urinary retention, bladder neck contracture or urethral stricture, blood transfusion, transurethral syndrome, urinary tract infections), long-term complications (incontinence: 95% oxybutinin, 5% artificial sphincter), equipment for KTP, HoLEP and TUMT only.
Int 1: £152
Int 2: £155
Int 3: £160
Int 4: £174
Int 5: £223
Int 6: £166
Int 7: £167
Int 8: £167
p value: NR
Cost-effectiveness
incremental cost per QALY
Int 3 vs. Int 1: £7,273
Int 6 vs. Int 3: £12,000
Int 2 dominated by Int 1.
Int 3 vs. Int 2: £833.
Int 4 dominated by Int 3, 6, 7, 8.
Int 5 dominated by any interventions.
Int 7 and 8 dominated by Int 6**.
Sensitivity analysis
Probabilistic sensitivity analysisAt the threshold of £20,000/QALY, Int 6 has a probability of being cost-effective of about 80%.
One way sensitivity analysisIf LOS TURP is 2 days instead of 3 days, Int 8 is cost-effective. Results not sensitive to start age, utility of ‘incontinence no remission’ state = utility of ‘incontinence remission’ state, utility of IPSS<8 is 0.97 instead of 1, risk data from all studies instead of UK studies only, test for obstruction after TUVP.
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
McDonald 2004192
Canada

Economic analysis:
Cost-utility analysis

Study design
Decision analysis*

Time horizon:
15 years

Discount rates:
Costs: 5%
Effects: 5%
Patient group: men 65 years old with moderate to severe symptoms of BPH and an enlarged prostate as determined by digital rectal examination who choose not to undergo immediate surgical treatment.Intervention 1:
Watchful waiting (WW)

Intervention 2:
Alpha-blockers (Doxazosin)

Intervention 3:
5-alpha-reducatse inhibitors (Finasteride)

Intervention 4:
Combination therapy with Doxazosin and Finasteride.
QALYs gainedInt 1: 8.608
Int 2: 8.787
Int 3: 8.709
Int 4: 8.930
p value: NR
Funding:
Merck Frosst Canada Ltd.

Limitations:
Partially applicable.

Additional outcomes:
Incremental cost per AUR averted and incremental cost per TURP averted.

Notes:
* based mainly on the PLESS256 and MTOPS studies191
** GBP calculated by using the 2008 PPP
*** calculated by NCGC
Mean cost per patient**
2003 CAD, cost of drugs (including 10% pharmacy mark-up charge and dispensing fee), visits (one full and one partial per year plus two partial for Group 1), hospitalisation, surgery, surgical complications, tests.
Int 1: $2,254 (£ 1,181)
Int 2: $4,615 (£ 2,418)
Int 3: $6,167 (£ 3,231)
Int 4: $9,477 (£ 4,966)
p value: NR
Cost-effectiveness **
incremental cost per QALY gained
Int 2 vs. Int 1***: $13,190 (£ 6,912)
Int 3 dominated by Int 2.
Int 4 vs. Int 2: $34,000 (£ 17,816)
Sensitivity analysis
One way SA.
Considering only patients with PSA>1.3 ng/ml or PSA >3.2 ng/ml the results were similar.
Results were not sensitive to discounting, probability of TURP following AUR, cost of TURP, cost of AUR.
Combination is no longer cost-effective when AUR rates are obtained from MTOPS instead of PLESS, treatment effect is decreased by 50%, or QALY weights from Baladi199621 are used.
Finasteride is more cost-effective than Doxazosin if it improves IPSS past year 4 by 2 points.
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Medicare Services Advisory Committee198
Australia

Economic analysis:
cost-utility analysis

Study design
Decision analysis

Time horizon:
20 years

Discount rates:
Costs: 5%
Effects: 5%
Patient group:
Patients with symptomatic benign prostatic hyperplasia.
Intervention 1:
TUNA

Intervention 2:
TURP
QALYInt 1: 12.2869
Int 2: 12.3082
p value: NR
Funding:
Report prepared from the National Health and Medical Research Council Clinical Trials Centre, University of Sydney for the Medical Services Advisory Committee.

Limitations:
Utilities were obtained from expert opinion and not elicited with recognised methods.

Notes:
* Calculated by using the 2008 PPP
Mean cost per patient
1999 AUD, cost of procedures, cost of side effects, cost of treatment failure (GP visits, surgery, hospitalisation, medical treatment).
Int 1: $8,296 (£4,165*)
Int 2: $6,910 (£3,469*)
p value: NR
Cost-effectiveness
cost per QALY gained
TURP dominates TUNA
Sensitivity analysis One-way SATUNA is cost-effective when either: probability that TURP fails within 6 months ≥20%; time horizon = 5 years; annual failure rate of TUNA ≤ 2.4%; probability of having TURP after TUNA fails =100%
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Murray2001207
UK

Economic analysis:
cost consequences analysis

Study design
RCT

Duration of follow-up:
9 months

Discount rates:
Costs: NA
Effects: NA
Patient group:
Men with benign prostatic hypertrophy in 33 general practices in the UK.

All patients
N: 112
Drop outs: 10

Group 1
N: 57
Age (mean +/- SD): 63.7 +/- 8.4
Drop outs: 3
Mean (SD) American Urological Association score: 15.64 (6.57)

Group 2
N: 55*
Age (mean +/- SD): 63.9 +/- 8.4
Drop outs: 7
Mean (SD) American Urological Association score: 14.85 (7.10)
Group 1:
Interactive multimedia programme with booklet and printed summary. Treatment options discussed were surgery, balloon dilatation of the prostate, drugs, and watchful waiting. Information comprised probabilities of the risks and benefits of each treatment, calculated on the basis of information on age, severity of symptoms, and general health entered by the patient at the beginning of the session. All patients saw the core interactive video disc, lasting about 45 minutes; viewing optional sections for further information took up to 60 min. more. A research nurse started the programme, taught the patient how to use it, and then withdrew.

Group 2:
Normal care from GP practitioner.
Mean (SD) decisional conflict score at nine monthsGroup 1: 2.23 (0.38)
Group 2: 2.55 (0.50)
p value: sig
Funding:
NHS national research and development programme, the BUPA Foundation, and the King's Fund.

Limitations:
Results on EQ-5D scores were not reported. The intervention might be different to the clinical practice with a consequent overestimation of costs.

Additional outcomes:
No difference in health utility scores (EQ-5D) and anxiety scores (data not provided). Mean decisional conflict score at 3 months (-0.3).
GPs and patients' perception of decision making at 3months was significantly different between the two groups with higher proportion of GPs and patients perceiving that the treatment decision had been mainly or only by the patients in Group 1.

Notes:
*Only 48 included in the economic analysis
Median change in American Urological Association scoresGroup 1: -1
Group 2: -2
p value: 0.8
Mean cost per patient
1999 GBP, Cost of equipment and staff time, consultations with GPs, referrals to urologists, other referrals, drugs, tests, diagnostic and surgical procedures.
Group 1: 594
Group 2: 188
p value: <0.001
Cost-effectivenessNR
Sensitivity analysisNR
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Nathan 1996211
UK

Economic analysis:
cost consequence

Study design
(e.g. RCT, Decision analysis, etc)

Duration of follow-up:
3 months

Discount rates:
Costs:
Effects:
Patient group: men requiring TURP

All patients
N: 40
Drop outs: 0

Group 1
N: 20
Mean age (range): 65.4 (57-77)
Mean IPSS score: 21.9 ± 4.2
Mean IPSS QoL ± SD: 4.9 ± 0.7
Mean Qmax ml/s (± SD): 10.2 ± 4.4
Drop outs: 0

Group 2:
N: 30
Mean age (range): 69.2 (57-81)
Mean IPSS score: 17.0 ± 4.3
Mean IPSS QoL ± SD: 4.9 ± 0.7
Mean Qmax ml/s (± SD): 7.2 ± 3.5
Drop outs: 0
Group 1:
Transurethral electrovaporisation of the prostate (TVP)

Group 2:
TURP
Mean IPSS score at 3 months (follow up interval not clear)Group 1: 2.86 ± 2.8
Group 2: 3.1 ± 2.3
p value: NR
Funding:
NR

Limitations:
Cost components included in the analysis were only those that significantly differed between interventions.

Additional outcomes:
There were more complications in the TURP group. There was no statistically significant or appreciable difference in the success rates among the two groups.
Mean IPSS QoL score at 3 months (follow up interval not clear)Group 1: 0.5 ± 7
Group 2: 0.9 ± 0.9
p value: NR
Mean Qmax ± SD mL/s at 3 months (follow up interval not clear)Group 1: 21.3 ± 5.9
Group 2: 20.6 ± 2.6
p value: NR
Mean cost per patient
1996 GBP, cost of fibres and consumables, transfusions, and hospital stay.
Group 1: £1,730
Group 2: £2,373
p value: NR
Cost-effectivenessNR
Sensitivity analysisNR
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Noble 2002222
UK

Economic analysis:
Cost-consequences analysis

Study design
RCT74

Duration of follow-up:
7.5 months

Discount rates:
Costs: NA
Effects: NA
Patient group: men with uncomplicated lower urinary tract symptoms (no acute or chronic urinary retention)

All patients
N: 340
Drop outs:

Group 1
N: 117
Dropouts: 1/117
Age, mean (±SD): 67.4±8.1
IPSS, mean (±SD): 19.1±6.6
IPSS-QoL, median(range): 4(2-6)

Group 2
N: 117
Dropouts:2/117
Age, mean (±SD): 66.4±7.9
IPSS, mean (±SD): 19.2±6.7
IPSS-QoL, median(range): 4(0-6)

Group 3
N: 106
Dropouts: 5/106
Age, mean (±SD): 67.2±7.8
IPSS, mean (±SD): 18.8±6.5
IPSS-QoL, median(range): 4(1-6)
Group 1:
Laser therapy with a noncontact side firing neodymium:YAG probe

Group 2:
Standard transurethral prostate resection

Group 3:
conservative management
Mean difference in IPSS from baselineGroup 1: -10.8
Group 2: -12.3
Group 3: -1.3
p value: NR
Funding:
Bard UK provided the laser fibres. South West and Northern Regional National Health Service Research and Development Directorates.

Limitations:
Resource use data were available only for 30% of the patients population.
The conclusions of the study were incorrect.

Additional outcomes:
Patient costs were higher for noncontact laser.

Notes:
* calculated by NCGC using mean cost and mean change in health-related quality of life utility
Mean difference in IPSS quality of life from baselineGroup 1: -1.9
Group 2: -2.2
Group 3: -1.3
p value: NR
Mean change in QALY from baselineGroup 1: 0.044
Group 2: 0.016
Group 3: - 0.001
p value: NR
Mean cost per patient
1998 GBP, cost of resources used in investigations, staff time, equipment, medication, hospital stay, rehospitalisation for catheter-free trial, other rehospitalisation, outpatient visits, GP and nursing visits, consumables (catheter bags, pads and other aids)
Group 1: £1,223
Group 2: £928
Group 3: £45
p value: NR
Cost-effectiveness*
cost per QALY gained
Group 1 vs. Group 2: £10,536
Group 1 vs. Group 3: £26,178
Sensitivity analysis
one-way
Cost of probes, their multiple use, and machinery lifetime were varied with no considerable difference in results.
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Norby2002223
Denmark

Economic analysis:
CEA

Study design
RCT224

Duration of follow-up:
6 months

Discount rates:
Costs: NA
Effects: NA
Patient group: Men ≥ 50 years between May 1996 and November 1999.

All patients*
N: 113

Group 1
N: 45
IPSSSD): 21.4 ±5.8

Group 2
N: 46
IPSSSD): 20.5 ±5.7
Group 1:
Interstitial laser coagulation (ILC).

Group 2:
Transurethral microwave thermotherapy (TUMT).
Mean difference in IPSS at 6 months from baselineSD)Group 1: 12.0 ±7.5
Group 2: 11.2 ±9.2
p value: Not sig
Funding:
Vejle County, Denmark.

Limitations:
Small sample size for economic analysis.
Short follow-up.
Limited applicability.

Notes:
* 22 patients were randomised to a mix of TUIP and TURP and therefore excluded. In the results this group dominates Group 1.
**ITT analysis was used for clinical outcomes but not for costs
**Data collected in 20 patients only.
*** Calculated by using the 2008 PPP
****Incremental analysis done by NCGC
Mean cost per patient**
1999 DKK, cost of hospitalisation, medications, examinations, follow-up visits, GP visits, nurse visits, and re-operations.
Group 1: 14,398 (£1,152***)
Group 2: 10,508 (£841***)
p value: NR
Cost-effectiveness****
cost per 1-point of reduction in IPSS
Group 1 vs. Group 2: DKK 4,862 (£ 388***) per point
Sensitivity analysis
One way
If TUMT catheters were reused once, Group 1 vs. Group 2 ICER = DKK 7,981 (£ 638***)
If ITT analysis is applied, Group 1 vs. Group 2 ICER = DKK 4,161 (£ 332***)
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Salonia 2006267
Italy

Economic analysis:
cost analysis

Study design
RCT

Duration of follow-up:
NR

Discount rates:
Costs: NR
Effects: NR
Patient group: consecutive patients with symptomatic benign prostatic hyperplasia in a large prostate (70 to 220 g) and documented bladder outlet obstruction.

All patients
N: 63


Group 1
N: 29
IPSS: 21.6
Age (mean): 68.0
Drop outs:

Group 2
N: 34
IPSS: 19.6
Age (mean): 67.4
Drop outs:
Group 1:
Open prostatectomy

Group 2:
HoLEP
Operative time (minutes)Group 1: 57.5
Group 2: 73.4
p value: 0.002
Funding:
Scientific Institute San Raffaele Hospital, Milan

Limitations:
Partial applicability.

Additional outcomes:
The amount of unplanned events was not significantly different.

Notes:
*calculated byvusing the 2008 PPP
Catheterisation time (hours)Group 1: 106.3
Group 2: 35.3
p value: 0.0001
Hospital stay (hours)Group 1: 131.0
Group 2: 64.6
p value: <0.0001
Mean cost per patient
2004 Euro, costs associated with the procedures (operating room time, disposables, blood transfusion) and hospital stay. Medical salaries were not included. Capital cost for HoLEP was 85% of actual capital cost. Holmium fibres were used at least 10 times.
Group 1: 2,869 (£2,079*)
Group 2: 2,356 (£1,708*)
p value: NR
Cost-effectivenessNR
Sensitivity analysisNR
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Stovsky2006288
USA

Economic analysis:
Cost consequences analysis

Study design
Decision analysis

Time horizon:
2 years

Discount rates:
Costs: NR
Effects: NR
Patient group:
patients with lower urinary tract symptoms indicative of BOH requiring procedural management with of the interventions indicated.
Intervention 1:
Photoselective vaporisation

Intervention 2:
TURP

Intervention 3:
TUNA

Intervention 4:
TUMT Targis

Intervention 5:
TUMT Prostatron 2.5
% change from baseline IPSS at 2 yearsInt 1: 76
Int 2: 66
Int 3: 44
Int 4: 46
Int 5: 39
p value: NR
Funding:
All the authors had financial interest and/or relationship with Laserscope

Limitations:
Discount rate NR.
Partially applicable: cost of inpatient stay in the USA is higher than in the UK, which favours laser.

Additional outcomes:
Qmax and QoL were also reported. The cost-effectiveness results did not change if those outcomes were used.

Notes:
* based on the assumption that PVP was performed in a hospital outpatient setting, TUNA and TUMT at a physician office site of service, TURP in a hospital inpatient setting, ILC at a physician office site of service (86%), ambulatory surgery centre (9%) and hospital outpatient setting (5%)
** converted into GBP by using the 2008 PPP
***incontinence, UTI, impotence, dysuria/irritative voiding, bladder neck stenoisis/stricture, urinary retention, hematuria
**** calculated by NCGC-ACC
% change from baseline Quality of Life score at 2 yearsInt 1: 83
Int 2: 73
Int 3: 61
Int 4: 52
Int 5: 24
p value: NR
% Qmax at 2 years from baselineInt 1: 221
Int 2: 117
Int 3: 28
Int 4: 45
Int 5: 45
p value: NR
Mean cost per patient*
2005 USD**, cost of intervention, follow-up care, adverse events***, re-treatment. Cost of pharmacological therapy not included.
Int 1: $ 3,589 (£ 2,315)
Int 2: $ 4,927 (£ 3,178)
Int 3: $ 6,179 (£ 3,985)
Int 4: $ 5,699 (£ 3,676)
Int 5: $ 5,488 (£ 3,562)
p value: NR
Cost-effectiveness****
cost per 1-point of %reduction in IPSS
Intervention 2 dominates Interventions 3, 4 and 5.
Intervention 1 dominates all the other interventions, including 2.
Sensitivity analysis
One way
Threshold SA
If ILC performed in a less costly setting, it is still dominated by PVP.
When retreatment rate of PVP = 17%, PVP and TURP are cost equivalent.

From: Appendix D, Evidence Tables

Cover of The Management of Lower Urinary Tract Symptoms in Men
The Management of Lower Urinary Tract Symptoms in Men [Internet].
NICE Clinical Guidelines, No. 97.
National Clinical Guideline Centre (UK).
Copyright © 2010, National Clinical Guideline Centre.

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