Cost-effectiveness analysis of minimally invasive surgical treatments for benign prostatic hyperplasia: implications for Japan’s public healthcare system

Figures & data

Figure 1. Markov state transition.

Table 1. IPSS change from baseline to year 5 from the random-effects NMA model^27,28.

	Baseline	3 months	6 months	1 year	2 years	3 years	4 years	5 years
WAVE	22.0	10.6	9.8	10.3	10.2	10.5	11.4	11.1
± SD	4.8	6.4	6.2	6.7	6.2	6.1	7.4	7.8
PUL	22.0	10.9	10.5	11.6	11.5	11.8	12.7	12.4
± SD	4.8	6.4	6.2	7.0	6.5	6.4	7.7	8.1

Abbreviations. IPSS, International Prostate Symptom Score; NMA, network meta-analysis; PUL, prostatic urethral lift; WAVE, water vapor energy therapy.

Table 2. AE rates.

WAVE AEs						PUL AEs
Periprocedural AEs	0–3 months	4–6 months	7–9 months	10–12 months	13–60 months	Periprocedural AEs	0–3 months	4–6 months	7–9 months	10–12 months	13–60 months
Immediate acute urinary retention^29	3.7%	NA	NA	NA	NA	Immediate acute urinary retention^23^,^30	0.7%	NA	NA	NA	NA
Short-term AEs	0–3 months	4–6 months	7–9 months	10–12 months	13–60 months	Short-term AEs	0–3 months	4–6 months	7–9 months	10–12 months	13–60 months
Bladder spasm* [n/a]	0.0%	0.0%	0.0%	0.0%	0.0%	Bladder spasm^30	3.6%	0.2%	0.2%	0.2%	0.0%
Urinary retention^29	3.7%	0.0%	0.0%	0.0%	0.0%	Urinary retention^30	0.7%	0.2%	0.2%	0.2%	0.0%
Urinary tract infection^29	3.7%	0.0%	0.0%	0.0%	0.0%	Urinary tract infection^30	2.9%	0.0%	0.0%	0.0%	0.0%
Pelvic pain^29	2.9%	0.0%	0.0%	0.0%	0.0%	Pelvic pain^30	17.9%	0.5%	0.5%	0.5%	0.0%
Hematuria^29	11.8%	0.0%	0.0%	0.0%	0.0%	Hematuria^30	25.7%	0.2%	0.2%	0.2%	0.0%
Dysuria^29	16.9%	0.2%	0.2%	0.2%	0.0%	Dysuria^30	34.3%	0.2%	0.2%	0.2%	0.0%
Urinary urge incontinence^29	0.0%	0.0%	0.0%	0.0%	0.0%	Urinary urge incontinence^30	3.6%	0.2%	0.2%	0.2%	0.0%
Frequency and urgency^29	5.9%	0.0%	0.0%	0.0%	0.0%	Frequency and urgency^30	7.1%	0.7%	0.7%	0.7%	0.0%
Encrusted implants [n/a]	0.0%	0.0%	0.0%	0.0%	0.0%	Encrusted implants^30	1.8%	1.8%	1.8%	1.8%	0.0%
Long-term AEs	0–3 months	4–6 months	7–9 months	10–12 months	13–60 months	Long-term AEs	0–3 months	4–6 months	7–9 months	10–12 months	13–60 months
Urinary incontinence^31	0.4%	0.4%	0.4%	0.4%	0.0%*	Urinary incontinence^33	1.3%	1.3%	1.3%	1.3%	1.3%

Abbreviations. AE, adverse event; PUL, prostatic urethral lift; WAVE, water vapor energy therapy.

*No AE was identified from published literature; 0.0% was assumed.

Table 3. Durability of treatment rates (proportions of patients without surgical retreatment)^22,36.

Proportion of patients without surgical retreatment	3 months	6 months	9 months	1 year	2 years	3 years	4 years	5 years
WAVE	98.7%	98.2%	97.9%	97.6%	96.7%	96.1%	95.5%	95.1%
PUL	98.4%	97.1%	96.0%	94.9%	91.0%	87.4%	84.0%	80.8%

Abbreviations. PUL, prostatic urethral lift; WAVE, water vapor energy therapy.

Table 4. Health state utilities.

	Source	Utility	Assumption
Treatment
WAVE	Assumption; Ackerman^38	−0.03	The disutility of transurethral microwave thermotherapy was applied
PUL	Assumption; Ackerman^38	−0.03	The disutility of transurethral microwave thermotherapy was applied
TURP	Bjerklund^39; Cher^40	−0.05	Apply the disutility score for 30 days
Catheterization	Chen^41	−0.05	The disutility value was derived from utility for improved urinary incontinence (0.92–0.87)
Health States
BPH Mild	Baladi^42	0.99	NA
BPH Moderate	Baladi^42	0.90	NA
BPH Severe	Baladi^42	0.79	NA
Death	NA	0
Periprocedural AEs
Immediate acute urinary retention	Ackerman^38	−0.18	NA
Short-term AEs
Bladder spasm	Ackerman^38	−0.06	NA
Urinary retention	Ackerman^38	−0.18	NA
Urinary tract infection	Ackerman^38	−0.07	NA
Pelvic pain	Assumption; Ackerman^38	−0.03	The disutility value of dysuria was used.
Hematuria	Assumption; Rognoni^43	−0.20	The disutility value of urinary urge incontinence was used.
Dysuria	Ackerman^38	−0.03	NA
Urinary urge incontinence	Ackerman^38	−0.20	NA
Frequency and urgency	Assumption; Ackerman^38	−0.03	The disutility value of dysuria was used
Encrusted implants	Assumption; Ackerman^38	−0.03	The disutility of transurethral microwave thermotherapy was applied
Long-term AEs
Urinary incontinence	Ackerman^38	−0.20	NA

Abbreviations. AE, adverse event; BPH, benign prostatic hyperplasia; PUL, prostatic urethral lift; TURP, transurethral resection of the prostate; WAVE, water vapor energy therapy.

Table 5. WAVE vs. PUL cost inputs for one procedure (in Japanese Yen).

Fee category	Description of specific fees	WAVE	PUL with 4.9^23 implants
Technical fee	Technical fee	123,000	123,000
	Material fee used in a surgical operation	390,378	482,378
	Drug fee used in a surgical operation	1,301	1,301
	Sum of technical fee	514,679	606,679
Anesthesia fee	General anesthesia	829	14,580
	Epidural anesthesia	–	–
	Spinal anesthesia	1,751	–
	IV anesthesia	396	–
	Local anesthesia	5,225	5,527
	General + epidural anesthesia	–	–
	Sum of anesthesia fee	8,201	20,107
Hospital fee	Hospital fee (DPC fee)	142,474	142,474
Total fee	Total treatment fee	665,354	769,260

Abbreviations. DPC, diagnosis procedure combination; IV, intravenous; PUL, prostatic urethral lift; WAVE, water vapor energy therapy.

Table 6. AE treatment cost inputs (in Japanese Yen) [Source: National lists of Medical Fee Points in Japan].

AE category	AE list	Costs	Codes or descriptions
Periprocedural AEs	Immediate acute urinary retention	¥76,110	DPC (110200xx02xxxx), extended length of stay 3 days
Short-term AEs	Bladder spasm	¥22,491	Tamsulosin tablets 0.2 mg 2 times/day for 5 days, Mirabegron tablets 25 mg once per day for 5 days 2 times office visit, 2 times checkup/diagnosis service, one prescription/dispensing service
	Urinary retention	¥21,800	Urethral dilatation (J066) 2 times office visit, 2 times checkup/diagnosis service
	Urinary tract infection	¥23,026	Clarithromycin antibiotic tablets 200 mg 2 times/day for 14 days 2 times office visit, 2 times checkup/diagnosis service, one prescription/dispensing service
	Pelvic pain	¥22,742	Paracetamol tablets 400 mg 3 times/day for 14 days 2 times office visit, 2 times checkup/diagnosis service, one prescription/dispensing service
	Hematuria	¥19,640	2 times office visit, 2 times checkup/diagnosis service
	Dysuria	¥22,206	Tamsulosin tablets 0.2 mg 2 times/day for 10 days 2 times office visit, 2 times checkup/diagnosis service, one prescription/dispensing service
	Urinary urge incontinence	¥23,843	Mirabegron tablets 25 mg once per day for 14 days 2 times office visit, 2 times checkup/diagnosis service, one prescription/dispensing service
	Frequency and urgency	¥23,843	Mirabegron tablets 25 mg once per day for 14 days 2 times office visit, 2 times checkup/diagnosis service, one prescription/dispensing service
	Encrusted implants	¥230,240	DPC (11013xxx97xxxx), length of stay 4 days Removal of debris in posterior urethra (K8152), Anesthesia (L0085)
Long-term AEs	Urinary incontinence	¥112,062	Solifenacin tablets 5 mg once per day for 365 days or Mirabegron tablets 25 mg once per day for 365 days According to expert assumption, solifenacin for urgency urinary incontinence: mirabegron for stress urinary incontinence = 2:1

Abbreviation. AE, adverse event.

Table 7. Base case results.

	Total Costs, ¥	Incremental Costs, ¥	Total QALYs	Incremental QALYs	ICER WAVE vs. PUL
1 Year
PUL	888,110	–	0.911	–	–
WAVE	734,134	−153,976	0.920	0.009	Dominant
2 Years
PUL	926,265	–	1.797	–	–
WAVE	750,874	−175,391	1.816	0.019	Dominant
3 Years
PUL	960,777	–	2.658	–	–
WAVE	765,397	−195,380	2.687	0.029	Dominant
4 Years
PUL	992,463	–	3.488	–	–
WAVE	778,515	−213,948	3.527	0.039	Dominant
5 Years
PUL	1,022,448	–	4.287	–	–
WAVE	791,069	−231,379	4.335	0.048	Dominant
Lifetime
PUL	1,429,458	–	15.388	–	–
WAVE	961,595	−467,864	15.564	0.176	Dominant

Abbreviations. ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life year; PUL, prostatic urethral lift; WAVE, water vapor energy therapy.

Figure 2. One-way sensitivity analyses (OWSAs).

Abbreviations. ICER, incremental cost-effectiveness ratio; LUTS, lower urinary tract symptoms; OWSA, one-way sensitivity analysis; PUL, prostatic urethral lift; QALY, quality-adjusted life year; TURP, transurethral resection of the prostate; WAVE, water vapor energy therapy.

Figure 3. Probabilistic sensitivity analyses (PSAs) scatter plots comparing WAVE versus PUL at 5-year and lifetime horizons.

Abbreviations. QALY, quality-adjusted life year; PSA, probabilistic sensitivity analysis; PUL, prostatic urethral lift, WAVE, water vapor energy therapy.

Figure 4. Cost-effectiveness acceptability curves (CEACs) at different time horizons.

Abbreviations. CEAC, cost-effectiveness acceptability curve; CI, confidence interval; PUL, prostatic urethral lift; QALY, quality-adjusted life year; WAVE, water vapor energy therapy.

Chughtai B, Rojanasarot S, Neeser K, et al. Cost-effectiveness and budget impact of emerging minimally invasive surgical treatments for benign prostatic hyperplasia. J Health Econ Outcomes Res. 2021;8(1):42–50. doi: 10.36469/jheor.2021.22256.

 PubMedGoogle Scholar

Chughtai B, Rojanasarot S, Neeser K, et al. A comprehensive analysis of clinical, quality of life, and cost-effectiveness outcomes of key treatment options for benign prostatic hyperplasia. PLoS One. 2022;17(4):e0266824. doi: 10.1371/journal.pone.0266824.

 PubMed Web of Science ®Google Scholar

McVary KT, Gange SN, Gittelman MC, et al. Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2016;195(5):1529–1538. doi: 10.1016/j.juro.2015.10.181.

 PubMed Web of Science ®Google Scholar

Roehrborn CG, Barkin J, Gange SN, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017;24(3):8802–8813.

 PubMed Web of Science ®Google Scholar

Roehrborn CG, Gange SN, Shore ND, et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. J Urol. 2013;190(6):2161–2167. doi: 10.1016/j.juro.2013.05.116.

 PubMed Web of Science ®Google Scholar

Dixon CM, Cedano ER, Pacik D, et al. Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia. Res Rep Urol. 2016;8:207–216. doi: 10.2147/RRU.S119596.

 PubMed Web of Science ®Google Scholar

National Institute for Health and Care Excellence (NICE). Lower urinary tract symptoms in men: management – Clinical guideline [CG97] 2015 [cited 2023 Aug 9]. Available from: https://www.nice.org.uk/guidance/cg97

 Google Scholar

McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-year outcomes of the multicenter randomized Sham-controlled trial of a water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2021;206(3):715–724. doi: 10.1097/JU.0000000000001778.

 PubMedGoogle Scholar

新医療機器の承認に関する情報. 新医療機器の承認に関する情報 2023.

 Google Scholar

Ackerman SJ, Rein AL, Blute M, et al. Cost effectiveness of microwave thermotherapy in patients with benign prostatic hyperplasia: part I-methods. Urology. 2000;56(6):972–980. doi: 10.1016/s0090-4295(00)00828-1.

 PubMed Web of Science ®Google Scholar

Bjerklund Johansen TE, Baker TM, Black LK. Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the combination of avodart and tamsulosin trial. BJU Int. 2012;109(5):731–738. doi: 10.1111/j.1464-410X.2011.10511.x.

 PubMed Web of Science ®Google Scholar

Cher DJ, Miyamoto J, Lenert LA. Incorporating risk attitude into Markov-process decision models: importance for individual decision making. Med Decis Making. 1997;17(3):340–350. doi: 10.1177/0272989X9701700311.

 PubMed Web of Science ®Google Scholar

Chen HW, Bercik RS, Werner EF, et al. Cost-effectiveness of percutaneous tibial nerve stimulation versus extended release tolterodine for overactive bladder. J Urol. 2012;187(1):178–184. doi: 10.1016/j.juro.2011.09.052.

 PubMed Web of Science ®Google Scholar

Baladi J-F, Menon D, Otten N. An economic evaluation of finasteride for treatment of benign prostatic hyperplasia. Pharmacoeconomics. 1996;9(5):443–454. doi: 10.2165/00019053-199609050-00007.

 PubMed Web of Science ®Google Scholar

Rognoni C, Tarricone R. Healthcare resource consumption for intermittent urinary catheterization: cost-effectivness of hydrophilic catheters and budget impact analysis. BMJ Open. 2017;7(1):e012360. doi: 10.1136/bmjopen-2016-012360.

 PubMed Web of Science ®Google Scholar