Cost-effectiveness analysis of pediatric immunization program with 15-valent pneumococcal conjugate vaccine in Japan

Figures & data

Figure 1. Decision analytic model of pediatric pneumococcal vaccination.

Abbreviations: V114: 15-valent pneumococcal conjugate vaccine; PCV13: 13-valent pneumococcal conjugate vaccine.

Table 1. Model inputs on pneumococcal disease incidence and case fatality rates, health utilities and costs.

	Input value
	Age group (years)
Parameters	0–1	1–2	2–5	5–18	18–35		35–50	50–65	65–75	75–85	85–100
Epidemiological inputs
PD annual incidence rates (per 100, 000)
IPD
IPD that is meningitis^a^,^b	0.5	0.5	0.5	0.2	0.2		0.2	0.2	0.3	0.3	0.3
IPD that is bacteremia without focus^a^,^c	5.8	5.8	5.8	0.1	0.1		0.1	0.1	1.5	1.5	1.5
IPD that is bacteremic pneumonia^a,c	1.3	1.3	1.3	0.5	0.5		0.5	0.5	2.0	2.0	2.0
PMS^d
% meningitis cases leading to neurological deficits	11.7	11.7	11.7	11.7	–		–	–	–	–	–
% meningitis cases leading to hearing loss	3.8	3.8	3.8	3.8	–		–	–	–	–	–
Inpatient NBPPe	539.3	561.6	464.6	5.7	11.8		11.8	89.6	436.1	1,217.4	1,414.8
Outpatient NBPP^e	280.8	280.8	280.8	20.0	53.7		53.7	69.9	73.6	37.0	4.0
Simple pneumococcal AOM^f	827.9	1,886.6	915.3	79.6	–		–	–	–	–	–
Recurrent pneumococcal AOM^f	72.1	176.9	75.3	6.6	–		–	–	–	–	–
Case fatality ratios
Meningitis^g	0.05	0.05	0.05	0.07	0.07		0.07	0.07	0.12	0.12	0.12
Bacteremia without focus/ bacteremic pneumonia^h	0.04	0.04	0.04	0.14	0.14		0.14	0.14	0.19	0.19	0.19
Inpatient NBPP^i	–	–	–	–	0.003		0.009*	0.023*	0.800	2.200	6.800
Utility inputs
	Age group (years)
	0–19	20–29	30–39	40–49		50–59	60–69	70–79	80–100
Health state utility values
Baseline (general population without PD)^j	0.9724	0.9520	0.9485	0.9460		0.9278	0.9285	0.8826	0.7980
PMS, neurological deficits^k	0.68
PMS, hearing loss^k	0.73
	Age group (years)
	0–18	18–100
QALY decrements related to each episode of PD events^l
Meningitis	0.0230	0.0709
Bacteremia without focus	0.0080	0.0709
Bacteremic pneumonia	0.0080	0.1300
Inpatient NBPP	0.0060	0.1300
Outpatient NBPP	0.0040	0.1300
Simple AOM	0.0050	–
Recurrent AOM	0.0050	–
Cost inputs
Vaccine Costs (in 2022 ¥)
Vaccine acquisition costs (per dose)^m
PCV13		7,200
V114		7,200
Vaccine administration costs (per dose)^n
PCV13		4,400
V114		4,400
	Age group (years)
	0–1	1–2	2–5	5–18		18–35	35–50	50–65	65–75	75–85	85–100
Costs per episode of PD events (in 2022 ¥)
Direct medical costs^o
Meningitis	819,243	819,243	813,915	741,301		539,339	539,339	539,339	499,997	499,997	499,997
Bacteremia without focus	402,734	402,734	385,855	329,291		801,931	801,931	801,931	875,430	875,430	875,430
Bacteremic pneumonia	143,878	142,151	142,151	142,151		376,903	376,903	376,903	552,340	552,340	552,340
Inpatient NBPP	143,878	142,151	142,151	142,151		312,202	312,202	312,202	478,538	478,538	478,538
Outpatient NBPP	26,919	26,919	27,629	16,419		33,923	33,923	33,923	33,923	33,923	33,923
Simple AOM	30,737	33,930	78,509	44,291		–	–	–	–	–	–
Recurrent AOM	30,737	33,930	78,509	44,291		–	–	–	–	–	–
Indirect costs^p
Meningitis	187,016	187,016	187,016	187,016		299,728	459,965	450,756	344,486	333,188	333,188
Bacteremia without focus	101,193	101,193	101,193	101,193		277,819	426,343	417,807	319,305	308,833	308,833
Bacteremic pneumonia	90,946	90,946	90,946	90,946		211,156	324,043	317,555	235,600	227,874	227,874
Inpatient NBPP	90,946	90,946	90,946	90,946		165,063	253,307	248,235	235,600	227,874	227,874
Outpatient NBPP	12,809	12,809	12,809	12,809		–	–	–	–	–	–
Simple AOM	28,180	28,180	28,180	28,180		–	–	–	–	–	–
Recurrent AOM	28,180	28,180	28,180	28,180		–	–	–	–	–	–
	Age group (years)
	0–1	2–15	16–19	20–24		25–34	35–44	45–54	55–64	65–74	75–100
Annual costs of PMS and premature death (in 2022 ¥)
Direct medical costs of PMS^q
PMS, neurological deficits	505,374	435,911*
PMS, hearing loss	76,311	74,999*
Costs of premature death
Annual earnings (in 2022 ¥)^r	–	–	424,107	1,892,936		2,693,717	3,250,851	3,670,283	3,044,312	1,221,045	304,845

Abbreviations: IPD: invasive pneumococcal disease; NBPP: Non-bacteremic pneumococcal pneumonia; AOM: acute otitis media; PMS: post meningitis sequelae; QALY: Quality-adjusted life year; PCV13: 13-valent pneumococcal conjugate vaccine; V114: 15-valent pneumococcal conjugate vaccine; NIID: National Institute of Infectious Disease; MHLW: Ministry of Health, Labour and Welfare; NHI: National Health Insurance; JPY: Japanese Yen; DPC: diagnostic procedure code.

Notes:

^a For individuals aged <5 years, annual IPD incidence rates were estimated using the overall IPD incidence rate and the distribution of different IPD types published by the NIID.^37,38 For the age groups >65, the rates were obtained from the Infectious Agents Surveillance Report (2023).³⁸

^b For the age groups between 5 and 65 years, annual meningitis incidence rates were sourced from Chang et al.³⁹

^c For the age groups between 5 and 65 years, annual incidence rates for bacteremia without focus and bacteremic pneumonia were estimated using the number of non-immonocomprised patients from Fukusumi et al.⁴⁰ and Tamura et al.¹⁵.

^d The percentages of individuals with meningitis who developed PMS for the age groups less than 18 years were obtained from Iwata et al.¹⁰

^e Annual incidence rates for NBPP by age group were estimated multiplying all-cause pneumonia incidence rate with the percentage of pneumonia incidence attributable to S. pneumoniae in the corresponding age group.^11,41 The incidence rates of all-cause pneumonia were sourced to from Takeuchi et al.¹¹ for age < 18 years and from Morimoto et al.⁴¹ for age ≥ 18 years. The proportions of inpatient and outpatient NBPP were derived from e-stat³⁵. For age groups <5 years, the percentage of inpatient pneumonia attributable to S. pneumoniae was obtained from Okada et al.⁴²; for outpatient pneumonia, the percentage was assumed to be 14.5%. For age groups ≥18 years and 5–18 years, the percentages of pneumonia incidence attributable to S. pneumoniae were obtained from Morimoto et al.⁴¹ and Takeuchi et al.¹¹, respectively.

^f All-cause AOM rates were obtained from the Sado Otitis Media Study.⁴³ The proportions of recurrent AOM (including tube placement) were obtained from Otsuka et al.⁴³ and Yamanaka et al.⁴⁴ and were applied to estimate the incident rates for simple and recurrent AOM. The percentage attributable to S. pneumoniae was 10.1% for simple AOM and 0.7% for recurrent AOM⁴⁵ and were multiplied by the all-cause simple and recurrent AOM incidence rates, respectively, to estimate simple and recurrent pneumococcal AOM incidence rates.

^g The case fatality ratios of meningitis for children <5 years were obtained from Iwata et al.¹⁰; those for the age groups ≥5 years were obtained from Chang et al.³⁹

^h The case fatality ratios of bacteremia without focus and bacteremic pneumonia for children <5 years were obtained from Nakano et al.⁴⁶; those for the age groups ≥5 years were obtained from Chang et al.³⁹

ⁱ The case fatality ratios of inpatient NBPP were obtained from Tashiro et al.⁴⁷ for the age groups 18–64 years, and from Morimoto et al.⁴¹ for the age groups ≥65 years. *0.009 was the case fatality rate for the age group of 35–55 years and 0.023 was the case fatality rate for the age group of 55–65 years. For patients ≤18 years, the model assumed no case fatality associated with inpatient NBPP compared to the background mortality rates.

^j The baseline utility values for the individuals without PD in Japan were reported by Shiroiwa et al.⁵⁷. Weighted average utilities of male and female populations were estimated for each age group.

^k Health state utilities for PMS were obtained from the study by Rubin et al.⁵⁸.

^l For children under 18 years old, the QALY decrements of IPD, pneumonia, and AOM were obtained from the study by Rubin et al.⁵⁸ For individuals 18 years and older, the QALY decrements were obtained from the studies by Mangen et al.⁵⁹ and Glick et al.⁶⁰

^m The vaccine acquisition cost for PCV13 was obtained from the MHLW data.⁶² Price parity was assumed for V114.

ⁿ Vaccine administration costs were estimated based on the MHLW guidance report and the NHI treatment fee schedule^{9, 63}, and included outpatient pediatric visit fee, injection fee, vaccine premium and consumer tax.

^o For the age groups <5 years, the costs for meningitis, bacteremia without focus, simple AOM and recurrent AOM were obtained from Hoshi et al.⁶⁴ For the age group 5–18 years, the costs for meningitis, bacteremia without focus, outpatient pneumonia and AOM were derived from Shiragami et al.⁴⁹ The diagnostic procedure code (DPC) statistics and DPC NHI scores were used to estimate the costs of meningitis and bacteremia without focus for the age groups 18–65 years, costs of bacteremic pneumonia for all age groups and costs for inpatient pneumonia for age groups <65 years.^65,66 For the age groups of ≥65 years, the costs of meningitis and bacteremia without focus were obtained from Jiang et al.⁶⁷; the costs of inpatient pneumonia were estimated using the weighted average of number of patients and costs of general ward and intensive care unit, which were obtained from Konomura et al. 2017 and converted into JPY using 101.5 as currency converter.⁶⁸ For outpatient pneumonia, the age groups <5 years were obtained from Ishiwada et al.⁶⁹ and the costs for age groups ≥18 years were obtained from Konomura et al.⁶⁸

^p Indirect costs refer to productivity loss related to PD treatment, which was incurred by adult patients and caregivers of pediatric patients. The indirect costs for the age groups <18 years were obtained from the study by Shiragami et al.⁴⁹ For the age groups ≥18 years, productivity loss related to hospitalization due to IPD and inpatient NBPP was considered and were calculated by multiplying the length of stay, which was obtained from the DPC statistics, and the median annual earnings for each age group.^65,66,71

^q Annual medical costs for PMS were estimated separately for the age groups of <2 years and 2–18 years, based on the discounted lifetime costs.⁷⁰

* These costs were estimated for the age groups 2–18 years.

^r Productivity loss due to premature death for the age groups ≥16 years was calculated by multiplying the labor force participation rate with the median annual earnings for each age group.^35,71

Table 2. Vaccine effectiveness of PCV13 and V114 in the base case.

	Vaccine type	Serotype-specific VE (%)
Disease	Serotype	1	4	5	6B	7F	9V	14	18C	19F	23F	3	6A	19A	22F	33F
IPD^a	PCV13	87	93	87	94	97	100	94	97	87	98	80	86	86	-	-
	V114	87	93	87	94	97	100	94	97	87	98	80	86	86	86	86
AOM^b (pneumococcal)	PCV13	86	57	86	57	86	57	57	57	57	57	15	100	91	-	-
	V114	86	57	86	57	86	57	57	57	57	57	15	100	91	57	57
NBPP^c	PCV13	77	77	77	77	77	77	77	77	77	77	77	77	77	-	-
	V114	77	77	77	77	77	77	77	77	77	77	77	77	77	77	77

Abbreviations: PCV13: 13-valent pneumococcal conjugate vaccine; V114: 15-valent pneumococcal conjugate vaccine; VE: vaccine effectiveness; IPD: invasive pneumococcal disease; AOM: acute otitis media; NBPP: Non-bacteremic pneumococcal pneumonia.

Notes:

^a The vaccine effectiveness (VEs) against IPD for PCV13 were estimated based on the VEs for PCV7⁵⁰ and the study by Moore et al.⁵¹ The VEs for serotypes 22 F and 33 F were assumed to be equal to the average VE among the shared 13 serotypes.

^b The VEs against pneumococcal AOM were obtained from the PCV7 clinical trial⁵² and the study by Pichichero et al.⁵³ The VEs for serotypes 22 F and 33 F were assumed to the same as the VE in the PCV7 clinical trial.⁵²

^c The VEs against inpatient NBPP were obtained from Lewnard et al.,⁵⁴ which were different between the primary series and the booster dose.

Table 3. Base-case results.

Outcomes	V114	PCV13	Incremental outcomes (V114 versus PCV13)
Clinical outcomes (undiscounted)
IPD cases	262	287	−25
NBPP cases	22,168	23,701	−1,333
Pneumococcal AOM cases	42,042	43,875	−1,832
PMS cases	3	4	−1
IPD deaths	13	15	−2
Pneumonia deaths^a	0	0	0
LYs and QALYs (discounted)
Total LYs	7,071,214	7,071,207	7
Total QALYs	6,875,443	6,875,418	24
Cost outcomes (in 2022 ¥, discounted)
Vaccine acquisition costs	22,375,381,278	22,375,379,359	1,919
Vaccine administration costs	13,673,844,114	13,673,842,942	1,172
IPD treatment costs	91,575,473	100,714,034	−9,138,561
Pneumonia treatment costs	2, 164,407,772	2,290,603,743	−126,195,971
AOM treatment costs	2,260,355,950	2,359,259,161	−98,903,212
PMS treatment costs	6,104,753	7,005,897	−901,144
Indirect costs	2,504,470,095	2,634,945,255	−130,475,159
Costs of premature death^b	–	–	–
Total costs	43,076,139,476	43,441,750,390	−365,610,955
ICER			V114 dominant

Abbreviations: PCV13: 13-valent pneumococcal conjugate vaccine; V114: 15-valent pneumococcal conjugate vaccine; IPD: invasive pneumococcal disease; AOM: acute otitis media; PMS: post meningitis sequelae; LY: life year; QALY: quality-adjusted life year; ICER: incremental cost-effectiveness ratio.

Notes:

^a The model assumed no case fatality associated with inpatient NBPP compared to the background mortality rates for patients ≤18 years.

^b Costs of premature death were only estimated for individuals aged ≥16 years and thus were not applicable for the base case, which only followed up a single birth cohort for 10 years.

Table 4. Incremental costs and effectiveness outcomes comparing V114 vs. PCV13 in the scenario analyses.

	Incremental outcomes (V114 vs. PCV13)
	Scenario 1	Scenario 2	Scenario 3	Scenario 4	Scenario 5	Scenario 6
Description of scenario analyses
Key assumptions/inputs in the scenario	Target population: Entire Japan population^c Time horizon: 100 years (i.e. lifetime)	Perspective: Healthcare payer	Pneumonia- and AOM-related outcomes were modeled based on VEs against all-cause pneumonia and all-cause AOM^d	No indirect effects	Vaccine coverage rate for V114 and PCV13: 95%	Vaccine coverage rate for V114 and PCV13: 90%
Corresponding assumptions/inputs in the base case	Target population: A single birth cohort Time horizon: 10 years	Perspective: Societal	Pneumonia- and AOM-related outcomes were modeled based on VEs against NBPP and pneumococcal AOM	Indirect effects on IPD were applied	Vaccine coverage rate for V114 and PCV13: 100%	Vaccine coverage rate for V114 and PCV13: 100%
Outcomes in the scenario analyses
Clinical outcomes, cases/deaths prevented (undiscounted)
IPD cases	2,664	25	25	24	24	23
Pneumonia cases	44,955	1,333	1,500	1,333	1,267	1,200
AOM cases	60,529	1,832	1,832	1,832	1,741	1,649
PMS cases	18	0	0	0	0	0
IPD deaths	346	1	1	1	1	1
Pneumonia deaths^a	138	0	0	0	0	0
LYs and QALYs (discounted)
Total LYs	3,011	7	7	7	7	7
Total QALYs	3,221	24	24	23	22	21
Cost outcomes (in 2022 ¥, discounted)
Vaccine acquisition costs	36,843	1,919	1,919	1,895	1,740	1,570
Vaccine administration costs	22,515	1,172	1,172	1,158	1,063	959
IPD treatment costs	−789,347,837	−9,138,561	−9,138,561	−8,767,865	−8,801,307	−8,646,054
Pneumonia treatment costs	−2,617,065,661	−126,195,971	−147,954,319	−126,196,000	−119,886,147	−113,576,325
AOM treatment costs	−1,937,158,151	−98,903,212	−98,870,853	−98,903,250	−93,958,029	−89,012,847
PMS treatment costs	−38,036,527	−901,144	−901,144	−870,309	−866,550	−831,957
Indirect costs	−2,966,418,822	–	−144,381,859	−130,368,258	−123,985,344	−117,495,530
Costs of premature death^b	−4,719,511,186	–	–	–	–	–
Total costs	−13,067,478,826	−235,135,796	−401,243,644	−365,102,630	−347,494,574	−329,378,183
ICER	V114 dominant	V114 dominant	V114 dominant	V114 dominant	V114 dominant	V114 dominant

Abbreviations: PCV13: 13-valent pneumococcal conjugate vaccine; V114: 15-valent pneumococcal conjugate vaccine; VE: vaccine effectiveness; IPD: invasive pneumococcal disease; AOM: acute otitis media; PMS: post meningitis sequelae; LY: life year; QALY: quality-adjusted life year; ICER: incremental cost-effectiveness ratio.

Notes:

^a The model assumed no case fatality associated with inpatient NBPP compared to the background mortality rates for patients ≤18 years.

^b Costs of premature death were only estimated for individuals aged ≥16 years and thus were not applicable for scenario analyses 2–4, which only followed up a single birth cohort for 10 years.

^c In this scenario, all age groups in the entire Japan population were included at the beginning of the model, while in the base case, only newborns were included at the beginning of model.

^d In this scenario analysis, the VE against all-cause inpatient pneumonia was 7.9% and 8.2% for the primary and booster series of PCV13, and 10.5% and 11.0% for the primary and booster series of PCV15. The VE against all-cause outpatient pneumonia was 2.1% for both primary and booster series of PCV13 and 2.7% for PCV15. The VE against all-cause simple and recurrent AOM was assumed to be the same for the primary and booster series. The VE against all-cause simple AOM was 0.6% and 1.0%, respectively, for PCV13 and PCV15. The VE against all-cause recurrent AOM was 0.04% and 0.1%, respectively, for PCV13 and PCV15.

Figure 2. One-way sensitivity analysis results (showing the most impactful parameters).

Abbreviations: ICER: incremental cost-effectiveness ratio; PCV13: 13-valent pneumococcal conjugate vaccine; V114: 15-valent pneumococcal conjugate vaccine; QALY: quality-adjusted life year; VE: vaccine effectiveness; IPD: invasive pneumococcal disease; AOM: acute otitis media; ST: serotype.

Notes: Tornado diagram showing the results of the one-way sensitivity analysis. The purple bars show the change in ICER from the base case when the higher value of an input was used whereas the light blue bars show the change in ICER from the base case when the lower value of the selected input was used while all other inputs remain constant.

Figure 3. Scatter plot of probabilistic sensitivity analysis.

Abbreviations: QALY: quality-adjusted live year; PSA: probabilistic sensitivity analysis.

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