Vaccinating Italian infants with a new multicomponent vaccine (Bexsero®) against meningococcal B disease: A cost-effectiveness analysis

Figures & data

Table 1. Results of CEA analysis broken down by different scenarios.

Scenario	Perspective	Cost of death	Number of vaccine doses	Disease incidence	ICER per QALY (€)
1*	Social	0	5	official data	109,762
2	Social	SHC	5	official data	109,191
3	Social	WTP	5	official data	104,657
4	NHS	0	5	official data	120,990
5*	Social	0	5	estimated data	26,599
6	Social	SHC	5	estimated data	26,029
7	Social	WTP	5	estimated data	21,494
8	NHS	0	5	estimated data	37,827

Figure 1. Incremental Cost-Effectiveness (ICE) ellipse scatterplots showing the distribution of values of incremental costs and incremental effectiveness resulting from the Monte Carlo simulation. Points below the threshold value indicate cost-effectiveness.

Figure 2. Cost-effectiveness acceptability curves (“vaccinate” and “do not vaccinate”). The figures show the probability of being cost-effective on varying the threshold value.

Figure 3. Impact of average annual incidence (per 100,000) of serogroup B invasive disease on the ICER (one-way sensitivity analysis). The probability of disease is per person.

Figure 4. Impact of vaccine effectiveness on the ICER (one-way sensitivity analysis).

Figure 5. Tornado diagrams evaluating the influence of each parameter of the model on ICER.

Figure 6. Simplified decisional tree: meningococcal serogroup B vaccination in infants.*Legend: amputation with substantial disability, anxiety, arthritis, depression, motor deficits, blindness, epilepsy or seizure, severe neurological disability, mental retardation (cognitive problems), hearing loss requiring cochlear implantation, moderate/severe bilateral hearing loss, moderate unilateral hearing loss, skin necrosis, scars, severe speech or communication problems, renal failure, chronic migraine.**Protection was assumed to begin after the second dose of the vaccine.

Table 2. Scenarios evaluated.

Scenario	Perspective	Cost of death	Number of vaccine doses [Primary cycle (2, 4, 6 and 12 months of age) and booster dose at 11 y]	Disease incidence
1*	Social	0	5	official data
2	Social	SHC	5	official data
3	Social	WTP	5	official data
4	NHS	0	5	official data
5*	Social	0	5	Estimated data
6	Social	SHC	5	Estimated data
7	Social	WTP	5	Estimated data
8	NHS	0	5	Estimated data

* Basal scenarios.

Table 3. Probability of sequelae.

Sequelae	Base case	Distribution
Amputation with substantial disability^a	0.01	Uniform (0.008; 0.012)
Anxiety^b	0.068	Uniform (0.0544; 0.0816)
Arthritis^b	0.025	Uniform (0.02; 0.03)
Depression^b	0.05	Uniform (0.04; 0.06)
Motor deficits^c	0.019	Uniform (0.0152; 0.0228)
Blindness^a	0.004	Uniform (0.0032; 0.0048)
Epilepsy or Seizure^a	0.02	Uniform (0.016; 0.024)
Severe Neurological disability^d	0.021	Uniform (0.0168; 0.0252)
Mental retardation (cognitive problems)^b,e	0.254	Uniform (0.196; 0.312)
Hearing loss requiring cochlear implantation^a	0.02	Uniform (0.016–0.024)
Moderate/severe bilateral hearing loss^a	0.05	Uniform (0.04; 0.06)
Moderate unilateral hearing loss^a	0.05	Uniform (0.04; 0.06)
Skin necrosis^b	0.015	Uniform (0.012; 0.018)
Scars^f	0.03	Uniform (0.024; 0.036)
Severe speech or communication problems^a	0.037	Uniform (0.0296; 0.0444)
Renal failure^b	0.019	Uniform (0.0152; 0.0228)
Chronic migraine^b	0.10	Uniform (0.08; 0.12)

^a According to [56];

^b According to [55];

^c According to [28];

^d According to [53];

^e According to [57];

^f According to [54].

Table 4. Health utilities of single sequelae.

Sequelae	Base case	Distribution
Amputation with substantial disability^a	0.613	Uniform (0.490; 0.7356)
Anxiety^b	0.687	Uniform (0.5496; 0.8244)
Arthritis^c	0.690	Uniform (0.552; 0.828)
Depression^b	0.729	Uniform (0.583; 0.875)
Motor deficits^d	0.830	Uniform (0.664; 0.996)
Blindness^e	0.260	Uniform (0.208; 0.312)
Epilepsy or Seizure^f	0.830	Uniform (0.664; 0.996)
Severe Neurological disability^a	0.060	Uniform (0.048; 0.072)
Mental retardation (cognitive problems mild/moderate)^g	0.541	Uniform (0.4328; 0.6492)
Hearing loss requiring cochlear implantation^f	0.810	Uniform (0.648; 0.972)
Moderate/severe bilateral hearing loss^f	0.910	Uniform (0.728; 1)
Moderate unilateral hearing loss^f	0.910	Uniform (0.728; 1)
Skin necrosis^h	0.900	Uniform (0.720; 1)
Scars^a	1.000	Uniform (0.8; 1)
Severe speech or communication problems^i	0.390	Uniform (0.312; 0.468)
Renal failure^l	0.820	Uniform (0.656; 0.984)
Chronic migraine^m	0.814	Uniform (0.6512; 0.9768)

^a According to [53];

^b According to [62];

^c According to [63];

^d According to [64];

^e According to [65];

^f According to [60];

^g According to [66];

^h According to [67];

ⁱ According to [68];

^l According to [69];

^m According to [61].

Table 5. Acute phase of disease: costs (no discount rate) were measured in € at January 2013 values and were referred to 1 case.

Parameter	Base case	Distribution
Medical care: cost of hospitalization per case^a	7,900	Gamma (25; 316)
Public Health Response^b	3,223	Gamma (25; 128)
Lost productivity of parent or relatives^c	870	Gamma (25; 35)
Lost productivity of patient^c	1,426	Gamma (25; 57)

^a According to [78];

^b Assumed based upon [53];

^c According to [8,79].

Table 6. Meningococcal sequelae. Costs (no discount rate) were measured in € at January 2013 values.

Parameters	Base Case	Distribution
Annual direct costs (1 case)
Amputation with substantial disability^a	7,339	Gamma (25; 293.6)
Anxiety^b	1,146	Gamma (25; 45.8)
Arthritis(1-y cost)^c	1,184	Gamma (25; 47.4)
Depression^d	3,192	Gamma (25; 127.7)
Motor deficits^e	7,682	Gamma (25; 307.3)
Blindness^f	4,076	Gamma (25; 163.0)
Epilepsy or seizure^g	2,272	Gamma (25; 90.9)
Severe neurological disability^h	94,880	Gamma (25; 3795.0)
Mental retardation (cognitive problems)^e	7,507	Gamma (25; 300.3)
Hearing loss requiring cochlear implantation^a	6,327	Gamma (25; 253.1)
Moderate/severe bilateral/unilateral hearing loss^a	3,163	Gamma (25; 126.5)
Skin necrosis^a	1,066	Gamma (25; 42.6)
Scars^h	533	Gamma (25; 21.3)
Severe speech or communication problems^i	9,796	Gamma (25; 391.8)
Renal failure^l	56,126	Gamma (25; 2245.0)
Chronic migraine^m	892	Gamma (25; 35.7)
	Annual indirect costs (1 case)
Special case education*^h	14,566	Gamma (25; 582.2)
Lost productivity of parent^^n	24,500	Gamma (25; 980.0)
Lost productivity of patient°^o	24,500	Gamma (25; 980.0)

^a According to [53];

^b According to [80];

^c According to [81];

^d According to [82];

^e According to [83];

^f According to [84];

^g According to [85,86];

^h According to [87];

ⁱ According to [30];

^l According to [88];

^m According to [89];

ⁿ According to [90,91,92];

^o According to [90,92,93].

* Applied to: motor deficits, blindness, epilepsy or seizure, mental retardation (cognitive problems), hearing loss and severe speech or communication problems.

ˆ Applied to: mental retardation (cognitive problems), severe neurological disability, severe speech or communication problems, epilepsy, blindness, motor deficit, severe amputations and hearing loss.

° Applied to: severe amputations, anxiety, depression, motor deficit, blindness, epilepsy or seizure, severe neurological disability, mental retardation (cognitive problems), Hearing loss requiring cochlear implantation, Moderate/severe bilateral/unilateral hearing loss, renal failure, severe speech or communication problems.

Table 7. The social costs (no discount rate) of death were measured in € at January 2013 values.

Age (years)	Willingness to pay (WTP)^a	Distribution	Human Standard Capital (HSC)^a	Distribution
<1	1,513,985	Gamma (25; 60559.4)	81,434	Gamma (25; 3257.1)
1–4	1,594,678	Gamma (25; 63787.2)	101,143	Gamma (25; 4045.7)
5–9	1,743,967	Gamma (25; 69758.5)	148,817	Gamma (25; 5941.9)
10–14	1,924,832	Gamma (25; 76993.1)	228,391	Gamma (25; 9135.6)
15–24	2,122,126	Gamma (25; 84887.8)	368,015	Gamma (25; 14720.6)
25–64	1,260,459	Gamma (25; 50418.1)	336,674	Gamma (25; 13466.9)
>64	96,178	Gamma (25; 3847.2)	40,377	Gamma (25; 1615.1)

^a According to [94].

Table 8. Costs associated with vaccination (€).

Direct costs
		Range
Parameter	Base Case	Min	Max	Distribution
Cost of the primary cycle of vaccination (4 doses)^a	200.00	100.00	300.00	Fixed
Cost of vaccine administration per dose^b	5.80	–	–	Fixed
Cost of hospitalization for 1 anaphylactic reaction^c	1,175	–	–	Fixed
Cost of 1 mild or moderate adverse event^d	3.40	–	–	Fixed

^a According to [96];

^b According to [97];

^c According to [78];

^d According to [98].