A cost-effectiveness evaluation comparing originator follitropin alfa to the biosimilar for the treatment of infertility

Figures & data

Table 1 Model input data: clinical background

Clinical data	Biosimilar FSH	Originator FSH
Treatment cycle 1
Number of subjects	220	113
Mean (SD) total dose r-FSH (IU)	1,555.7 (293.00)	1,569.2 (259.20)
Clinical pregnancy rate per embryo transfer (%)	90 (40.2)a	55 (48.2)a
Patients with live-born children (%)	80 (35.7)a	50 (43.9)a
Treatment cycle 2
Number of subjects	72	38
Mean (SD) total dose r-FSH (IU)	1,612.3 (217.67)	1,604.9 (216.61)
Clinical pregnancy rate per embryo transfer (%)	25 (38.5)b	10 (27.8)b
Patients with live-born children (%)	22 (33.8)b	9 (25)b
Treatment cycle 1
OHSS (%)c	14 (5.6)d	4 (3.3)c
Grades of OHSS
Mild/moderate (%)	4.8	2.5
Severe (%)	0.8	0.8

Notes:

a Based on number of patients with embryo transfer – Cycle 1 (Biosimilar FSH: 224; Originator FSH: 114);

b based on number of patients with embryo transfer – Cycle 2 (Biosimilar FSH: 65; Originator FSH: 36);

c OHSS;

d based on per-protocol population (Biosimilar FSH: 249; Originator FSH: 123). Data derived from European medicines agency assessment report.³

Abbreviations: FSH, follicle-stimulating hormone; OHSS, ovarian hyperstimulation syndrome; SD, standard deviation.

Table 2 Model input data: health costs

Cost data	Cost per unit in € – Italy	Cost per unit in € – Italy
Routine intervention
DRG 359 “uterus and adnexa nonmalignant, without cost specification”	2,124.52^Citation7	4,289.51^Citation8
Ex-factory price Originator FSH (75 IU)	27.38^Citation9	20.16^Citation10
Ex-factory price Biosimilar FSH (75 IU)	21.90^Citation9	20.16^Citation10
Follow-up: blood test for beta-HCG (pregnancy test)	9.98^Citation7	15.00^Citation10
Clinical follow-up visits until first ultrasound: gynecological visit + ultrasound of lower abdomen	52.68^Citation7	83.07^Citation10
OHSSa mild/moderate
N.2 gynecological visit	20.66^Citation7	50.90^Citation10
N.2 ultrasound of lower abdomen	32.02^Citation7	32.17^Citation10
N.2 hematology laboratory tests	7.41^Citation7	10.60^Citation10
N.2 hematocrit laboratory tests	0.69^Citation7	6.11^Citation10
N.2 creatinine laboratory test	1.13^Citation7	2.90^Citation10
N.2 electrolytes laboratory tests	4.30^Citation7	3.86^Citation10
N.2 hepatic laboratory tests	14.30^Citation7	14.50^Citation10
OHSS severe
DRG 369 “Menstrual disorders and other disorders of the female reproductive system”	800.35^Citation7	1,657.28^Citation8

Note:

a OHSS.

Abbreviations: DRG, diagnosis-related group; FSH, follicle-stimulating hormone; OHSS, ovarian hyperstimulation syndrome.

Table 3 Results of the CEAa

Strategy	Cost (€)	Incremental cost (€)	Efficacy	Incremental efficacy	ICERb (€)	Cost per live birth (€)
Italy
Biosimilar FSH	3,483	–	0.47	–	–	7,411
Originator FSH	3,663	180	0.52	0.05	3,600	7,044
Spain
Biosimilar FSH	6,342		0.47			13,494
Originator FSH	6,387	45	0.52	0.05	900	12,283

Notes:

a CEA;

b ICER.

Abbreviations: CEA, cost-effectiveness analysis; FSH, follicle-stimulating hormone; ICER, incremental cost-effectiveness ratio.

Figure 1 Tornado diagram – Italy.

Abbreviation: OHSS, ovarian hyperstimulation syndrome.

Figure 2 Tornado diagram – Spain.

Abbreviation: OHSS, ovarian hyperstimulation syndrome.

Figure 3 CE acceptability curve – Italy.

Abbreviation: CE, cost effectiveness.

Figure 4 CE acceptability curve – Spain.

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