Burden of uterine fibroids in Italy: epidemiology, treatment outcomes, and consumption of health care resources in more than 5,000 women

Figures & data

Table 1 Unit costs included in the analysis

	Cost		Cost
GnRH analogs		Reliever medications
Decapeptyl^*fl 1.25 mg+2 mL+1 sir	€393.22	Activelle^*28 cpr Riv 1 mg+0.5 mg	€9.23
Decapeptyl^*fl 3.75 mg+2 mL+1 sir	€174.97	Angeliq^*28 cpr Riv 1 mg+2 mg	€17.41
Enantone^*im sc fl+s 11.25 mg rp	€317.45	Crinone^*Gel Vag 8% 15 appl 1d	€53.51
Enantone^*im sc fl+s 3.75 mg rp	€158.28	Dufaston^*14 cpr Riv 10 mg	€4.70
Enantone^*im sc sir 11.25 mg/mL rp	€337.94	Esolut^*12 Ov Vag 200 mg	€12.16
Enantone^*im sc sir 3.75 mg/mL rp	€165.38	Femoston 2/10^*14 cpr Ro+14 Gial	€9.23
Gonapeptyl depot^*sir 3.75 mg+so	€162.25	Fostimon^*10 fl 75 ui+10f	€129.07
Suprefact^*iniet 1f 5.5 mL 1 mg/mL	€19.33	Gestodiol^*21 cpr Riv 75+30 mcg	€2.89
Suprefact^*spray nas 0.1 mg/erog	€30.67	Ginoden^*21 cpr Riv 0.075+0.03 mg	€4.21
Zoladex^*sc 1 sir 3.6 mg rp	€188.24	Gonal F^*(600 ui) 1050 ui/1.75 mL	€564.86
Zoladex^*sc sir 10.8 mg rp	€461.53	Gonal F^*Sc 10 fl 75 ui+10 sir 1 mL	€286.06
Ulipristal acetate		Gonal F^*Sc 10 fl 75 ui+10 sir 1 mL	€438.68
ESMYA^*28 CPR 5 mg	€221.78	Gonal F^*Sc 1 pen 450 ui/0.75 mL+12	€171.63
Diagnostics		Gonasi Hp^*Im Sc 1 fl 5000 ui/1 mL	€5.16
Abdominal ecography	€43.88	Gonasi Hp^*Im Sc 3 fl 2000 ui/1 mL	€6.85
Abdominal magnetic resonance	€242.25	Kipling^*21 cpr Riv 0.075+0.03 mg	€2.74
Hysterosalpingography	€118.7	Lentogest^*Im 1f 341 mg/2 mL	€3.77
Computerized bone mineralometry	€43.19	Lutenyl^*30 cpr 5 mg	€13.62
Surgical interventions		Lutogin^*30 cps Molli 100 mg	€4.95
Laparoscopy	€2,854.25	Luveris^*Sc 3 fl 75 ui+3 fl Solv	€127.00
Laparotomy	€3,240.99	Milvane^*21 cpr Riv	€4.75
Hysteroscopy	€1,986.36	Minulet^*21 cpr 0.075 mg+0.030 mg	€4.21
Hysterectomy	€3,083.49	Naemis^* 24 Cpr 1.5+3.75 mg	€9.20
		Nomegestrol Farmit^*30 cpr 5 mg	€8.45
		Ovitrelle^*Sc 1 pen 250 mcg/0.5 mL	€41.11
		Ovitrelle^*Sc 1 sir 250 mcg/0.5 mL	€43.19
		Pergoveris^*Sc 10 fl 150 ui/75 ui	€1,197.23
		Planum^*21 cpr 0.15 mg+0.03 mg	€4.60
		Practil^*21 cpr 0.15 mg+0.03 mg	€4.59
		Pregnyl^*Im 3f 5000 ui+3f 1 mL	€14.68
		Primolut Nor^*30 cpr 10 mg	€5.68
		Progeffik^*Os Vag 15 cps 200 mg	€5.18
		Progeffik^*Os Vag 30 cps 100 mg	€5.19
		Proluton^*Im 1f 250 mg 1 mL	€2.63
		Prometrium^*Os Vag 15 cps 200 mg	€5.40
		Prometrium^*Os Vag 30 cps 100 mg	€5.40
		Prontogest^*Iniet 3f 1 mL 100 mg/M	€4.98
		Puregon^*Im Sc 5 fl 100 ui/0.5 mL	€260.67
		Puregon^*Sc 1 cart 600 ui/0.72 mL	€326.19
		Puregon^*Sc 1 cart 900 ui/1.08 mL	€465.98
		Tranex^*30 cps 250 mg	€4.93
		Tranex^*30 cps 500 mg	€8.84
		Tranex^*Iv 6f 5 mL 500 mg	€6.59
		Triminulet^*21 cpr Riv	€4.80
		Ugurol^*20 cpr 250 mg	€3.71
		Ugurol^*Iv Os Loc 5f 5 mL 500 mg	€3.80
		Ugurol^*Iv Os Loc 6f 5 mL 500 mg	€4.28

Abbreviation: GnRH, gonadotropin-releasing hormone.

Table 2 Demographics and health care history of women with diagnosis of uterine fibroids: comparison between surgical and nonsurgical patients

	Total, N (%)/mean (SD)	Surgery, N (%)/mean (SD)	No surgery, N (%)/mean (SD)	P-value
Patients included	5,665	2,433	3,232
North	2,352 (41.5%)	1,730 (73.6%)	622 (26.4%)
Central	751 (13.3%)	276 (36.8%)	475 (63.2%)
South	2,562 (45.2)	427 (16.7%)	2,135 (83.3%)
Age	45.8 (6.2)	46.2 (5.5)	45.4 (6.6)	<0.001
Charlson index	0.8 (1.5)	0.5 (1.1)	1.0 (1.7)	<0.001
Charlson index >1	880 (15.5%)	269 (11.1%)	611 (18.9%)	<0.001
Age, years
18–25	1.8 (3.2)	0.4 (0.8)	2.0 (3.4)	NS
26–35	0.8 (1.8)	0.3 (0.8)	1.1 (2.0)	<0.001
36–45	0.8 (1.6)	0.5 (1.1)	1.0 (1.8)	<0.001
46–55	0.8 (1.3)	0.6 (1.1)	0.9 (1.5)	<0.001
North	0.5 (1.2)	0.4 (1.1)	0.6 (1.4)	<0.001
Central	1.1 (1.7)	0.7 (1.1)	0.7 (1.4)	NS
South	0.7 (1.3)	0.9 (1.2)	1.1 (1.8)	<0.01
Diagnostics	0.9 (1.6)	0.6 (1.1)	1.1 (1.9)	<0.001
Abdominal ecography	0.6 (1.3)	0.5 (0.9)	0.7 (1.5)	<0.05
Abdominal magnetic resonance	0.0 (0.2)	0.0 (0.2)	0.0 (0.2)	NS
Hysterosalpingography	0.0 (0.1)	0.0 (0.1)	0.0 (0.1)	<0.001
Computerized bone mineralometry	0.3 (0.6)	0.1 (0.4)	0.3 (0.8)
Patients who took medications	4,209 (74.3%)	977 (40.2%)	3,232 (100.0%)	<0.001
Systemic hormonal contraceptives	205 (3.6%)	113 (4.6%)	92 (2.8%)	<0.001
Progestins	1,036 (18.3%)	443 (18.2%)	593 (18.3%)	NS
Combination progestin/estrogen	22 (0.4%)	4 (0.2%)	18 (0.6%)	<0.05
Tranexamic acid	1,361 (24.0%)	577 (23.7%)	784 (24.3%)	NS
GnRH analogs	3,156 (55.7%)	244 (10%)	2,912 (90.1%)	<0.001
Ulipristal acetate	392 (6.9%)	36 (1.5%)	356 (11.0%)	<0.001

Abbreviations: GnRH, gonadotropin-releasing hormone; NS, not significant.

Figure 1 Number of patients, included in the main study, divided according to the following criteria: health districts in nonsurgical patients (A), age groups in nonsurgical patients (B), type of surgery in surgical patients (C), and age groups in surgical patients (D).

Abbreviation: GnRH, gonadotropin-releasing hormone.

Table 3 Demographics and health care history of women with diagnosis of uterine fibroids treated with GnRH analogs or ulipristal acetate

	Total N (%)/mean (SD)	GnRH analogs N (%)/mean (SD)	Ulipristal acetate N (%)/mean (SD)	P-value
Patients included	1,352	1,075	277
North	238 (17.6%)	123 (11.5%)	115 (41.5%)
Central	286 (21.2%)	237 (22.0%)	49 (17.7%)
South	828 (61.2%)	715 (66.5%)	113 (40.8%)
Age (years)	45.2±6.0	45.3±6.1	45.0±5.6	NS
Charlson index	0.9±1.6	1.0±1.7	0.6±1.0	<0.001
Charlson index >1	273 (20.2%)	239 (22.2%)	34 (12.3%)	<0.001
Age, years
18–25	2.6 (3.8)	3.2 (4.0)	0	NS
26–35	1.0 (1.8)	1.1 (1.9)	0.8 (1.0)	NS
36–45	0.9 (1.6)	1.0 (1.6)	0.7 (1.2)	NS
46–55	0.9 (1.6)	1.0 (1.7)	0.5 (1.1)	<0.001
North	0.8 (1.6)	1.3 (2.0)	0.4 (0.9)	<0.001
Central	0.5 (1.0)	0.5 (1.0)	0.4 (0.8)	NS
South	1.1 (1.8)	1.1 (1.8)	0.8 (1.4)
Diagnostics	0.1 (0.4)	0.1 (0.4)	0.1 (0.4)
Abdominal ecography	0.1 (0.3)	0.1 (0.3)	0.1 (0.4)	NS
Abdominal magnetic resonance	0.0 (0.1)	0.0 (0.1)	0.0 (0.1)	NS
Hysterosalpingography	0.0	0.0	0.0	−
Computerized bone	0.0 (0.2)	0.0 (0.2)	0.0 (0.1)	<0.01
mineralometry
Patients who took medications	124 (9.2%)	79 (7.3%)	45 (16.2%)	<0.001
Systemic hormonal	3 (0.2%)	1 (0.1%)	2 (0.7%)	NS
contraceptives
Progestins	49 (3.6%)	35 (3.3%)	14 (5.1%)	NS
Combination progestin/estrogen	1 (0.1%)	1 (0.1%)	2 (0.0%)	NS
Tranexamic acid	83 (6.1%)	50 (4.7%)	33 (11.9%)	<0.001
Surgery	148 (10.9%)	84 (7.8%)	64 (23.1%)	<0.001
No surgery	1,204 (89.1%)	991 (92.2%)	213 (76.9%)	<0.001
Multivariate analysis (logistic regression)
Covariates	OR	95% CI		P-value
Region
North	1.000
Central	0.219	0.144	0.334	<0.001
South	0.188	0.133	0.267	<0.001
Age	1.005	0.981	1.030	NS
Charlson index	0.814	0.718	0.923	0.001
Diagnostic tests++
No	1.000
Yes	0.521	0.315	0.861	<0.05
Concomitant medications++
No	1.000
Yes	2.180	1.420	3.346	<0.001
Surgery+++
No	1.000
Yes	1.945	1.303	2.903	0.001

Notes:

+ At least one of abdominal ecography, abdominal magnetic resonance, hysterosalpingography, computerized bone mineralometry.

++ At least one of systemic hormonal contraceptives, progestins, combination progestin/estrogen, tranexamic acid.

+++ At least one of laparoscopy, laparotomy, hysteroscopy, hysterectomy.

Abbreviations: GnRH, gonadotropin-releasing hormone; NS, not significant; OR, odds ratio.

Figure 2 Number of prescribed and reimbursed medication packages per patient. Ulipristal (A) and GnRH analogs (B).

Abbreviation: GnRH, gonadotropin-releasing hormone.

Figure 3 Distribution of total direct costs per patients in the main study: overall (A) and divided by surgical and nonsurgical patient groups (B).

Figure 4 Distribution of total direct costs per patients in the ancillary study: overall (A) and divided by GnRH and ulipristal acetate patient groups (B).

Abbreviation: GnRH, gonadotropin-releasing hormone.