Cost-effectiveness of transient elastography for liver fibrosis screening in Thai patients with diabetes mellitus

Table 1 Input parameters

Input parameter	Distribution	Base-case value	SE	Ref.
Test performance1 (%)
FIB-4 index ≥ 1.3				Alkhouri et al[18]
Sensitivity	Beta	66.0	1.2
Specificity	Beta	65.0	1.4
SAFE score ≥ 0				Alkhouri et al[18]
Sensitivity	Beta	87.3	0.8
Specificity	Beta	35.1	1.4
TE, LSM ≥ 7 kPa				Selvaraj et al[10]
Sensitivity	Beta	80.1	2.1
Specificity	Beta	73.0	2.6
Epidemiological data
Prevalence of MASLD				Phisalprapa et al[12]
Age 18-39.9 years	Beta	0.353	0.013
Age 40-59.9 years	Beta	0.348	0.002
Age ≥ 60 years	Beta	0.244	0.004
Prevalence of MASLD with significant fibrosis				Primary data (Supplementary Table 2)
Age 30-39.9 years	Beta	0.304	0.096
Age 40-49.9 years	Beta	0.333	0.068
Age 50-59.9 years	Beta	0.304	0.037
Age 60-69.9 years	Beta	0.404	0.031
Age 70-79.9 years	Beta	0.403	0.041
Age ≥ 80 years	Beta	0.659	0.074
Incidence of MASLD (cases per 1000 patient-years)	Beta	42.8	2.2	Park et al[21]
Treatment effectiveness
RRR of lifestyle modification	Log-normal	0.204	0.124	Vilar-Gomez et al[8]
Transitional probability
No MASLD - MASLDF0	Beta	0.043	0.002	Park et al[21]
MASLDF0 - no MASLD	Beta	0.024	0.013	Le et al[22]
MASLDF0 - MASLDF1	Beta	0.063	0.025
MASLDF1 - MASLDF0	Beta	0.025	0.017
MASLDF1 - MASLDF2	Beta	0.067	0.025
MASLDF2 - MASLDF1	Beta	0.045	0.022
MASLDF2 - MASLDF3	Beta	0.056	0.024
MASLDF3 - MASLDF2	Beta	0.058	0.024
MASLDF3 - MASLDF4/CC	Beta	0.044	0.021
MASLDF4/CC - MASLDF3	Beta	0.046	0.022
MASLDF4/CC - DC	Beta	0.043	0.041	Gruneau et al[23]
MASLDF4/CC - HCC	Beta	0.008	0.017
DC - HCC	Beta	0.029	0.045
DC - LT (age ≤ 70 years)	Beta	0.003	0.012
HCC - LT (age ≤ 70 years)	Beta	0.012	0.027
Utilities
DM	Beta	0.753	0.116	Deerochanawong et al[32]
MASLDF0-F3	Beta	0.753	0.116
MASLDF4/CC	Beta	0.748	0.042	Chongmelaxme et al[19]
DC	Beta	0.603	0.022	Prakongsai et al[24]
HCC	Beta	0.380	0.015	Levy et al[33]
LT	Beta	0.570	0.015
Post LT	Beta	0.683	0.015	Prakongsai et al[24]
Costs
Direct medical costs, 2023; THB (USD)
FIB-4 index	Gamma	271.0 (7.8)	NA2	Riewpaiboon[34]
SAFE score	Gamma	355.4 (10.3)	NA2
Transient elastography	Gamma	2000.0 (57.7)	500.0 (14.4)	Primary data
Lifestyle modification program	Gamma	1426.8 (41.2)	356.7 (10.3)	Riewpaiboon[34]
Treatment, THB (USD) per year
DM without MASLD	Gamma	9579.6 (276.6)	2394.9 (69.1)	Primary data (Supplementary Table 4)
DM with MASLDF0-F3	Gamma	12340.9 (356.3)	3085.2 (89.1)	Primary data (Supplementary Table 4)
DM with MASLDF4/CC	Gamma	38746.5 (1118.6)	9686.6 (279.6)	Primary data (Supplementary Table 4)
DC	Gamma	151164.1 (4363.9)	37791.0 (1091.0)	Chongmelaxme et al[19] and Thongsawat et al[35]
HCC	Gamma	184822.2 (5335.6)	46205.5 (1333.9)
LT	Gamma	683432.3 (19729.9)	170858.1 (4932.5)
Post LT	Gamma	110287.1 (3183.9)	27571.8 (796.0)
Direct non-medical costs, THB (USD) per visit
Secondary hospital
Food	Gamma	33.1 (1.0)	4.0 (0.1)	Riewpaiboon[34]
Transportation	Gamma	91.2 (2.6)	5.2 (0.1)
Tertiary hospital
Food	Gamma	66.2 (1.9)	6.7 (0.2)	Riewpaiboon[34]
Transportation	Gamma	179.7 (5.2)	14.6 (0.4)

¹The sensitivity and specificity of the tests were compared to liver biopsy, a reference standard for liver fibrosis diagnosis.

²The values were not presented because the sensitivity analyses were performed using standard errors of the unit costs. The unit costs ± standard errors of aspartate aminotransferase, alanine aminotransferase, and globulin were 84.4 ± 21.1 Thai baht (THB, 2.4 ± 0.6 United States dollars [USD]), while the unit cost of platelet count was 102.1 ± 25.5 THB (2.9 ± 0.7 USD).

CC: Compensated cirrhosis; DC: Decompensated cirrhosis; DM: Diabetes mellitus; F: Fibrosis stage; FIB-4: Fibrosis-4 index; HCC: Hepatocellular carcinoma; LSM: Liver stiffness measurement; LT: Liver transplantation; MASLD: Metabolic dysfunction-associated steatotic liver disease; RRR: Relative risk reduction; NA: Not applicable; SAFE: Steatosis-associated fibrosis estimator score; THB: Thai baht; USD: United States dollars.

Table 2 Cost-utility analysis outcomes, screening age at 50 years

Outcome	No screening	FIB-4 + TE	SAFE + TE	TE alone
Life expectancy (years)	25.30	25.33	25.33	25.34
Total lifetime cost, THB (USD)	198681.9 (5735.72)	199481.6 (5758.8)	199883.2 (5770.4)	200402.6 (5785.4)
Total QALYs	12.788	12.798	12.803	12.805
Compared to no screening
Incremental cost, THB (USD)		799.7 (23.1)	1201.3 (34.7)	1720.7 (49.7)
Incremental QALYs		0.011	0.015	0.017
ICER, THB (USD) per QALY gained		75961.0 (2192.9)	80384.5 (2320.6)	98964.5 (2857.0)
Interpretation		Cost-effective1	Cost-effective1	Cost-effective1
Extended dominance analysis
Incremental cost, THB (USD)		799.7 (23.1)	401.6 (11.6)	519.3 (15.0)
Incremental QALYs		0.011	0.004	0.002
ICER, THB (USD) per QALY gained		75961.0 (2192.9)	90927.9 (2625.0)	212678.2 (6139.8)
Interpretation		Cost-effective1	Cost-effective2	Not cost-effective3

¹Compared to no screening.

²Compared to fibrosis-4 index + transient elastography.

³Compared to steatosis-associated fibrosis estimator score + transient elastography.

FIB-4: Fibrosis-4 index; ICER: Incremental cost-effectiveness ratio; QALY: Quality-adjusted life-year; SAFE: Steatosis-associated fibrosis estimator score; TE: Transient elastography; THB: Thai baht; USD: United States dollar.

Table 3 Budget impact analysis

Parameter	Y1	Y2	Y3	Y4	Y5	Total
Total population	21348831					21348831
New population		1028431	1011655	1033245	1046481	4119812
Patients with DM	2113534	9331	9179	9375	9495	2150915
Patients evaluated with scoring system	1902181	8398	8261	8438	8546	1935824
FIB-4 + TE
Patients with FIB-4 ≥ 1.3	1004193	2990	2941	3004	3042	1016170
Patients undergo TE	903774	2691	2647	2703	2738	914553
Total BIA, THB (USD)	2323021957 (67062996)	7657269 (221057)	7532362 (217451)	7693112 (222091)	7791661 (224936)	2353696361 (67948531)
Average annual budget, THB (USD)						470739272 (13589706)
SAFE + TE
Patients with SAFE ≥ 0	1687835	7338	7219	7373	7467	1717232
Patients undergo TE	1519052	6604	6497	6635	6720	1545509
Total BIA, THB (USD)	3714212955 (107225095)	16194000 (467502)	15929840 (459876)	16269803 (469691)	16478221 (475707)	3779084819 (109097872)
Average annual budget, THB (USD)						755816964 (21819574)
TE alone
Patients undergo screening	1690827	7465	7343	7500	7596	1720732
Total BIA, THB (USD)	3381654830 (97624521)	14930254 (431019)	14686708 (423989)	15000141 (433037)	15192295 (438584)	3441464227 (99351150)
Average annual budget, THB (USD)						688292845 (19870230)

BIA: Budget impact analysis; DM: Diabetes mellitus; FIB-4: Fibrosis-4 index; SAFE: Steatosis-associated fibrosis estimator score; TE: Transient elastography; THB: Thai baht; USD: United States dollar; Y: Year.