An economic evaluation of tofacitinib for the treatment of moderately-to-severely active ulcerative colitis: modeling the cost of treatment strategies in the United States

Figures & data

Figure 1. Model diagram. For the first base case analysis, Strategy 1 was TOFA ?> IFX ?> VEDO ?> GOL, Strategy 2 was ADA ?> IFX ?> VEDO ?> GOL, Strategy 3 was TOFA ?> ADA ?> IFX ?> VEDO and Strategy 4 was ADA ?> TOFA ?> IFX ?> VEDO. Abbreviations. ADA, adalimumab; ADR, adverse drug reaction; GOL, golimumab; IFX, infliximab; TNFi, tumor necrosis factor inhibitor; SOC, standard of care; TOFA, tofacitinib; UC, ulcerative colitis; VEDO, vedolizumab.

Table 1. Treatment strategies evaluated in the analyses.

	Comparison 1		Comparison 2
	Strategy 1	Strategy 2	Strategy 3	Strategy 4
TNFi-naïve subpopulation (Base case) (n = 204)
1st treatment	TOFA	ADA	TOFA	ADA
2nd treatment	IFX	IFX	ADA	TOFA
3rd treatment	VEDO	VEDO	IFX	IFX
4th treatment	GOL	GOL	VEDO	VEDO
Overall moderate-to-severe population (n = 452)
1st treatment	TOFA	ADA	TOFA	ADA
2nd treatment	IFX	IFX	ADA	TOFA
3rd treatment	VEDO	VEDO	IFX	IFX
4th treatment	GOL	GOL	VEDO	VEDO
TNFi-exposed sub-population (n = 249)
1st treatment	TOFA	ADA	TOFA	VEDO
2nd treatment	VEDO	VEDO	ADA	ADA

Note that the TNFi-exposed strategies only included two treatments.

Abbreviations. ADA, adalimumab; GOL, golimumab; IFX, infliximab; TNFi, tumor necrosis factor inhibitor; TOFA, tofacitinib; VEDO, vedolizumab.

Table 2. Efficacy and safety assumptions used to populate the model.

Treatment	Efficacy				Safety***
	TNFi-naïve		TNFi-exposed		Major ADR	Minor ADR
	Induction (Clinical response)	Maintenance (Remission)	Induction (Clinical response)	Maintenance (Remission)
TOFA (8 week induction)^11^,^12^,^24	64.0%	42.0%	52.0%	37.0%	0.77%	3.85%
TOFA (16 week induction)*	78.9%	42.0%	69.5%	37.0%	0.77%	3.85%
IFX^25	66.9%	34.7%	43.0%**	16.1%**	5.30%	32.00%
ADA^26	57.1%	22.0%	36.7%	10.2%	4.30%	17.00%
GOL^27	51.0%	28.0%	32.8%**	13.0%**	5.70%	16.00%
VEDO^28	53.1%	45.8%	39.0%	37.2%	7.00%	7.00%

*Induction estimates for the 16-week period for TOFA were calculated based on analysis of the A3921139 trial. It was assumed that the maintenance rates would be identical for those who showed clinical response in induction, regardless of the length of the induction period.

**These estimates were calculated based on the assumption that the ratio of TNFi-naïve-to-TNFi-exposed efficacy rates were the same across TNFi therapies, such that the observed ratio for ADA was then applied to IFX and GOL.

Note that an upper respiratory tract infection was selected as the representative minor ADR and a serious infection was selected as the representative major ADR.

Abbreviations. ADA, adalimumab; ADR, adverse drug reaction; GOL, golimumab; IFX, infliximab; TNFi, tumor necrosis factor inhibitor; TOFA, tofacitinib; VEDO, vedolizumab.

Table 3. Cost-related outcomes for each treatment strategy based on a hypothetical 1 million member plan.

	Comparison 1			Comparison 2
	Strategy 1	Strategy 2	Δ	Strategy 3	Strategy 4	Δ
	TOFA → IFX → VEDO → GOL	ADA → IFX → VEDO → GOL		TOFA → ADA → IFX → VEDO	ADA → TOFA → IFX → VEDO
TNFi-naïve sub-population (Base case scenario) (n = 204)
Cost PMPM	$1.11	$1.34	−$0.23	$1.15	$1.25	−$0.10
Treatment costs	$24,328,905	$29,366,949	−$5,038,044	$25,358,525	$27,578,241	−$2,219,715
Administration costs	$242,955	$329,981	−$87,026	$185,327	$191,055	−$5,728
MRU costs	$1,889,368	$2,107,006	−$217,638	$1,928,652	$2,018,710	−$90,058
Toxicity costs	$250,965	$412,022	−$161,057	$226,525	$279,723	−$53,198
Total costs	$26,712,192	$32,215,957	−$5,503,764	$27,699,029	$30,067,728	−$2,368,699
Total remitters	70	43	28	65	59	6
NNT			7			36
Cost per remitter	$189,920	$378,491	−$188,571	$212,979	$253,337	−$40,358
Overall moderate-to-severe population (n = 452)
Cost PMPM	$2.50	$2.98	−$0.48	$2.60	$2.77	−$0.17
Treatment costs	$54,553,116	$65,078,017	−$10,524,900	$56,920,519	$60,848,592	−$3,928,073
Administration costs	$585,018	$762,876	−$177,858	$451,732	$446,316	$5,416
HCRU costs	$4,369,512	$4,781,962	−$412,450	$4,467,847	$4,574,447	−$106,601
Toxicity costs	$598,061	$930,180	−$332,119	$539,430	$623,667	−$84,238
Total costs	$60,105,707	$71,553,034	−$11,447,327	$62,379,528	$66,493,022	−$4,113,495
Total remitters	136	83	53	123	121	2
NNT			9			298
Cost per remitter	$221,513	$430,643	−$209,130	$254,068	$274,214	−$20,146
	TOFA → VEDO	ADA → VEDO		TOFA → IFX	VEDO → IFX
TNFi-exposed sub-population (n = 249)
Cost PMPM	$1.39	$1.61	−$0.22	$1.34	$1.54	−$0.21
Treatment costs	$30,629,323	$35,353,882	−$4,724,559	$29,211,075	$33,634,936	−$4,423,861
Administration costs	$174,973	$237,792	−$62,819	$216,150	$285,889	−$69,739
HCRU costs	$2,467,556	$2,751,749	−$284,193	$2,535,903	$2,837,523	−$301,621
Toxicity costs	$196,958	$343,120	−$146,162	$167,445	$306,946	−$139,500
Total costs	$33,468,810	$38,686,543	−$5,217,733	$32,130,573	$37,065,294	−$4,934,721
Total remitters	66	32	34	56	19	37
NNT			7			7
Cost per remitter	$253,083	$611,500	−$358,417	$287,840	$960,596	−$672,756

Abbreviations. ADA, adalimumab; ADR, adverse drug reaction; GOL, golimumab; HCRU, healthcare resource use; IFX, infliximab; NNT, number needed to treat; PMPM, per member per month; TNFi, tumor necrosis factor inhibitor; TOFA, tofacitinib; VEDO, vedolizumab.

Figure 2. Sensitivity analyses associated with the TNFi-naïve base case scenario results. Note the difference of Comparison 1 refers to the cost PMPM of Strategy 1 (TOFA → IFX → VEDO → GOL) minus the cost PMPM of Strategy 2 (ADA → IFX → VEDO → GOL). The difference of Comparison 2 refers to the cost PMPM of Strategy 3 (TOFA → ADA → IFX → VEDO) minus the cost PMPM of Strategy 4 (ADA → TOFA → IFX → VEDO). Abbreviations. ADA, adalimumab; GOL, golimumab; IFX, infliximab; PMPM, per member per month; TNFi, tumor necrosis factor inhibitor; TOFA, tofacitinib; VEDO, vedolizumab.

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