Cost-Effectiveness of Repository Corticotropin Injection for the Treatment of Acute Exacerbations in Multiple Sclerosis

Figures & data

Figure 1 Schematic of the state-transition model. Treatments include RCI, PMP, IVIg was given over 30 days. The administration is consistent with current clinical practices and recommendations.

Abbreviations: IVIg, intravenous immunoglobulin; PMP, plasmapheresis; RCI, repository corticotropin injection.

Table 1 Baseline Patient Distributions by EDSS State and Relapse Severity

Parameter	Initial Distribution^Citation46 (N=125)	Mild/Moderate Relapse^Citation28,Citation29	Severe Relapse^Citation28,Citation29
EDSS 0	1.65%	98.3%	1.7%
EDSS 1	9.09%	95.6%	4.4%
EDSS 2	20.66%	89.9%	10.1%
EDSS 3	23.97%	69.5%	30.5%
EDSS 4	10.74%	40.0%	60.0%
EDSS 5	3.31%	13.4%	86.6%
EDSS 6	23.14%	4.4%	95.6%
EDSS 7	6.61%	1.6%	98.4%
EDSS 8+	0.83%	0.0%	100.0%

Notes: Patients with EDSS of 4.0 have a significant disability but are self-sufficient and up and about some 12 hours a day, are able to walk without aid, or rest for 500 meters; those with EDSS of 4.5 have a significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance, are able to walk without aid, or rest for 300 meters.³⁰

Abbreviation: EDSS, Expanded Disability Status Scale.

Table 2 Adjusted Monthly Transition Probabilities During the Off-Treatment Period

EDSS State	RCI	PMP or IVIg
Response to exacerbation
EDSS 0	0.0685	0.0974
EDSS 1	0.0723	0.1027
EDSS 2	0.0632	0.0900
EDSS 3	0.0703	0.1000
EDSS 4	0.0685	0.0974
EDSS 5	0.0498	0.0711
EDSS 6	0.0378	0.0542
EDSS 7	0.0400	0.0573
EDSS 8+	0.0400	0.0573
Exacerbation to response
EDSS 0	0.3016	0.0068
EDSS 1	0.3010	0.0067
EDSS 2	0.3025	0.0068
EDSS 3	0.3013	0.0068
EDSS 4	0.3016	0.0068
EDSS 5	0.3047	0.0069
EDSS 6	0.3066	0.0069
EDSS 7	0.3063	0.0069
EDSS 8+	0.3063	0.0069

Abbreviations: EDSS, Expanded Disability Status Scale; IVIg, intravenous immunoglobulin; PMP, plasmapheresis; RCI, repository corticotropin injection.

Table 3 SAEs for Treatments

Adverse Event	Value	Source
RCI
Asthenia	1.60%	Kaplan 2020^Citation46
Urinary tract infection	1.60%	Kaplan 2020^Citation46
PMP
Bleeding	4.90%	Heatwole 2011^Citation27
Infection	4.90%	Heatwole 2011^Citation27
Catheter occlusion	2.40%	Heatwole 2011^Citation27
Deep vein thrombosis	2.40%	Heatwole 2011^Citation27
IVIg
Fever	14.80%	Heatwole 2011^Citation27
Increased creatinine	14.80%	Heatwole 2011^Citation27
Abnormal liver function tests	8.00%	Heatwole 2011^Citation27
Stroke	0.60%	Heatwole 2011^Citation27

Abbreviations: IVIg, intravenous immunoglobulin; PMP, plasmapheresis; SAE, serious adverse event; RCI, repository corticotropin injection.

Table 4 Economic Input Parameters

Cost Parameter	Value		Source
Treatment costs
RCI^a	$39,864 per vial^b		Red Book^Citation47
PMP
Albuminar^® 5% (40 mL/kg; per session)^c	$180.00^b		Red Book;^Citation47 Navarro-Martinez 2020^Citation48
Administration cost
Central venous catheter (including supplies)	$1010.49		Winters et al^Citation49
Tubing set and other supplies	$282.74		Winters et al^Citation49
Fibrinogen lab test	$101.90		CPT 85384^Citation50
Plasma exchange equipment amortization	$353.90		Winters et al^Citation49
Service contract amortization	$148.05		Winters et al^Citation49
Professional costs (3 hours)	$1037.52		CPT 99214^Citation50
Facility cost^d	$1575.44		CPT 99236^Citation50
IVIg
Gamunex-C^® (400 mg/kg; per session)^e	$130.12^b		Red Book^Citation47
			Katz 2006^Citation51
Administration cost
IVIg infusion supplies	$202.90		CPT 96365, 96366^Citation50
Professional costs (2 hours)	$691.68		CPT 99214^Citation50
Facility cost^d	$1575.44		CPT 99236^Citation50
Adverse events
Asthenia	$2020		Strand 2020^Citation52
Urinary tract infection	$1412		Hagiwara 2013^Citation53
Bleeding	$581		Heatwole 2011^Citation27
Catheter occlusion	$2264		Heatwole 2011^Citation27
Deep vein thrombosis	$5355		Heatwole 2011^Citation27
Infection	$2032		Heatwole 2011^Citation27
Fever	$2032		Heatwole 2011^Citation27
Increased creatinine	$302		Heatwole 2011^Citation27
Abnormal liver function tests	$293		Heatwole 2011^Citation27
Stroke	$77,062		Heatwole 2011^Citation27
Direct medical costs	Mild/Moderate	Severe
Ambulatory care	$72.45	$17.39	O’Brien 2003^Citation54
Inpatient	$485.61	$1962.89	O’Brien 2003^Citation54
Physician visit	$25.93	$25.93	O’Brien 2003^Citation54
Home health services	$120.79	$311.59	O’Brien 2003^Citation54
Direct non-medical costs	Mild/Moderate	Severe
Community service	$96.50	$96.96	Oleen-Burkey 2012^Citation21
Alterations and adaptations	$372.65	$347.95	Oleen-Burkey 2012^Citation21
Travel/Meals	$40.32	$180.17	O’Connell 2014^Citation55
Indirect costs	Mild/Moderate	Severe
Medically related absenteeism	$165.01	$241.31	Parisé 2013^Citation56
Reduced productivity at work (presenteeism)	$349.69	$496.29	Oleen-Burkey 2012^Citation21
Disability	$187.43	$513.96	Parisé 2013^Citation56
Informal care	$304.80	$564.72	Oleen-Burkey 2012^Citation21
Family’s loss of earnings	$161.85	$239.89	Parisé 2013^Citation56

Notes: ^a2.33 vials are assumed per relapse. ^bWholesale acquisition costs. ^cThe model assumes six sessions²⁷ and an average weight of 79 kg.³³ Based on a dose of 40 mL/kg, the cost of 5% albumin per session is $1260 or $7560 for six sessions. Including the administration costs, the total cost of treatment per session is $5770 (or $34,620 for six sessions). ^dAssumes outpatient facility costs for administration of PMP and IVIg. ^eThe model assumes five doses²⁷ and an average weight of 79 kg.³³ Based on a dose of 400 mg/kg, the cost of IVIg is $4164 per session or $20,820 for five sessions. Including the administration costs, the cost of treatment per session is $6634 (or $33,168 for five sessions). Note that the model also includes maintenance treatment for IVIg every 4 weeks, so the overall cost of treatment with IVIg is considerably larger.

Abbreviations: CPT, current procedural terminology; IVIg, intravenous immunoglobulin; PMP, plasmapheresis; RCI, repository corticotropin injection.

Table 5 Health Utilities of Remission/Response and Exacerbation/Relapse for Baseline MS

EDSS State	Remission/Response	Mild/Moderate Relapse	Severe Relapse
EDSS 0	0.8752	0.7842	0.5732
EDSS 1	0.8342	0.7432	0.5322
EDSS 2	0.7802	0.6892	0.4782
EDSS 3	0.6946	0.6036	0.3926
EDSS 4	0.6253	0.5343	0.3233
EDSS 5	0.5442	0.4532	0.2422
EDSS 6	0.4555	0.3645	0.1535
EDSS 7	0.3437	0.2527	0.0417
EDSS 8+	0.0023	−0.0887	−0.2997

Abbreviation: EDSS, Expanded Disability Status Scale.

Table 6 Cost-Effectiveness of RCI Compared to PMP or IVIg

Treatment	Incremental Costs	Incremental QALYs	ICER
Payer at 1 year
RCI vs PMP	$4839	0.115	$42,078
RCI vs IVIg	($79,867)	0.120	Dominant
Societal at 1 year
RCI vs PMP	($10,508)	0.115	Dominant
RCI vs IVIg	($95,923)	0.120	Dominant
Payer at 2 years
RCI vs PMP	($6827)	0.241	Dominant
RCI vs IVIg	($177,939)	0.248	Dominant
Societal at 2 years
RCI vs PMP	($39,184)	0.241	Dominant
RCI vs IVIg	($211,229)	0.248	Dominant
Payer at 3 years
RCI vs PMP	($18,551)	0.368	Dominant
RCI vs IVIg	($275,954)	0.376	Dominant
Societal at 3 years
RCI vs PMP	($67,972)	0.368	Dominant
RCI vs IVIg	($326,372)	0.376	Dominant

Notes: RCI is the reference category; positive cost represents the cost incurred with RCI; positive QALYs represent QALYs gained with RCI.

Abbreviations: ICER, incremental cost-effectiveness ratio; IVIg, intravenous immunoglobulin; PMP, plasmapheresis; QALY, quality-adjusted life-year; RCI, repository corticotropin injection.

Table 7 Breakdown of Costs

Parameter	RCI	PMP	IVIg
YEAR 1
Treatment cost	$55,494	$38,427	$119,897
AE cost	$394	$2071	$4811
Direct cost	$13,924	$24,475	$24,971
Indirect cost	$32,002	$47,349	$48,058
Total cost	$101,814	$112,322	$197,737
QALYs	0.608	0.493	0.488
YEAR 2
Treatment cost	$55,494	$38,427	$206,137
AE cost	$394	$2071	$4811
Direct cost	$27,496	$49,713	$50,375
Indirect cost	$62,843	$95,200	$96,133
Total cost	$146,227	$185,411	$357,456
QALYs	1.175	0.934	0.927
YEAR 3
Treatment cost	$55,494	$38,427	$292,377
AE cost	$394	$2071	$4811
Direct cost	$40,268	$74,209	$74,922
Indirect cost	$91,864	$141,285	$142,282
Total cost	$188,020	$255,992	$514,392
QALYs	1.709	1.341	1.333

Abbreviations: AE, adverse event; IVIg, intravenous immunoglobulin; PMP, plasmapheresis; QALY, quality-adjusted life-year; RCI, repository corticotropin injection.

Figure 2 Results of the probabilistic sensitivity analyses for the cost-effectiveness of RCI compared to PMP or IVIg from a US payer perspective over two years.

Abbreviations: IVIg, intravenous immunoglobulin; PMP, plasmapheresis; RCI, repository corticotropin injection; QALY, quality-adjusted life-year; WTP, willingness-to-pay.

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