The evidence that associates medical and economic-based rationales for making early diagnosis and initiating treatment

The economic burden associated with multiple sclerosis (MS) is substantial. Patients with MS incur medical costs 2 to 3 times those of all enrollees in a managed care organization. In a study published in 2010 by Asche et al,1,411 MS cases (65.6% female) were matched to 7,055 “healthy comparison” cases (65.6% female). The cases were included in the evaluation if the ICD-9 340 coding for definite MS was made at any time during the period under study. In the analyses of all-cause health care services during the 12-month post-index period, MS patients were significantly more likely to use all categories of health services examined. Overall medical costs were 4.7 times higher for newly diagnosed MS patients during the first 12 months. Although it cannot be established how many of these patients could have had their direct healthcare costs reduced through the use of the gMS®Dx, the number of visits and evaluations incurred and documented by this study cohort were conceivably performed during the phase prior to definitive diagnosis and treatment, and that this process could have been shortened with additional information on the CIS-to-RRMS risk in specific cases. (Asche et al, All-Cause Health Care Utilization and Costs Associated with Newly Diagnosed Multiple Sclerosis in the United States. J Manag Care Pharm, 2010;16(9):703-12)

 

Medical costs per relapse

The clinical trials for CIS converting to RRMS testing the DMTs for early treatment established efficacy primarily based on their capacity to postpone relapse occurrences in the studied populations. O’Brien evaluated the Medical costs per MS relapse in Multiple Sclerosis using three levels of relapse types:

1. Low-Intensity Episode in which only Initial Contact was usual care physician
2. Moderate Intensity Episode in which Initial Contact was usual care physician but also Emergency Department, Intervention, Hospital Day Care and Home Administration were involved
3. High Intensity Episode in which Initial Contact was usual care physician but also Emergency Department, Intervention, Hospital Admission and Post Discharge Service was required.

In 2002 US dollars, the first, low level episodes cost $243, moderate at $1,847, and the High-intensity $12,870. These costs may underestimate true costs, as they only cover treatment, and not the work-up of the differential diagnosis for a given episode. (O’Brien J., et al. BMC Health Serv Res. 2003:3(1):17-28. Table 1) It is expected that using the the gMS®Dx test will establish an earlier, more definitive threshold for making a definite diagnosis of RRMS and making the argument for initiating early treatment. Further, this data argues that these steps will reduce the number of costly clinical MS relapses.

The cost effectiveness of current disease modifying therapies. 

In a recent review published in the journal Neurology, Noyes et al found that compared to treating patients with all levels of disease, starting DMT earlier was associated with a lower (more favorable) incremental cost-effectiveness ratio compared to initiating treatment at any disease state. They noted, “Our sensitivityanalyses reemphasize the need for early DMT initiation and suggest that starting DMT earlier, at EDSS 2 or before, could be more cost effective than starting DMT for patients with MS at later stages of the disease. One potential reason for this result is that starting DMT earlier may defer the substantial costs associated with late-stage MS and disability.” (K. Noyes et al, Inpatient utilization cost-effectiveness of disease-modifying therapy for multiple sclerosis, Neurology, 2011)

 

Carl V. Asche, PhD, MBA; Mendel E. Singer, PhD; Mehul Jhaveri, PharmD, MPH;
Hsingwen Chung, BS Pharm, MS; and Aaron Miller, MD

• This is the first such study to assess the direct health care costs and resource utilization among newly diagnosed MS patients compared with healthy members of commercial health plans. Overall medical costs were 4.7 times higher for newly diagnosed MS patients.
• Less than one-half of the nearly $19,000 in the first 12 months of costs after diagnosis of MS could be attributed to medical claims with diagnosis codes for MS in any field on the claim.
• MS injectable drugs accounted for approximately one-fourth of total direct medical costs for newly diagnosed MS patients in the first 12 months after diagnosis. 

OBJECTIVE: To estimate the additional health care utilization and costs in otherwise healthy patients with newly diagnosed MS.
RESULTS: Mean Health Care Expenditures in 12-Month Post-Index Period

Health Care Expenditures by Service Category	MS Patients n=1,411
	Mean (SD)	Dollars
Inpatient services	4,110	19,673
MS diagnosis on claim	1,802	12,846
Emergency room services	432	1,290
MS diagnosis on claim	53	354
Injections, MS drugs	137	1,605
Physician visits, all	849	879
MS diagnosis on claim	265	366
Neurologist visits	615	4,244
MS diagnosis on claim	153	297
Laboratory services	409	990
MS diagnosis on claim	82	318
Radiology services	1,693	3,801
MS diagnosis on claim	705	1,720
PT/OT/speech, swallowing	295	1,019
MS diagnosis on claim	75	602
Other outpatient services	4,753	11,209
MS diagnosis on claim	1,285	4,213
Outpatient pharmacy	6,151	8,574
MS drugs	4,436	7,828
Anticonvulsants	165	701
Antidepressants	194	479
Antipsychotics	24	253
Urinary antibiotics	3	23
Amphetamines	81	444
Adrenals	24	144
Other	1,225	3,070
Total	18,829	28,973
Claims with MS diagnosis or treatment	8,839	17,825

• This economic model, constructed using data from pivotal randomized placebo-controlled clinical trials, predicted that patients with RRMS would experience 2.55 relapses and 0.44 disability progression steps over a 2-year period without DMD treatment.
• Over 2 years, for treatment with glatiramer acetate, IFN β-1a IM injection, IFN β-1a SC injection, and IFN β-1b, respectively, reductions in number of clinical relapses were estimated at 0.66, 0.42, 0.74, and 0.70, respectively. Reductions in number of disability progression steps were estimated at 0.05, 0.15, 0.12, and 0.11, respectively.
• IFN β-1a SC injection, IFN β-1b SC injection, and glatiramer acetate have the most favorable estimated costs per relapse avoided ($80,589; $87,061; and $88,310; respectively), and IFN β-1a IM injection has the least favorable cost-effectiveness ratio ($141,721 per relapse avoided).
• This model differs from those previously published because it (a) used a 2-year time horizon based on 2-year pivotal, randomized, double-blind, placebo-controlled clinical trial data without extrapolating to a 5-year or lifetime time horizon; and (b) measured as the primary endpoint relapses averted rather than endpoints that rely on the perception and measurement of preference, such as QALYs.

OBJECTIVE: The primary objective of this analysis was to evaluate the 2-year cost-effectiveness of 4 disease modifying drugs (DMDs) used as first-line treatment of RRMS: glatiramer acetate, interferon (IFN) β-1a IM injection, IFN β-1a SC injection, and IFN β-1b SC injection.
RESULTS: Base-Case Results: Discounted Per Patient Clinical Outcomes, Costs, and Savings Over 2 Years

	Glatiramer Acetate	IFN β- 1a IM	IFN β- 1a SC	IFN β- 1b SC	No DMD Treatment
Clinical outcomes
Relapses	1.88	2.13	1.84	1.81	2.55
Relapses avoided	0.66	0.42	0.74	0.70	-
Disability progression steps	0.40	0.30	0.33	0.33	0.44
Disability progression steps avoided	0.05	0.15	0.12	0.11	-
Costs and Savings
Medical cost: relapses and disease progression	$9,537	$10,513	$9,060	$9,231	$12,733
Medical savings	$3,196	$2,221	$3,673	$3,502	-
Cost of DMD therapy	$49,068	$48,473	$50,389	$52,010	$0
Total MS-related cost	$58,605	$58,986	$59,449	$61,241
Cost per relapse avoided	$88,310	$141,721	$80,589	$87,061	-