This study presents an analysis of the CE of DMT use by patients with MS that is based solely on evidence from the United States, including data on drug effectiveness, patient health preferences, health care utilization, lost productivity, and cost information. Our estimates of the ICERs for all 4 examined DMTs were on the order of a million dollars per QALY. While there is no formal CE threshold in the United States, these estimates are an order of magnitude greater than the CE of many commonly accepted therapies for chronic illness.30
Hence, our study indicates that it is very unlikely that under current prescribing and pricing patterns, DMTs may be considered cost-effective for patients with RRMS and SPMS in the United States. The DMT cost-reduction analysis suggested that the probability that the ICER of DMT could be below $700,000/QALY is near 0.
Our results indicate that the cost of DMT represents a substantial fraction of total health-related costs for patients with MS in the United States amounting to about 50% of 10-year cumulative costs. Lowering the prices of the DMTs by 67% to match prices in other industrialized countries31
would improve the CE of these therapies. Indeed, we demonstrate that when DMT costs in our model were reduced by 2-thirds, the CE of DMTs became comparable to the CE of other accepted interventions.30
For instance, the annual cost of interferon β-1a IM in the United Kingdom is about £8,000 ($12,000) compared to ~$25,000 ($34,000 in 2010) in the United States.32
Our sensitivity analyses 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.
Inpatient utilization was low (0.18 hospitalizations per person per year) and contributed about 30% ($22,000–$26,000 per person in hospitalization costs over 10-year period) of medical costs in DMT medication costs of patients with MS. One reason for this is that the vast majority of relapses, which used to significantly contribute to the rate of hospitalization, are now managed in outpatient or home-based settings.
While the US models presented important evidence on cost-effectiveness of MS DMTs in the United States,7–10
these models have weaknesses that limit their current use for health policy and clinical practice decisions that we discussed earlier. Our model addresses these major concerns, mainly by using newly data collected after the DMTs were introduced to the US market. Our results are consistent with results reported in other studies conducted by independent academic groups,7,12
but are substantially less favorable than the results of industry-sponsored investigations.8,16,33,34
This is likely due to the funding effect and the conflict of interest bias that may enter into the model design, estimating parameters, and interpretation of CE study results.35
We also recognize potential sample selection issues. Because healthier patients may be more likely to enroll in a registry or a study, our estimates of effectiveness may be overestimated while the cost estimates are likely to be underestimated. Finally, the composition of patients in the “support therapy” arm is fairly heterogeneous and may include patients who choose to receive no therapy, as well as those who do not have access to therapy.