Budget impact analysis of biosimilar natalizumab in the US.

OBJECTIVES: Biosimilars provide an opportunity for a more sustainable and cost-effective treatment for multiple sclerosis (MS). This study evaluated the potential financial impact of implementing a formulary change from reference to biosimilar natalizumab (NTZ) from the US commercial payer perspective. STUDY DESIGN: The budget impact of transitioning to biosimilar NTZ for the treatment of relapsing-remitting MS (RRMS) was estimated over a 3-year time horizon based on real-world dosing. Additional scenario analyses were conducted by varying the price differential of biosimilar NTZ. METHODS: The target population was estimated from a 1-million-member hypothetical commercial health plan. Model inputs were drug acquisition costs and treatment-related and patient coinsurance costs. Budget impact and cost savings per member per year were calculated by assuming a biosimilar uptake of 10% in year 1 to 20% in year 3. RESULTS: Over 3 years, 255 patients were estimated to be treated with high-efficacy disease-modifying therapies for RRMS. The inclusion of biosimilar NTZ onto a formulary would result in cumulative cost savings to payers of $452,611 over 3 years, with mean savings per treated member per year of $1179, $1769, and $2359 in years 1, 2, and 3, respectively. One-way sensitivity analyses indicated that budget impact results were most sensitive to drug acquisition costs of both reference and biosimilar NTZ. CONCLUSION: Adoption of biosimilar NTZ can yield considerable cost savings to US health plans that could result in increased treatment access for patients with RRMS.

Economic burden of multiple sclerosis in the United States: A systematic literature review.

BACKGROUND: Multiple sclerosis (MS) is chronic progressive disease that poses a significant economic burden to patients and health care systems in the United States. We conducted a systematic literature review to provide up-to-date insights on the economic burden of MS in the United States. OBJECTIVE: To comprehensively review and summarize the latest published evidence on the economic burden of MS with a focus on cost, resource use, and work productivity. METHODS: A systematic literature search was conducted using the Embase and Medline databases to identify studies, published between January 2011 and July 2022, reporting cost, resource use, or work productivity outcomes among people with MS in the United States. Clinical trials, economic modeling studies, and review articles were excluded. Details of eligible studies, including study design, patient population, and study outcomes for the overall population, as well as subgroups of interest, were extracted and summarized qualitatively. RESULTS: Overall, 65 studies reporting cost, resource use, or work productivity data were included with majority of studies using claims data. The direct costs associated with MS ranged from $16,614 (2006) to $72,744 (2017) per patient per year with diseasemodifying therapies (DMTs) being the major cost contributors accounting for 43%-78%. The indirect costs reported ranged from $9,122 (2017) to $30,601 (2011) per patient per year with absenteeism, early retirement, and informal care being the key drivers for indirect costs. Costs, resource use, and work impairment were significantly higher for patients with severe disability compared with those with mild disability. Pharmacy costs were the major cost drivers in patients with mild, moderate, and severe disability. Similarly, patients with relapses incurred significantly higher costs, resource use, and work impairment compared with those without relapses. Additional hospitalization charges were the major driver of higher costs in patients who experienced relapses compared with those without relapses. CONCLUSIONS: Direct costs, particularly DMTs, appear to be the major cost drivers for people with MS in the United States. Availability of lower-cost therapies may considerably decrease the economic burden on these patients and the health care systems. Future research focusing on indirect costs, intangible costs, and their contributors would contribute to further understanding of economic burden to avoid underestimation of the financial burden experienced by the patients.

Event and Cost Offsets of Switching 20% of the Type 1 Diabetes Population in Germany From Multiple Daily Injections to Continuous Subcutaneous Insulin Infusion: A 4-Year Simulation Model.

BACKGROUND: Most patients with type 1 diabetes (T1D) administer insulin by multiple daily injections (MDI). However, continuous subcutaneous insulin infusion (CSII) therapy has been shown to improve glycemic control compared with MDI. OBJECTIVE: The objective was to determine the key medical event and cost offsets generated over a 4-year period by introducing CSII to T1D patients who have inadequately controlled glucose metabolism on MDI in Germany. METHODS: A decision-analytic budget impact model, simulating a treatment switch scenario, was developed. In the base case, all T1D patients received MDI, while in the switch scenario, 20% of the eligible T1D population, randomly selected, moved to CSII. The model focused on 2 medical endpoints and their corresponding cost offsets: severe hypoglycemic events requiring hospitalization (SHEH) and complication-borne diabetic events (CDEs) avoided. Event rates and costs were taken from the literature and official sources, adopting a health insurance perspective. RESULTS: Compared with the base case, treating 20% of patients with CSII in the switch scenario resulted in 47 864 fewer SHEH and 5543 fewer CDEs. This led to total cost offsets of €183 085 281 within the 4-year time horizon. Of these, 92% were driven by avoided SHEH. Compared to an expected budget impact (cost increase) of 83%, only treatment costs considered, the total impact of the switch scenario amounted merely to a 24.5% increase in costs (reduction by 58.5% points; a factor of 3.4). CONCLUSION: The use of CSII resulted in fewer SHEH and CDEs compared to MDI. The incurred CSII implementation costs are hence offset to a substantial degree by cost savings in complication treatment.