Budget impact of xanomeline and trospium chloride for the treatment of adults with schizophrenia in the United States.

backgroundSchizophrenia is a severe mental health condition affecting up to 1.2% of the US population, resulting in an estimated economic burden of approximately $343 billion in 2019. Traditional treatments primarily target dopamine receptors and include first- and second-generation antipsychotics, which are associated with chronic adverse events (AEs) (eg, severe movement disorders, metabolic syndrome). Management of these AEs entails considerable clinical implications and economic burden, leading to increased health care expenditures for patient care and symptom control. Recently, the US Food and Drug Administration (FDA) approved xanomeline and trospium chloride (X/T), a novel treatment targeting muscarinic rather than dopaminergic receptors. X/T has demonstrated efficacy in reducing both positive and negative symptoms of schizophrenia, with a more tolerable AE profile than traditional standard of care.

objectiveTo estimate the budget impact of incorporating X/T in a hypothetical 1 million-member US health plan, with Medicare, Medicaid, and commercial coverage, to treat adults with schizophrenia.

methodsA 3-year budget impact model was developed in Microsoft Excel to estimate the number of schizophrenia patients eligible for second-line treatment within a health plan and the total treatment-related costs. The 10 largest first- and second-generation antipsychotic treatments by market share across payer type were the comparators included in the base case analysis. The model captured drug acquisition, administration, and treatment-emergent AE management costs to estimate the budget impact on a total per year and per member per month (PMPM) basis.

resultsIntroducing X/T as a second-line treatment for adults with schizophrenia to a 1 million-member health plan results in a PMPM budget impact ranging from $0.0177 in year 1 to $0.1006 in year 3. The total annual budget impact is estimated to be between $212,479 and $1,219,085 in year 1 and year 3, respectively. X/T also results in reduced AE management costs over 3 years ($11,336 692 vs $11,276,020) driven by lower rates of tardive dyskinesia and metabolic syndrome associated with X/T use. Sensitivity and scenario analyses demonstrated minimal budget impact sensitivity to parameter variations, with results most sensitive to the cost of X/T and inputs used to estimate the size of the eligible patient population.

conclusionsThe safety and tolerability profile of X/T, coupled with its minimal PMPM budget impact of $0.0177 in year 1 up to $0.1006 in year 3, based on market uptake of 1%, 2%, and 3% in years 1, 2, and 3, respectively, supports the inclusion of X/T on the formularies of third-party US health care plans for adults with schizophrenia.