Background: The biosimilar market is growing rapidly, as evidenced by 41 approvals and 37 launches to date. As adalimumab biosimilars launch in the United States, competition among biosimilar and reference adalimumab will likely increase across multiple reference indications, including rheumatology, dermatology, and gastrointestinal diseases, which may lead to decreased payer costs.
Objective: To evaluate the costs of adding biosimilar adalimumab to a US commercial plan by exploring various utilization and price differential scenarios.
Methods: A 3-year budget impact model for a US commercial plan of 1 million people was developed to assess switching from reference adalimumab or any self-injectable reference tumor necrosis factor (TNF) inhibitor to biosimilar adalimumab. Pharmacy and medical costs were analyzed through high- and low-conversion scenarios from reference adalimumab and the TNF inhibitor class. Price reductions of 5% to 60% relative to reference adalimumab based on previous biosimilar launches were also explored. Short-term medical costs were evaluated as additional simple and complex office visits, with scenarios of half of switch patients having 1 visit up to all switch patients having 10 visits.
Results: In a target population of 1,863 patients, switching from reference adalimumab to biosimilar adalimumab had cumulative cost savings of $5,756,073 with slow conversion (10%-20% over 3 years) and $28,780,365 with fast conversion (50%-100% over 3 years). Similar results were seen when switching from any other self-injectable reference TNF inhibitor. Cost savings more than $1 million were seen with a 10% conversion from reference adalimumab and a 15% price reduction from reference adalimumab. Additional office visit scenarios had a negligible impact on budget, with no changes in per-member-per-month costs until all switch patients had 10 additional complex visits, in which per-member-per-month costs increased by $0.02.
Conclusions: In a hypothetical plan of 1 million lives, use of biosimilar adalimumab in commercial plans can lead to significant cost savings for payers because of increased competition. Greater and faster biosimilar conversion rates from reference adalimumab and other reference TNF inhibitors resulted in decreased costs. Additionally, even with short-term medical expenditures, cost savings were still realized when switching to biosimilar adalimumab.
Background: Outcomes-based agreements (OBAs) are agreements between payers and manufacturers in which payment for medications is tied to patient outcomes. These contracts aim to measure the value of prescription medications on predefined clinical indicators in real-world patient populations. OBAs are gaining traction in the United States as the health care industry shifts from volume-based to value-based care. Multiple sclerosis (MS) is an appealing therapeutic area for OBAs because of its prevalence, high cost of medications, and multiple effective therapeutic options.
Objective: To describe findings from an OBA that was prospectively conducted in a large regional health system for patients with MS taking interferon β-1a or dimethyl fumarate.
Methods: In this prospective real-world analysis, commercial or health insurance exchange members were included based on the parameters of the OBA. Disability progression was assessed using a patient-reported outcome, patient-determined disease steps (PDDS). In the OBA, members aged 18 years or older with an MS diagnosis were included in the contract. A baseline score was collected for eligible members, with follow-up scores occurring between a 90-day and 180-day postbaseline score. If a follow-up score was greater than the baseline score, a subsequent PDDS score was collected between 90-days and 120-days to determine if the PDDS score remained elevated, indicating that the member had disability progression.
Results: During the contract period, 410 patients were eligible for PDDS collection, with 241 and 169 patients in the dimethyl fumarate and interferon β-1a cohorts, respectively. There were 162 patients who were lost to follow-up, and 64 patients who were ineligible per contract parameters. Of the remaining 184 eligible patients (107 on dimethyl fumarate and 77 on interferon β-1a), 21 (11%) patients had confirmed disability progression (6 on dimethyl fumarate [5.6%] and 15 on interferon β-1a [19.5%]).
Conclusions: Our findings suggest that meaningful patient-reported outcomes, such as disability progression, can be operationalized in an innovative OBA.
Background: Type 1 diabetes mellitus (T1DM) is a prevalent chronic endocrine disorder and accounts for 5%-10% of all diabetes cases worldwide. T1DM can have a substantial impact on health care utilization. Although it is well known that individuals with diabetes are at a greater risk of mental health disorders, specific evidence addressing the health care burden of comorbid depression/anxiety in people affected by T1DM is lacking.
Objective: To assess health care resource utilization (HCRU) among adults with T1DM and comorbid depression or anxiety.
Methods: We identified individuals aged 18 to 64 with a T1DM diagnosis from January 1, 2017, to December 31, 2021, using a 25% random sample of the IQVIA PharMetrics Plus for Academics database. The index date was the date of the first medical claim with a T1DM diagnosis. Eligibility required continuous medical and prescription coverage for 12 months before (baseline) and after (follow-up) the index date. Comorbid depression/anxiety and baseline characteristics were assessed during the baseline period. The following 2 mutually exclusive groups were created: individuals with T1DM and comorbid depression/anxiety, and those with only T1DM. To balance baseline demographic and clinical characteristics between the groups, we implemented 1:1 propensity-score matching. We assessed all-cause, diabetes-related, and major adverse cardiovascular event-related HCRU during the follow-up period. Logistic (binary) and negative binomial (count) regression models examined the association between comorbid depression/anxiety and HCRU across types of health care settings.
Results: Out of 6,491 eligible individuals with T1DM, 1,168 (18%) had either depression or anxiety. In the matched cohort of 2,314 individuals, those with T1DM and comorbid depression/anxiety had significantly higher odds of all-cause emergency department visits (odds ratio = 1.67; 95% CI = 1.39-2.00) and higher rates of physician office visits (incidence rate ratio = 1.37; 95% CI = 1.27-1.47) and other outpatient encounters (incidence rate ratio = 1.23; 95% CI = 1.13-1.34) than those with only T1DM. Findings were similar for diabetes-related and major adverse cardiovascular event-related HCRU.
Conclusions: Comorbid depression/anxiety among individuals with T1DM results in significantly higher HCRU than T1DM alone. The findings underscore the importance of effective management of comorbid depression/anxiety in the T1DM population.
Background: Dose escalation of biologics may restore response in patients with Crohn's disease (CD) who experience inadequate response or loss of response, but the rates of dose escalation and subsequent adverse clinical outcomes have not been well characterized.
Objective: To evaluate the rate of dose escalation of biologics and associated adverse clinical outcomes and economic outcomes in biologic-naive patients with CD.
Methods: ODESSA-CD (real wOrld Dose EScalation and outcomeS with biologics in IBD pAtients with Crohn's Disease) was a retrospective cohort study conducted using claims data from IBM MarketScan databases. Adults with CD with at least 1 claim for an index drug (adalimumab, infliximab, ustekinumab, or vedolizumab) between January 1, 2017, and December 31, 2018, and no claims for biologics in the 6 months prior (ie, biologic naive) were included. Follow-up ended on June 30, 2020. Cox proportional hazards models and logistic regression models were used to compare the rate of dose escalation and the likelihood of adverse clinical outcomes and costs after dose escalation, respectively.
Results: Of the 2,664 eligible patients, most (71.4%) were younger than 50 years and 50.5% were male. The rate of dose escalation was higher with the anti-tumor necrosis factor α (TNFα) treatments adalimumab (hazard ratio [HR] = 1.703; P < 0.0001) and infliximab (HR = 1.690; P < 0.0001) compared with vedolizumab, but there was no significant difference between ustekinumab and vedolizumab (HR = 0.842; P = 0.730). After dose escalation, the likelihood of infection, sepsis, and inflammatory bowel disease-related hospitalization did not differ among biologics (anti-TNFα vs vedolizumab: odds ratio [OR] = 1.141, P = 0.599; ustekinumab vs vedolizumab: OR = 0.891; P = 0.836); however, corticosteroid use was more likely with anti-TNFα treatment than with vedolizumab (OR = 1.740, P = 0.002). Among patients whose dose was escalated, index drug costs were likely to be higher with anti-TNFα treatment and ustekinumab than with vedolizumab (anti-TNFα vs vedolizumab: ratio of expected cost = 1.429, P = 0.002; ustekinumab vs vedolizumab: ratio of expected cost = 3.115, P < 0.0001).
Conclusions: Patients who were biologic naive and received ustekinumab or vedolizumab were less likely to undergo dose escalation than those who received anti-TNFα treatment. Adverse clinical outcomes after dose escalation were similar among these biologics but with different costs. These analyses may inform providers and payers of the clinical and economic implications of dose escalation.
Background: Two classes of newer glucose-lowering drugs (GLDs), sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists, improve cardiovascular and renal outcomes among patients with type 2 diabetes (T2D). However, racial and ethnic minority groups carry higher cardiovascular risks but have lower access to newer GLDs. Contextual-level social determinants of health (SDOH) may be the underlying factor associated with newer GLD adoption.
Objective: To identify the association between contextual-level SDOH and real-world adoption of newer GLDs among Medicare beneficiaries and to examine the nonstationarity in the associations.
Methods: Data were from 15% random samples of January 2017 to December 2018 nationwide Medicare beneficiaries. We identified patients with T2D who did not use newer GLDs in the year before the index date-January 1, 2018-and followed the cohort for 1 year to record their status of initiating a newer GLD. We used a geographically weighted multivariable Poisson regression model to determine to what extent the SDOH-newer GLD initiation association (β coefficient) varied geographically.
Results: We identified 795,469 eligible Medicare beneficiaries with T2D during the study period from our dataset. Of the study cohort, mean age was 73.1 (SD = 10.5) years, 424,312 (53.3%) were female, 562,994 (70.8%) were non-Hispanic White, 96,891 (12.2%) were non-Hispanic Black, 84,744 (10.6%) were Hispanic, and 29,645 (3.7%) were Asian/Pacific Islander. Newer GLD initiation was negatively associated with the percentage of the population reporting non-Hispanic Black race, Hispanic ethnicity, and unemployment, as revealed by nonspatial regression analyses. The county-level median household income was also associated with higher newer GLD initiation. The spatial analysis presented distinct distributions of local parameter estimates for each contextual-level SDOH.
Conclusions: We identified key contextual-level SDOH associated with real-world adoption of newer GLDs and explored their geographic variation through spatially explicit, data-driven analytical approaches. Identifying areas of strong association between SDOH and newer GLD initiation is crucial for policymakers to allocate resources and develop interventions that address structural inequities.