bevacizumab (BP 01 / Bevqolva / BP01)

Cost-effectiveness of finotonlimab plus bevacizumab versus sorafenib as first-line therapy in unresectable hepatocellular carcinoma in China.

Xu Huihui H, Yu Shengjian S, Yang Yan Y, Bian Haoze H et al.

Hepatocellular carcinoma (HCC) imposes a substantial health burden in China. Finotonlimab plus bevacizumab recently prolonged progression-free survival (PFS) and overall survival (OS) vs. sorafenib, but its economic value remains unknown. Here we evaluated the cost-effectiveness of finotonlimab plus bevacizumab vs. sorafenib from the Chinese healthcare system perspective. Parametric survival models were fitted to extrapolate PFS and OS. Total costs, life-years (LYs), quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), incremental net monetary benefit (INMB), and incremental net health benefit (INHB) were estimated at a willingness-to-pay (WTP) threshold of $27,906 per QALY. Uncertainty was evaluated by one-way and two-way sensitivity analyses, probabilistic sensitivity analysis (PSA), subgroup analyses, scenario analyses, and price simulations. In the base-case analysis, sorafenib yielded 1.74 LYs and 1.25 QALYs at a total cost of $10,303.10, whereas finotonlimab plus bevacizumab yielded 3.01 LYs and 2.18 QALYs at a total cost of $58,595.49. Compared with sorafenib, the combination increased costs by $48,292.39 and generated gains of 1.27 LYs and 0.93 QALYs, resulting in ICERs of $38,203.46 per LY and $51,899.31 per QALY. INMB (-$22,325.82) and INHB (-0.80 QALYs) were negative. Sensitivity analyses identified PFS utility and bevacizumab cost as key drivers, but all ICERs remained above the WTP threshold. In PSA, the mean ICER was $50561.81 per QALY, and the probability of cost-effectiveness was 0% at the prespecified threshold. Based on the assumptions and inputs used in the present model, finotonlimab plus bevacizumab was unlikely to be cost-effective compared with sorafenib at the prespecified WTP in China.

When precision medicine meets rigid vaccination: bridging the policy gap for patients on biologics.

He Dingxian D, Zhang Yunlu Y, Luo Sushan S, Feng Tianxing T

Evaluating the feasibility of health care databases for assessing the safety of switching between originator biologics and biosimilars.

Mendelsohn Aaron B AB, DeFor Terese A TA, Audrey Djibo Djeneba D, Myers Scott M SM et al.

Real-world data (RWD) have received considerable attention recently, namely, with regard to their value in providing further evidence about the benefit-risk profile for medicinal products beyond clinical trial data. RWD may be particularly useful for establishing interchangeability and supporting switching decisions between originator biologics and their biosimilars. To evaluate the fitness of 3 US health care databases-a national, commercial health plan, a regional integrated delivery network (IDN), and a multipayer, national claims-based database (henceforth, multipayer database)-for capturing data from clinical trials assessing interchangeability between originator biologics and biosimilars across multiple therapeutic areas. We identified 8 clinical trials examining switching between originator biologics and biosimilars from the published literature and ClinicalTrials.gov. All variables representing inclusion/exclusion criteria, interventions, and outcomes from these trials were recorded and grouped into 8 categories: assessment, behavior, demographic, diagnostic, laboratory, procedure, treatment, and vital signs. The 3 databases were then individually evaluated based on the availability of variables identified from the clinical trials and by calculating the percentage of observed data in each database for all relevant variables across the clinical trials, overall and within the above categories. The population size varied across the databases (4 million for the regional IDN through 170 million patient-lives in the multipayer database). All databases had complete (100%) capture for procedure, treatment, and vital signs data and performed well for capturing diagnostic information (78%-100%). Most demographic information (eg, age, sex) was captured; however, race and ethnicity was not available for all databases. Seventy-one percent of the behavior data (eg, whether the patient was sexually active) was captured by the commercial health plan and the regional IDN, but only 29% by the multipayer database. Assessment data (eg, survival, functional status) varied across the databases, with the regional IDN having 93% data capture vs 37% and 16% in the commercial health plan and multipayer database, respectively. Notable differences among the databases were also observed for laboratory data; the regional IDN had complete capture vs only 6% in the multipayer database. Health care databases provide information such as diagnoses, treatments, and some outcomes that may be useful for generating real-world evidence relevant to biosimilar regulatory assessment. However, details on treatment effectiveness may be limited. Specific databases should be evaluated according to their unique attributes to select the most appropriate source(s) of information for a given research need. Further studies are warranted to evaluate data accuracy and timeliness in health care databases.

Treatment Patterns and Pathways of Systemic Drug Therapy in Patients With Plaque, Erythrodermic, and Generalized Pustular Psoriasis: A Retrospective Cohort Study in Japan.

Tada Yayoi Y, Maeda Yoshiko Y, Hasegawa Miyuki M, Sakaguchi Motonobu M et al.

Systemic psoriasis treatment options have rapidly expanded in Japan, including the approval of tyrosine kinase 2 and interleukin-36 receptor inhibitors in 2022. However, contemporary real-world treatment patterns across plaque, erythrodermic, and generalized pustular psoriasis remain incompletely characterized. Using a Japanese hospital-based insurance claims database (Medical Data Vision Co. Ltd.), we conducted a retrospective cohort study for patients with these psoriasis subtypes who initiated systemic drug therapy between 2020-2023 and had a ≥ 12-month observation period. Overall, 3965 patients with plaque psoriasis, 80 with erythrodermic psoriasis, and 128 with generalized pustular psoriasis were included (median age, 62-66 years). Most patients initiated systemic therapy with a single drug. A phosphodiesterase 4 inhibitor was the most frequently prescribed index treatment for plaque psoriasis (48.8%), whereas a vitamin A derivative was most commonly prescribed for erythrodermic and generalized pustular psoriasis (42.5% and 42.2%, respectively), suggesting a distinctive Japan-specific prescription pattern. The median proportion of days covered for index treatment was nearly 100% across all subtypes. Among the index treatments, biologics generally showed longer time to discontinuation than oral medications. Elderly patients were more likely to receive a phosphodiesterase 4 inhibitor or a vitamin A derivative as index treatment than younger patients, and biologics were more commonly selected for patients with psoriatic arthritis than for those without. Early uptake of tyrosine kinase 2 inhibitor was observed in 2023. Over a median observation period of approximately 30 months, > 85% of patients received three or fewer lines of systemic drug therapy and approximately 50% remained on at least one systemic drug therapy throughout the study period. This first comprehensive Japanese claims database analysis of multiple psoriasis subtypes provides an updated real-world treatment landscape in Japan and helps address an important evidence gap arising from rapidly evolving systemic treatment options and limited contemporary real-world data.