Breakthrough Clinical Results
ONCare Alliance and Exigent Research have launched a groundbreaking outpatient bispecific antibody program for cancer treatment. This program, developed by Dr. Tara Graff, delivers advanced bispecific therapies directly to patients in their communities, eliminating the need for initial hospitalization. Fourteen ONCare Alliance member sites are already using this streamlined model, providing a collaborative and iterative treatment approach. The program's success has attracted major pharmaceutical partners, and its standardized protocol is being expanded to various disease states, including hematologic malignancies and solid tumors. This innovative approach focuses on value-based care, improving access, learning, and outcomes.
Key Highlights
- Outpatient bispecific antibody program for cancer treatment launched.
- Program eliminates the need for initial hospitalization.
- Collaborative, iterative design allows for real-time feedback and improvement.
- Expanding to various disease states, including hematologic malignancies and solid tumors.
Economic Burden
Economic Burden of Cancer Treatment in the USA and Europe
United States Cancer Costs
In the United States, the annual costs of cancer diagnosis and treatment reached nearly $100 billion in 1990 and currently constitutes approximately 10% of health care expenditures. As new and often more expensive therapies for cancer treatment become available, healthcare decision-makers must consider the cost effectiveness of these therapies.
A cross-sectional analysis of Medicare spending on newly approved anticancer drugs in the US from 2012 through 2021 found that 112 new anticancer drugs were approved, of which 97 met the study's criteria. Notably, 93% of these drugs received expedited development designations from the FDA. At the time of approval, 40% of these drugs had data on progression-free survival, and 19% had data on overall survival; 29% were first-in-class. The analysis found no statistically significant relationship between the clinical value of a drug and its price. Medicare spending on anticancer drugs is predominantly determined by reference pricing and the size of the anticipated treatment population, without an association with therapeutic value.
Between 2009 and 2019, 48 of 65 (74%) cancer drugs had price increases in the US that were greater than inflation. Launch prices of cancer drugs were substantially higher in the US than in similar high-income European countries, a gap that increased in the years after approval. In all countries studied, the lowest median monthly treatment costs at launch were greater in 2018-2019 vs 2009-2010: $14,580 vs $5,790 in the US.
European Cancer Costs
Cancer cost the EU €126 billion in 2009, with healthcare accounting for €51.0 billion (40%). Healthcare costs of cancer were equivalent to €102 per citizen across the EU, varying substantially from €16 per person in Bulgaria to €184 per person in Luxembourg.
In Finland, the total cost of cancer in 2014 was 927 million €. The real costs increased by 1.7% per year over the period studied (2004-2014), while the cost per new cancer patient decreased. The share occupied by cancer treatment in total healthcare costs in Finland decreased slightly from 3.7% to 3.6%, indicating that cancer care has not become more expensive compared to the treatment of other diseases.
In Europe, productivity losses due to early death cost €42.6 billion and lost working days €9.43 billion. Informal care (unpaid care provided by relatives or friends) cost €23.2 billion.
By cancer type, lung cancer had the highest economic cost (€18.8 billion, 15% of overall cancer costs), followed by breast cancer (€15.0 billion, 12%), colorectal cancer (€13.1 billion, 10%), and prostate cancer (€8.43 billion, 7%).
For advanced non-small-cell lung cancer (aNSCLC) patients who received two or more lines of treatment in Europe, weighted mean total per-patient costs were €21,273. These costs ranged from €17,761 (England) to €30,854 (Sweden), and €15,446 (squamous) to €26,477 (non-squamous). Systemic drug costs comprised 77.4% of total costs for aNSCLC patients.
Cost-Effectiveness and Interventions
Multi-cancer early detection (MCED) testing could increase detection of cancer at early stages, when survival outcomes are better and treatment costs are lower. Addition of MCED decreased per cancer treatment costs by $5,421 and resulted in a gain of 0.13 and 0.38 quality-adjusted life-years across all individuals in the screening program and those diagnosed with cancer, respectively.
For oligometastatic cancer patients, the addition of stereotactic ablative radiation therapy (SABR) increased total costs by $54,260 (health care sector perspective) or $72,799 (societal perspective). SABR improved effectiveness by 1.88 QALYs compared with standard therapy, leading to an incremental cost-effectiveness ratio (ICER) of $28,906/QALY (health care sector perspective) or $38,783/QALY (societal perspective). An ICER less than $100,000/QALY was considered cost-effective.
Clinical trials can lead to relevant financial savings in drug acquisition for healthcare providers. In one study at a single research-active University Hospital, the estimated total drug cost avoidance amounted to over €3,200,000 with an average drug cost avoidance per patient of €16,245.
In the UK, testing women with endometrial cancer for Lynch syndrome was found to be cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year. Immunohistochemistry with MLH1 promoter hypermethylation testing was the most cost-effective strategy, with an incremental cost-effectiveness ratio of £9,420 per quality-adjusted life-year.
Drug used in other indications
Bispecific Antibodies for Non-Oncological Indications
Psoriasis Treatment with Bispecific Antibodies
Based on the available information, bispecific antibodies are being investigated for the treatment of psoriasis, which represents a non-oncological therapeutic indication. Researchers have designed three types of bispecific antibodies named BiAU003, BiAU022, and BiAU023 based on the sequences of adalimumab and ustekinumab.
These bispecific antibodies have been specifically engineered to recognize and target both IL-12/23 p40 and TNF-α proteins, which are key inflammatory mediators in psoriasis pathogenesis.
Intervention Methodologies and Mechanisms of Action
The intervention methodologies for these bispecific antibodies in psoriasis treatment include:
- Dual targeting of IL-12/23 p40 and TNF-α proteins
- Inhibition of IFN-γ secretion from immune cells
- Suppression of ELAM-1 protein expression on endothelial cells
The specificity and binding capacity of these bispecific antibodies were determined using ELISA techniques. Their mechanism of action was studied through several experimental models:
- Human umbilical vein endothelial cells (HUVECs) were co-treated with bispecific antibodies and TNF-α to examine the level of endothelial leukocyte adhesion molecule-1 (ELAM-1)
- Human peripheral blood mononuclear cells (PBMCs) were cultured with IL-2 and IL-12 in the presence or absence of bispecific antibodies
- Commercial ELISA kit was used to detect interferon γ (IFN-γ) concentration in the supernatant
Animal Models and Efficacy
For in vivo testing, a psoriasis model was constructed in BALB/c mice through subcutaneous injection of IL-12 and TNF-α. The mice were subsequently treated with the bispecific antibodies. Key findings include:
- Bispecific antibodies inhibited the formation of psoriasic skin
- The treatment showed equal or superior effect compared to control antibody drugs
- Efficacy was evaluated by measuring psoriasic skin thickness and scale under microscopy after H&E staining
These findings suggest that bispecific antibodies targeting both IL-12/23 p40 and TNF-α represent a promising therapeutic approach for psoriasis treatment, demonstrating the potential application of this technology beyond oncology.
Company drugs in pipeline
ONCare Alliance Drug Pipeline Information
After thorough examination of all available data, I cannot provide information about ONCare Alliance's drug pipeline or the indications they are targeting. There is no information available in the provided context regarding ONCare Alliance's pharmaceutical products, investigational drugs, or clinical development programs.
The context does not contain any details about: - ONCare Alliance's clinical pipeline - Disease indications or therapeutic areas they focus on - Any oncology or other products in development - Current status of any clinical trials
Without specific information present in the source material, I cannot detail which indications ONCare Alliance has drugs in pipeline for or describe their current clinical development activities.