Over the past year, Oncology Insights highlighted the oncology topics driving meaningful clinical and economic debate. As we enter the new year, we reflect on the developments already shaping managed care decision making and influencing oncology care delivery.

Learnings and impact generated from artificial intelligence (AI) systems

AI continues to gain traction across health care, supporting risk stratification, utilization management, claims analytics and administrative efficiency. Machine learning is now embedded in care and medication management programs, while generative AI is emerging for documentation and patient communication. Real world evidence suggests AI enabled programs may improve identification of high risk populations and lower per member per month costs. Regulatory oversight is evolving, highlighted by the January 2025 U.S Department of Health and Human Services Strategic Plan for AI, which emphasizes ethical, transparent and equitable use. Responsible implementation will be critical to realizing operational and clinical benefits. Ensuring AI is equitable, responsible and unbiased use can enable better resource utilization and improved patient and provider experiences.

Radiopharmaceutical Discovery and Use Gaining Momentum 

Radiopharmaceuticals represent a growing class of targeted therapies delivering radiation directly to tumor cells. Recent approvals, including Lutetium Lu177 dotatate (Lutathera) and Lutetium Lu 77 vipivotide tetraxetan (Pluvicto), demonstrated meaningful survival benefits in select populations. However, treatment costs approach $300,000 per course. FDA drug classification and updated CMS reimbursement for diagnostic radiopharmaceuticals may further increase utilization and spend. Managed care considerations include patient selection, site of care optimization, nuclear medicine capacity and utilization management to balance access with affordability.

Pancreatic cancer: Innovative therapy approved, but unmet need continues

Zenocutuzumab zbco (Bizengri®) received FDA accelerated approval in December 2024 for advanced pancreatic cancer with NRG1 gene fusions, a rare biomarker. Clinical data show a 40% response rate, though overall survival remains immature. With an annual wholesale acquisition cost (WAC) of approximately $617,500, budget impact and cost effectiveness are key concerns. Coverage decisions should emphasize biomarker confirmation, line of therapy placement and outcomes monitoring, as the broader value of this niche therapy remains uncertain.

From detection to drug impact: the potential of liquid biopsy in cancer

Liquid biopsy technologies support non invasive detection, genomic profiling, treatment monitoring and minimal residual disease (MRD) assessment across the cancer continuum. Payer adoption remains uneven and largely limited to advanced disease and select hematologic malignancies, with commercial MRD coverage generally aligned to NCCN guidelines. FDA endorsement of MRD as a surrogate endpoint in multiple myeloma may accelerate drug approvals and downstream spend. Coverage decisions should weigh validated clinical utility, guideline alignment, sequencing with tissue biopsy and real world outcomes as interest in multicancer early detection expands.

BiTEs and Roadblocks 

Bispecific T cell engagers (BiTEs) have rapidly expanded across hematologic and select solid tumors, offering high response rates and off the shelf availability. Annual WACs range from approximately $189,000 to over $1 million, with inpatient admissions for step up dosing and toxicity management driving total cost of care. Variable utilization reflects infrastructure needs and access disparities. Managed care strategies include patient selection, site of care optimization, outpatient dosing where feasible and evaluation of response durability.

Carting away REMS and the impact on CAR T utilization

In June 2025, FDA removal of REMS requirements for BCMA  and CD19 directed CAR T-therapies reduced administrative burden and may modestly increase utilization and outpatient use. However, therapy cost, toxicity risk and infrastructure requirements remain unchanged. From a payer perspective, REMS removal may shift site of care dynamics rather than reduce spend. Continued scrutiny of long term outcomes and identification of patients most likely to benefit will remain central to value assessments.

Optimizing immunoglobulin use in multiple myeloma: clinical and managed care perspectives

Patients with multiple myeloma, particularly those receiving BCMA directed therapies, face elevated infection risk. While guidelines support immunoglobulin replacement in select settings, real world use varies and cost effectiveness evidence is mixed. IVIG and subcutaneous immunoglobulin contribute to rising medical benefit spend but may reduce serious infections and hospitalizations. Managed care approaches include guideline aligned use, IgG thresholds assessment, dosing and site of care optimization and outcomes tracking to balance infection prevention with financial sustainability.

Innovations Driving the Future of Breast Cancer Care 

Breast cancer treatment continues to evolve with expanding use of antibody‑drug conjugates (ADCs), oral selective estrogen receptor degraders (SERDs) and investigational proteolysis-targeting chimeras (PROTACs).  ADCs are moving earlier in treatment and into combination regimens, increasing drug and infusion related costs. Oral SERDs rely on biomarker testing, shifting care toward precision sequencing. For payers, these advances raise considerations around biomarker testing coverage, line of therapy placement and preferred agent strategies as therapies enter earlier disease settings.

Built for speed: the evolving landscape of oncology trials 

Adaptive and accelerated oncology trial designs, driven by the 21st Century Cures Act, are shortening novel therapy time to market. While these approaches enable earlier access to promising treatments, they often rely on limited datasets with immature overall survival and durability outcomes. High‑cost drugs approved through adaptive designs present challenges for payers managing uncertainty in long‑term value. Managed care consideration include evaluation of evidence gaps, real‑world data requirements and potential outcomes‑based or risk‑sharing arrangements. As rapid approvals become more common, formulary strategies must balance innovation access with heightened scrutiny of clinical value, cost trajectory and post‑approval evidence generation.

Small Cell Lung Cancer: Breakthrough Therapies, Rising Costs and the Road Ahead for Payers

Small cell lung cancer (SCLC) remains highly lethal, though recent approvals are changing treatment and cost dynamics. First line chemoimmunotherapy offers modest benefit, while newer therapies such as tarlatamab (Imdelltra®) demonstrate meaningful survival gains in later lines. Recent approvals have introduced higher‑cost targeted options, including lurbinectedin‑based maintenance and tarlatamab (Imdelltra®), a first‑in‑class DLL3‑directed bispecific T‑cell engager demonstrating a meaningful overall survival benefit in the second‑line setting. Managed care considerations encompass line‑of‑therapy placement, toxicity mitigation, site‑of‑care optimization, real‑world outcomes and managing the growing budget impact of an expanding targeted therapy pipeline.