Sridhar, Arthi

68 Background: While immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, their high cost and limited global supply pose major challenges. Optimizing ICI dosing to achieve a minimum effective dose that has shown to maintain clinical benefit may be a potential solution with significant savings to the health system. We investigated potential savings in Medicare that could be attained from alternative ICI dosing. Methods: We conducted a literature review including original Phase 1/2 trials describing the minimal effective dose of three commonly used ICIs: Pembrolizumab (P), Nivolumab (N) and Atezolizumab (A). Alternate dosing strategies based on existing data for Pembrolizumab (2 mg/kg), Nivolumab (1 mg/kg) and Atezolizumab (4 mg/kg) were proposed. Publicly available CMS data on Medicare Part B expenditure for these therapies was utilized to obtain average cost per dosage unit, mg/dosage unit, and number of Medicare beneficiaries between 2018-2021. Average cost per dose and total cost per ICI was calculated based on current FDA approved dosing and alternate dosing strategies. Results: The average wholesale cost per fixed dose for P (200 mg), N (480 mg), and A were $9,242.00, $12,460.80, and $8,616.00, respectively. Implementing the proposed alternate dosing strategies led to a substantial reduction in drug costs: P ($7,393.60), N ($2,076.80), and A ($2,297.60). The ensuing cost savings were calculated based on the annual number of Medicare beneficiaries. From 2018-2021, the average total savings were estimated to be $95,545,182 for Pembrolizumab, $294,734,264 for Nivolumab, and $62,937,582 for Atezolizumab (Table). The cumulative average total cost savings from 2018-2021 exceeded $453 million. Conclusions: We demonstrate potential savings in Medicare with implementation of an alternative ICI dosing strategy. Our study underscores an urgent need to better understand clinical efficacy and cost savings from a patient perspective, and feasibility from a regulatory standpoint. This perspective may hold considerable global implications, providing a roadmap for cost-effective care in the domain of immunotherapy. [Table: see text]

At the Summit on Cancer Health Disparities held in 2023, the session on Access to Cancer Care in Low- and middle- income countries (LMIC) highlighted several efforts globally. The collaborative efforts of Dana Farber Cancer Institute and the Ministry of Health in spearheading the Butaro Cancer Center of Excellence (BCCOE) in Rwanda was one such initiative. They were able to set up the BCCOE to address the unmet need of cancer care in this area and have trained nurses in East Africa to help establish other similar centers. They also serve as the single radiotherapy center for the entire of the country. Another such collaborative effort between Massachusetts General Hospital and the cancer center in Botswana in setting up sexual health education initiatives for women undergoing pelvic radiation was highlighted. They started with a quality improvement project to demonstrate the benefit of sexual health education and proper vaginal dilator use amongst women in this demographic. They were able to demonstrate that 90% of patients were able to complete an in-person 6-week workshop with clear benefits noted on a long-term basis. To highlight examples of best practice examples of equitable partnerships, examples of partnerships between Instituto Nacional de Cancerologia in Mexico City and UCSF was described. It was emphasized that for successful collaborations, equitable bidirectional partnerships are key. The thought leaders in this field also highlighted challenges associated with global oncology and the need for inclusion of minorities in clinical trials to improve cancer care for all globally.

The treatment metastatic non-small cell lung cancer (NSCLC) is largely influenced by the incorporation of immune checkpoint inhibitors (ICI) in the frontline setting. There are several ICI approved for the management of NSCLC based on the PD-L1 expression of the tumors. PD-L1 is a controversial biomarker with various inconsistencies in expression owing to temporal and spatial heterogeneity. Tumor mutational burden is another much studied biomarker associated with its own challenges and questionable concordance with tumor PD-L1 expression. In this article, we aim to discuss the challenges associated with the existing biomarkers, highlighting the need for emerging biomarkers that can help with decision making in the management of this there where several therapeutic options exist. There are emerging “me too” PD-1/PD-L1 drugs which may serve its purpose in many counties where there is limited access to current approved ICIs. What is increasingly apparent is the need to move the needle forward in the treatment of NSCLC and we will discuss the challenges associated with the current therapeutic landscape and the emerging checkpoints and the future directions that are being explored in the management of metastatic NSCLC.