Above-Brand Strategic Plan to Get Approval for Subcutaneous PD-1 Ligand Inhibitors for the Treatment of HR-NMBIC

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Presentation: 19:32


High-risk non-muscle invasive bladder cancer (HR-NMIBC) is a subtype of bladder cancer that is at a high risk of progressing to muscle-invasive disease. An estimated 82,290 adults in the United States will be diagnosed with bladder cancer, of which 20% to 30% are at a high risk. Standard of care for HR-NMIBC is radical cystectomy. The object of this capstone project was to develop an above-brand strategic evidence plan to get regulatory approval for subcutaneous PD-1 ligand inhibitors for the treatment of HR-NMIBC. The steps to create the evidence plan included identifying the unmet needs of the current treatment regimen, study the competitor landscape to identify areas of differentiation and create a budget impact model and a cost effectiveness analysis. Regarding unmet needs, one study found that patients were willing to accept a 20% increase in risk of progressing to MIBC for additional 2.3 years until radical cystectomy, while another study showed a decrease in quality of life associated with current treatment. The competitor landscape for subcutaneous PD-1 Ligand Inhibitors are IV formulations of the same drug. A significant differentiator is the route of administration. The budget impact model (BIM) and the cost effectiveness analysis (CEA) should have a time horizon of 1 year and the information could be obtained from ongoing clinical trials, a prospective cohort study analyzing health care resource utilization as well as a patient preference study and a physician survey. Beyond BIM and CEA, other options to enhance value would include advisory board to establish treatment consensus and PROM development. Overall, subcutaneous formulations of PD-1 ligand inhibitors can have tremendous value in addressing the unmet needs of current treatment, and this capstone identified significant steps to get regulatory approval.



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