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

Document Type

Presentation

Loading...

Media is loading
 

Publication Date

4-12-2023

Comments

Presentation: 19:32

Abstract

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.

Language

English

This document is currently not available here.

Submit Feedback on Presentation

Share

COinS