Systematic Literature Review for an oncology drug's global launch

Project background

A revolutionary oncology drug with a novel mode of action was set to launch in a new breast cancer indication. Asc Academics performed a systematic literature review (SLR) to capture all available comparative clinical and economic evidence to demonstrate the product’s value in this new indication by highlighting its clinical and economic benefits.

Challenges faced

The new breast cancer indication posed significant challenges due to a lack of comparative evidence in the literature. To address this, we expanded our scope to include evidence from the breast cancer category in which this indication was previously classified. However, differences between the two categories added complexity to the analysis, making it challenging to ensure the relevance and robustness of the findings.

Our solution

A robust search strategy and strict inclusion criteria ensured that the collected evidence was comprehensive and of high quality. Given the scarcity of direct evidence, we critically appraised the included studies to ensure validity and reliability. Our approach involved:

• Synthesizing evidence: bridging the evidence gap by leveraging data from the current standard of care.

• Crafting a value story: using the synthesized evidence to create a comprehensive value narrative for adaption of the current standard of care.

• Stakeholder focus: tailoring the complicated adaption of the standard of care into clear opportunities to ensure the findings resonate with decision-makers in global markets.

Our impact

Through these efforts, we successfully demonstrated the clinical and economic value of the drug for the new breast cancer indication. The SLR results were incorporated in a global value dossier distributed worldwide to support country-specific reimbursement processes. The oncology drug got approved by medical agencies for this new breast cancer indication, and the subsequent paradigm shift caused a change in the clinical landscape of breast cancer. Our work was crucial for this transition, and we continue to work with the client to this day.