A Comprehensive Review of Methods to Measure Oral Oncolytic Dose Intensity Using Retrospective Data.

Area of Science:

• Pharmacoeconomics
• Oncology
• Real-world evidence

Background:

• Assessing real-world oral oncolytic effectiveness requires understanding actual drug use.
• Traditional adherence measures (e.g., refill frequency) do not capture dose variations or administered amounts.
• Relative dose intensity (RDI) is a valuable metric for intravenous drugs, but its application to oral oncolytics in real-world studies is limited.

Purpose of the Study:

• To identify studies utilizing administrative claims data to measure real-world oral oncolytic dose intensity or similar metrics.
• To evaluate existing methodologies for capturing oral oncolytic exposure beyond simple adherence.

Main Methods:

• A comprehensive literature search was conducted in PubMed using keywords related to oncology drugs, dosage, and retrospective data sources.
• Titles and abstracts were screened by two independent reviewers, with full-text review for relevant studies.
• Studies were included if they focused on oral oncolytics, reported dosage, and utilized retrospective data.

Main Results:

• The search yielded 1,640 publications, with 17 studies addressing oral oncolytic dose concepts using retrospective data.
• Only 5 of these 17 studies reported dose intensity or RDI, primarily using medical records or electronic health records (EHR).
• No studies were found that combined dosing and duration into a single dose intensity measure using claims data.

Conclusions:

• There is a clear need for a claims-based measure of dose intensity for oral oncolytics to better assess real-world effectiveness.
• Existing EHR-based studies provide a foundation for developing such a claims-based measure.
• Future research should focus on developing and validating dose intensity metrics for oral oncolytics using administrative claims data.