The quality of oral anticancer medication (OAM) use impacts clinical care, care coordination, patient safety, and outcomes, including disparities in care, patient and caregiver experience, population health, and total health care costs. To monitor the quality of OAM use, measures assessing the degree to which patients take OAMs as prescribed was the number one measurement priority rated by 23 national experts and patients convened by PQA in 2022-2023.
Due to the complex nature of OAM use, a phased and nuanced approach is necessary to appropriately account for these important and unique attributes. Examples of complexities of OAM use that pose challenges to standardized measurement include:
- Multiple types of available OAMs, each with differing purposes in cancer treatment.
- OAMs are often prescribed as part of complex cancer-specific treatment regimens with atypical dosing schedules.
- Clinically appropriate periods of medication non-use, which may be difficult to distinguish from medication non-adherence.
- OAMs may be switched during therapy due to poor response, evidence of drug interactions, or intolerance of side effects.
The current two-year project (2025-2026) aims to establish the evidence supporting the formative analytic methods for measuring adherence or persistence to OAMs—a critical step toward standardized measurement assessing the quality of OAM use. Specifically, this project uses a data-driven approach to group OAMs together that have similar attributes allowing for standard approaches to quality measurement.
In year one, the project team conducted a literature review, identified key methodological considerations for measuring adherence or persistence, and created a one-of-a-kind OAM database.
The literature review identified 13 unique adherence and persistence methodologies and found that adherence and persistence were not defined or calculated in a consistent manner within the literature, and the rationale for the method selected was often not reported.
Key methodological considerations were identified by mapping the decisions that one often comes to when selecting an adherence or persistence methodology. This yielded a large, complex decision tree that was synthesized to five key considerations when deciding how to assess adherence or persistence.
The OAM database was created to catalog OAMs and aggregate OAM-specific information (i.e., clinical attributes) based on the five identified methodological considerations. Attributes were chosen if they were identified as important within the context of measuring adherence or persistence. Attributes were transformed from descriptive text to a standard, quantitative format to allow for statistical modeling in year two.
All of these efforts have been guided by ten subject matter experts. To date, they have weighed in on the construction of the OAM database related to attributes such as dosing, adverse effects, discontinuation, intentional treatment interruptions, combination regimens, and off-label use. These experts will continue to provide critical input through year two of the project.
The progress made in year one will enable the clustering of OAMs into a number of groupings. These groupings will reveal the necessary considerations for measuring adherence or persistence to OAMs. Multiple approaches to measuring adherence or persistence are expected. Validation of these approaches is expected in the next phase of the project, which will start no sooner than 2027.
PQA partnered with the University of Rhode Island College of Pharmacy and the University of Mississippi School of Pharmacy on this research. This work was made possible in part with support from AstraZeneca, Eli Lilly and Company, Pfizer, and Boehringer Ingelheim.