Advancing the Quality of Oral Anticancer Medication Use

Oral anticancer medications (OAMs) are a growing and important tool in the fight against cancer. More than 120 FDA-approved OAMs were used in clinical practice in 2022, and OAMs represent more than one-third of cancer medications in the development pipeline.

The quality of OAM use impacts clinical care, care coordination, patient safety and outcomes – including disparities in care, patient and caregiver experience, population health and prevention of cancer recurrence – and total health care costs.

Given the clinical importance, cost and growing use of these medications, there is strong interest among payers, manufacturers, providers, clinicians and patients to advance how we evaluate the quality of their use, especially in value-based care.

We want to know if patients are using these medications consistently, appropriately and safely. And who should be credited with supporting medication adherence or persistence, which helps position the patient for the best outcome?

These are important but difficult questions to answer.

The uniqueness of OAMs and the complexity of their use present distinct challenges in measuring adherence or persistence to therapy in a standardized way. Here are four key challenges to standardized measurement:

1. Multiple types of OAMs are available, each with differing purposes in cancer treatment (e.g., neoadjuvant or adjuvant chemotherapy vs. adjuvant endocrine therapy for the prevention of recurrence).

2. OAMs are often prescribed as part of complex cancer-specific treatment regimens with atypical dosing schedules, which can involve cycling or bursting of medication.

3. Drug holidays, where the provider temporarily discontinues therapy, resulting in clinically appropriate periods of medication non-use, may appear as medication non-adherence.

4. OAMs may be switched during therapy due to poor response, evidence of drug interactions, or intolerance of side effects.

These challenges are leading reasons why there is a lack of relevant OAM quality measures available today for health plan and pharmacy performance assessment.

PQA, the Pharmacy Quality Alliance, is the national quality organization focused on improving safe, effective and appropriate medication use. We are advancing quality innovation and research to develop new methods to evaluate OAM use quality.

Our work on OAM use quality began in 2022. We convened 23 national clinical and methodological experts and patient representatives. Over a series of workshops, they agreed the development of a health plan performance measure to assess the degree to which patients take their OAMs as prescribed is a top priority.

Adherence or persistence to OAMs is an important intermediate health care outcome to track, as it can stimulate efforts to address the many barriers and challenges associated with OAM use.

You can read more about this work in our August 2023 report, Recommendations to Improve the Quality of Oral Anticancer Medications.

Although prior efforts by others have focused on oncology quality measurement gaps, little progress has been made to develop meaningful, standardized OAM quality measures for health plan performance.

There is no current validated methodology for measuring adherence or persistence to OAMs for potential use in a national quality program.

This is challenging, uncertain and groundbreaking work, and PQA’s next step is to build the evidence base and analytic methods for measuring adherence or persistence to OAMs. Our team is steeped in foundational methods, such as the proportion of days covered (PDC) methodology, but those are not well suited for developing a standardized, valid and feasible measure for OAM use.

We need to understand the clinical aspects of OAMs, including indications, real-world use and effectiveness, dosage regimens, and implications of common side effects. We also need to consider potential existing methodologies for assessing adherence or persistence, how they may need to be modified to incorporate clinical data sources, or whether new methodologies are required. This is essential for moving toward standardized health plan performance measurement assessing the quality of OAM use.

We need the engagement, support and participation of the cancer community and health care professionals with a role in OAM use. Together, we can improve the quality of OAM use, support better outcomes for patients and measure the contributions of providers and clinicians whose care and services support patients.

Micah Cost is chief executive officer of the Pharmacy Quality Alliance (PQA). PQA is dedicated to improving safe, effective and appropriate medication use and addressing issues that impact a person’s ability to access and use medications. Through quality measurement, research and education, PQA’s consensus-driven initiatives help improve health care outcomes and lower costs.