In the second of a two-part series, leaders of industry associations present their expectations for pharmacy operators for this year.

Former Defense Secretary Donald Rumsfeld once observed that “there are known knowns. There are things we know we know. We also know there are known unknowns. That is to say we know there are some things we do not know. But there are also unknown unknowns. The ones we don’t know we don’t know.”

Micah Cost

While this quote is a bit of a word salad that can make your head spin, I believe it encapsulates the work and experiences of nonprofit organizations, especially the Pharmacy Quality Alliance. Since PQA’s inception, we have remained committed to learning what we don’t know about quality medication use, to make the unknowns known, and ultimately to make those known to the broader health care industry.

One of the important lessons that I’ve learned in my time at PQA is that the quality of measures, rather than the quantity of measures, is the key to ensuring access, driving better care and achieving optimal outcomes for patients. In many health care settings, there are existing quality measures to evaluate care access, quality and delivery. One complex area where there is limited information about quality of care and is important to our members and stakeholders is oral anticancer medications (OAMs).

Optimizing the quality of OAM use is a priority for PQA’s members and stakeholders working to advance value-based models of care. OAM use quality — which includes patient access, appropriate use, safety, adherence and related medication management services — impacts clinical care, care coordination and outcomes, including disparities, patient and caregiver experience, and total health care costs.

The uniqueness of OAMs and their use presents distinct challenges in measuring adherence or persistence to therapy in a standardized way. Examples of complexities of OAM use that pose challenges to standardized measurement include:

• 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).

• OAMs are often prescribed as part of complex cancer-specific treatment regimens with less uniform dosing schedules, which in some cases include “drug holidays” where the provider temporarily discontinues therapy, resulting in clinically appropriate periods of nonadherence.

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

These complexities and challenges call for new approaches to advancing medication use quality.

In 2022, we launched the PQA Quality Innovation and Research Center (QuIRC) to accelerate progress in medication use quality and focus on clinical outcomes and provider contributions to care. QuIRC brings together the data, infrastructure and resources needed to develop new, complex quality measures; support their implementation; and create tools and solutions for improving medication use and medication management services. QuIRC is ideal for answering the methodology questions needed to advance the prioritized health plan measure concept for adherence or persistence to OAMs.

Under QuIRC, we launched last year a Quality Innovation and Research Initiative (QIRI) for oncology. It is a multiphase initiative that leverages PQA’s convening, research and measure innovation powers to improve the quality of OAM use.

We completed phase I of this initiative in 2023, and phase II will begin in 2024. Here is a review of our work so far, and what’s to come. PQA’s work is informed by recent national research and current oncology practice. In phase I of the initiative, our team reviewed more than 30 oncology-focused studies and concluded that numerous approaches have been used for measuring OAM adherence or persistence in both objective (i.e., independent of patient report or recollection) and subjective ways (survey-based approaches, patient interviews, medication calendars), but these approaches are not validated for OAMs or feasible for national quality programs like the Medicare Part D Star Ratings. This underscores the need for standardized measurement to enable accurate assessment of performance and comparisons across measured entities.

PQA then convened 23 national clinical and methodological experts and patient representatives to participate in three PQA Convenes workshops between late 2022 and early 2023 to prioritize OAM quality research and measurement opportunities. To monitor the quality of OAM use, a health plan performance measure to assess the degree to which patients take their OAMs as prescribed was the No. 1 measurement priority identified by PQA Convenes workshop participants. Although prior efforts by others have focused on oncology quality measurement gaps, little progress has been made to develop meaningful, standardized OAM quality measures to assess health plan performance.

PQA released in August a report, “Recommendations to Improve the Quality of Oral Anticancer Medications,” which includes a summary of phase I, including our environmental scan, key takeaways from the workshops and PQA’s planned next steps — including identifying adherence and persistence methodologies for use in performance measurement.

Phase 2 of this initiative is scheduled for launch in 2024 and aims to provide foundational evidence for standardized methods to measure adherence or persistence to OAMs.

Developing meaningful, standardized quality measures to assess health plan performance on OAM adherence or persistence is complicated by many factors unique to OAMs. This will be groundbreaking work, but PQA is firmly committed to making the unknowns known in this important area of health care.

Certainly PQA’s initiative in oncology is only one of a host of key priorities for our organization, but the quality of OAM use and its impact on clinical and economic impacts cannot be understated. Together with our members and stakeholders, I am confident we will achieve success in driving meaningful quality improvement and optimal outcomes for patients.

Micah Cost is CEO of the Pharmacy Quality Alliance. 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.