Consensus Recommendations To Improve Biomarker Testing in Oncology: Findings from the AMCP Market Insights Program

Although biomarker testing is central to precision oncology, significant gaps remain in education, protocols, timeliness, and equity according to an article published this past June in the Journal of Managed Care & Specialty Pharmacy. According to the study’s authors, by adopting consensus-driven best practices, managed care organizations can play a pivotal role in ensuring that biomarker testing fulfills its promise, delivering more effective, equitable, and cost-conscious cancer care.

Precision medicine has changed oncology by making it possible to make therapy decisions based on molecular indicators that can be acted on. Timely biomarker testing can greatly enhance survival and treatment outcomes for malignancies like non-small cell lung cancer. Even if this is a good sign, adoption in the actual world is still not consistent. A lot of people who could benefit from biomarker-driven medicines don't obtain the right tests or treatments.

Diana Brixner, B. Pharm., Ph.D.

Recognizing this gap, the Academy of Managed Care Pharmacy (AMCP) convened a market insights program led by Diana Brixner, B.Pharm., Ph.D., professor emeritus in the Department of Pharmacotherapy at the University of Utah, to identify barriers, establish best practices, and develop consensus recommendations for managed care stakeholders.

The program used a three-phase modified Delphi process that included expert interviews with oncologists, pharmacists, payers, and administrators to identify unmet needs and propose best practices. The second phase included a national survey of managed care professionals to further delve into challenges and opportunities (achieving 109 responses). The third involved a consensus survey. The survey was presented to a subset of experts who participated in the first phase to establish recommendations from 22 proposed best practices. Consensus required a mean response of at least 3.3 or 100% agreement/strong agreement on a 4-item Likert scale.

The program identified five critical areas of unmet need in biomarker testing: education, guidelines and protocols, timeliness, process, and equity. Education for healthcare providers was identified as the most selected unmet need by phase two respondents (72%). Equity was also critical, with 88% of Phase 2 respondents viewing addressing health disparities in biomarker testing as somewhat or very important. Furthermore, phase two respondents identified harmonizing guidelines, policies, coding, and payment systems (28%) and the high cost of tests (25%) as the biggest challenges in developing coverage criteria.

Out of 22 proposed best practices, nine achieved consensus among the expert panel. These consensus recommendations spanned five domains. With respect to test ordering, payers should provide coverage based on published guidelines (mean response 3.63), cover testing for FDA-approved biomarkers (mean 3.75), allow for reflex test ordering (mean 3.63) and provide coverage for next-generation sequencing (NGS) (mean 3.5).

The second domain of test performance showed agreement that payers should support interdisciplinary collaboration to ensure appropriateness of test selection and accuracy of results (mean 3.25). The domain for treatment decisions found agreement that payers should support prioritizing biomarker testing before treatment initiation (mean 3.63).

Cost-effectiveness consensus supported payers assessing policies promoting cost-effective care by considering overall health care implications and savings from accurate early treatment selection (mean 3.25). Lastly, for the domain of health disparities, experts agreed that payers should emphasize broad genetic testing to reduce disparities stemming from limited diversity in clinical trials (mean 3.00) and work to mitigate access barriers to testing and treatment for underserved populations (mean 3.38).

The AMCP agreement outlines many implementable solutions for managed care organizations to enhance the significance of biomarker testing in oncology. First, coverage policies should be in line with guidelines based on evidence to make sure that testing techniques are consistent and not too different from each other. Supporting reflex and NGS testing can make workflows even smoother and find more actionable mutations. Education is also very important; patients, clinicians, and payers all need to know more about the benefits of biomarker testing and how to read the data. Moreover, promoting interdisciplinary collaboration via molecular tumor boards and shared decision-making frameworks might improve the precision and applicability of testing in clinical settings. It is still important to address inequities and more has to be done to make testing more available and make sure that research includes a wide range of people. Finally, cost-effectiveness should be looked at not only in terms of the initial cost of testing but also in terms of the savings that come from choosing the best medication and getting better results for patients.