Genomic medicine can deliver unprecedented opportunities for individualized care and improved clinical outcomes. However, differences in payer coverage and the high costs of genomic tests leave many without access, especially patients without insurance coverage or who cannot pay out-of-pocket. Efforts to address coverage and cost-related disparities often concentrate on improving payer coverage policies, but commercial manufacturers of genetic tests may offer financial assistance programs (FAPs) to uninsured/underinsured patients. FAPs provide payment assistance for patients without insurance coverage or who are unable to afford the cost of testing. Yet, there has been little research on FAPs, including their frequency and effectiveness in reaching patients requiring assistance. Our research elucidates the crucial role FAPs play in access to genomic medicine, especially among underserved and minority populations. This presentation focuses on FAPs and ELSI-related questions, particularly around the healthcare system and industry partnerships where many of these programs operate. Healthcare systems increasingly partner with commercial manufacturers to assist underinsured/uninsured patients in accessing testing. But FAPs also augment manufacturers' goals and provide a competitive advantage. For example, manufacturers can potentially increase test prices by creating demand through FAPs. Additionally, FAPs allow manufacturers to gather a database of genetic information without regulation on how this data is used. Also concerning is whether FAPs are a sustainable model of access because companies may suddenly end their programs, leaving patients without affordable testing options. A concerted effort is needed to address these ELSI-related questions and ensure FAPs’ transparency, ethical integration, and support patient access to genomic medicine.
Emily Mrig, University of California, San Francisco; Kathryn Phillips, University of California, San Francisco
