By Stephanie Murg, Managing Director, G2 Intelligence
With “precision medicine” and “personalized medicine” initiatives in the spotlight, the American Association for Clinical Chemistry (AACC) is looking to seize the momentum with a call for policies that ensure access to and appropriate reimbursement for tests that enable tailored treatment. The organization’s position paper, issued June 17, also emphasizes the central role that innovative laboratory tests play in precision medicine.
While endorsing efforts underway to improve patient outcomes by personalizing care, the AACC statement calls attention to the hurdles that remain. One such challenge is the reimbursement environment: a particular concern with low-volume tests (those specific to diseases or conditions that affect small subsets of the population), for which sufficient data may not be available to comply with payers’ evidentiary requirements. AACC encourages public and private payers to develop clear, consistent evidence criteria for coverage of companion diagnostics that would account for the relatively smaller affected patient and population subsets.
“With the use of laboratory tests, healthcare professionals are increasingly able to identify and monitor precisely targeted, individualized therapeutic interventions that improve patient outcomes,” said AACC CEO Janet B. Kreizman. “To ensure the full benefits of this approach are realized, AACC urges payers to cover personalized medicine tests so that all patients can afford them.”
The statement also singles out the innovative power of laboratory-developed tests: “an integral component in precision/personalized medicine, as they allow the clinical team to tailor innovation to immediate clinical needs.” With regard to the prospect of imminent regulation of LDTs, AACC holds that “FDA should not adopt policies that hinder test innovation.”
At the same time, the position statement encourages FDA to expand its efforts to include information in the product labeling for relevant drugs or other pharmaceutical products that urge healthcare providers to test for certain genetic or other biomarkers prior to prescribing the drug or other pharmaceutical product.