To improve patient access to useful new genetic tests and therapeutics that have clinical impact, physicians gathered at the Interim Meeting of the American Medical Association (AMA) voted today to encourage the development of a comprehensive strategy that facilitates more consistent coverage of genetic/genomic tests and precision medicine.
"Precision medicine tests, technologies and therapeutics are increasingly being adopted into clinical practice as evidence of their effectiveness grows," said AMA Board Member William E. Kobler, M.D. "However, many patients do not have access to precision medicine because most public and private health insurers do not offer coverage for genetic or genomic services unless certain clinical criteria and evidentiary standards are met. As a result, access to this next generation of clinical testing services is often limited."
According to a report considered by physicians at the AMA policy-making meeting, there is considerable variability among public and private payers with regard to the evidentiary requirements for coverage of genetic/genomic tests and services. Newly adopted AMA policy addresses the lack of transparency and standardization across payer coverage determination processes, which may hinder patient access to valid and meaningful tests and therapeutics, as well as future innovations in genetic/genomic precision medicine.
AMA policy encourages public and private payers to adopt processes and methodologies for determining coverage and payment for genetic/genomic precision medicine that:
Promote transparency and clarity;
Involve multidisciplinary stakeholders, including genetic/genomic medicine experts and relevant national medical specialty societies;
Describe the evidence being considered and methods for updating the evidence;
Provide opportunities for comment and review as well as meaningful reconsiderations; and
Incorporate value assessments that consider the value of genetic/genomic tests and therapeutics to patients, families and society as a whole, including the impact on quality of life and survival.
Currently, there is a well-established clinical evidence base to support coverage of a broad range of genetic/genomic tests. Newer tests are rapidly and continuously becoming available, but the clinical usefulness of many new genetic tests and therapeutics cannot feasibly be demonstrated using traditional approaches, which includes randomized controlled trials (RCTs) for evidence generation.
Novel research approaches are required. As such, the AMA encourages coverage and payment policies for genetic/genomic precision medicine that are evidence-based and take into account the unique challenges of traditional evidence development through RCTs, and work with test developers and appropriate clinical experts to establish clear thresholds for acceptable evidence for coverage.
The AMA will support continued research and evidence generation demonstrating the validity, meaningfulness, short-term and long-term cost-effectiveness and value of precision medicine.