A new analysis suggests that diagnostics are being overlooked, slowing progress in precision health despite advances in targeted therapies.

A new analysis published in Science argues that diagnostic tests are being overlooked in the US and globally, slowing progress against major diseases despite rapid advances in targeted therapies and precision health.

The authors, led by researchers at the University of California – San Francisco (UCSF), note that nearly half of the world’s population lacks adequate access to diagnostics. These tests receive less investment for research and development and lower insurance reimbursement than drugs, which the authors say creates barriers to innovation.

“Most people can easily understand how a new drug or surgery might help a patient,” says Kathryn Phillips, PhD, a professor of health economics in the School of Pharmacy at UC San Francisco and the lead author of the study, in a release. “But the tests that guide medical decisions are just as critical.”

Therapeutic Advances Outpacing Diagnostics

Advances in therapies are currently outpacing the development of the tests needed to guide their use. For example, while many patients do not respond to GLP-1 drugs for obesity and diabetes, the study notes that few tests currently exist to predict which patients will benefit.

Alzheimer’s disease presents another challenge. While new drugs are available to slow disease progression at a cost of $30,000 per year, the blood tests that match patients to the most beneficial treatments cost approximately $1,000. Unlike the drugs, these tests rarely qualify for insurance coverage. This can lead to medical decisions made without necessary information, potentially resulting in patients receiving inappropriate treatments or no treatment at all, according to the analysis.

Regulatory and Reimbursement Barriers

The analysis highlights that diagnostic tests are often handled separately from the treatments they support. The Food and Drug Administration (FDA) reviews tests differently than drugs, and insurers use different payment structures. Drugs are also significantly more likely to receive expedited FDA review than tests.

“Regulatory and payment policy should evolve in tandem with scientific and technological advances,” says Robert M Califf, MD, former commissioner of the FDA and co-author of the paper, in a release. “The current misalignment between how we evaluate diagnostics for consideration of allowing marketing and the system for reimbursement decisions about diagnostics versus drugs leaves powerful tools on the shelf and provides inadequate data to make good decisions about which diagnostic tools should be eschewed for lack of benefit in the real world.”

The authors suggest that policymakers take specific steps to address these gaps, including reviewing tests and treatments together, streamlining the approval process for tests, and improving how diagnostics are evaluated and paid for.

“Our hope is that this work helps people—patients, policymakers, insurers, and researchers—recognize diagnostics as essential to good health care—and not just an afterthought,” says Phillips, who directs the UCSF Center for Translational and Policy Research on Precision Medicine, in a release.

ID 451601072 © Weerapat Wattanapichayakul | Dreamstime.com

Related Reading: