Government Benefits

The Multi-Faceted Challenge of “Right-To-Try”

The Multi-Faceted Challenge of “Right-To-Try”

By Keith Saunders

Terminal illness is arguably the hardest challenge in healthcare for patients, families, healthcare providers, insurers, and regulatory bodies alike. Each party has competing priorities, and the “right-to-try” bill is an attempt to reconcile these differences of opinion. While over 38 states already have “right-to-try” laws in place, the recently passed House bill H.R. 5247 would apply the legislation at the federal level. A competing Senate Version, S. 204, was passed last summer.

For patients with a terminal illness, right-to-try could open one final door for treatment via a non-FDA approved drug or a not yet clinically approved procedure when all other proven treatment options have been exhausted.  This option is particularly attractive to younger patients and their families with little to no treatment alternatives. Providers want to offer their patients what they consider to be the best possible care, but may have differences of opinion with patients about exactly what that means.  The FDA wants to ensure proper research and protocols are followed, which means completing time-intensive clinical studies. Insurers want to provide coverage to patients who truly need the care, but they’re in the unenviable position of being asked to fund therapies or treatments that have yet to be established as effective by the medical community. Clinically unproven treatments not only carry a high price tag, but can be costly from a quality of life perspective while offering no guarantee of success.

Ultimately, the bill represents the intersection of individual free will, regulatory oversight, effective medical practices, and insurer liability. The federal “right-to-try” bill seeks to balance the interests of all constituencies; however, like any legislation, the bill cannot satisfy all factions. Even if approved, insurers may still not have enough products to provide patients or can still choose to seek FDA approval after the bill’s passage. Furthermore, access to such experimental drugs still heavily weighs in favor of the affluent who can navigate the healthcare system.

In the end, the one true positive is more awareness of the issue within the medical community, which is the first step in making any substantial, legislative change.