KENNETH THORPE: Don’t refuse lifesaving drugs to Georgians

More than 150,000 Georgians live with Alzheimer’s disease — a greater number than the population of Savannah. Some 51,000 have cancer, the second-leading cause of death here and nationwide. Many thousands more suffer from rare diseases.

These are just some of the Peach State residents who will be affected if we follow the lead of Massachusetts, Tennessee and Oregon, which all have made formal requests to stop covering a subset of potentially lifesaving drugs under Medicaid. The Tennessee and Oregon requests are currently under review by the Biden administration, and if they get the green light, they will set a precedent that endangers millions of Americans.

Medicaid provides health insurance to 88 million lower-income citizens, including nearly 2 million in Georgia. Normally, Medicaid must cover nearly any FDA-approved prescription medicine.

But with their waiver requests, state-level Medicaid officials are rejecting their obligation to cover drugs that were authorized via the FDA’s accelerated-approval pathway.

The federal government established accelerated approval back in 1992, initially to speed up the delivery of HIV drugs. Over the past three decades, the FDA has approved more than 270 treatments this way, including drugs for many kinds of cancer and a variety of rare diseases — which previously had few or no viable treatments.

The Medicaid administrators seeking these waivers suggest that accelerated-approval drugs impose a heavy burden on state budgets and fail to deliver substantial benefits to patients. But both assertions are flat-out wrong.

Accelerated approval is designed to allow quicker access to new medicines by measuring success in a different way. Instead of waiting for a clinical milestone, such as being cured of a disease, accelerated approval looks for “surrogate endpoints” — measuring, for instance, a goal like tumor shrinkage or a reduced viral load count. This can be crucially important for drugs that increase lifespan or improve quality of life, but can’t yet be proven to completely cure a disease.

Accelerated approval gets these drugs to patients sooner. In so doing, it saves lives and addresses the needs of patients with chronic, rare and irreversible diseases. The organization Friends of Cancer Research calculated that, because of the accelerated-approval pathway, cancer patients gain access to new oncology treatments 3.4 years sooner than they would if those drugs went through the traditional approval process that required overall survival data. This quicker access has contributed to a 30% reduction in cancer deaths since 1991.

But what about states’ claims that accelerated-approval drugs are just too expensive to cover?

The numbers don’t bear it out. Using data from the FDA and the Centers for Medicare and Medicaid Services, the Partnership to Fight Chronic Disease calculated that accelerated-approval medicines accounted for less than half a percent of total Medicaid spending from 2007 to 2020. In Tennessee, Oregon and Massachusetts in 2020, they accounted for less than a third of a percent. In Georgia, the figure was even lower, just 0.23%.

Nor do accelerated-approval drugs account for significant increases in Medicaid spending. In Georgia, they contributed less than half a percent to such hikes between 2007 and 2020.

There’s no doubt that state budgets are being impacted by rising Medicaid costs. These are due to such factors as expanding enrollment and the rising costs of physician visits, home health care, and hospital services. But accelerated-approval drugs are simply not the reason.

We need more new treatments. About six in 10 Americans live with chronic diseases like cancer and diabetes, and we still have no FDA-approved therapy for 93% of the rare diseases that together affect some 30 million people in the United States. The sooner we can get effective medicine to these patients, the better.

Accelerated approval helps us do that. No state should deny coverage of these advanced drugs to its most vulnerable citizens.