Indication for Heart Health Marks a New Era in Obesity Treatment

It’s official. FDA now says that semaglutide, in doses used to treat obesity, can prevent heart attacks, strokes, and deaths in persons with cardiovascular disease and overweight or obesity. This is nothing short of the dawn of a new era in obesity treatment. FDA Division Director John Sharretts said it clearly:

“This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”

A major advance for public health. Let that sink in. This changes the calculation for many aspects of obesity care.

A New Indication

If you care to get into the weeds, what the FDA did yesterday was to approve a new medical indication for using the Wegovy brand of semaglutide:

“To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.”

Will Health Plans Deny Access to Life-Saving Medication?

Of course, this puts health plans on notice. Their efforts to block patients from receiving semaglutide for obesity or overweight will actually increase the odds of heart attacks, strokes, and deaths – for patients who already have cardiovascular disease.

Obesity Action Coalition CEO Joe Nadglowski put it plainly:

“Obesity care is both life saving and life changing. The FDA label change for semaglutide demonstrates this clearly with a 20% reduction in major adverse cardiac events for people with existing cardiovascular conditions. Payers should have been providing coverage for anti-obesity medications prior to the announcement. Now there should be no doubt that this treatment must be covered. Lives are at stake.”

Implications for Public Policy

In many calculations for public policy, the presumption was that obesity treatment is nice to have – not an “essential benefit.” That kind of thinking will not hold up to scrutiny going forward. Harvard’s Caroline Apovian describes the advance this milestone represents:

“This is another giant leap in the right direction. We must treat obesity before it leads to irreversible conditions and major adverse cardiovascular events.”

Policy makers who moan that treating obesity will be costly are starting to sound stupid. The truth is that health costs are spiraling out of control because health systems let the consequences of untreated obesity spiral out of control. This will have to stop.

Implications for Drug Makers

This will also put some significant pressure on drug makers. Failure to ensure access to a life-saving drug while making billions of dollars in profits on it simply does not look good. It looks more like profiteering.

The supply of Wegovy has been inadequate for years now and the list price is stuck at very high levels. Terry Maratos-Flier, a physician and researcher, expressed obvious frustration:

“This feels like a joke! I prescribe semaglutide as Wegovy/Ozempic. Meanwhile patients cannot find meds – even in lucky happenstance insurers approve coverage and co-pay isn’t absurd. Stop reporting on expanded indications till you fix drug supply.”

This frustration will only grow if Novo Nordisk doesn’t fix it quickly.

Get to Work

Three cheers for the dawn of a new era in obesity treatment. Now let’s all get to work on living up to the responsibility to meet its potential.

Click here for the announcement from FDA, here for the announcement from Novo Nordisk, and here for the new prescribing information. For further perspective, click here, here, and here.

The Seine at Dawn, painting by Charles Angrand / WikiArt

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March 9, 2024