I have been reflecting on whether or not I have prematurely exited RMD and whether I should get back in. It is an ongoing battle, I have to say.

This article in the WSJ yesterday, 15 Jul 2024, crystallises a different perspective as to why RMD’s single product moat is likely to continue to be under pressure from obesity-related drugs.

This is the same approach AVH is taking in the current study that it is undertaking that treating vitiligo with RECELL GO will lead to better mental health benefits to prove to the insurers that using RECELL GO has got broader benefits/cost savings beyond the immediate “cosmetic” improvement of treating vitiligo.

I have images of a group of vikings carrying a battering ram to punch a hole in the castle moat .... maybe I am thinking of Asterix??

Article in full is below.

Disc: Not Held in SM or IRL

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Whether millions of people will be able to afford one of the hot new weight-loss drugs could hinge on whether they cure the sleep apnea of people like Damon Sedgwick.

Sedgwick, a technology business analyst in Sydney, enrolled in a clinical trial in 2022 to test whether taking weekly injections of Eli Lilly’s anti-obesity drug Zepbound would alleviate the sleep apnea that had plagued his nights for years.

The medical thesis: Hefty weight loss from the drug would help open the airways of Sedgwick and other study subjects, reducing the frequent stops and starts to breathing while they slept.

The business thesis: Proving health benefits of drugs such as Zepbound beyond weight loss could persuade more health insurers to finally reimburse the expensive drugs, opening the door to billions of dollars in more sales.

Ozempic, Zepbound and their GLP-1 cousins have become wildly popular, ringing up more than a million prescriptions a week. But many people can’t get the medicines because their health plans don’t cover them and the drugs would cost upward of $1,300 a month out of pocket.

Health plans have traditionally shied away from paying for drugs that would help people to lose weight. Many plans have balked at reimbursing the new anti-obesity medicines because of cost.

Eli Lilly and Novo Nordisk, the drugs’ makers, are betting insurers that have been resistant to covering weight-loss treatment will be more inclined to reimburse for other uses. That is why the companies are sponsoring studies evaluating the medicines for a range of applications, from treating heart, kidney and liver disease to Alzheimer’s and sleep apnea.

“It builds this wall of evidence,” said Derek Asay, senior vice president of government strategy and federal accounts at Lilly. “It helps give that reason to believe there’s more than weight loss here.”

The studies are among the most closely watched by patients, doctors and investors.

Validation that the drugs work in sleep apnea alone would mean, Jefferies analysts estimate, $5 billion in additional sales for Zepbound. For tens of thousands of people seeking to take one of the drugs, it would also mean the difference between filling a prescription or not.

Positive study results could also transform care. In sleep apnea, said Dr. Ron Grunstein, a professor of sleep medicine at the Woolcock Institute of Medical Research in Australia who helped run the Lilly-funded study, “You could argue this is just as important as the discovery of CPAP therapy 40 odd years ago,” referring to continuous positive airway pressure.

The efforts are already gaining traction. In March, the Food and Drug Administration approved Wegovy to reduce the risk of heart attacks and strokes, based on a Novo Nordisk-sponsored study finding a 20% reduction in cardiovascular risk.

This cleared the way for some Medicare prescription-drug plans to pay for Wegovy’s use for the first time in patients with cardiovascular disease, though federal law still bars Medicare from covering the drugs for weight loss alone.

Some 3.6 million Medicare beneficiaries, about a quarter of the Medicare population, had both cardiovascular disease and excess weight—which could make them eligible for Wegovy coverage, health-policy nonprofit KFF estimated.

Meantime, insurers such as Sanford Health Plan, a nonprofit based in Sioux Falls, S.D., with about 200,000 members, are exploring covering the drugs for preventing heart attacks and strokes in people with cardiovascular disease.

“I do foresee more purchasers opting to include those medications as part of a comprehensive benefit program,” said Dr. Tommy Ibrahim, Sanford’s chief executive, though employers may ask people to try less expensive options or get prior approval first.

The new Wegovy heart use will lead to $3.2 billion in more yearly sales, BMO Capital Markets analysts estimate.

Originally developed for diabetes, the main ingredients of Novo’s Wegovy, Lilly’s Zepbound and related drugs work by mimicking gut hormones and suppressing appetite. The resulting weight loss, researchers, the drugs’ makers and patients surmised, could have other health benefits.

Take sleep apnea. About 30 million Americans have the disease, an interruption of breathing that can cause near-term fatigue and long-term complications such as heart problems if untreated.

Obesity is a common cause because fat deposits around the neck and mouth can narrow a person’s airway. Losing weight can ease or eliminate sleep apnea. Weight loss from bariatric surgery, for instance, can improve the condition.

Many patients use a CPAP machine—to get the oxygen they need. But the machines’ bulky masks can be uncomfortable.

Lilly launched sleep-apnea testing after seeing evidence tirzepatide—the drug that would become Zepbound—could treat obesity.

Sedgwick, 53 years old, enrolled in the Lilly-funded study of Zepbound, seeking both to lose weight and relieve his sleep apnea.

At the start, he spent an overnight at the Woolcock Institute, a sleep and respiratory clinic in Sydney, for a baseline evaluation. Researchers attached devices to his body to monitor his sleep and breathing, and recorded him with cameras and microphones as he tried to sleep. He couldn’t use a CPAP machine.

“Awful,” was how he described trying to sleep that night. Researchers determined he had severe sleep apnea.

He started losing 4 or 5 pounds a week. At his next overnight sleep-clinic visit, after about five months on Zepbound, researchers found that Sedgwick’s sleep apnea had all but disappeared—so much so that they recommended he stop using the CPAP machine.

By the end of the study in the fall of 2023, Sedgwick had lost more than 70 pounds and showed no signs of sleep apnea at the final overnight clinic visit. On a recent trip, he didn’t bring along his CPAP machine. “It was good not to travel with one,” he said.

Across the nearly 470 patients in two Lilly studies, Zepbound reduced the severity of sleep apnea by more than 60% compared with a placebo, according to the company. Many study subjects on Zepbound returned to normal breathing.

Lilly has applied to the FDA to approve Zepbound’s use to treat sleep apnea. A decision could come by the end of this year.