This is a good news/bad news story. But mostly good.
The Food & Drug Administration (FDA) has approved another drug for the treatment of obesity.
The drug, Zepbound, was already FDA-approved under the name Mounjaro for the treatment of Type 2 diabetes. Tirzepatide, the active ingredient in both drugs, has been shown to accelerate weight loss.
Zepbound will be available in six doses (from 2.5 milligrams up to 15 milligrams) by the end of 2023 with a – here’s the not-so-good news – list price of $1,060 for a one-month supply. But high cost is common among the new generation of drugs.
Eli Lilly will offer a savings program for Zepbound, allowing some patients to pay as little as $25 for a one- or three-month supply. Patients whose insurance doesn’t cover the drug could pay $550 for a one-month supply – still steep, but an improvement. (See more below about insurance.)
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Plenty of people feel these drugs are worth the price. Because in many cases, they’re highly effective. According to one of the trials used by the FDA to approve the medication, patients taking 15 milligrams of Tirzepatide (the highest dose) lost an average of 20.9% of their body weight in 72 weeks. That added up to about 49 pounds for patients in the study.
How do they work? In simplest terms, they reduce food cravings and help people recognize when they’re full. People using these medications eat less, sometimes a lot less, because they get full faster.
We asked Matthew Tucker, a physician assistant (PA) at Novant Health Salem Surgical Weight Loss in Winston-Salem, what patients should know about Zepbound and similar drugs.
Who should consider these drugs for weight loss? Is BMI a good yardstick?
BMI is the barometer insurance companies use when evaluating whether a patient qualifies for treatment for obesity management, so it’s a good barometer for health care providers, too. Patients with a BMI of 30 or higher – or as low as 27, if certain chronic conditions like high blood pressure, high cholesterol and diabetes are present – can be considered candidates.
Clinically, though, BMI doesn’t tell the full story. Patients have many different body types. Take athletes, for example, like football players, weightlifters, body builders, etc. They can have significantly increased levels of lean muscle mass, which can sometimes actually push them into what would typically be the obese category, despite having a potentially normal body fat percentage. BMI cannot account for this, as it is strictly a measurement of weight in relation to height – and not overall body composition.
If you’re on, say, Wegovy or Ozempic now, should you switch to Zepbound?
That’s a complicated question. There are side effects with every medication, as well as the possibility of a plateau in weight loss, and any of these may be an indication for a patient and provider to discuss alternative options. It’s important that clinicians and patients discuss the risks and benefits of each medication, and the patient’s weight loss and health goals to determine which options are right for them
Is there research about the long-term effect of these drugs for weight loss?
Some of these medications are so new that we do not yet have long-term data on them. Short-term data indicates they’re safe and effective, but the longest these medications have been studied is 72 weeks.
Anything – besides long-term effects – we don’t know about these drugs? Anything you wish you knew that’s not available yet?
It will be interesting to see how insurance coverage for Zepbound compares to other options. Some policies don’t cover anti-obesity medications at all. Some policies have certain requirements that need to be completed, like participating in a weight-loss program for a specified number of months, before getting approval to start these medications.
What are common questions patients ask you?
Patients want to know the risks and benefits, side effects, how much weight they can expect to lose on the medication, as well as how this compares to the amount of weight they need and/or want to lose, dosing, how it’s administered – it’s an injectable medication – and, of course, cost.
You mentioned side effects …
Yes; they include nausea, diarrhea, constipation, vomiting, bloating, heartburn. Most of these are mild to moderate, and they tend to resolve over time. Those side effects are most pronounced when a patient first starts the medication and again when they increase their dose.
You also mentioned cost. These drugs are expensive. Do you foresee a time they'll be more affordable?
The best-case scenario is that more insurance companies begin approving coverage for these medications.
Do insurance companies seem to prefer one drug over the others? And are they covering these drugs when they’re prescribed for weight loss, as opposed to treatment for diabetes?
Insurance companies don’t seem to have a preference. But some insurance companies may require that a patient try other anti-obesity medication classes before they’ll approve one of these newer medications. It’s also common for insurance companies to deny coverage of these medications altogether.
How does someone start on these drugs? Do you begin them on the lowest dose and then gradually step it up?
Correct. Everyone starts on 2.5 milligrams, the lowest dose available, which they inject once a week. From there, the dose can increase monthly by increments of 2.5 milligrams to one of the maintenance doses, which could be 5, 10 or 15 milligrams at the highest.
How do clinicians determine which drug to prescribe? Are they interchangeable?
They’re not exactly interchangeable. I always begin by discussing the data with patients. We’ll also discuss cost and the necessity of getting prior insurance authorization. And we can help with that process; we have staff whose primary role is getting this important information from insurance companies for each patient.
We discuss the risks and benefits of each medication available, as well as the contraindications to each of these medications with respect to each patient’s individual medical history.
The newer class of medications are referred to as incretin-based therapies, and include the medications Tirzepatide – sold under the brand names Mounjaro and Zepbound – and Semaglutide – sold under the brand names Ozempic and Wegovy, among others.
We also discuss the older anti-obesity medication options, for example, phentermine (first introduced to treat obesity in 1959). It’s important for providers to know if patients have tried any of these medications in the past, and insurance companies may want to know this, as well.
How closely do you monitor patients on these drugs? And, are they supposed to test their own blood sugar at home?
We do try to see patients fairly frequently – every six to eight weeks – when they are on anti-obesity medication therapy. We want to learn about any side effects they’re experiencing and measure their progress.
It is very important for patients with diabetes to check their blood sugar regularly while on these types of medications.
How often are you prescribing these drugs? And how pleased are you and your patients with the results?
We are prescribing this class of medication every day, and the patients and I are pleased with the results they’re seeing.
How long do people need to be on these drugs? Is it a lifetime commitment?
My goal, when I prescribe any of these medications, is to improve my patients’ health.
The treatment of obesity is, however, a lifelong commitment. I often tell patients: “Obesity isn’t something you are; it’s a condition you have.” It’s a chronic and relapsing condition. If it’s not treated, it will come back. These medications are tools in a toolkit of options meant to help in the goal of obesity management.
In our office, we often talk about five pillars of weight loss:
- Physical activity
- Behavioral modification
- Nutrition
- Medication
- Surgery
If we compare the effectiveness of these drugs with the effectiveness of gastric bypass – the surgery that’s been around the longest and studied the most – roux en y gastric bypass results in a 30% to 35% reduction in total body weight. Tirzepatide in one study showed a mean weight loss of 20.9% of total body weight at the 15-milligram dose after 72 weeks. While this is a significant amount of weight loss, it is still not on par with bariatric surgery. As a result, there are certainly patients for whom I continue to recommend surgery for the management of their obesity.
Patients should learn about all the tools available to them, and work with their providers to choose the best method or combination of methods.
Our No. 1 goal is helping patients change their lives for the better.
