[ad_1]
Health-care marketplace Sesame on Wednesday announced a new clinical weight loss program that will help eligible consumers access compounded versions of Novo Nordisk‘s blockbuster obesity drug Wegovy for $249 per month.
Sesame allows patients to book and pay for appointments with doctors and specialists directly through its website, so it cuts out middlemen such as insurers.
The company said it is adding compounded semaglutide — the active ingredient in Wegovy and Novo Nordisk’s diabetes injection Ozempic — to its platform to help users safely access obesity and diabetes treatments at a time when many of the branded drugs are in short supply. Sesame already offers branded weight loss and diabetes drugs through its platform, including through a partnership with Costco.
But the company’s new program could serve as a more affordable weight loss alternative, as compounded medications are typically cheaper than their branded counterparts. Wegovy and Ozempic both cost roughly $1,000 per month before insurance, and most weight loss programs from competing digital health companies do not include the cost of those medications.
“We are, based on this drug supply shortage, on behalf of American consumers, making a version of compounded semaglutide available to our users at … [a] very accessible price point,” Michael Botta, president and co-founder of Sesame, told CNBC in an interview. “In fact, we think it’s probably the most affordable price point the consumer can find on an apples to apples basis.”
Wegovy and Ozempic are part of a highly popular class of weight loss and diabetes medications called GLP-1s, which mimic certain gut hormones to tamp down a patient’s appetite and regulate their blood sugar. The treatments have exploded in popularity in recent years, and some analysts predict the industry could generate more than $100 billion in annual revenue by 2030.
Supply shortages are one of the biggest hurdles for Novo Nordisk and its main rival, Eli Lilly, since spiking demand can make it difficult for many patients to find the treatments. When brand-name GLP-1 medications are in shortage, certain manufacturers can prepare compounded versions if they meet U.S. Food and Drug Administration requirements.
The lowest dose of Wegovy is in short supply, but all other doses of the drug and Ozempic are available, according to the FDA’s drug shortage database.
Compounded medications are custom-made alternatives to branded drugs designed to meet a specific patient’s needs, such as not being able to swallow a pill or being allergic to the dye of a certain product. Those compounded drugs can be prescribed, made and dispensed under two sections of the Federal Food, Drug and Cosmetic Act.
That law created two classes of compounding pharmacies. The FDA regulates so-called 503B pharmacies, which can make larger batches of medications without individual prescriptions. Meanwhile, 503A compounding pharmacies can create custom medications for individual patients and are largely regulated by states rather than the FDA.
But both Wegovy and Ozempic are under patent protection in the U.S. and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients in their drugs to outside groups. The companies say that raises questions about what some manufacturers are selling and marketing to consumers.
Novo Nordisk and Eli Lilly have both stepped in to address illicit versions of their treatments, suing weight loss clinics, medical spas and compounding pharmacies across the U.S. over the past year. The FDA last month also said it had received reports of patients overdosing on compounded semaglutide due to dosing errors such as patients self-administering incorrect amounts of a treatment.
Botta said Sesame initially “stayed very far away” from compounded medications because the company felt uncertain about their purity and quality. But he said the more Sesame learned about compounded versions of GLP-1s, the “more we see that they’re effective, they seem to be quite safe. People tend to have a good experience taking them.”
Sesame then sent its teams to inspect several 503B compounding pharmacies.
“What we decided to do was work with a compounding pharmacy that certainly meets our bar when it comes to inspecting their processes, their quality, their output,” Botta said.
The compounding pharmacy partnered with Sesame will manufacture prefilled, single-use syringes rather than a single vial of medicine that patients have to measure themselves. Botta said that could help patients “avoid the risk that comes from overfilling a syringe, over-injecting, taking too much — overdosing on this medication.”
To participate in Sesame’s new program, patients will have to fill out an intake form and select a health-care provider. They will have a consultation with the provider via video, complete some lab work and receive a prescription if the provider decides it is appropriate.
Patients will be able to access ongoing consultations via video chat, as well as a nutrition, fitness and mindfulness content library. The content will not be immediately available upon the launch of the new program Wednesday, but Sesame said it will be live in about two weeks.
Anyone who signs up in the interim will automatically get access to it when it is available, the company added.
“There are millions upon millions of Americans who are struggling both with obesity itself and with all of the downstream effects of obesity,” Botta said. “Being able to connect patients who otherwise are struggling with the supply shortage is something we think is worth doing.”
[ad_2]
Source link