Eli Lilly sells vials of its weight-loss drugs directly to consumers

Eli Lilly announced new plans to begin selling low-dose vials of its weight-loss drug, Zepbound, directly to consumers. Compared to pre-filled doses, the vials will be sold at a significantly cheaper cost.

A one-month supply of the 2.5-milligram dose of Zepbound will cost $399, while a one-month supply of the five-milligram dose will cost $549. In comparison, pre-filled doses of Zepbound cost $1,059 a month, regardless of their dosage. However, unlike the pre-filled Zepbound pens, these drugs will come in vials, with syringes to draw out each dose.

These lower-cost vials of Zepbound will only be available through Eli Lilly's DTC telehealth program, LillyDirect. However, the vials will not be covered by insurance, which means patients will have to pay for them out of pocket. In addition, patients who purchase the lower-cost doses will not qualify for the company's discount savings program.

"Despite obesity being recognized as a serious chronic illness with long-term consequences, it's often misclassified as a lifestyle choice, resulting in many employers and the federal government excluding medications like Zepbound from insurance coverage," said Patrik Jonsson, EVP and president of Lilly Cardiometabolic Health and Lilly USA.

"Outdated policies and lack of coverage for obesity medications create an urgent need for more innovative solutions," Jonsson added. "Bringing Zepbound single-dose vials to patients will help more people living with obesity manage this chronic condition. We will also continue to advocate for a system that better aligns with the science."

Expert reaction

According to outside experts, the decision to offer lower-cost vials could help Eli Lilly regain customers who are currently using compounded versions of their drug, which typically cost between $250 to $450 a month.

Compounded drugs aren't subjected to the same oversight as traditionally approved medications, and there could be health risks involved with taking them. In July, FDA issued an alert warning people of potential overdoses when using compounded GLP-1 drugs, with some people giving themselves as much as 20 times more than the intended dose.

"There is no reason why any single U.S. person should be on a non-F.D.A. approved medicine that is not controlled for safety, quality and effectiveness," Jonsson said. "This is a way of just safeguarding the U.S. population."

According to Advisory Board's Chloe Bakst, Eli Lilly's move to lower the cost of certain vials of Zepbound is a direct response to the rise in compounded versions of Zepbound in the market.

In a press release from Eli Lilly, they call out the "dangers posed by the proliferation of counterfeit, fake, unsafe or untested knock-offs of Lilly's medications." However, FDA notes that one of the major dangers of compounded iterations of these drugs is the lack of auto-injectors and patients' lack of familiarity with withdrawing medication from a vial into a syringe.

"The LillyDirect model, in which a patient with a prescription can purchase the medication directly from Lilly, does not provide a solution to this challenge," Baskt said. "If patients received the prescription through a telehealth visit with a provider with whom they may not have a relationship with, it may be harder for patients to know who to go to with questions."

President Joe Biden praised Eli Lilly's decision, using it as an example of his work to lower prescription drug costs.

"[I] am pleased to see one of these manufacturers, Eli Lilly, taking steps to lower their price by offering a direct-to-consumer version of their medication for less than half the price they used to charge," Biden said in a statement. "This is a welcome first step for American families struggling to access these drugs."

Bakst noted that even patients whose insurance already covers Zepbound may be interested in Lilly's lower-cost offering. In addition to the potential cost savings, this offering "may circumvent any prior authorization requirements or utilization management strategies attached to the coverage of the GLP-1, such as participation in an employer's lifestyle management offering or BMI restrictions."

"It will be interesting to see if Novo Nordisk responds with a lower cost offering, or if they try to differentiate themselves from Lilly and work more aggressively with employers and purchasers to get their products covered by insurance," Baskt said.

Pfizer launches its own DTC platform

Following in Eli Lilly's footsteps, Pfizer announced plans to launch its own DTC platform called PfizerForAll, which will allow patients to quickly access different medications, including migraine treatments and vaccines.

Through the platform, patients can connect with a doctor through the telehealth company UpScriptHealth. They will also be able to get prescriptions delivered to their home, find copay cards and other potential prescription savings, order diagnostic tests, and more.

According to Aamir Malik, Pfizer's chief U.S. commercial officer, the company hopes the platform will make access to the medications easier. "Navigating our healthcare system is time-consuming. It's complicated. It's overwhelming," Malik said. "And the last thing that anybody needs when they're trying to get the care that they need for themselves or a loved one is to have to navigate that complex, painful, difficult system."

And while the platform prominently features information on Pfizer's own products, it will not be limited to just those. For example, the platform's VaxAssist service will allow users to select either the Pfizer-BioNTech vaccine or the Moderna vaccine.

In a release, the company said the DTC service will allow patients to use their existing insurance and pharmacy benefits. The platform will also offer live customer support and other resources to help users with the insurance coverage process. If any Pfizer medications are prescribed, eligible consumers will also be matched with relevant affordability programs and support services.

"People often experience information overload and encounter roadblocks when making decisions for themselves or their family in our complex and often overwhelming U.S. healthcare system. This can be extremely time-consuming and lead to indecision or inaction—and as a result, poor health outcomes," Malik said. "We are pleased to offer PfizerForAll to help relieve this burden on people, especially as we enter the fall season in the U.S., and streamline the path for those seeking better health."

Ultimately, Bakst suspects that the success of manufacturers' DTC offerings will depend on the demand for their products.

"The high demand and supply challenges for diabetes and obesity products makes DTC offerings more attractive to consumers," Baskt explained. "For Pfizer, it's unclear the value add they can provide."

"Patients likely know that they can walk into a pharmacy or urgent care and get a flu vaccine or COVID-19 shot — that care is already provided at a DTC level," Baskt said. Still, Bakst anticipates that other manufacturers will follow suit with DTC platforms in response to Pfizer and Lilly.

To learn more about the major trends shaping the industry, check out these resources:

• How to navigate the evolving high-cost drug landscape
• Diabetes and obesity market trends

(Blum, New York Times, 8/27; Eli Lilly news release, 8/27; Lovelace, Jr., NBC News, 8/27; Sforza, The Hill, 8/27; McPhillips, CNN, 8/27; Khemlani, Yahoo! Finance, 8/27; Laise, MarketWatch, 8/27; Park, Fierce Pharma, 8/27; Bettelheim, Axios, 8/28)