Direct-to-consumer model may improve drug access, but providers warn about possible biases
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Key takeaways:
- New direct-to-consumer program allows people with diabetes, obesity and migraine to fill some prescriptions through LillyDirect Pharmacy Solutions.
- Providers raised concerns that LillyDirect may erode the patient-provider relationship.
A new direct-to-consumer health care program launched by Eli Lilly has the potential to improve access to diabetes, obesity and migraine medications in the United States.
On Jan. 4, Eli Lilly announced the launch of LillyDirect, a digital health care experience offering access to independent telehealth providers and direct home delivery of Lilly medications fulfilled through third-party pharmacy dispensing services. LillyDirect also includes a search tool for finding in-person providers and disease state and health care educational information. The program is initially offering care for three diseases: diabetes, migraine and obesity.
“A complex U.S. health care system adds to the burdens patients face when managing a chronic disease,” David A. Ricks, chair and CEO of Lilly, said in a press release. “With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes. LillyDirect offers more choices in how and where people access health care, including a convenient home delivery option to fill Lilly medicines they have been prescribed.”
The announcement of LillyDirect could be a turning point in how people acquire medications, according to Susan Cornell, PharmD, CDCES, FAPhA, FADCES, associate director of experiential education and professor in the department of pharmacy practice at Midwestern University College of Pharmacy in Downers Grove, Illinois, and a Healio | Endocrine Today Editorial Board Member.
“There are too many middlemen from the time the drug leaves the manufacturer to the time it gets into the patient’s hands,” Cornell told Healio. “We have the pharmacy benefits manager, we have a wholesaler, we have the pharmacists, potentially a mail order, so by the time it gets to the patient, there’s a whole bunch of steps in between. This is direct to the patient.”
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, a clinical pharmacy specialist and director of education & training in diabetes technology in the department of endocrinology, diabetes and metabolism at the Cleveland Clinic Diabetes Center and a Healio | Endocrine Today Editorial Board Member, applauded Lilly for devising a new type of program. However, she said, the program has a few shortcomings, one of which is that patients will get the benefits of easier access only to medications manufactured by Lilly.
“I’m excited about the possibilities, because I want to improve access for patients, and access has been a huge issue,” Isaacs told Healio. “I just wish this could be done by some other [organization] not directly industry funded so that it’s more open to all patient assistance for lots of different drugs as opposed to one manufacturer.”
Sangeeta Kashyap, MD, assistant chief of clinical affairs in the division of endocrinology, diabetes and metabolism at NewYork-Presbyterian/Weill Cornell Medical Center and a Healio | Endocrine Today Co-editor, said despite increasing access to medications, Lilly may be inserting the company too far into the patient-provider relationship.
“I don’t think drug companies should be prescribers,” Kashyap told Healio. “Drug companies should be suppliers. The providers should be people who are objective, who are more focused on the patient, their needs and their specific circumstances. They are crossing a lot of boundaries here.”
Improving medication access
Cornell, Isaacs and Kashyap said improving access to the company’s medications can be a big benefit of LillyDirect for patients. According to information provided by email to Healio by a Lilly spokesperson, any patient who is prescribed a Lilly medication that is available as part of LillyDirect will be able to fill that prescription through LillyDirect Pharmacy Solutions. Medications included in the initial rollout are galcanezumab-gnlm (Emgality) for treating migraine, Lilly insulins with the exception for insulin lispro for treating diabetes, and tirzepatide (Zepbound) for treating obesity. LillyDirect Pharmacy Solutions is listed as a pharmacy option for all major electronic health record systems.
“Fulfillment of Lilly medicines is not limited to providers listed as care options on our website, but is open to all providers,” the Lilly spokesperson told Healio. “Providers and patients are also free to select other pharmacy options for fulfillment of their Lilly medicine prescriptions.”
Lilly is not fulfilling the prescriptions directly, according to the spokesperson. LillyDirect uses licensed third-party pharmacies to dispense and arrange for shipping of the medications.
Isaacs said one of the benefits of LillyDirect Pharmacy Solutions is that savings cards and other affordability solutions will be automatically applied for patients who qualify when they fulfill a prescription through LillyDirect.
“We know cost is an issue,” Isaacs said. “One of the problems is that there are some programs available [to lower out-of-pocket costs], but people don’t always know about them. The providers prescribing the medications don’t always let people know about a copay card or a program that’s available, and then the pharmacies that people go to don’t always know how to process these things correctly. By having a system where you’ve got pharmacies that are on board and know how to apply these coupons and discount codes, like the Lilly Cares program, that will improve access.”
Cornell said another benefit is that LillyDirect can get medications into the hands of patients who need them, particularly tirzepatide for obesity. As Healio previously reported, shortages of semaglutide (Ozempic/Wegovy, Novo Nordisk) and tirzepatide have been an issue for providers and patients for more than a year. Some prescribers said one reason for the shortages was that social media influencers and celebrities were using semaglutide and tirzepatide off-label to lose weight and encouraging the public to do the same. In response to this, Lilly issued a public letter in January stating that tirzepatide should not be used for cosmetic weight loss.
Additionally, the drug shortages led to a rise in counterfeit forms of diabetes and obesity medications not manufactured by the pharmaceutical companies. The FDA issued multiple warnings in 2023 about counterfeit semaglutide circulating in the U.S. drug supply chain. Lilly’s public letter from January also warned patients to avoid using counterfeit forms of tirzepatide.
“Access to the GLP-1 medications has boomed in the last year, especially from the weight-loss perspective,” Cornell said. “Part of the problem right now is, who is the recipient of these GLP-1s? Is it truly the person who needs it or is it the person who just wants it? That’s where we’re seeing Lilly getting involved, because they’re seeing that the people who need it, can’t get it.”
LillyDirect may have great impact in improving access to obesity care as a whole, Cornell said.
“The biggest thing right now that we’re battling is the fact that obesity still isn’t recognized as a disease state,” Cornell said. “Most [providers] recognize it, but from a payer perspective, nobody’s paying to do weight management. That’s where we could have a hiccup here. That could be part of the reason why LillyDirect is doing this.”
Concerns surrounding bias, treatment decisions
Despite potential for improving access to medications, Lilly could become too involved in patient care, some experts told Healio. LillyDirect includes a tool for patients to find an in-person provider near them. The information in the tool is compiled and maintained by Healthgrades, according to a disclaimer on the website.
Additionally, LillyDirect provides three telehealth options. The website connects patients with 9amHealth for type 2 diabetes, Cove for migraine and FORM for obesity care. The Lilly spokesperson indicated that all of the providers on LillyDirect are independent from the company and that treatment decisions and prescribing are made at the discretion of each provider’s care team.
“These independent providers may provide a range of care options, including prescribing medications (either Lilly medicines or others) or other treatment options,” the spokesperson said. “Lilly is not suggesting consumers seeking care through a provider listed on LillyDirect will be prescribed a Lilly treatment.”
Additionally, the spokesperson said Lilly does not receive compensation from providers on LillyDirect for referrals and providers are not incentivized to promote Lilly products.
Even with this reassurance, some providers still expressed concern about potential conflicts of interest.
“I’m hoping anyone that holds a professional license would not bias toward one drug or one therapy and not use one that might be better for a given individual,” Isaacs said. “But [bias] is a huge concern.”
Kashyap said her biggest apprehension about LillyDirect is that it could set back the practice of diabetes and obesity medicine by curtailing interactions between providers and patients.
“The problem with this direct system is it kind of bypasses physician engagement with the patient,” Kashyap said. “My concern is it’s going to lead to reduced follow-up of the patient with the physician, which is the most important thing, because we are constantly assessing and reassessing how patients are doing on these medications.”
Kashyap said safety is another concern, with tirzepatide approved for the treatment of obesity only in November. Health care providers are still learning about tirzepatide and other newer diabetes and obesity medications and must closely monitor patients receiving them, she said.
“Not everyone needs to be on medication,” Kashyap said. “Some people definitely need it; others may not need it. That’s why a physician approach is usually a stepwise approach. You assess them, you find out what their expectations are, you think about if their obesity or diabetes is complicated by other issues. How severe are their comorbidities? How severe is their condition? Should you prescribe them tirzepatide, or should you prescribe them semaglutide [Ozempic/Wegovy, Novo Nordisk]? Then you talk with them about the risks, benefits, what are their expectations, how long they’ll probably need to be on these medicines. All those things are critical pieces of a personal interaction between a physician [and a patient].
“My fear is this is bypassing the physician’s trust,” Kashyap continued. “It’s going to create mistrust and it’s going to skew the [patient’s] knowledge too, because the information they get from a drug company’s going to be different than the information they get from a physician.”
Will LillyDirect be a game changer?
One of the biggest questions moving forward is how much of an impact LillyDirect will have on health care. According to the Lilly spokesperson, the company plans to update and expand LillyDirect with new products, partners and services that fall within Lilly’s therapeutics focus. This could open up LillyDirect to other specialties and disease states.
Cornell said she would be surprised if LillyDirect does not have a large impact on health care. She said the program could ease access to care beyond medications and other pharmaceutical companies could roll out similar initiatives.
“People want to improve their health and have access to quality care and therapies,” Cornell said. “I say therapies globally because it has to do with more than just the drugs. Even access to a support group or a coaching group is not always covered by insurance and can be costly for people who need this. I’d be surprised if [LillyDirect] didn’t take off.”
Isaacs, however, said she is uncertain whether the direct-to-consumer model will become widespread. She said she believes that Lilly will need to invest in marketing the program to patients because many providers will not want to direct their patients toward LillyDirect and away from their own care teams. Additionally, Isaacs said Lilly will be competing with online compounded pharmacies and other virtual programs that offer diabetes and obesity interventions.
“People will be watching closely to see how this plays out,” Isaacs said. “Does this even pick up steam? Are patients going to use this? And then does it impact patient care? Does it impact volume of prescriptions?”
Kashyap said she believes that Lilly will invest heavily in online and social media advertising to drive patients to their platform. However, potential online advertising also brings up some concerns about privacy and patient confidentiality.
“Social media is now being used to recruit patients for clinical trials,” Kashyap said. “There’s already a lot of sharing of people’s information. That’s another concern of mine; I wonder where they’re going to get this data from. Are they going to get it from social media sources? That, to me, is bothersome because there’s a confidentiality between someone’s health and [the patient’s provider]. Once drug companies get involved with prescribing drugs, the trust and that confidentiality is going take a major hit.”
References:
- Lilly launches end-to-end digital health care experience through LillyDirect. Available at https://investor.lilly.com/news-releases/news-release-details/lilly-launches-end-end-digital-healthcare-experience-through. Published Jan. 4, 2024. Accessed Feb. 1, 2024.
For more information:
Susan Cornell, PharmD, CDCES, FAPhA, FADCES, can be reached at scorne@midwestern.edu.
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, can be reached at isaacsd@ccf.org.
Sangeeta Kashyap, MD, can be reached at srk4008@med.cornell.edu.
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