More pharma companies are launching direct-to-consumer drug platforms and the rise of these self-pay services could improve access to medicines but also raise concerns about oversight and accountability.
The Digital Medicine Society is leading a cross-sector effort, in partnership with pharma companies, virtual-first providers and digital pharmacies, to establish a scalable blueprint for direct-to-patient pharma models as the market continues to evolve.
As Big Pharmas increasingly roll out platforms for direct-to-consumer drug sales, most offering steep discounts on popular medications, many patients are open to using the new services, Fierce Pharma Marketing reported. Three-quarters of U.S. consumers are “somewhat” or “very” likely to use DTC drug sale services, a survey found.
Eli Lilly launched LillyDirect in January 2024 and in the past two years, the number of drugmakers looking to sell their products directly to consumers has continued to grow. TrumpRx, a drug discount platform, launched earlier this year, while last month Johnson & Johnson launched a website to sell some of its drugs directly to U.S. patients. Women's health provider Maven Clinic and other virtual-first care providers have signaled direct-to-patient as a priority area for expansion, while digital pharmacies and integrated virtual prescribing models continue to scale.
Pharmaceutical companies are facing significant downward pricing pressure while, at the same time, consumerism is a growing trend in healthcare, which marks a timely opportunity to build trusted pathways to scale direct-to-patient models responsibly, according to Jennifer Goldsack, CEO of DiMe, a non-profit organization dedicated to advancing digital health technologies.
“Direct-to-patient models are already reshaping how patients access care, particularly in therapeutic areas where demand has outpaced the capacity of traditional brick-and-mortar approaches,” Goldsack said.
The DiMe-led initiative, called Optimizing Direct-to-Patient (DTP) Strategies for Pharma, will focus on establishing an operational, regulatory and evidence-based foundation to ensure DTP models "operate safely, consistently and in a way that earns trust," Goldsack said.
"Pharma is going to have to figure out how they continue to get patients access to their drugs at prices that they can afford if they are going to continue capturing revenue to be able to reinvest in R&D, and we are very motivated to make sure we continue to develop new medicines. At DiMe, we are also very motivated to make sure that every patient who could benefit from access to a treatment that can improve their life is able to do that," Goldsack said in an exclusive interview with Fierce Healthcare about the new initiative.
The new initiative currently involves four leading pharma companies, with plans to add more. Founding partner companies involved in the initiative include Coalesce Health, DistributeRx, Fullspan Health, Health Advances, Phil, Inc., S3 Connected Health, Welldoc, Wheel and Ypsomed.
Cash-pay pathways for drugs have expanded rapidly in response to access constraints, pricing complexity and unmet demand particularly in high-demand areas like GLP-1 therapies.
"Patients themselves are increasingly turning towards virtual pathways in order to access the care they need," Goldsack said. "In an era of policy tailwinds, downward pricing pressure on drugs and in an era where patients are telling us that they enjoy accessing care in a timely fashion and being provided not just with a prescription, but with a complete solution with that prescription arriving on their doorstep and then ongoing support as they take that prescription, we believe that DTP pharma pathways are not just an opportunity for cash-pay for GLP-1s, but it is actually going to emerge as a true care pathway that is going to improve value to patients, improve access to patients and be able to sustain pharma to continue investing in R&D."
She added, "If we believe that that's the case, we need to make sure that the way this care pathway is established is trustworthy and accessible to everyone, delivers value to the entire market, with clear roles and responsibilities for the different stakeholders, all the way from expert clinical providers down to the provision of the medication at the best price for the patient."
Done well, direct-to-patient models have the potential to expand access to the treatments patients need at prices they can afford, while strengthening trust in how care is delivered, Goldsack said.
The DTP pharma initiative will map the market, regulatory and policy landscape and translate it into clear, actionable guidance to support teams operationalizing self-pay models. It will also define how to measure patient access and affordability, enabling more transparent and equitable approaches to care, according to Goldsack.
The coalition also will focus on a structured approach to assessing the appropriateness of direct-to-patient models, grounded in regulatory readiness, patient benefit and commercial viability. And the project will highlight examples of both successful and cautionary approaches to scaling DTP models, with a focus on what drives access, affordability and trust in practice.
These efforts will help to "de-risk" DTP pharma pathways as a new care model, Goldsack noted.
As direct-to-patient models grow, there is wide variability in clinical oversight and independence, marketing practices and patient transparency and alignment across prescribing, fulfillment and follow-up care, according to Goldsack. Cash-pay pathways are developing quickly without a clear, system-level framework to support it, she asserts.
Some fast-scaling DTP models are facing increased regulatory and legal scrutiny for their business practices. The Food and Drug Administration has sent warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. In February, FDA issued a warning letter to fast-growing telehealth company Medvi for allegedly violating federal regulations regarding the marketing of compounded drug products. There's also a pending class action lawsuit accusing Medvi of violating California’s anti-spam law.
The DiMe-led initiative has concrete objectives to "tame the Wild West before it becomes the Wild West," noted Anand Iyer, chief AI officer at Welldoc, a digital cardiometabolic solution that is a founding partner of the initiative.
The initiative is designed to align stakeholders across clinical care, prescribing, fulfillment, patient services and patient engagement. Once the framework has been established, cross-sector partners can then begin to build on these efforts to advance the market, Iyer noted.
"You can start to build tools that could be used by the stakeholders who are participating, for example, building ROI tools or building readiness matrices," he said in an interview.
Welldoc, which has received 11 510(k) clearances from the FDA for its diabetes digital health solution, brings regulatory and clinical expertise to these cross-sector efforts, he said.
"Our total health approach, using AI to help manage these multiple chronic conditions, is built on the rigor and expertise that one would need to fuel this forward direction in DTP," he said.
Wheel, another founding partner, is a virtual care technology and services company that has helped to stand up telehealth platforms for nearly a decade, working with digital health companies, pharmacies, health plans and pharma companies.
"There's a lot of experimentation in direct-to-patient, but there hasn't really been a solid, clear path forward for this is what works across a wide range of therapies, so we're excited to help shape that future," Michelle Monaco, chief product officer at Wheel, said in an interview with Fierce Healthcare.
"There's a lack of cohesion, and for us to solve the gaps of care that exist, it really is going to require the whole ecosystem. The challenge isn't getting the patient to have a drug prescribed, it's actually making it work in their life. There are the education and the awareness programs that pharma is really good at that today and there are people working really hard on access and affordability. There are other players working on convenience, and this is bringing it all together and trying to do it in a way that is deeply compliant. It has to be safe. It has to be thinking about improving outcomes over time, not just how do we prescribe and then move on," Monaco noted.
Consumers expect faster, simpler ways to get treatment, and that shift isn’t slowing down, noted Michelle Davey, CEO of Wheel in a statement. "But building for access is different from building for the full patient journey. To do that well, you need clear standards, clinical independence, and accountability from the start. That’s what will define which models actually last, and this initiative is an important step in getting there," Davey said.
"A well-designed DTP program transforms the prescription access experience from a transaction into a relationship," Josh Zeidman, senior vice president of business development at PHIL Inc., said in a statement. "This requires building a frictionless experience that gives patients what they want: transparent, affordable pricing with coverage support, multiple access pathways, and a clear path forward to start and stay on therapy on their terms. Pharmaceutical manufacturers that do this well will see the impact where it matters most: patient starts, adherence, and long-term therapy outcomes."
The initiative launches as there is growing recognition of the limitations of current cash-pay models, including TrumpRx, for insured populations. At a STAT event in March, Chris Klomp, a top official at the Centers for Medicare and Medicaid Services (CMS), acknowledged that TrumpRx was not intended for most Americans with insurance.
The goal was not actually some massive reach,” Klomp said, according to STAT's reporting. Klomp added that “170 million Americans are commercially insured, 68 million Americans are on Medicare, the balance are on Medicaid and CHIP largely. TrumpRx is not for most of them—it’s cash pay.”
To attract more patients to direct-to-consumer drug platforms, North Carolina Republican Greg Murphy, M.D., a prominent physician voice in the House of Representatives, recently introduced a new bill that would compel insurers to apply the cost for drugs purchased from cash-pay platforms to deductibles and out-of-pocket maximums. The Every Dollar Counts Act aims to lower patients' out-of-pocket costs for pharmaceuticals. Murphy, a consistent critic of insurers and pharmacy benefit managers, notes in an announcement that consumers have increasingly embraced DTC offerings as costs rise.