More pharmaceutical companies are launching direct-to-consumer drug platforms, and the rise of these co-pay services may improve access to medicines, but may also raise concerns about oversight and accountability.
The Digital Medicine Society is leading a cross-disciplinary effort to partner with pharmaceutical companies, virtual first providers, and digital pharmacies to establish a scalable blueprint for direct-to-patient pharma models as the market continues to evolve.
Major pharmaceutical companies are increasingly rolling out direct-to-consumer platforms, most of which offer deep discounts on popular drugs, making many patients more willing to take advantage of the new services, Fierce Pharma Marketing reported. Three-quarters of U.S. consumers use DTC drug distribution services “somewhat” or “extremely,” the survey found.
Eli Lilly launched LillyDirect in January 2024, joining a growing number of drug manufacturers looking to sell their products directly to consumers over the past two years. Drug discount platform TrumpRx launched earlier this year, and last month Johnson & Johnson launched a website to sell some drugs directly to U.S. patients. Women’s health provider Maven Clinic and other virtual first care providers have signaled direct-to-patient care as a priority area for expansion, while digital pharmacies and integrated virtual prescribing models continue to expand.
Pharmaceutical companies are facing significant price pressures, while at the same time consumerism is growing in healthcare, making this a timely opportunity to create trusted channels to responsibly scale direct-to-patient models, said Jennifer Goldsack of DiMe, a nonprofit organization dedicated to advancing digital health technology.
“Direct-to-patient models are already reshaping the way patients access care, especially in treatment areas where demand is outpacing the capabilities of traditional brick-and-mortar approaches,” Goldsack said.
The DiMe-led initiative, called Optimizing Direct-to-Patient (DTP) Strategies for Pharmaceutical Companies, will focus on establishing an operational, regulatory and evidence-based foundation to ensure DTP models are “operated safely, consistently and in a manner that earns trust,” Goldsack said.
“Pharmaceutical companies need to figure out how to make their medicines available to patients at prices they can afford if they are to continue to have the revenue to reinvest in research and development. We are very motivated to ensure that we continue to develop new medicines. At Me, we are also very motivated to ensure that all patients who would benefit from life-improving treatments are able to do so,” Goldsack said in an exclusive interview with Fierce Healthcare about the new initiative.
Four major pharmaceutical companies are currently participating in this new initiative, with more on the way. Founding partner companies involved in this effort include Coalesce Health, DistributeRx, Fullspan Health, Health Advances, Phil, Inc., S3 Connected Health, Welldoc, Wheel, and Ypsomed.
Cash payment channels for pharmaceuticals are rapidly expanding in response to access constraints, pricing complexities, and unmet demand, particularly in high-demand areas such as GLP-1 therapy.
“Patients themselves are increasingly turning to virtual pathways to get the care they need,” Goldsack said. “In an era of policy tailwinds, downward pressure on drug prices, and patients telling us they enjoy being able to access care in a timely manner and have a complete solution where not only their prescriptions are delivered, but the prescriptions delivered to their door and ongoing support in taking those prescriptions, we believe that DT We believe that the P-Pharma pathway is not just a GLP-1 cash payment opportunity, but rather emerges as a true care pathway that actually increases value to patients and improves treatment efficacy, ensuring access to patients and allowing pharmaceutical companies to continue investing in research and development.”
He added: “If we believe this to be the case, we need to ensure that the way this treatment pathway is established is reliable, accessible to everyone, and delivers value across the market, with clear roles and responsibilities for the various stakeholders, from expert clinical providers to delivering medicines at the best price to patients.”
Goldsack said that if the direct-to-patient model works well, it can expand the ability for patients to get the care they need at an affordable price, while also strengthening trust in how care is delivered.
The DTP Pharma Initiative maps the market, regulatory and policy landscape and translates it into clear, actionable guidance to support teams supporting the operation of self-pay models. It will also define how patient access and affordability will be measured, allowing for a more transparent and equitable approach to care, Goldsack said.
The coalition will also focus on a structured approach to assessing the appropriateness of direct-to-patient models based on regulatory readiness, patient benefit, and commercial viability. This project will also feature examples of both successful and cautious approaches to extending DTP models, with a focus on what actually drives access, affordability, and trust.
These efforts will help “de-risk” the DTP drug pathway as a new model of care, Goldsack said.
As direct-to-patient models have grown, Goldsack said, there has been wide variation in clinical oversight and independence, marketing practices, patient transparency and coordination of prescribing, fulfillment and follow-up care. She argues that cash payment channels are rapidly evolving without a clear system-level framework to support them.
Some rapidly expanding DTP models are facing increased regulatory and legal scrutiny of their business practices. The Food and Drug Administration has sent a warning letter to a telemedicine company that is making false or misleading claims about compounded GLP-1 products offered on its website. In February, the FDA issued a warning letter to fast-growing telemedicine company Medvi for allegedly violating federal regulations regarding the sale of compounded drugs. A class action lawsuit accusing Medvi of violating California’s anti-spam law is also pending.
The DiMe-led initiative has a specific goal: “to tame the Wild West before it becomes the Wild West,” said Anand Iyer, chief AI officer at Welldoc, a founding partner of the initiative that provides digital cardiometabolic solutions.
The initiative is designed to align stakeholders across clinical care, prescribing, fulfillment, patient services, and patient engagement. Once the framework is established, Iyer said cross-sector partners can begin to build on these efforts to move the market forward.
“We can start building tools that are available to participating stakeholders, for example, building ROI tools and building readiness matrices,” he said in an interview.
Welldoc has received 11 510(k) clearance from the FDA for diabetes digital health solutions and brings regulatory and clinical expertise to these cross-disciplinary efforts, he said.
“Our total health approach, which uses AI to help manage these multiple chronic diseases, is built on the rigor and expertise needed to advance this direction of progress in DTP,” he said.
Another founding partner, Wheel, is a virtual care technology and services company that has been working with digital health companies, pharmacies, health plans, and pharmaceutical companies to help launch telehealth platforms for nearly a decade.
“While there is a lot of experimentation going on in direct-to-patient therapy, there is still no solid, clear path forward that this will be effective across a wide range of treatments, so we are excited to help shape that future,” Michelle Monaco, Wheel’s senior vice president and head of product, said in an interview with Fierce Healthcare.
“There’s a lack of consistency, and it’s really going to take an entire ecosystem to solve the gaps in care that exist. The challenge is not getting patients prescribed drugs, but actually making drugs work in their lives. Today, we have education and awareness programs that drug companies are good at, and we have people working hard on access and affordability. We have other players working on convenience, and this is bringing everything together and trying to do it in a thorough way.” We have to think about not just how to prescribe and move on, but how to improve outcomes over time,” Monaco said.
Wheel CEO Michelle Davey said in a statement that consumers expect faster and easier treatments, and that change is not slowing down. “But building for access is different from building for the entire patient journey. Doing it well requires clear standards, clinical independence, and accountability from the start. That’s what will actually define which models will last, and this work is an important step in getting there,” Davey said.
“A well-designed DTP program transforms the prescription access experience from a transaction to a relationship,” Josh Zeidman, senior vice president of business development at PHIL Inc., said in a statement. “To do that, we need to create a frictionless experience that gives patients what they want: transparent and affordable pricing with coverage support, multiple access routes, and a clear path to start and continue treatment on their terms. Pharmaceutical companies that do this well will see benefits where it matters most: patient initiation, adherence, and long-term treatment outcomes.”
This initiative comes amid growing awareness of the limitations of current cash payment models, including TrumpRx, for insureds. At a STAT event in March, Centers for Medicare and Medicaid Services (CMS) executive Chris Klomp acknowledged that TrumpRx does not cover most insured Americans.
“The goal wasn’t really mass reach,” Klomp said, adding, “170 million Americans have commercial insurance, 68 million Americans have Medicare, and the rest goes primarily to Medicaid and CHIP,” according to a STAT report. TrumpRx is not for most people and is a cash payment. ”
To attract more patients to direct-to-consumer platforms, Dr. Greg Murphy, R-North Carolina, a prominent physician voice in the House, recently introduced a new bill that would require insurance companies to apply deductibles and out-of-pocket limits to the cost of drugs purchased from cash-pay platforms. The Every Dollar Counts Act aims to reduce out-of-pocket costs for medications for patients. Murphy, a consistent critic of insurance companies and pharmacy benefit managers, noted in the announcement that consumers are increasingly accepting DTC services as costs rise.
