What Should Pharma Manufacturers Know Before Launching DTC Programs?

While plenty of telehealth and online drug dispensing companies have rolled out direct-to-consumer (DTC) offerings, two pharma manufacturers have unveiled their own digital platforms this year in a bid to streamline and simplify consumers’ experience with the U.S. health care system. Other drugmakers are likely to launch similar offerings, say industry experts, as they offer benefits to various stakeholders. Still, certain challenges exist for those stakeholders, and manufacturers will need to ensure that they take certain steps — both pre- and post-launch — to set themselves up for success while remaining compliant with various regulations.

On Aug. 27, Pfizer Inc. launched PfizerForAll, a “user-friendly digital platform designed to make access to healthcare and managing health and wellness more seamless for people across the U.S.” It is aimed at Americans with migraine, COVID-19 or flu and offers adult vaccinations for conditions such as COVID-19, flu, respiratory syncytial virus (RSV) and pneumococcal pneumonia.

The platform allows consumers to make same-day in-person doctor appointments via Zocdoc or $35 telehealth appointments through UpScriptHealth. Other partners include Alto Pharmacy, Amazon and Instacart. People can use their existing insurance for products and their health savings accounts and/or flexible savings accounts to pay for their telehealth visits.

Both prescription and over-the-counter medications, as well as diagnostic tests for COVID and flu, can be ordered through the program and then delivered to a person’s home or to a pharmacy. The platform offers people the ability to schedule appointments for vaccinations.

Consumers also can access copay savings, affordability programs and patient support services for Pfizer medications, as well as speak with a customer service agent who can help explain prior authorizations and other insurance requirements.

And it’s not focused only on Pfizer medicines: PfizerForAll gives people the choice of the Pfizer/BioNTech COVID vaccine or Moderna’s.

When it unveiled the platform, Pfizer pointed to an American Academy of Physician Associates poll finding that 65% of respondents said that it is “overwhelming and time-consuming” to coordinate and manage health care. In addition, 73% said that the U.S. health care system does not meet their needs.

Consumers are experiencing “information overload” and “roadblocks” when trying to navigate the health care system, said Aamir Malik, executive vice president and chief U.S. commercial officer at Pfizer. “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.”

Lilly Launched Similar Program Earlier This Year

The new offering is similar to that of Eli Lilly and Co.’s LillyDirect, an “end-to-end digital healthcare experience” that the company launched on Jan. 4. That platform is focused on people with obesity, migraine and diabetes, and its LillyDirect Digital Pharmacy offers certain Lilly medications through third-party online fulfillment services such as Truepill — which also services Mark Cuban Cost Plus Drug Company — Eversana and Amazon Pharmacy.

In addition, Lilly is partnering with the telehealth platforms Form Health Inc. for obesity, 9amHealth for diabetes and Cove for migraine. Providers are not obligated to prescribe Lilly drugs, the company said. It also is working with Healthgrades to allow patients to locate providers near them for in-person care.

Consumers also can access Lilly’s cost-saving offerings and have medications delivered to their home free of charge. As with PfizerForAll, LillyDirect can help patients navigate the health care system, and both companies offer educational information for patients about their condition.

“A complex U.S. healthcare system adds to the burdens patients face when managing a chronic disease. With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes,” said David A. Ricks, Lilly’s chair and CEO, when unveiling the offering. “LillyDirect offers more choices in how and where people access healthcare, including a convenient home delivery option to fill Lilly medicines they have been prescribed.”

Sources: Other Pharma Companies Have Shown Interest

According to Avalere Health’s Mark Gooding, a managing director, and principal Brigit Kyei-Baffour, other pharma firms expressed interest in DTC after the rollout of LillyDirect, leading to anticipation that other companies will try out similar opportunities. “Several factors…have led to this interest, including previous pressures/concerns that channel discounts and concessions could have been ‘stacked’ in setting a Best Price, though CMS has clarified that a forthcoming rule would not include a proposed policy change that would have created this risk.”

In addition, they tell AIS Health, a division of MMIT, “telehealth services and online pharmacies are trending industries, and manufacturer DTC programs may support expanded patient access and engagement for specific therapeutic areas.”

The platforms are focusing on only a few conditions at this point, although Pfizer has said that PfizerForAll has “the potential to address a broader range of needs and conditions.” Likewise, Lilly has said that “LillyDirect will continue to be updated and expanded to improve the customer experience,” with the possibility of “new products, partners and services, such as” adherence programs.

But only certain conditions may be well-suited for such offerings. “Chronic conditions for patients whose care and condition have stabilized are good candidates for DTC programs” such as diabetes or migraine that is well managed, says Shannon Wiley, a member at law firm Bass, Berry & Sims PLC. “These patients can access specialists through a DTC channel, but the telehealth encounters do not require testing or labs. Patients with these types of stabilized conditions are already actively engaged in managing their own day-to-day treatment, and the convenience of a DTC offering adds value to patients looking to carve back some of the time the condition takes away from them.”

Gooding and Kyei-Baffour also point to self-administered agents that aren’t very complex as good candidates for such programs. Self-administered drugs “are easily administered at home and are not covered by Medicare Part B, which may incentivize patients to opt for discounts where they can.” Costly agents with offerings that would allow patients to benefit from “even greater direct access to discounts/cost-savings” would also be potential options. Not as good of a fit may be “rare and ultra-rare diseases where it is difficult to ‘find’ those patients.”

Programs Can Benefit Variety of Stakeholders

DTC offerings can offer a range of benefits. Patients can have medications delivered to their home, which may be particularly important to people with mobility challenges or who reside in remote areas, say Gooding and Kyei-Baffour. In addition, they “provide a one-stop-shop place to manage medications,” schedule appointments and access discounts and adherence programs.

Providers may gain access to patients “in earlier stages of disease, leading to lower provider cost and time depending on the product,” as well as an increase in “awareness of the clinical signs and symptoms that give providers clues to diagnosis.”

And manufacturers benefit from “new opportunities to engage patients and broader potential access channels,” they point out, as well as patients’ and providers’ better knowledge of disease states and their treatments.

On the flip side, patients who have several prescriptions from different manufacturers may have to navigate multiple platforms to get their medications instead of having the convenience of picking all of them up at once at their local pharmacy, point out Gooding and Kyei-Baffour. And as patients’ knowledge of their condition grows, it “may lead to increased pressure to ask providers for the drugs even if it does not fit their therapeutic plan.”

Providers will need to make sure they are monitoring their patients’ adherence to therapy and may need to increase their communication to patients about their medications. In addition, “understanding the appropriate use(s) for the therapies means outreach to manufacturers’ medical science liaisons.” And, says Wiley, physicians will need to make sure the programs are integrated into patients’ care plans and that “DTC encounters do not result in further fragmented care.”

In a statement earlier this year after the launch of LillyDirect, the American College of Physicians expressed its concern over websites that allow consumers to order prescription drugs directly from manufacturers by using telehealth services.

“For telemedicine services to take place responsibly, there should be an established and valid patient-physician relationship, or the care should happen in consultation with a physician who does have an established relationship with the patient,” said Omar T. Atiq, M.D., president of the organization. “These direct-to-consumer services have the potential to leave patients confused and misinformed about medications. While efforts to remove barriers to care are important, they should not devalue the proven benefits of the patient-physician relationship.”

Without that relationship, critics maintain, follow-ups to ensure medications are taken as directed or that any side effects are managed may not occur.

DTC models also can bypass other entities such PBMs, group purchasing organizations (GPOs) and wholesalers, cutting down on the crowded and complicated supply chain. And that also allows drugmakers to avoid paying rebates on their drugs, which can add up. A September 2023 report from the American Enterprise Institute examined discounts off list price for four GLP-1s: Lilly’s diabetes drug Mounjaro (tirzepatide) — which has since been approved for weight loss as Zepbound — and Novo Nordisk A/S’s Ozempic (semaglutide) and Rybelsus (semaglutide), both diabetes drugs, and its weight-loss medication Wegovy (semaglutide).

After concessions such as rebates and coupons, the net prices for the agents in the first quarter of 2023 were between 48% and 79% off the list price.

Challenges Exist for Manufacturers

Manufacturers that offer DTC programs will need to contend with “managing technology integration, protecting patient data,” as well as “market access to therapies promoted in rural areas,” maintain Gooding and Kyei-Baffour.

“The legal and regulatory framework for DTC programs is complex,” adds Wiley. “Manufacturers who approach a DTC platform as purely a marketing solution may find their expectations challenged by regulatory constraints.”

The arrangements, she tells AIS Health, “implicate many different laws, and the legal contracts governing these types of programs are detailed and require careful review. Legal counsel with expertise in fraud and abuse laws, off-label marketing, corporate practice of medicine and intellectual property, among others, should be consulted. Also, manufacturers would be wise to implement audit functions to ensure internal compliance and compliance of its contracted vendors.”

More specifically, say Gooding and Kyei-Baffour, manufacturers’ “key compliance checks” should address “quality and safety of care, patient privacy, regulatory compliance, technology integration and addressing existing system issues.” And drugmakers should “emphasiz[e] increased and transparent communication between pharmacies and prescribers.”

To offer DTC programs, manufacturers will need to work with a telehealth provider and often a contracted pharmacy, as well as potentially vendors such as hub providers for patient support services, Wiley states.

“Manufacturers should look for experience and vendors with well-developed compliance processes that are specifically geared to DTC offerings,” she asserts. “The ability to provide services in all U.S. states and territories is table stakes for DTC vendors. While DTC programs vary and historically have been cash pay, the industry is moving to offering care that is covered by insurance. This necessitates that vendors be broadly contracted with insurance companies.”

In addition, say Gooding and Kyei-Baffour, manufacturers should seek out partner organizations that have the following:

• “Strict patient privacy policies and procedures,
• Sophisticated privacy software,
• Established and reliable distribution infrastructure,
• An established and user-friendly online interface, and
• Access to patient registries or relationships with advocacy groups who have access directly to patients.”

Ultimately, says Wiley, “I expect to see continued growth of DTC offerings. Patients want the same convenience they are accustomed to with ordering groceries, clothes, takeout, etc.”