Bass, Berry & Sims attorney Shannon Wiley discussed the challenges that pharmaceutical manufacturers may face when offering direct-to-consumer (DTC) programs. Two pharma manufacturers recently announced digital platforms to offer benefits to patients and others; however, as the article outlines, there are challenges to these programs that manufacturers need to be aware of in order to stay compliant with various regulations.
From a patient perspective, Shannon said that “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. “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.”
Pharma manufacturers need to understand the “complex” regulatory framework of DTC programs, Shannon warned. “Manufacturers who approach a DTC platform as purely a marketing solution may find their expectations challenged by regulatory constraints.”
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, Shannon stated.
In partnering with these vendors, Shannon said “Manufacturers should look for experience and vendors with well-developed compliance processes that are specifically geared to DTC offerings. 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.”
The full article, “What Should Pharma Manufacturers Know Before Launching DTC Programs?,” was published on September 5 by AIS Health as part of its Spotlight on Market Access series and is available online.