Bass, Berry & Sims attorney Shannon Wiley provided insight for an article in AIS Health – Spotlight on Market Access outlining what pharma manufacturers should know before launching direct-to-consumer (DTC) programs. While there are benefits to DTC programs – such as streamlining the process for patients to get access to certain drugs – manufactures should be aware of potential issues so they remain compliant with regulations.
First, not all patients or medical conditions are good candidates for DTC programs. “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, Shannon explained. “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.”
In speaking of the regulatory challenges, Shannon said, “The legal and regulatory framework for DTC programs is complex. Manufacturers who approach a DTC platform as purely a marketing solution may find their expectations challenged by regulatory constraints.”
Additionally, certain compliance challenges exist for drug manufacturers in care coordination among various providers and platforms. “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.”
When asked about the future of DTC programs, Shannon said, “I expect to see continued growth of DTC offerings. Patients want the same convenience they are accustomed to with ordering groceries, clothes, takeout, etc.”
The full article, “What Should Pharma Manufacturers Know Before Launching DTC Programs?” was published by AIS Health – Spotlight on Market Access on December 11 and is available online.