Three Steps to Protect Your Patient Support Program from “White-Coat Sales” Concerns

In May 2017, Novo Nordisk settled a lawsuit that alleged it ran an illegal marketing program to increase sales of its diabetes products (http://www.fiercepharma.com/pharma/novo-nordisk-reaches-settlement-white-coat-sales-scheme-lawsuit).  Novo designed the program “to help physician offices better understand diabetes and patient care,” commented a company representative. The program was administered by a third party who provided program and disease state expertise.

Helping healthcare providers understand and improve patient care has long been an important goal of bio-pharmaceutical companies. Patient support programs are part of almost every major brand and therapeutic area. They provide patients with critical information and access to services that may otherwise be unavailable to them.

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  • How can you protect your brand’s patient support program from the scrutiny and expense experienced by Novo’s diabetes program?

There are three critical steps that should be followed for any patient support program, whether it be an “in-person” program, like the Novo program, or an “over-the-phone” program like many others.

Step One – Program Design: Conduct pre-program research to understand exactly what patients need from a support program. Then, design the best protocols and communication channels to deliver on the specific patient needs. Patients may tell you what they think they need, or what they think you want to hear. At this stage of the program design, interviewing patients would be the best way to gather input.

  • Step two is the critical step that is often overlooked.

Step Two – Independent Assessment: Hire an organization that is independent of the company and independent of the program-administering firm to assess whether the program is being carried out in accordance with design. Include details about the independent assessment in the internal Medical, Legal, and Regulatory review submission and offer to provide periodic reports on the program design and adherence to protocol. This is such a critical step because the independent firm should be able to tell you about patient behavior. Understanding patient’s behavior while in the program is more important to the results and refinements than what is said by patients during patient research interviews.

Step Three – Program Improvement: Make adjustments to the program based on results from the ongoing independent assessment. There is little chance that the originally designed program will meet the actual needs of patients. Adjusting the program based on the independent assessment will improve program outcomes and demonstrate commitment to the program’s intent to improve the lives of patients with illness.

There is little doubt that patient support programs will receive increased scrutiny and attention from regulators in the coming years. This will come at a time when patients are in even greater need of the support that can come from bio-pharma sponsored programs.

Avoiding risks and improving patient outcomes can be as simple as adding an independent assessment to your patient support program. Centerfirst has assessed hundreds of thousands of interactions in the healthcare market and can give you the confidence of independence and expertise for your patient support program. Contact us to learn more.