As a health and clinical psychologist, I’ve spent the last ten years helping the healthcare industry around the globe address the self-management needs of patients living with long-term conditions. It’s through this international lens that I’ve come to appreciate the challenges and opportunities specific to the US market, where I’ve been based for the last three years. Everyone knows the US healthcare market is unique, but it is perhaps not until you live and work in the US, that you can really understand how that difference impacts the development of patient support programs.

Navigating the Med Legal and Regulatory (MLR) Landscape

All healthcare markets are subject to rules and regulations, and the US market is no exception. Here, it is especially important to understand how a MLR team interprets the rules and regulations to help ensure that submissions are prepared accordingly. While the degree of regulation can be either more or less than other markets, my experience is that US pharma have a tendency to be cautious and conservative.Of course, this approach mitigates risk and bias, but it also means that strategies are often needed to ensure it doesn’t also limit the ability of pharma-sponsored programs to effectively support patients.

In practice this means we must work creatively to get more holistic and supportive health messages incorporated into patient support programs. This creativity extends to how we engage with the MLR review team initially and over time. Integral to this is educating MLR teams on the evidence-base supporting content development and considering the ordering of a MLR submission. Creativity is also required when accommodating MLR challenges yet also trying to maintain the integrity of the messaging. This may simply be a matter of changing the positioning of the materials, or it may be more specific and involve amending the language used in the materials. Either way, it helps to have rigorous scientific support to provide proof points for the MLR review.

Supporting Patients Beyond Access and Reimbursement

Necessarily, and unlike most other healthcare markets where access to most treatment is free or low cost, US pharma places high priority on alleviating any access and reimbursement challenges that might confront a patient when prescribed a new treatment. Although there is an increasing awareness among US pharma of the need to support a patient across their treatment journey, many still think they are delivering effective patient support just because they have engaged Hub services or Specialty Pharmacy to help with the practicalities of access and reimbursement. While this type of support is an important first step, as it helps to assure that the patient actually receives the medicine they need, it is not enough. Pharma need to provide patients with ongoing support to drive persistence with treatment over the longer term. In comparison to other markets, US pharma are slow to adopt patient initiatives that are geared towards supporting treatment persistence beyond collecting the first prescription. This is a huge and valuable opportunity for US pharma, and it is encouraging to see more and more companies seeking to address this need.

The US healthcare market is indeed unique, and that can pose challenges for the delivery of patient support. Once the challenges of the market are understood, they can be addressed and even leveraged as opportunities to create and deliver effective support programs for US-based patients. To this end, the discipline of health psychology can help develop effective patient support that is strategic and evidence-based, and help pharma navigate MLR review as they seek to address the adherence needs of their patient populations.