September 29, 2021

The Importance of Medical Affairs for Market Access and Commercial Success


Philip Gialenios, Former President and Chief Operating Officer

Today, biopharma companies face increasing pressures that impact how they commercialize their therapies, including their market access strategies. These same pressures also impact the approval of new diagnostic tests.

Gaining market access is a complicated process, and it requires the coordinated management of a long list of complex and challenging activities. One of these challenging activities is the need to better understand all the stakeholders impacting market access. In this new landscape, biopharma companies must rethink why and who they engage as key decision-makers impacting market access; even more important is when to engage them (again, the same applies to diagnostic companies). Enter now into the discussion is the transitioning and increasingly important role of Medical Affairs.

How a Medical Affairs Team Affects Market Access

Market Access is without a doubt the key driver in predicting success for biopharmas and diagnostic companies. The requirements for gaining approval by responsible regional healthcare evaluation bodies (FDA in the U.S.) and then securing payer, provider, and patient adoption of new therapeutics are rapidly evolving. The need for real-world clinical evidence showing confirmed efficacy along with building region-specific and patient population-specific cost-effectiveness data has become paramount for new therapies. Add on top of this approval by patient advocacy groups. Medical Affairs enters as the group uniquely positioned to effectively add the right value to an evolving Market Access strategy. Coordinating therapeutic evaluations within regional and national healthcare systems, facilitating, collecting, and collating real-world evidence data, and guiding the progress of therapeutics through positive regulatory review all fall within the purview of Medical Affairs. These responsibilities easily dovetailed with other Medical Affairs activities such as gaining positive key opinion leader advocacy and generating country-specific clinical developmental data. However, new training and new structural models must be implemented to realize the true benefits of a new Medical Science Liaison (MSL) team and to optimize the impact on the wider organization and commercial resources responsible for embracing this game-changing strategy. Biopharma must transition to new models and diagnostic companies need to consider how a Medical Affairs team can positively impact their future market access strategies.

With their medical credentials, scientific know-how, and credibility among stakeholders, Medical Affairs professionals are emerging as the natural “owners” of scientific knowledge and data within the organization and across the life cycle of a biopharma therapeutic (and diagnostic tests). This potential offers Medical Affairs the opportunity to leave behind its former status as a support function and to forge a new role as a primary strategic pillar of the organization. The new healthcare landscape is starting to shape the types of evidence-based data required both from a regulatory perspective and in response to the increasing sophistication of other stakeholders. Many anticipate increased FDA receptiveness to RWE even beyond label expansion and safety purposes with regulators now considering novel trial designs and endpoints.

Meanwhile, the shift to value-based pricing relies on real-world data to evaluate the comparative effectiveness of treatments, and this presents another opportunity for Medical Affairs to better support payers along with providers. Similarly, there is potential to support health systems that wish to develop their own treatment guidelines and enhance clinician decisions; a move to precision medicine derive from population-level insights based on the health system’s own data. Finally, patients are increasingly doing their own research,tracking their own data, and monitoring their own outcomes. Their desire to share their own experiences and seek guidance from others presents further opportunities for Medical Affairs.

The Future of Medical Affairs

In the near future (and already occurring), we see a broad expansion of Medical Affairs engagements across payers, providers, patients, and others. These engagements will occur across a broad range of touch points that will be most often digital in nature and designed to provide tailored information focused on improving patient outcomes. These activities will be supported by pooling patient data from a myriad of internal and external sources enabling the Medical Science Liaison to understand and work with providers to better inform decisions impacting patients. Already we are seeing Medical Affairs transitioning to personalized approaches, seeking to understand physician preferences across their entire treatment pathway and tailoring interactions down to individual providers and even patients. Medical Affairs is also emerging as a key provider of information to patients through a seamless combination of engagements on social platforms, and new tools that support patients on their medical journey in fully compliant ways. Medical Affairs’’ deep understanding of new data sources will enable MSL’s to pilot new ways to use and interpret information, in conjunction with other Commercial resources, to continuously refine and improve the individual patient experience.

Finally, moving to outcome-based contracting as the norm will require Medical Affairs to be a key contributor to these agreements. Medical Affairs is well-positioned to be the expert actively engaging payers, providers, and patients to support the generation and use of outcome data redefining the total cost of care for specific patient populations. Expect to see more formal partnerships with payers focused on reducing the total cost of care and improving patient outcomes. Medical Affairs must effectively facilitate an understanding of the medical drivers of cost of care and drive optimal patient care, especially where biopharma companies are taking on risk as they actively support physicians and engage with patients using real-time platforms. Medical Affairs and their colleagues in Market Access will be forced to work even closer together to provide the necessary, data-driven, and comprehensive view of outcome-based value necessary to ensure contract performance, support market access, and deliver future commercial success.

In the near future, Medical Affairs will have advanced significantly in terms of its status, role, and influence on biopharma and needs to do the same with diagnostics and medical device companies. Organizations seeking to develop a best-in-class Medical Affairs function need to begin addressing several key factors to improve both the external engagement and the internal structure, processes, and capabilities of their Medical Affairs teams. These efforts and emphasis on repositioning Medical Affairs as a new strategic pillar of any life sciences organization is a crucial part of future strategies that ensure ongoing market access, payer, provider, and patient adoption, and ultimately, commercial success.