The five evolution's that are impacting the role of Medical Affairs departments today
Medical information has become more accessible through social media and digital platforms such as the ‘Health A to Z’, a website created by the UK’s NHS. This has raised expectations and demands from patients, healthcare professionals (HCPs), and medical leaders for relevant and detailed, but digestible information, at their fingertips.
As a result, organizations need to explain and contextualise increasingly complex medical science to a diverse range of stakeholders (Figure 1). This offers new opportunities for engagement and Medical Affairs professionals are ideally placed to respond, as both scientific and communications experts.
Pfizer collaborated with Dimensions to create open access clinical trial visualizations, which are more accessible to clinicians:
A key differentiator for successful organizations will be the ability to make communications truly valuable to their internal and external stakeholders. The sheer number of stakeholders and their demand for information informs a wide range of communications styles and outputs, based on final requirement and stakeholder background.
For instance, according to one study, 61% of HCPs identify greater personalization as the main differentiator for making medical engagement more valuable, followed by receiving more real-world evidence (RWE), especially related to the impact of treating patients remotely (54% of responses), and information on therapeutic innovations that enable home care and patient self-administration (51%).
HCPs would also like more visibility of commercial factors. While information related to product efficacy and safety continue to be top priorities, as identified by 70% of HCPs, information about the economic value of new therapies is now moving up their priority list. (Figure 2).
Figure 1: Key stakeholders for Medical Affairs liaison.
Figure 2: Top 10 information priorities for HCPs in 2022 and in future (France, Germany, Italy, Spain, UK, US).
The pharmaceutical industry also needs to address the lack of advocacy and inadequate representation of the patient voice internally, because this not only puts the organization at risk of not meeting real patient needs but also fuels scepticism around pharma motivations within the healthcare ecosystem.
The biopharmaceutical industry recently ranked among the least trusted industries, partly due to its distance from patients. By contrast, doctors’ offices and physician groups were regarded as the most trusted sources of information by consumers.
The pandemic closed some of the trust gap between pharma and patients as the public became interested in research efforts and the issues relating to vaccine development. Medical Affairs teams can now seize this window of opportunity to build on this interest, strengthen trust and broaden its scope to other treatment areas.
By providing a clear means to have a dialogue and effectively bridging the gap between patients and the business, Medical Affairs can lead the way in regaining the trust of physicians, patients and the general public. Medical science liaisons (MSLs) also play a part here by providing support and unbiased medical information to Key Opinion Leaders (KOLs) and helping maintain patient and KOL relations.
The pandemic and the consequent remote operations also changed the way businesses think about location and engagement. In the medical field, a hybrid model of engagement looks set to stay. In fact, in one survey, a majority of participating healthcare professionals (HCPs) across the UK, France, Germany, Italy, Spain and the US report that their interactions with MSLs have changed permanently, with more remote and virtual engagement, live virtual educational events, and fewer in-person meetings.
This further expands the reach of Medical Affairs since it is easier to connect with a broader range of people in different locations, and it gives them more flexibility in the way they interact with stakeholders.
Cost pressures on health systems the world over are growing. In parallel, competition is also intensifying in the pharmaceutical sector and market exclusivity time for first-in-class products is shrinking, driving efforts to discover the next generation of blockbuster drugs. A prime example is offered by the growth of oncology and immune-modulator pipelines across the industry.
Real-world data (RWD) is enabling outcome and value-based contracts where the payer (i.e., NHS England or healthcare insurers in the US) pays different prices for the same drug depending on how well that drug performs once available to patients. One example is Bluebird Bio, which embraced outcomes-based pricing for beta-thalassemia gene therapy in Europe, with a five-year, results-driven installment payment plan. As part of the plan, Bluebird will reimburse contracted commercial and government payers up to 80% of the therapy cost if a patient fails to achieve and maintain transfusion independence up to two years following infusion.
This model is being embraced by start-ups and is at the heart of the US healthcare debate concerning prescription drug expenditure. In the pharmaceutical industry itself, 71% of executives support the model, and believe the pricing model could help improve patient outcomes while promoting innovation, rewarding manufacturers for bringing innovative and effective products to market. However, it also increases pressure on medical affairs professionals, by raising expectations for the level and quality of data required to support a drug.
Medical Affairs is being recognised as a core and increasingly important function in the pharmaceutical sector, with a growing remit that includes generation of real-world evidence, patient advocacy and identification and external stakeholder engagement as well as liaising with policy makers and payers.
They are becoming the “owners” of scientific knowledge and data within pharmaceutical organisations, transitioning from mainly supporting the efforts of other departments to being strategic players within the organisation, on a par with those involved in Research & Development, Commercial, and Market Access.
Medical Affairs departments, in their new pivotal role, have a growing influence over other functions (Figure 3). Rather than solely providing accurate medical information, it is a key department with a direct impact on the business outcomes of the organisation, driving the overall medical strategy, and representing the brand rather than just specific products.
As one expert, Bora Erdemli, leader of ZS’s Medical Affairs service line in Europe explains the function has moved from:
"full-time custodian of scientific information” to be the “scientific face of the overall organisation”
and increasingly CEOs in the pharmaceutical sectors are expected to come from a medical affairs background.
Figure 3: Medical Affairs' sphere of influence.