Originally published in PharmaTimes
By Bob Muratore
The most important role in the emerging future of the pharmaceutical industry is medical affairs – a responsibility long viewed as a support function.
For decades the medical affairs role was defined primarily by information support and the management of routine regulatory reporting requirements. Fast forward and medical affairs now encompasses strategy, safety, communications, post-launch trials, field teams and much more – a sort of command central of pharma.
Amazon recently announced that it is entering the healthcare business, looking to control costs but also to empower the consumer. With increased access to information, skyrocketing expectations and recent regulatory changes, the urgency to embrace a new, more outcome-driven system has never been greater.
One thing seems certain: If the pharmaceutical industry is going to to defend itself against being ‘Amazoned’ it needs to go beyond simply proving the effectiveness of the drugs produced. It needs to prove its value to the overall system and the ability to improve patient outcomes.
Medical affairs (MA) will be the single most powerful force in helping pharma do just that. Those in MA now find themselves with direct responsibilities throughout the product lifecycle, interacting with virtually all stakeholders – both internal and external. But the fact is that pharma and the companies who support it will need to invest even more in MA to keep up with the rapidly evolving interactions among stakeholders in a notoriously complex industry.
Medical affairs: past and future
At the heart of the pharma model has always been the clinical and commercial functions. Product development was under clinical, while marketing and product lifecycle management was owned by commercial. As the pharma industry grew, so did the perception that commercial exerted a disproportionate influence over the development process, scientific communications and other medical and clinical functions. This led to a series of interventions by Health and Human Services, Office of Inspector General and the Food and Drug Administration.
As a result, pharmaceutical companies were forced to separate the medical affairs, commercial and clinical functions into increasingly independent organisations with medical affairs taking a direct leadership role in communications with both internal and external stakeholders.
Now, MA departments typically report to C-level staff and have budgets and teams of their own. In just the last two years, MA teams have grownby 12 percent, and we should expect that number to go up drastically in the near future.
It’s simple: those who fail to invest aggressively in MA will be at a significant disadvantage as the industry continues its dramatic shift to a patient-outcome and value-based system.
Outcome-based models are changing the way business is done
For a long time, experts have been talking about the increasing role of consumers in their own healthcare. Today, patients are able to track their own health status and treatment outcomes, as well as engage with advocacy groups to increase understanding and set expectations about quality of care and outcomes on a broader scope. With the proliferation of social media and patient-empowerment platforms, the voice of the patient is stronger than ever.
Amazon’s health insurance plans have put even more focus on patient outcomes because healthier employees are better for business.
In the not-too-distant future, pharmaceutical companies without meaningful outcomes and clinical data could find themselves outside the Amazon healthcare circle, which could be particularly risky if Jeff Bezos has wider ambitions in the field.
Big Pharma must make cost-effectiveness analyses and treatment support initiatives predicated on a patient’s entire treatment journey and outcome, not just whether they continue to purchase the product or the impact of the medicine provided. It is critical that pharma finds ways to support the patient throughout their treatment.
Commercial can’t do that, clinical can’t do that
Only medical affairs is able to put all of the pieces together. Medical affairs should play the leadership role in developing a complete map of the patient journey, beginning with desired outcomes – needs and expectations about the quality of care received and the outcome of that care.
One of the key ways the industry will be tracking a patient’s journey is to utilise real-world evidence (RWE), which is patient-outcome data gathered outside randomised controlled trials. Recent legislation, such as the 21st Century Cures Act, will likely increase the demand for RWE, yet just 47 percent of respondents in a recent survey say they have a plan in place to support real-world evidence, and among those there is no clear consensus on a specific role to lead that support, according to ZS.
This represents a gigantic opportunity for companies to step up and become leaders in the proliferation of RWE in their product lifecycles, and medical affairs teams will be the owners of how RWE is gathered and implemented.
What MA needs now is more comprehensive, strategic partners to complement its expanded roles and responsibilities. There are integrated strategic and implementation service companies that support both the clinical and commercial sides of pharma with comprehensive offerings, but no such full-service offerings dedicated to medical affairs.
All indications suggest a fundamental long-term shift in the drug development and commercialisation pathway. Pharma manufacturers must adjust to the new world order smartly, and medical affairs will play a critical role. There is a new navigator setting the course through an uncharted healthcare landscape.
Bob Muratore is principal at RPM Consulting.