Whether a generic or a branded competitor, a new drug’s entry into a market can be destabilizing for the incumbent — and the researchers who pioneered the treatment’s breakthroughs.
But this is the nature of business. So, when a competitor emerges, it’s up to the incumbent company to prove the value of its treatment.
The healthcare sector is unique in this regard because marketing doesn’t own this task, nor can it. Rather, it’s the medical teams who must prove the treatment’s efficacy in the marketplace.
At this stage of a drug’s lifecycle, the work of the medical affairs team takes on new importance.
Much of the work needed to support a late life cycle drug gets done early on, in the first weeks and months the product is in the market.
This is when medical teams collect crucial post-launch data and begin to identify what specific patient populations are benefitting from the drug. In decades past, incumbent companies had a bit more runway to do this work. As Bain partners Christoph Schlegel, Michael Retterath and George Eliades point out, however, the average drug today has a four-year window before competitors emerge.
“Companies with launches that repeatedly outperform expectations are adept at communicating the key clinical and nonclinical beneﬁts of a new product to prescribing physicians and other decision makers,” they write. “Often they also use post-launch data and services to further differentiate their product from the competition.”
This is where medical affairs teams come in. MA’s work in stakeholder engagement is what connects a treatment data, the key clinical and nonclinical benefits, and the HCPs who need to understand those insights.
That’s what gives a pharmaceutical product the traction it needs to differentiate itself from future competitors later in its lifecycle.
In December 2019, FDA researchers Ryan Conrad and Randall Lutter published a paper that shows how the entrance of generics into a market puts downward pressure on drug prices. As subsequent generic competitors emerge, prices drop further.
Certainly, this is good news for many members of the medical affairs stakeholder network, even as the drug company’s profit margins erode. But this doesn’t mean MA teams must straddle a conflict of interest. Rather, it begs a macro-level reframing.
As McKinsey researchers Matthias Evers, et al. point out, medical affairs must think and communicate in terms of value. For HCPs and patients, value often entails continuity of treatment, or making sure the people who benefit from a specific treatment have uninterrupted access to that treatment.
“Stakeholders now need a deep understanding of how a new product will add value,” writes Tom Disley at Reuters Events. “In the case of health systems, it isn’t just about comparative effectiveness, it is about looking more broadly at health system outcomes and determining whether a product contributes a net gain, or loss.”
Ksenia Kavoun, manager of strategic initiatives for the provincial government of Alberta, Canada, offers an example of what it looks like to defend an incumbent drug against competition on the basis of value.
Kavoun writes how Sanofi’s drug Fabrazyme, used to treat Fabry disease, faced new competition in 2018. “Sanofi S.A. had a strong adherence program for patients on Fabrazyme infusions,” she writes. “The company tracked adherence metrics and patient liaisons would reach out to patients and providers if patients were missing doses.”
That focus on adherence and treatment continuity allowed Sanofi to retain “the lion’s share of the market.”
The nature of medical affairs’ work puts it in a position to support a therapy’s defense for three distinct reasons:
Clinical trial data is crucial in getting a drug to market, but Schlegel, Retterath and Eliades at Bain note that HCPs want to see more than phase III data when selecting treatment options.
That’s why MA teams spend so much time collecting data from the market. “The insights that MSLs bring back into the company are critical because they are real-world and happening in real time,” says Jennifer Vernazza, director of global medical operations at Apellis Pharmaceuticals.
This kind of data helps HCPs make better therapeutic decisions. The more data available — and the more patient groups segments analyzed — the easier it is for care providers to choose one drug over another.
And when there are gaps in the data, medical affairs can help identify opportunities for its generation.
Within each stakeholder relationship, the idea of value takes on different dimensions. Payers, patients and care providers all define value according to their own needs.
This came up during the Medical Affairs Professional Society’s annual meeting in March 2019. In her summary of the meeting, Peloton Advantage VP of Strategic Services Jill Condello reports how attendees collectively recognized MA’s responsibility to communicate the voice of patients, or to act as “patient access champions.”
That’s the relationship in which category-defining concepts of value can emerge. By elevating the patient voice, MA can help precisely segment patient groups who best respond or best adhere to a treatment. Then, they can push to translate those patient experiences into data and shareable insights.
Here’s how all of the real-world data and insights gain legitimacy.
Medical affairs teams can connect with so many stakeholders at so many different levels because the conversations are rooted in science, not business.
“Anytime a person in medical affairs puts across a point of view that isn’t patient driven or scientific driven…then they are failing to fulfill the objective of the function,” says Rob Scott, who retired from AbbVie as its chief medical officer in May 2020.
This allows MA teams to serve as a linchpin in a network in which deep knowledge gets created, whatever the business value of that knowledge. Against that backdrop, then, conversations about adherence, continuity and drug effectiveness can be had in good faith.
Going forward, expect medical affairs to play an ever-increasing role in supporting drugs throughout their life cycles.
One point in that cycle is the emergence of competition, but any incumbent drug’s defense against a competitor must be built around value creation for many groups at the broadest levels. This means there’s a bigger picture to consider.
Michael Zaiac, Novartis’ European head of medical affairs oncology, puts this nicely:
“The circle of medicine development, licensing, reimbursement and commercialization requires the creation of value for all stakeholders and being focused on sustainable value generation is thus a must for Medical Affairs professionals who play a pivotal role in all aspects of this circle.”
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