Just as care and rigorous testing are crucial for the early stages of a drug’s life cycle, vigilance and real-world data gathering are crucial for the late stages of a drug’s life cycle.
Drug manufacturers must keep track of patient outcomes, respond to inquiries about off-label use, remain aware of market realities and keep abreast of regulatory developments as they pertain to their late life cycle drugs.
Medical affairs plays a major role in all of these responsibilities. Below are five things a medical affairs team can do to help support mature therapies — and the care providers and patients who rely on them.
The market for a mature drug will certainly change as loss of exclusivity approaches. That doesn’t mean the company must yield a competitive advantage, however. If your company’s drug is still the most effective treatment for a given condition, make sure your commercial teams understand this.
“Indeed, while there is a clear distinction between medical affairs and commercial operations, there is a need for the two towork together, particularly at a strategic level,” writes consultant Manolo E. Beelke, M.D., Ph.D. “Medical affairs within this context can support marketing messages by identifying and eventually collecting the data to prove commercial statements, such as having the best-in-class drug for a particular disease.” It’s then up to the marketing teams to reinforce that message.
That said, market positioning might not necessarily reflect the drug’s effectiveness. Dr. R.B. Smarta, chairman and managing director at Interlink, suggests the measures such as product reformulation, new clinical trials, identifying new markets or brand refreshes as strategies that MA and commercial teams could support.
Whatever late-stage commercial strategy fits best, be sure all teams work proactively to execute it. Dr. Neal Hansen, a trainer in the management of late life cycle drugs, notes that any successful life-cycle management strategies need at least six years to be planned and executed before the loss-of-exclusivity event occurs. With a shorter runway — e.g. three years — Dr. Hansen says options for taking advantage of commercial opportunities are greatly diminished.
The FDA permits medical affairs teams to talk about off-label uses of a drug when the inquiry is unsolicited. If the inquiry even appears to be solicited, however, that runs afoul of regulations. MSLs must be sure they’re holding conversations on the right side of that regulation, then.
There are a few ways they can do this. MA teams can:
We have an extensive guide to what medical affairs can do and cannot do when talking about off-label drugs. You can see that post here.
Access to clinical data and real-world data about a drug’s effectiveness can make medical affairs teams truly reliable partners for healthcare professionals. This is especially true in the U.S. healthcare system’s embrace of value-based care and value-based pricing.
“There is potential to support health systems develop their own pathways and guidelines based on their own data, to enhance decision support for clinicians and precision medicine through big data, and to derive population-level insights,” McKinsey senior partner Matthias Evers, Ph.D., and his colleagues write.
Supporting precision medicine professionals, especially, could be a focus in the coming years. As Elaine Quilici writes in Pharmaceutical Executive’s February 2020 issue, precision medicine and biopharmaceuticals are seeing tremendous growth both in monetary terms and in terms of practice. But the route from biomarker testing to drug prescriptions has yet to find alignment. There are still issues with how HCPs are delivered reports and how doctors interpret those reports, Quilici says.
“Something seems to be getting lost in the flow between laboratory professionals and physicians, and pharma would benefit from stepping in to offer support before the issues grow exponentially along with the field,” she explains.
Even in fields where practice and treatment are mature, medical affairs can support HCPs by simply reassuring them that needed supplies are available and ready to ship. The COVID-19 pandemic underscored just how important things like supply chains are. This is another area where MA can support an HCP’s decision making.
“Manufacturers with very high reliability usually have what is called a mature quality management system,” writes Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
“However, purchasers currently are not able to readily identify those manufacturers. With today’s regulatory landscape, buyers actually have very limited information linking the medicine they buy with the facilities in which it was manufactured, other than the knowledge that the product was made under CGMP.”
Labeling is typically seen as a regulatory activity, but there is also a competitive advantage available to pharmaceutical companies that prioritize consumer information availability. This, too, is a role MA can step into.
For example, consultant Graham Francis notes how companies working in a variety of national markets can gain an advantage by ensuring labels are quickly available in all applicable languages, especially in countries where communities of linguistic minorities live.
What’s more, companies that make their labeling information digitally available to all will be in a position to earn the trust of market stakeholders, writes Irena Milobratovic, senior regulatory affairs manager at Arriello. “The question now is how organisations might start to prepare themselves to fully exploit the future reality of online product information provision,” Milobratovic writes.
“It may be early days, particularly in the pharma sector, but early providers of online product information are likely to be applauded by the market for their visible commitment to transparency and patient safety.”
Patient voice is a crucial input for clinical trials, and patient experiences should also inform the management of late life cycle drugs.
Researchers Rahma Warsame, M.D., and Anita D’Souza, M.D., M.S., write in Mayo Clinic Proceedings that patient-reported outcomes (PROs) are useful in comparative effectiveness research, which then can be used to inform HCR decision making and market positioning, as noted above. Further, PROs can give all stakeholders a better understanding of what a person experiences during treatment as well as a clearer picture of treatment outcomes, they write.
Again, MSLs should act as the shepherds of this information to ensure all stakeholders have access to the patient’s perspective on treatment experience and effectiveness.
Such data is certainly collected at the clinical level, but important conversations are also happening online among patients and care advocates. Social media specifically “has become a powerful tool that pharmaceutical companies use to identify, listen to, engage, and collaborate with patients to improve drug discovery, development, and utilization,” James Gillespie and David Ormesher write at Clinical Leader.
“Social media analyses are apt for an in-depth characterization of the patient experience, with one ultimate goal to aid patients in disease management.”
Medical affairs operates within these intersections of patient conversations, medical information requests, market intelligence, regulatory updates, and events and symposia. Understanding how the needs of all these stakeholders overlap at various points can help a drug manufacturer better understand life cycle management strategies for its mature therapies.