Redefining Medical Need
To truly understand unmet medical need, we need to stop focusing on the disease and start talking to patients, says Allergan CMO, Gavin Corcoran
For HIV-positive patients, treatment has come a long way. Once a death sentence, the virus was first battled with a cocktail of medicines that offered a genuine lifeline to patients but was far from practical. Desperately sick people would have to remember to take multiple medicines at different frequencies throughout the day, swallowing fistfuls of pills with each meal.
This is the kind of challenge that comes to mind for Gavin Corcoran, Chief Medical Officer at Allergan, when he considers how pharma should frame the concept of unmet needs. “When I was in practice, a lot of what I did was infectious diseases and HIV care. There were a wide range of medicines to choose from but one medicine had to be taken three times a day, another four times a day, and another twice a day. For patients, that’s almost impossible, as your whole life revolves around, ‘Oh my goodness, did I take my medicine on time?’ The ‘unmet medical need’ in this case wasn’t that they needed different drugs, it was a treatment regimen they could manage their life around.”
For Corcoran, today we need a new approach to identifying unmet medical need. “In the past, we often assumed that true unmet medical need was when there was no therapy, or limited therapy, for a particular disease.”
Not just pharma; as part of its fast-track approvals process, the FDA defines filling an unmet need as “providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.”
“To me, we need to change our thinking around this a little bit,” says Corcoran. “Instead of looking at it just from a disease standpoint, which is important, we also need to look from a patient-centric standpoint. What are patients’ unmet medical needs? It may be something as simple as a convenience factor; could we get the treatment burden down to taking it once a day, once a week, once a month? In addition to the therapeutic benefits of new treatments, from a patient standpoint the advances in reducing treatment burden would be life-changing.”
For patients with a psychiatric disease who might struggle to remember to take a medicine, for example, an injection once a week or once a month could change their lives. “That’s a huge unmet medical need,” he says.
With its role in patient-centricity, Medical Affairs is well placed to consider unmet needs in this way, says Corcoran. “That’s how Medical Affairs gets involved on the clinical side. We ask, what’s in it for the patient? Is this medicine really going to deliver the improvement in quality of life that patients are looking for? So, even if it is a new mechanism of action and might control the disease a bit better, but it’s so inconvenient or doesn’t give the quality of life or the side effects are intolerable, then it’s not really delivering an unmet medical need. That molecule runs the risk of just being yet another medicine that comes to market but is unaccepted to patients.”
Medical Affairs teams can also harness their experience to look at what it’s like for patients. At Allergan, they also work alongside Health Economics and Outcomes Research teams to understand the patient journey and bring insights into the development process. What’s more, a field-based Medical Affairs team works with HCPs to explore practice patterns and find out what works and what doesn’t for patients. This information is then brought back to the clinical development team to help boost patient recruitment into trials.
However, as well as clinical data, Medical Affairs is also well-placed to bring the wealth of insights that real-world evidence offers to the table. “We are using electronic data more and more in our efforts. We are now looking at new ways to use wearables like an Apple Watch or Fitbit to collect data passively, so that it’s less of an interruption to a patient's life.”
As for getting detailed patient input to the development process, “the jury is still out on the best way to do that,” says Corcoran, but it could be through patient advocacy groups, patient representatives, or getting patients to review protocols.
“We have a product in development for diabetic gastroparesis, an area of medicine that has not seen a new treatment in 30 years,” he says. “So, what really matters to patients? Do they want better control of their gastroparesis, do they want to feel better and what does that mean? We can look at it from a clinical standpoint and say we’ve got to take it from a score of three down to zero, but, in truth, a minimal change may be life-changing for patients. Our Health Economics and Outcomes Research teams have worked hard to understand from a patient’s perspective, what is meaningful for them in their daily lives by understanding the patient journey. We are now getting deeper and deeper into what that patient journey looks like for these patients.”