As complex treatments are developed for ever-more-targeted patient populations and second- and third-generation therapies challenge first-in-class medications, questions of value are increasingly driving patient access. And rather than Market Access teams working in a silo, Medical Affairs is joining the value conversation. Here MAPS speaks with Annemarie Clegg, Chief Medical Officer, OPEN Health, about the evolving role of Medical Affairs in providing context for payers, regulators and policy makers whose decisions can dramatically affect which patients can access industry innovations, and thus influence the impact of these innovations on patient benefit.
MAPS: Value has always been part of the conversation between industry and payers – why, now, is value getting so much attention?
Annemarie: The last decade saw the development not just of new treatments, but entirely new classes of treatments – think immunotherapy and gene therapies. When you’re a first-in-class therapy or a new targeted treatment for a rare disease, value is closely tied to enhanced efficacy and/or improved tolerability relative to the current standard of care. But now as new agents enter the market, first-generation innovative therapies are no longer the only option for patients. Costs have skyrocketed, but the number of options has also skyrocketed, and in the US and EU, decision-making bodies are starting to take a closer look at cost and value. Now, efficacy/safety is just the cost of admission – you need that to get on the playing field – and when comparing treatments, you have to take into account holistic aspects of the patient experience like the effects on downstream patient outcomes that aren’t always picked up in the duration of a typical registrational clinical trial. The calculation of value becomes a lot more complex.
MAPS: Market Access teams generally sit within Commercial. Why has Medical Affairs become an important collaborator in this space?
Annemarie: The most important trend driving the role of Medical Affairs in value creation is the amount of data needed to support market access, payer decisions and patient outcomes. When you have therapies that are increasingly specifically targeted to smaller and smaller groups of patients, you have that many more value stories. Millions of patients take a drug like Lipitor™. But maybe only 20,000 take the targeted treatment against their kind of arthritis. The science behind these new agents is complex and rapidly evolving; Medical Affairs can help make sense of all the data, and tailor communication plans for the respective stakeholders.
MAPS: But wouldn’t there be less data generated from smaller clinical trials or other studies with smaller patient populations?
Annemarie: It’s not just a one-to-one match between a drug and a patient group. Previously you could come up with one value story for an agent and cover anyone who could take that therapy. Now you have a single agent with multiple indications across many patient segments, each with a different value story. Agents are given differently, to different patients, resulting in different outcomes. And for each of these indications, Medical Affairs is becoming more and more essential in providing context by knitting together elements such as burden of disease, disease natural history, patient-centered outcomes, and real world evidence to create customized value stories for each different patient segment.
MAPS: It sounds like this is forcing Medical Affairs to change the way it does things.
Annemarie: Traditionally, Medical Affairs has been focused on peri- and post-launch. But now it’s no longer Medical Affairs taking the baton from R&D after phase three and off we go; it’s a more holistic, integrated evidence generation plan with Medical Affairs becoming involved earlier on in the product life cycle, contributing to strategy and evidence generation that ultimately supports value demonstration that underpins market access.
MAPS: We’ve heard MAPS members talking a lot about earlier Medical Affairs involvement but not necessarily from a market access perspective. Why does the idea of “value” require early Med Affairs involvement?
Annemarie: I see three perspectives. First, Medical Affairs is a voice at the table that can help integrate insights from the marketplace to shape planning. We’re getting real-time feedback from the field and from Med Info requests, so we understand the gaps – we understand what people don’t understand. Then Medical can bring that voice of patients and patient outcomes to trial design. If we’re going to be making value claims, we need to be measuring those outcomes in trials. Traditionally, R&D would like to have the smallest number of outcomes possible in a trial to de-risk it – really, just safety and efficacy. But to show value, we have to show the holistic impact and to do that, Medical Affairs needs to identify, understand and include the patient voice earlier in the development process.
MAPS: And second?
Annemarie: Secondly, Medical Affairs can bring the perspective of what’s feasible and reasonable in a real-world space – what is it patients and providers really want from a drug not just in terms of safety and efficacy, but in terms of quality-of-life issues that patients see as making a real difference in their lives. Medical Affairs can provide a more holistic, pragmatic view of an agent’s use in the wild.
MAPS: And third?
Annemarie: Because Medical Affairs is out in the world listening to the healthcare ecosystem beyond the organization, it tends to know the challenges a new treatment will face and can help prepare organizational communications to establish the value proposition in a rational, sequential manner. Medical can help craft a communications cascade that strengthens the clinical narrative. Medical Affairs was built on a foundation of relationship management and clear communication, and it remains a key piece here, bringing that level of communication awareness and relational IQ. Medical understands how to communicate to key groups and by being involved earlier, we have the opportunity to drive the evidence generation necessary to support the downstream communication cascade.
MAPS: Back to the practical – how does Medical Affairs actually deliver on these potential benefits to the organization?
Annemarie: I like to think of it in terms of collate, curate and collaborate. We collate data sources, taking together all the clinical data like safety, efficacy, burden of disease, HEOR data, etc. Then we curate the ones that are most important, distilling all these data in a way that is accessible. And then we communicate these data for audiences of patients, payers and providers in a way that’s most useful for market access. More and more, we’re seeing this from Market Access MSL teams – teams within Medical Affairs dedicated to speaking the payer language.
MAPS: The mission of Medical Affairs has always been and remains ensuring that patients benefit from industry innovations. How do you see the value conversation benefitting patients?
Annemarie: You can have an agent that looks fantastic in clinical trials but if you can’t demonstrate the full value proposition for payers to show why they should include it in the formulary, access will be prohibitive and getting the drug will be yet another obstacle for patients already dealing with disease. Ensuring the agent that provides the greatest benefit to patients also has the appropriate level of market access and reimbursement also ensures that patients will be able to take advantage of the best treatments to affect their lives in meaningful ways.