Architects of Value
Dr Ameet Nathwani, Chief Medical Officer at Sanofi, discusses the vital role Medical Affairs is playing in using data to demonstrate value
Proving the effectiveness of a medicine used to be a ‘simple’ case of getting great efficacy data from phase III clinical trials. But the world has changed, as payers demand companies demonstrate the value of their drugs. Now, with more than two-thirds of medicines subject to post-approval commitments, along with the explosion in digital and data health, companies are being challenged to continuously prove the value of their medicines across not just one market but all healthcare systems.
The resulting huge quantities of clinical and real-world data in support of reimbursement and continued use of a medicine has seen Medical Affairs skyrocket. Sanofi CMO, Dr Ameet Nathwani has a background in Medical Affairs. “We have to become an agile evidence generating engine,” he told eyeforpharma. “We have to develop the data scientifically, put the data into context for a healthcare system, and, in particular, be able to describe the value in terms of the benefit to patients. All this has become a fundamental skill.”
A continuous learning ecosystem
To maximize the potential of these new pools of data, pharma needs to identify processes to harness real-world evidence (RWE) in order to achieve better research outcomes, says Nathwani. “I’d love to see us move towards a way to continuously develop evidence about our products from research all the way through to end of lifecycle,” he says. “That’s a very big statement but what it actually means is the ability to continually gather and analyze data, to understand its impact and act on the information, to redefine benefit-risk and re-target so that it becomes a continuous loop of action and data. This would be immensely cost-effective and give a high level of precision.”
Proficiency with RWE has become a make-or-break capability for the pharmaceutical industry; if companies fail to build effective RWE-based systems, they risk losing control of the value communication around their own drugs.
The big question, of course, is how to deliver that aspiration. “You know that the benefit-risk at registration is very different to when it’s in market, so how do you do that in a continuous manner and at a low cost?” he asks.“With 70% of our products needing continuous evidence generation, what we don’t want is a situation where we can’t afford to do it. We need to become much more agile and effective in order to develop that capacity.”
Mastering the data
Delivering this level of evidence generation will involve a fundamental overhaul of the R&D model plus a seamless and integrated approach to evidence development that brings together clinical data from randomized clinical trials and, in parallel, patient and outcome-related data from RWE-orientated programs, he says. However, blending this into an R&D and regulatory process early will require some adjustment in the R&D models.
The technological barriers that hindered companies from exploiting this wealth of real-world evidence in the past have mostly been removed, says Nathwani. However, one barrier remains – how to customize evidence to meet regional, national and international regulatory and payer needs. “The FDA is moving towards publishing its patient-reported outcomes (PROs) online; we can leverage those lessons, but it’s really hard to customize evidence for every region, market, regulator and system. What’s frustrating is that, despite ICH (International Conference on Harmonization), the way regulators assess information and data varies. That makes it very difficult for an industry that’s trying to find a cost-effective, global solution. It would be wonderful if regulators and payers could agree the relevant outcomes for a given disease, especially where there is a difference between what regulators and payers want. However, I’m not convinced that this level of convergence will happen soon without agreement with scientific societies, patient groups, payers and regulators early on during the development of a new therapeutic.”
Reimbursement will increasingly hinge on RWE, real-world evidence, with payment for medicines dependent on real-world impact for patient groups, says Nathwani. “Proficiency with RWE has become a make-or-break capability for the pharmaceutical industry; if companies fail to build effective RWE-based systems, they risk losing control of the value communication around their own drugs,” he says, adding that other stakeholders, such as payers, data analytics companies and academia are currently enhancing their capabilities. “Building and delivering the required capabilities is the work of Medical and it will place Medical Affairs in a strategic position as real ‘architects of value’.”
The key question is, does the data offer new insights? “If you look at what comprises real-world evidence, it has so many components. Who is mastering the ability to take unstructured data – internal, external, competitive – and bring it into a database with ‘predictalytics’ (high-level predictive analytics) to predict outcomes? To experiment with that, we need to develop a brand new capability, a science, a statistical methodology, an analytic capability, a precision around it,” he says. “This isn’t just taking data from claims databases and turning it into a valuable position after the product is available. This is a fundamental shift in the way that you construct your value proposition from the outset. The role of Medical is going to be key because you need to precisely document outcomes, measuring on a continuous basis and ensuring that you understand all the levers and drivers for these outcomes and the value drivers as well.”
Communicating the value story
The onus is on pharmaceutical companies to overhaul their evidence generation model so that it delivers integrated, rapid-response evidence development across the full life cycle, says Nathwani. Clear communication and the active dissemination of evidence to all relevant audiences in a timely, easy-to-understand, user-friendly, cost-effective way will play a critical in communicating the value story.
He sees room for innovation. “Today, as an industry, we send tens of thousands of physicians to congresses, but is that the model of the future? We need to look at a scenario where the data from congresses is streamed to physicians in an appropriate manner at their desktops with natural language programming, translations, etc. so they get the information in a timely manner where it’s relevant to them, where they can interact with it, engage with it. The world of transporting people to receive the latest scientific data will become obsolete, if the trends we see in the appetite for consuming scientific content online continues,” he says.
With the breadth and depth of RWE data growing at an exponential rate, we are only scratching the surface of its value. While the industry is in agreement about the value of RWE, the question remains: Will companies be able to fully leverage the available data in order to drive better patient outcomes? The time is right to invest in a Medical Affairs organization capable of creating a strategic competitive advantage.
A dreamer, like a good architect, sees the vision of a ‘new normal’ and strives to make it happen, and Nathwani is determined to dream big. “My job is to push the frontier, to show the way forward. Once you demonstrate some quick wins that really add value to our patients, it’s easier to get people on board.”