Integrated evidence has become a critical function within the pharmaceutical industry, as manufacturers focus their efforts to gather and disseminate the most critical evidence to prove the value of their products. We’re seeing definite progress in integrated evidence strategy, planning, generation and dissemination. That’s cause for optimism but we’re not at the point where everyone is fluent yet.
While the pharmaceutical industry has taken meaningful steps to elevate the proof points supporting the value of their medications, advancements have been inconsistent so far. It’s like learning a foreign language: Knowing the alphabet is a good start. But the ultimate goal is to master the new language and eventually be prepared to speak with all types of people, regardless of their dialect. That’s where we believe integrated evidence needs to go.
Pharma organizations have a siloed structure, which benefits them in many ways—for example, in gaining a deep understanding of customers across healthcare verticals or in developing deep research expertise. When it comes to integrated evidence, however, this siloed structure leads to a lack of transparency, collaboration and communication. This doesn’t work well at a time when proof points are becoming increasingly more important. The pharma companies that have a sharper integrated evidence strategy can better create, validate and share evidence that differentiates their products, helping their customers make more informed decisions that lead to better outcomes for patients.
If you’re looking for a reason to rethink your integrated evidence capability, here are three:
- Everyone is asking for proof. Stakeholders across healthcare want more proof of what works, when, for whom and how. Whether it’s in a clinical setting or across the dinner table, providers, patients and payers are asking more questions about the evidence behind these products. At the same time, regulators and health technology assessments (HTAs) are coming out with guidelines for different ways to show proof and create new pathways to regulatory success.
- Competition is rising. All pharma companies are working in a more competitive environment. This has historically been true across general and specialty medicines and is becoming increasingly true in oncology and rare diseases. Even emerging treatment areas, such as cell and gene therapies, pose new challenges that require thinking differently. The fact is that every focus area could use more proof points that demonstrate how their products are unique.
- Precision is paramount. Because we are defining diseases in a more-granular fashion, it’s vital to foster an understanding of how specific products will be effective for subsets of patients sharing unique characteristics, such as cancer patients with a BRCA2 gene mutation. Offering personalized treatments and improved outcomes, precision medicine can displace a one-size-fits all approach. However, it’s up to the pharma industry to educate the healthcare community about the evidence that helps everyone understand these more-precise patient populations and the products in development to treat them.
As customers’ lines of inquiry grow more sophisticated, they become more knowledgeable and empowered to access the information they’re looking for. What a great opportunity to rise up and meet them by delivering the proof points they want—when and how they want them.
The pharmaceutical industry has a unique opportunity to get better at enhancing its value propositions with compelling evidence and to make this a priority now. In a webinar ZS led with Reuters, the industry leaders who participated identified risk and innovation, internal alignment and effective dissemination as the top three gaps in their organizations when it comes to their integrated evidence capabilities (see figure 1). Through our conversation, we took a deep dive into what ZS and our panelists are seeing across each of the areas that are presenting challenges and covered what is needed for integrated evidence strategies to succeed.
Risk and innovation are not optional. This key success factor for improving the integrated evidence capability is not a matter of “if” but “when.” Those who hesitate to explore new methods to generate evidence, who play it safe from the sidelines while others take risks and innovate, are being left behind.
Not only does the industry need to invest in new types of data such as genomics, imaging and patient-reported outcomes (PROs) to create new types of evidence, but it also needs to explore direct-to-source methods with providers and patients.
Data alone will not yield evidence, said Zsuzsanna Devecseri, Sanofi Genzyme’s vice president and head of global oncology medical affairs, who spoke as a webinar panelist. “To generate evidence, you need to ask the right scientific question and know the right scientific hypothesis to test.” Using innovative tools and research methods to better understand existing data and generate new types of data is the path forward. “If these two could link together,” she added, “then we will probably be much more successful answering clinical questions for physicians and patients.”
Within clinical development, companies need to introduce innovative research methods designed to reduce time to market and enhance overall evidence, including but not limited to single arm trials, basket trials and pragmatic trials.
In observational research, companies need to be more comfortable generating and disseminating brand-level evidence, moving away from low-risk strategies such as patient and class-level evidence. The healthcare industry is ready to embrace broader application of real-world evidence (RWE) as a method to generate observational research. ZS’s 2021 RWE benchmarking study suggests that the pharmaceutical industry is making strides in this effort, with more than 60% of pharma organizations polled by ZS reporting that they have significantly enhanced their analytical skills, tools and platforms to support RWE. Yet 54% still struggle to expand RWE use cases, due to lack of standardization and prioritization.
Accepting—indeed, embracing—risk to explore new ways to generate truly differentiated evidence will separate the leaders from the laggards. Whether it’s a push for objective or long-term end points, a view on comparative effectiveness or a novel type of research, the regulatory agencies, HTAs and other customers are already asking pharma to take these risks.
No one denies the lack of transparency and communication about proof points is a byproduct of pharma’s siloed approach to engaging customers, but this challenge is not insurmountable. Over the past five years, the industry has been creating cross-functional integrated evidence planning (IEP) teams to tackle this issue. In ZS’s medical affairs outlook report, 82% of respondents reported having an IEP process at their company, with 25% of these processes led by medical affairs. Looking at other ZS clients, we see a variety of global product and portfolio teams, value and access teams, RWE and Health Economic Center of Excellence (HEOR) teams taking the lead in IEP.
With proper governance models, cross-functional teams, new roles and processes, organizations can align internally on the most important evidence, collaborate better and begin to introduce integrated evidence earlier in the clinical development cycle.
“This idea of working cross-functionally is non-negotiable. It’s not optional,” said webinar panelist Chris Boone, AbbVie’s vice president and global head of health economics and outcomes research. Governance is critical to leverage great volumes of external evidence data now being collected in new ways, including via patient wearables.
Boone said his company’s Health Economic Center of Excellence (HEOR) helps AbbVie engage external groups, payers and providers on collaborative research.
Starting too late in the clinical development process can create downstream issues that significantly hamper the true opportunity for products to help patients. At ZS, we recommend the proof of concept stage, or where value is first proven for the asset, as the right starting point for pharma to determine its appropriate proof points and begin its integrated evidence journey. This can include early evidence around disease burden and unmet needs, biomarker identification, and alternative trial designs featuring enrichment strategies and pragmatic trial approaches.
Devecseri echoed this point when speaking on the webinar panel. “We start right after proof of concept, when you really have a clear understanding of how the development program will look,” she said. “And then, you can identify the key evidence gaps,” drawing on input not only from internal cross-functional teams but from external stakeholders as well. “I’m so proud that Sanofi includes the patient’s perspective and the patient’s voice, in the development program.”
Ready to reinforce these mindset changes are powerful new digital tools that will help drive transparency across the organization, reduce what are currently very labor-intensive processes, and generate access to the right data. These tools will help pharma teams identify gaps, avoid redundant efforts and prioritize the right studies.
The third key success factor in winning with evidence requires stretching beyond traditional information-sharing practices to ensure the full scope of evidence-related benefits is not only conveyed but understood.
“There’s really no value in us generating all this evidence if we can’t effectively disseminate it to the right people at the right time,” said Debbie Drane, CSL Behring’s senior vice president of global commercial development, during the webinar.
Dense literature laden with footnotes, scientific posters, peer-reviewed articles and endless tables of data all have their place, but the urgent need now is a compelling “story.” This is not a sales pitch but rather an objective, customized narrative that frames evidence in bite-sized, user-friendly ways that payers, providers and patients can understand based on their specific needs and within the context of their own role.
Michael Aboud, VP and global franchise medical head at ViiV, raised this issue in the webinar and said, “I believe that we should have a narrative about our data…if we invest the time and money in generating robust, compelling data, we should also say what do we think this data says.”
This requires evolving traditional research dissemination (and generation) methods so that they are more nimble, giving organizations the agility to engage with customers using more dynamic evidence insights that are actionable. In support of these changes, organizations should introduce novel field training approaches, including immersive experiences and gamification, to make sure their teams can effectively communicate these evidence-based narratives.
Developing a sophisticated integrated evidence capability will require new types of proof points and data, enhanced internal collaboration and transparency (often through digital solutions), and more actionable dissemination of evidence. The industry must make these advancements, as stakeholders across the healthcare ecosystem are saying it’s time to get better with evidence to advance pharma’s value propositions.