We live in the era of information and data, where collecting additional evidence to continue demonstrating the value and benefit of therapies over time has become second nature in our industry – almost. And while we have been doing this for years to an extent, two milestones have propelled this more recently: a culture shift dictated by the broader industry from “nice to have” to “need to have”, and the availability of more sophisticated solutions (incl. digital tools) that allow us to collect such information at scale and help us unlock its true value.

It is hard to pin exactly when the first systematic exercise of RWE collection in pharma started, but the booming RWE solutions market now spans therapeutic areas, with Oncology specifically accounting for a quarter of the market in 2020 and projected to double to USD 560.5m by 2026 (leading with approx. 60% of the US market alone)! However, RWE solutions in Oncology have focused primarily on the R&D phase of therapies, with solutions augmenting clinical trials and data curated to support regulatory filings.

The impact of RWE across the value chain encourages the use of broader solutions

From a pure pharma perspective, RWE can bolster all aspects across the traditional value chain, from R&D (e.g., Merck & Pfizer used iKnowMed EHRs in trials to expedite Avelumab’s development and approval), to Market Access (e.g., Pfizer & Flatiron utilizing RWE, EMR and insurance claims to support Palbociclib’s label expansion in a new patient segment in less than 1 year) and ongoing Commercial Positioning (e.g., how can real-world OS values differ from clinical trials and what does this mean for therapies?). From a stakeholder view patients, physicians, insurers and pharma/solution providers become a lot more involved in the process feeding into the idea of overall therapeutic value itself.

If everyone is getting more convinced of RWE, what is hindering us from more broadly implementing this? Firstly, certain infrastructure and organizational readiness is required to generate good quality and meaningful data, deal with the amount of RWE we are generating and use it purposefully. A second consideration is the lack of strategic investment from pharma and RWE providers together to come up with sustainable, long term solutions. And finally, we should not ignore entrenched behaviors from all stakeholders involved that may inhibit the broader adoption of RWE (e.g., lack of data reporting, reliance on traditional metrics and “live” assessments etc.).

The maturing RWE environment holds promise @Eradigm

Digital and data analytics have certainly helped advance the field of RWE and given rise to dedicated RWE solutions providers (e.g. Aetion, Canopy), who have been attractive partners to Top Pharma eagerly seeking to integrate novel solutions in their portfolios (e.g., Merck with Ontada; Roche with Fitterly; Takeda with TriNetX).

In parallel, we have been witnessing an industry-wide shift to establish cross-disciplinary collaborations (e.g., RWE Alliance, ORIEN) that aim to advance the use of RWE and more closely engage with regulators and policymakers alike, to establish guidelines around the use and impact of such data on treatment access and value. Some outcomes? Increased PDUFA requirements and discussions among the FDA to refine guidelines on data quality and the use of RWE by Pharma within Oncology, and increased receptiveness of payers, even in the US, to integrate RWE in their discussions and formulary decisions (e.g., CVS with Tempus).

In this evolving setting, a key consideration arises: how do we prioritise opportunities and include them in our strategy?

Keeping up: ways to stay ahead of the RWE game

Pharma players are approaching their RWE footprint from different angles (RWE tool development, R&D acceleration, national registries, and reimbursement solutions etc.), but with increasing pressure from the overall field and different stakeholders, the stakes are higher to get it right and drive true change. And while there are numerous discussions out there on this, here are some quick thoughts:

  • Start early within programmes, indication areas or markets with multidisciplinary teams discussing the data and its use
  • Invest in RWE capabilities across the pharma value chain that support the lifecycle of therapeutics
  • Focus on solutions that integrate a variety of data
  • Adopt dynamic and market-specific strategies that are frequently revisited
  • Establish a RWE-mature organization with the appropriate culture shift, executive level buy-in and dedicated roles, budget and long-term strategies