What is RWE?  

Real-world evidence (RWE) is the clinical evidence regarding a drug or diagnostic based on real-world data from clinician and patient use. It can be created by assessing health data from many sources, including electronic health records, patient chart information, and digital health applications. 

Why is RWE important?  

RWE may be more helpful than clinical trial data because it better reflects the tendencies of diverse patient populations in a typical healthcare setting. Simply put, different types of patients may have varying outcomes from therapy. This uncertainty can make population health decision makers uneasy about the benefits and risks of a drug after launch. Using RWE can effectively demonstrate the real-world value of a treatment for population health decision makers, HCPs and patients. 

Going digital can help add a real-world element to clinical trials.

Applications and digital devices can provide data by instantly capturing many health parameters and outcomes in real-time. “Since 2016, the percentage of trials using connected medical device technologies doubled and is now 8%, with 10% of Phase II and III trials now including connected devices.”  

Incorporating digital applications and biomarkers into clinical trial designs may accelerate trial timelines and remove selection biases such as location with remote monitoring, allowing clinical trials to reflect real-world patient populations better.  

Are digital health applications and devices covered by insurance?  

Payer coverage of digital health apps and patient wearables is not a given, but interest in determining appropriate reimbursement is increasing. Some large payers have built digital formularies and are analyzing the value of several commercial reimbursement models. Centers for Medicare & Medicaid Services (CMS) has been slow to establish formal policies for digital health devices, but policies are pending.  

What does this mean for you? 

Because RWE and digital health applications can help communicate the value of therapies beyond highly controlled clinical trials, there is a need for pharmaceutical companies to get this information into the hands of population health decision makers. Legal and regulatory hurdles surrounding the publishing of RWE mean that these companies must find innovative ways to effectively disseminate information. 

The right partner can work with pharmaceutical companies to recommend tactics and solutions that ensure population health decision makers have access to the appropriate RWE for therapies to provide the proper care for their patients.  


About the Author:

Sara Rubin has over 19 years of pharmaceutical experience, with a focus on brand strategy, launch readiness, market access, and account manager strategy and initiatives. She’s led market access work in areas such as contracting, pricing, distribution, and market research, and helped develop strategic programs including value-based contracts, launch readiness plans, and payer value messaging. Sara has in depth experience in specialty and rare diseases, as well as a background with medical/Part B and pharmacy/Part D drugs. As a Managed Markets Strategist, Sara is focused on providing subject matter expertise to support both in-market and pre-launch brands to develop market access plans for population health decision makers.

Prior to joining Syneos Health, Sara held market access, marketing, and sales roles on the pharmaceutical side, including 7 years with Solvay Pharmaceuticals and over 6 years with Eli Lilly and Company. Sara led several launches and gained experience in oncology, men’s health, and cardiovascular health.

Sara has spent the last 10 years focused on oncology market access. She led the thoracic market access team at Lilly focused on Alimta and launched Portrazza. Sara has created market access strategies in over a dozen cancer types across solid tumors and hematology.