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Expect More From…Real World Evidence (RWE)!

Writer's picture: Kelly PrymiczKelly Prymicz

Want to improve your members’ health while improving our global health equity? Need to achieve these lofty goals while balancing a plan budget and keeping premiums at a reasonable cost? If it seems like an impossible task given the shortage of time and resources, you’re in luck! The answer is simple. Leverage the FDA’s push for Real World Evidence (RWE) initiatives. RWE provides key safety and efficacy information while broadening the original enrollment population. This crucial information provides what might otherwise have been unknown. RWE gives us the opportunity to examine nuances as to how a drug reacts for a specific age, gender, ethnicity, genetic variables, geographical location, and/or comorbidities. With technological advances and AI capabilities of processing large amounts of these data points, clinicians and future medical developments will have ready access to RWE.


There are numerous ways to contribute, here are just a few ways to get involved:


  1. Promote (and incentivize) clinical trials enrollment after a drug is approved for use in the market. The figure below demonstrates the a significant uptick of available trials. The type of trials are multifactorial, ranging from advocacy groups looking at value and affordability (interventional pharmacoeconomics or IVPE) to conditional FDA approvals based upon completion of further confirmatory trials. A 2024 analysis demonstrates that drugs included in the FDA Breakthrough Therapy programs came to market 23% faster, which creates a gap in practical use knowledge. By promoting the use of RWE trials, clarity for safe and efficacious use can come to light. 

 


2. Reimburse or proactively steer members to providers and health care systems who routinely contribute to the FDA's Sentinel Initiative and MedWatch Online Voluntary Reporting Form or global databases such as EHR4CR | IMI Innovative Medicines Initiative to monitor safety and identify patient trial candidates.

3. Encourage patients to be their own advocates by sharing and tracking their own experiences in real time on platforms such as My Health | PatientsLikeMe or engaging in established advocacy groups for chronic conditions like multiple sclerosis Accelerated Cure Project to rare disease National Organization for Rare Disorders.

 

By educating and promoting RWE, most members, or those they love, can reap the benefits. Outcomes will impact cost effectiveness conversations. RWE fills a gap in the lack of head-to-head trials available. Whether reviewing a rare condition impacting a limited number of patients to widescale conditions such as obesity, RWE deployment is one significant way plan sponsors can achieve their goals of improving members’ mental, physical, and financial health.

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