The Shift to Value Demands Real World Data

By On
 
 
Once upon a time, all that pharmaceutical companies had to do to get their drugs on formulary was to package their clinical data and convince payers that their products performed better (or better enough) in clinical trials. Contracts were struck and the revenues flowed. For most new specialty drugs, those days are now history. With the average retail price of a specialty drug used on a chronic basis exceeding $53,000 (according to an AARP study), nearly 200 times the average price of generics, payers are demanding that pharmaceutical companies make data-driven, value-based cases before access is granted. Even when payers are convinced, they build stipulations into value-based contracts that require manufacturers to prove that outcomes are being met with their covered lives, or else the pharmaceutical company will face additional penalties or further restrictions.

This all means that the data that manufacturers have used to drive regulatory approval are insufficient for garnering payer formulary access. Companies are being required to prove that their drugs work in the real world – not just within the carefully controlled environment of a clinical study. Across therapeutic areas from osteoporosis to oncology, payers have and are currently using real world evidence studies to define their formularies. Payers want to know how expensive specialty drugs will perform as patients adhere to (or in most cases don’t adhere to) their medications, and outside of the rarified air of a traditional clinical trial.

Equally importantly, payers want to know how drugs affect the most important (and most expensive) health outcomes. Clinical data showing that a drug performed some percentage better than either a category leader or a placebo is now insufficient for new specialty drugs. Instead, payers need to know how health outcomes improved and how effective the drugs were at keeping patients out of the hospital and away from the catastrophic costs.

While it may sound easy, providing this kind of data is far from simple....(to continue reading, visit Electronic Health Reporter).  


For more posts on how digital health tools can impact pharmaceuticals, read:

"Pharmaceutical Companies Need to Jump into the Digital Therapeutics Game. Now." by Jon Chen

"Why the Digital Therapeutics market is poised for epic takeoff" by Ryan Rossier

 

Written By:
Todd Greenwood
Share This Post
Stay Connected


Related Blog Posts

{{ item.name }}

{{ item.meta_description }}

{{ item.full_name }} | |

Join Our Mailing List

Fresh content delivered right to your inbox from us at Medullan.