Silver Spring, MD – For the first time in 20 years, The FDA has issued new draft guidance on how pharmaceutical companies can communicate healthcare economic information (HCEI) with payers. This changes the how, but not the kinds of information that can be shared. Pharmaceutical companies can still only share approved indication information.
The guidance works to clarify the following (but not limited to):
- How to prepare HCEI
- What parties are approved to share HCEI
- Examples of analysis
- What supporting information
Now, payers are demanding an integrated approach. They don’t want to talk to a commercial account manager one day, and then a medical-science liaison the next day, and the field healthcare economic and outcomes information liaison another day. They want an integrated singular representation, and this guidance can accelerate that change. This can be a net positive for industry if they embrace it and update their ways of working. – Peter Weissberg; Group Director of Market Access with Intouch Solutions
Why This Matters:
Anytime an organization gains an update within their guidelines after 20 years is a great accomplishment. However as organizational guidelines are brought up to speed, it can also translate into more hurdles and burden on reporting and auditing needs. As marketers in the pharmaceutical space, we need to be diligent on helping drive content strategies that allow ease of monitoring. It will also be interesting to watch what doors this opens within the payer world to help drive better patient care and centricity.