For those working in or around the pharmaceutical or biologics industry, it is understood that the issues a product faces in coming to market are not confined to the FDA. In other words, while the FDA focus is strictly on the science surrounding a product (most of the time, Plan B being a notable and frankly, shameful exception), the truth is that economic considerations are very important. Those concerned with marketing, communications and product strategy have to understand reimbursement issues.
Today’s reimbursement environment is extremely complex. The issues that a new product faces are multiple and vary depending on several factors such as whether or not it is a first-in-class drug or biologic, alternative treatment availability and current treatment guidelines. You have to understand insurance and how it works and is influenced. And with the advent of the prescription drug benefit, a clear understanding of Medicare and Medicaid, their interaction, and the differences between Part B and Part D.
In that regard, I want to steer you to another blog, authored by Kip Piper. He is a former White House budget office and CMS senior advisor. He also is a former state Medicaid director and state health commissioner. This is his picture, as he says, on a good day.
The Piper Report is an excellent resource for not only learning about Medicare, but for keeping up with changes and outlooks for the future. It is my favorite healthcare blog (other than my own, of course) and it is a good source for continuing education for those working the marketing and communications aspects of drugs, devices and biologics.