By Tiffani White
Quick Perspective on Drug and Device Manufacturer Communication with Payors
The Food and Drug Administration (FDA) on January 19, 2017 released the draft guidance Drug and Device Manufacturer Communication with Payors to address common questions regarding firms’ health care economic information (HCEI) with entities (payors) with expertise in the area of health care economic analysis regarding prescription drugs, investigational drugs, and devices before FDA approval. These FDA communication guidelines will increase the transparency of drug firms and payors and positively influence health care economic decisions in a timelier manner moving forward.
In order for the payors to make informed decisions about current and future health care, the HCEI must provide factual and concise information on the drug product. This information will affect drug formularies lists, prior authorization requirements, and the price point of tier drugs. This guidance will dictate future product-related programs to defer cost of prescription drugs and increase the therapies available to individualize patient care once the drug or device receives FDA approval.