Let’s imagine you’re a big city mayor and it’s time to order a new fleet of police cars for next year. Applying due diligence, you set out to compare various models from a variety of manufacturers. You’ll want to look at new safety features and advanced technologies as well as basic vehicle specs, such as miles per gallon. And, of course, you want to know how much the vehicles will cost the city.
Now let’s say all of this information is very difficult to obtain. Your staff has to send separate and specific requests regarding each item, i.e., the brakes, the bumpers, the windshields, the seatbelts, the MPG, and how much next year’s models are expected to sell for. Complicating matters, you have to track down different executives to get each query answered…and if you forget to ask about the brakes, no one will tell you about the brakes!
Thankfully, researching automobiles is straightforward because manufacturers can proactively share this information with consumers on their websites, so you can do a side-by-side comparison. Not so with new pharmaceuticals coming to market.
The above scenario could well describe the work that population health care decision makers engage in every day when trying to determine the value of therapies already on the market. It’s even tougher to find information on products moving through the Food and Drug Administration (FDA) pipeline. Currently the sharing of clinical and health care economic information on products awaiting approval is significantly restricted by federal laws and FDA regulations.
The result is that decision makers face major hurdles in gaining product information right at the moment they need it the most: a year and a half out, during the forecasting and rate-setting process for the upcoming coverage year.
To address this dilemma, AMCP has taken the lead in advocating for the creation of a safe harbor to provide such information. Our recommendation for a Preapproval Information Exchange, or PIE, would allow biopharmaceutical manufacturers to proactively share clinical and health care economic information on pipeline medications with population health decision makers at least 12-18 months prior to FDA approval.
The recommendation stems from a recent AMCP forum of stakeholders representing managed care, biopharmaceutical manufacturers, academia, providers, health economists, patients and others.
More details: The information would be limited to only a narrow audience of biopharmaceutical manufacturers and population health decision makers. PIE should be limited to only new molecules and expanded indications. The exchange of information under PIE should be bidirectional and continue until FDA approval. And the safe harbor should not be restricted to only clinical or scientific-evidence based information.
Creating PIE would allow population health decision makers to:
● Support more accurate forecasting and rate setting, which enables all patients affordable access to new therapies upon FDA approval;
● Increase the use of value-based payment models by providing sufficient time to implement these models in a timely and effective manner upon FDA approval; and
● Make coverage decisions for emerging therapies granted breakthrough designation immediately upon FDA approval.
AMCP has been a leader in this space and already has an established process for communicating information on marketed biopharmaceutical products to decision makers. This process, the AMCP Format for Formulary Submissions and its online AMCP eDossier System, could be adapted for PIE. The full recommendations were published in the January 2017 issue of AMCP’s Journal of Managed Care & Specialty Pharmacy (www.jmcp.org), and can be accessed at http://bit.ly/PIEproceedings.