A Blog by AMCP CEO Susan Cantrell



Making PIE to Better Serve Patients


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.

Susan A. Cantrell, RPh, CAE is CEO of the Academy of Managed Care Pharmacy 


Century Cures Act Advances AMCP's FDAMA Goals, Improves Value-Based Communications Between Manufacturers and Managed Care Pharmacy


December 22, 2016 

Who says Congress can’t get anything done…and with bipartisan support to boot? With impressive speed and purpose, the House and Senate overwhelmingly passed the 21st Century Cures Act in the waning days of the 114th Congress, followed by President Obama’s prompt signature. ... Read more 


Pharmacy Profession Comes Together to Help Document and Improve Patient Outcomes Through Medication Therapy Management


November 7, 2016 

People can accomplish remarkable things when they work toward a common goal. That’s what happened recently when a diverse group of pharmacy stakeholders gathered to develop standardized terms for medication therapy management (MTM) services. ... Read more 


AMCP really knows how to get things done!


October 13, 2016 

Not long ago a respected individual in the health care arena told one of my senior staff: “Compared to other associations I work with, AMCP really knows how to get things done.” You cannot imagine how proud I felt ... Read more 


AMCP Volunteers Are a Happy Lot


September 20, 2016 

There are many ways to measure the health and vitality of a professional association. The most crucial indicators, I’ve found, center on the engagement of an organization’s volunteers. This can be measured in the number of volunteer opportunities provided, the number of members who sign up, and the level of satisfaction they get from volunteering. ... Read more 


The Post Cites Pharmacists’ Expanding Role on Medical Teams


August 26, 2016 

Last week I saw a headline that jumped off the page: “America’s other drug problem: Giving the elderly too many prescriptions” (Washington Post, Aug. 15). I couldn’t read it fast enough and encourage members to do likewise, as it highlights two of the most important developments in health care. ... Read more 


Seizing Opportunity: AMCP Nexus 2016 Offers Knowledge, Advancement and More


August 3, 2016 

“Healing is a matter of time, but it is sometimes also a matter of opportunity,” said the great Hippocrates, father of western medicine.

Opportunity, in fact, is a crucial element in the work that managed care pharmacy professionals engage in every day to improve the health, wellbeing and “healing” of millions of patients. We seize opportunities to find the right medicines for the right patients at the right time. ... Read more 


BRC Now Lets You Look It Up


July 13, 2016 

It was only ten years ago when biosimilars were so new that the New York Times described them as “so-called.” As late as five years ago newspapers put quotation marks around the term, as in “biosimilars.” At the time some still called them “follow-on” biopharmaceutics. ... Read more 


Is FDAMA Section 114 Finally Ready for Prime Time?


June 24, 2016 

Information is the life blood of managed care pharmacy. Of the “competent and reliable scientific” variety, that is.

Our profession operates best when we have broad access to the latest evidence-based data on the multitude of products coming to market today. We can plan, we can assess. With this information, managed care pharmacy professionals can help health care providers and patients select the right drug for the right patient at the right time, while making appropriate use of our scarce health care dollars. ... Read more 


Getting it straight with the updated AMCP Format!


May 19, 2016 

Using the best evidence possible to make informed health care decisions is a hallmark of managed care pharmacy. But making sense of the data often is no easy task, especially when it comes to analyzing pharmaceuticals and the value they bring to patients and the health care system... Read more 


CEO Susan Cantrell Addresses AMCP Annual Meeting


May 10, 2016 

New&Views announces a new monthly column by CEO Susan A. Cantrell, RPh, CAE, on breaking news and critical issues. Her first column presents her recent address―her first to the membership―at AMCP’s recent Annual Meeting.

“It is truly an honor to be standing before you today as the Academy’s new CEO. While new to the AMCP staff, I’ve been an observer and at times a participant in the terrific work of this organization. ..." Read more.