The following are excerpts from remarks that AMCP CEO Susan A. Cantrell, RPh, CAE, delivered during the AMCP Nexus 2016 General Session on Oct. 4.
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…I can’t take much credit, though — I’ve been CEO only since February. No, this is about the entire organization:
● From our dedicated board members to our hard-working volunteer committee members;
● From the AMCP Foundation trustees, with their bold vision, to our founding members and past presidents whose counsel I value;
● From our loyal corporate members to our generous sponsors and exhibitors;
● From AMCP’s amazing staff — as dedicated and talented a group of professionals as I’ve ever worked with — to our 8,000 members, who volunteer, present at meetings, visit Capitol Hill, and most importantly…live and breathe the principles of managed care pharmacy every day.
On the biggest challenges facing manage care pharmacy and the health care system, AMCP is there for you. Let’s take…rising pharmaceutical spending. There’s no denying the dramatic shift in drug spend, as well as the explosion in biopharmaceutical innovation.
According to IMS, total spending on medicines in the U.S. increased 8.5 percent in 2015 — specialty drug spend rose almost twice as fast. Compare that to the projected 5.5 percent rise in overall health care spending. The year 2014 in particular saw dramatic increases: prescription drug spending increased 12.2 percent.
So what is AMCP doing about it?
AMCP today is a leader in trying to change the conversation ― from one focused on cost to one about value. Sometimes the newest, most innovative and most expensive medicines deliver the most value. And sometimes older therapies do. We believe value should play an important part in choosing which medications to use and ensuring the wise use of our health care dollars.
● AMCP is a leader in promoting post-market surveillance — through BBCIC — and the use of real world evidence to measure value.
● Since 2010 the AMCP eDossier has given formulary decision makers the research, reviews and tools to make informed, evidence-based decisions.
● And since 2000, the AMCP Format for Formulary Submissions has provided a framework for manufacturers to share information about safety, efficacy and value.
More recently, AMCP has truly been in the thick of things.
In a value-based world, information — of the “competent and reliable scientific” kind — is the coin of the realm. In particular, health care economic information. It allows managed care pharmacy professionals to measure the value of medications and identify the most appropriate ones for patients. We need a process whereby biopharmaceutical manufacturers — which often have this information — can share it with population health decision makers.
This is where section 114 of the Food and Drug Administration Modernization Act (FDAMA) of 1997 comes in. This section was intended to create that process, but it has never been fully implemented.
Whether you say “fa-damn-uh” or “fa-dahm-uh” — ya’ know, like “to-may-toes, to-mah-toes” from that old Gershwin tune — it doesn’t really matter. We’re not going to “call the whole thing off,” as the song goes. Quite the contrary, AMCP is all in:
● Last March a stakeholder forum convened by AMCP produced consensus recommendations on improving and updating Sec. 114.
● During that forum another consensus emerged about access to clinical and economic information: payers need manufacturers to share this information earlier in the process so they can build it into forecasting and premium calculations.
● So three weeks ago AMCP again gathered stakeholders to develop recommendations on sharing off-label economic and clinical information for medications prior to FDA approval.
Separately, AMCP is advocating for clarification and responsible expansion of Section 114 here in Washington, DC. Later this month AMCP will brief congressional staff on these recommendations and possible legislative options. And in November AMCP will be presenting these recommendations to the FDA during its public hearing and comment period.
“Compared to other associations I work with, AMCP really knows how to get things done.” I really like the sound of that.
“AMCP really knows how to get things done.”