AMCP Forum on Cholesterol Management Urges Use of Proven Therapies and Management Strategies for PCSK9 Inhibitors

 Alexandria, Va., March 30, 2016 — Patients with high cholesterol should use proven and less expensive therapies, such as statins, before trying the new and more expensive class of specialty cholesterol drugs known as PCSK9 inhibitors, according to recommendations published in the April 2016 issue of the Journal of Managed Care & Specialty Pharmacy (JMCP). 

The document also calls for developing management strategies that ensure PCSK9 inhibitors are targeted to patients who would derive the greatest benefit.

The recommendations stem from a Sept. 16, 2015, Academy of Managed Care Pharmacy (AMCP) Partnership Forum titled “Driving New Advances in Dyslipidemia Management.” The event gathered more than 40 experts from health plans, pharmacy benefit management companies, specialty pharmacies and medical societies to suggest modifications to current treatment guidelines for dyslipidemia (e.g. high cholesterol) in light of the new PCSK9 inhibitors coming to market.

The forum proceedings containing the recommendations can be accessed at or by clicking here.

“It’s important to use new therapeutic advances in the most efficient manner possible,” says AMCP CEO Susan A. Cantrell, RPh, CAE. “The combination of a prevalent chronic condition with new expensive treatment options makes it imperative that health care decision makers have the long-term clinical, financial and real-world information they need to fully evaluate the value of drugs.”

The proceedings document notes that the long-term clinical benefits of PCSK9 inhibitors are not yet fully elucidated, creating a complex situation for third-party payers who must determine how to allocate limited resources.

Forum participants suggested that prior authorization requirements for PCSK9 inhibitors could support the goal of ensuring proven therapies such as statins are first fully utilized. Participants also recommended greater collaboration and improved information sharing among stakeholders, as well as increased collection and evaluation of real-world evidence, and use of cost-effectiveness analyses.

Looking ahead, participants called for the development of a national database to gather more meaningful data regarding the impact of specialty medications like PCSK9 inhibitors on clinical outcomes. Such a database would be invaluable for determining the real-world impact of specialty medications, and would support the development of sensible third-party payer benefit structures, coverage decisions, medical policies and risk-sharing contracts.

The forum was sponsored by Lilly USA, LLC, MedImpact Healthcare Systems, Inc., Merck & Co., Inc., PerformRx, Pfizer Inc. and Sanofi.

According to the Centers for Disease Control and Prevention, 73.5 million adults — or more than 31 percent of adults in the U.S. — have high levels of LDL, or “bad,” cholesterol. Current guidelines to treat the disease were created before the arrival of PCSK9 inhibitors, which are now coming to market. A February 2015 Health Affairs article estimates the new PCSK9 inhibitors could add $200 billion to annual health care spending.