CRT: How will generic clopidogrel affect U.S. antiplatelet market?
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WASHINGTON, D.C.—While the introduction of generic clopidogrel will undoubtedly impact the selection of antiplatelet drugs for patients with acute coronary syndromes (ACS), an expert panel at the Cardiovascular Research Technologies (CRT) meeting on Feb. 5 discussed considerations impacting those decisions, as well as the slow uptake of third-generation antiplatelet agents.

The forthcoming introduction of general clopidogrel to the U.S. market will have a “substantial impact” on the U.S. antiplatelet market, said David J. Cohen, MD, of St. Luke’s Mid America Heart Institute in Kansas City, Mo. Looking to the European market, which already sells the generic agent, clopidogrel is the dominantly used agent.

“Currently, brand name clopidogrel is the dominant agent in the U.S., but cost doesn’t enter the mind of U.S. physicians because all the agents are priced fairly similarly,” Cohen added. “However, once there are multiple generic alternatives to clopidogrel and the price is greatly reduced, the lower co-pays will lead the patients to request the cheaper version. When this occurs, our patients will start to ask us why we are prescribing the more expensive prasugrel [Effient, Eli Lilly/Daiichi Sanyko] or ticagrelor [Brilinta, AstraZeneca].”

This will make physicians think even more carefully about the benefits of these newer drugs, and whether they can justify its prescription, he added.

With the reduction in mortality with the third-generation antiplatelet options, the cost per year-of-life results saved are strong, said Cohen, but the mortality benefit is ultimately a decision for health insurance companies to decide whether it is worth covering the drugs.

Most insurance companies are willing to stomach $30,000 per year of life saved, noted C. Michael Gibson, MD, of Beth Israel Deaconess Medical Center in Boston.

“Ticagrelor comes in very favorably based on that figure and its proven mortality benefit,” Cohen commented.

Speaking to the mortality benefit with third-generation antiplatelet drugs, Ron Waksman, MD, of Washington Hospital Center in Washington, D.C., questioned why their uptake in practice has been so low—especially when compared with the rapid uptake of dabigatran (Pradaxa, Boehringer Ingelheim).

Pharmacy benefit managers are driving many of these considerations, said Gibson. For example, by placing ticagrelor into a tier 3 pricing structure, which requires the full co-pay, they match the price of the patient’s co-pay for clopidogrel.

“Clinical practice isn’t always driven by what clinical trialers and academicians [say] are important,” said Cohen, who exemplified the uptake of clopidogrel in the late 1990s. “Efficacy didn’t drive this decision to uptake; it was about side effects and convenience—once a day, as opposed to twice-daily. This is similar to Pradaxa vs. warfarin decision.”

Waksman asked whether a clinical trial comparing prasugrel and ticagrelor could potentially impact the practice.

“Because we’re not sure of the outcome, it’s almost imperative that this trial takes place,” said E. Magnus Ohman, MD, of Duke Health System in Durham, N.C. “It needs to be a large, simple trial, including about approximately 20,000 to 30,000 patients.”

Most of the panelists agreed that this trial is important from a clinical standpoint, but may be less likely from an industry standpoint because of the costs involved.

“If we follow 20,000 patients for this type of trial at an approximate price tag of $20,000 per patient, this trial would cost a company $400 million to $500 million, and the uptake doesn’t increase, the return on investment isn’t guaranteed,” explained Gibson.

Thus, the panelists agreed that despite its clinical worth, it may not practically occur.