Amgen Resolves Repatha Access Kerfuffle With Express Scripts

On eve of congressional hearing, the pharmacy benefit manager assures Amgen that Repatha is available to its employees.

A skirmish between Amgen Inc. and Express Scripts Holding Co. over whether Amgen employees have formulary access to the firm's own PCSK9 inhibitor,  Repatha, underscores the point pharmaceutical sponsors have been making during the current drug pricing debate: that the current rebating system is complicated and doesn't necessarily produce the lowest prices. But it also underscores the point that pharmacy benefit managers have been making: that what sponsors are doing and saying about prices won't necessarily bring costs down either.

The Repatha conflict came to a head the day before a congressional hearing on Rx drug prices and the supply chain. After the House Energy & Commerce's Health Subcommittee posted the prepared testimony of Kave Niksefat, Amgen VP and head of US value and access, Express Scripts objected to Niksefat's claims that it was not allowing Amgen employees to receive Repatha (evolocumab).

Rep. Janice Schakowsky, D-IL, revealed the controversy during the 9 May hearing. She questioned Niksefat's assertion in his original testimony that Repatha is unavailable to Amgen employees because of a multi-year agreement with its pharmacy benefit manager that favors high rebates.

"One hour after learning that, your PBM, Express Scripts, planned to call that statement 'flat out false,'" Schakowsky said.  "It's just unacceptable that you were willing to tell a falsehood in your official congressional testimony today before you were called out."

Niksefat replied that Amgen's benefits team "received clarification after months of discussions late yesterday and we corrected the testimony to ensure that it was accurate."

An Express Scripts spokesperson said the PBM did not make any contract changes and that Amgen changed its testimony when it learned what it submitted was incorrect.

"There was an honest misunderstanding between Amgen and Express Scripts about whether our employees have access to the lower-list-price option of Repatha," Amgen told The Pink Sheet. Amgen spoke with Express Scripts the day before the hearing, "resolved the confusion, and submitted revised testimony to reflect those discussions."

Formulary Hurdles

During the hearing, Niksefat said Amgen has had difficulty getting its lowest price option of Repatha on formularies. He said this is at least in part due to that fact that Amgen must compete both on lowest net price and largest total rebate. He said the lower list price can result in a lower total rebate overall.

In October 2018, Amgen introduced a version of the cholesterol-lowering agent with a new national drug code and a list price of $450 per month, a 60% reduction from Repatha's original wholesale acquisition cost. (Also see "Amgen Drops Repatha List Price 60% To Cut Medicare Co-Pays And Boost Use" - Pink Sheet, 24 Oct, 2018.) 

At a 9 April Senate Finance Committee hearing on drug pricing, executives from Express Scripts and other leading PBMs noted challenges in moving to the lower priced Repatha alternative. (Also see "Senate Panel Questions Early PBM Response To Repatha Price Cut " - Pink Sheet, 9 Apr, 2019.)

In his written testimony, Niksefat said Amgen is preparing to discontinue the original list price option of Repatha by the beginning of 2020. He said that without a transition period, Amgen was concerned that commercial health plans and PBMs would immediately shut off access to Repatha in favor of the other PCSK9 inhibitor on the market that offers a higher overall rebate based on a higher list price, referring to Sanofi and Regeneron Pharmaceuticals Inc.'s Praluent (alirocumab).

Repatha is currently not included in Express Script's national preferred formulary but is an option on several of the PBM's other formularies, including the formulary that Amgen accesses.

During the hearing, Pfizer Inc. cited the difficulties it has had getting its biosimilars on formularies. (Also see "Pfizer, Express Scripts Clash Over Biosimilar Formulary Placement" - Pink Sheet, 13 May, 2019.)