After a rough year for Bayer and Johnson & Johnson's anticoagulant Xarelto, the companies hoped the competition would take it easy in 2019. Pfizer and Bristol-Myers Squibb's Eliquis had other plans.
After totting up a 23% share of the field in the first quarter of 2019—the same share as 12 months ago—Xarelto continues to fall behind Eliquis, which gobbled up a whopping 39% of the warfarin alternative market in the first week of April, Credit Suisse analyst Vamil Divan wrote in a Monday investor note. And that follows a first-quarter sales report showing Xarelto's increased list price was offset by discount pressure and competition, Divan noted.
With Eliquis expanding, what's going on with Bayer and J&J's declining blockbuster?
Divan said Xarelto has been the continued victim of aggressive U.S. price discounting and increased competition in recent years, a one-two punch that has offset the drug's increased price. Part of that discounting frenzy has been tied to a 2018 Medicare policy change that has kept sales revenue low.
Sales of Bayer and J&J’s blockbuster warfarin alternative have flagged for six straight quarters while sales of Eliquis, which now boasts a 39% share of the market, have continued to grow. A third competitor, Boehringer Ingelheim’s Pradaxa, sits in third place with 3% despite being first to market.
In the week ending April 12, Xarelto reported more than 204,000 total prescriptions compared with nearly 343,000 for Eliquis. That equated to a roughly 5% drop in scripts week over week for Xarelto, according to IQVIA.
With competition stiffening for anticoagulants, aggressive U.S. discounting has knocked Xarelto for a loop, leading to stagnant growth projections from J&J, which called 2019 a “trough year” in an earnings call with investors last week. In the first quarter of 2019, the med’s sales slipped 6.3% to $542 million.
That drop is partially tied to a recent change in federal law known as the “donut hole” provision, which requires drugmakers to offer significant discounts to Medicare Part D coverage. Divan said the donut hole manufacturers’ discount will step up as high as 70% starting this year.
To counteract flagging sales, J&J has eyed Xarelto label expansions, but Divan said the effects of new indication approvals on the company’s sales would only be felt over the long term.
In October 2018, the FDA approved Xarelto’s use in coronary and pulmonary artery disease (CAD/PAD) that analysts said could rake in an additional $1.5 billion per year. However, Divan said the company was preaching patience with Xarelto’s expanding label, arguing that blockbuster sales in CAD/PAD could take years to materialize.
Chasing new indications is nothing new for Xarelto, and the CAD/PAD win follows a pair of major flops for the drug in blood clot and heart disease trials in October 2018. Despite less-than-rosy results in those trials, J&J continues to hold out hope Xarelto could earn an approval in both categories.
Prior to those hiccups, Bayer stopped a separate Xarelto trial in 2017 after treatment of stroke patients showed few benefits above aspirin for prevention of a second stroke or embolism.