Sanofi Sues Mylan, Claims EpiPen Maker Used Price Hikes, Rebates to Shut Out Competitor

The pharmaceutical giant Sanofi today sued Mylan over its effort to keep a rival to the EpiPen from gaining traction in the market, in a case that could shed light on the upside-down economics of drug pricing.

The filing in US District Court in New Jersey claims that when Mylan knew Sanofi’s Auvi-Q was close to reaching the market in January 2013, Mylan ran up the price of EpiPen, then offered pharmacy benefit managers (PBMs) and state Medicaid officials “new and unprecedented rebates” in exchange for commitments to keep Auvi-Q off formularies.

Sanofi’s claims come after Congress has made Mylan one of the pharmaceutical industry’s poster children for anti-consumer pricing practices. Last summer, frustration with EpiPen’s $608 list price, which was more than 4 times what it cost in 2008, caused a public uproar that led to hearings and investigations by the US Department of Justice and Federal Trade Commission, among others.

Epinephrine saves patients who have gone into anaphylactic shock, making devices that deliver an automatic injection the drug essential for those with severe allergies. When EpiPens expire, they must be replaced if they haven’t been used, and it is typical for schools to ask parents whose children have severe allergies to replace injectors kept at the nurse’s office at the start of each school year. Thus, EpiPen’s rising prices hit hard on families buying supplies for home, school, and for children to keep with them. Newer insurance designs often require more cost-sharing than seen in the past, setting up the consumer backlash seen last summer.

In the filing, Sanofi claims that the Auvi-Q device received favorable reviews from physicians because it was smaller than the EpiPen and came with voice instructions that could help a user or caregiver inject the epinephrine while under stress.

“Faced with this competitive threat to its EpiPen monopoly, and seeing Auvi-Q gaining share month-by-month after its launch, Mylan erected artificial bariers to US consumers’ access to and use of Auvi-Q,” the filing states. Steps that Sanofi claims Mylan took to protect market share include:

• Mylan “took the extreme step” of requiring schools that took part in its discount program would not use any rival to the EpiPen. The suit states that Mylan has since rescinded this step.
• Mylan misclassified the EpiPen to state and federal health officials to pay lower rebates than required to Medicaid, which Sanofi said allowed the company to pay for inflated rebates to commercial payers.
• Because of the price increases, Mylan could link steep rebates with conditions that payers and PBMs exclude Auvi-Q, “which third-party payers would (and did) find … practically impossible to refuse.”
• Sanofi alleges that Mylan “engaged in misleading advertising and other promotional activities to poison the well for Auvi-Q with doctors, key thought leaders, and consumers.

Mylan’s tactics meant that Auvi-Q dropped from a 13% market share in late 2013 to 7% in 2014. By contrast, the filing states, Auvi-Q topped 30% of the market in 2015 in Canada, where Mylan does not market the EpiPen.

Sanofi outlines the fallout that Mylan has experienced, which includes a $465 million settlement with the Department of Justice and federal health officials for improperly classifying EpiPen with Medicaid. “But,” the suit says, “Mylan has never been called to task for its antitrust violations.” The suit asked the court to find Mylan guilty of violations of the Sherman Antitrust Act and award triple damages.

The Auvi-Q device is now distributed by a smaller company called Kaleo Pharma, which also markets an injection system from naloxone, the drug that can counteract an opioid overdose.