Doctor receiving cash Humira isone of the world's biggest-selling medications, bringingin $18.4 billion in 2017–roughly two-thirds of AbbVie'srevenue. (Photo: Shutterstock)

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California's insurance regulator is suing AbbVie Inc., allegingthat the pharmaceutical giant gave illegal kickbacks to health-care providers inorder to keep patients on its blockbuster rheumatoid arthritis drugHumira.

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The company “engaged in a far-reaching scheme including bothclassic kickbacks — cash, meals, drinks, gifts, trips, and patientreferrals — and more sophisticated ones — free and valuableprofessional goods and services to physicians to induce and rewardHumira prescriptions,” the California Department of Insurance saidin a statement.

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Related: Doctors receiving kickbacks 14.5 times more likelyto prescribe opioids

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According to the state, AbbVie paid for registered nurses thatit called ambassadors to help doctors with patients who were takingHumira. While the nurses were represented to patients as anextension of the doctor's office, they were trained to tout thedrug while downplaying its risks, the state said.

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“AbbVie spent millions convincing patients and health careprofessionals that AbbVie Ambassadors were patient advocates — infact, the Ambassadors were Humira advocates hired to do one thing,keep patients on a dangerous drug at any cost,” InsuranceCommissioner Dave Jones said in the statement.

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The alleged misconduct “is particularly egregious because it'swell known the drug has very adverse side effects,” said Jones in apress conference. Under the ambassador system, complaints orconcerns about serious infections, blood problems, or even heartfailure — all known side effects of Humira — could go unreported topatients' physicians, he said.

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The allegations “are without merit,” AbbVie spokeswoman AdelleInfante said in a email. The company complies with state andfederal laws governing interactions between health-care providersand patients, she said. Its services help patients and “in no wayreplace or interfere with interactions between patients and theirhealth-care providers,” she said.

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Humira is one of the world's biggest-selling medications. Thedrug brought in $18.4 billion in 2017, accounting for roughlytwo-thirds of North Chicago, Illinois-based AbbVie's revenue.Private insurers have paid out $1.2 billion in Humira-relatedclaims, according to Jones.

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AbbVie's shares dropped after the news of the lawsuit, falling2.9 percent to close at $92.61 in New York.

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Jones is intervening in a whistleblower complaint filed inCalifornia by a nurse who was employed as an AbbVie ambassador inFlorida several years ago. The suit, filed in Alameda CountySuperior Court, seeks three times the amount of each claim made forHumira as a result of the alleged kickbacks. The lawsuit involvesprivate insurance claims, said Nancy Kincaid, a spokeswoman for theCalifornia Department of Insurance.

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“We conducted an investigation. We believe there is strongevidence that fraud was committed against private insurancecompanies,” said Kincaid.

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The same whistleblower has filed a separate false claims lawsuitin federal district court in Illinois. Earlier this year, the U.S.declined to intervene in that lawsuit.

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Critics have accused AbbVie of seeking an excessive number ofpatents on trivial improvements to keep competition for Humira offthe market, a technique known as “evergreening.”

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AbbVie has sought some 247 U.S. patent applications on the drug,with 89 percent of those filed after the drug was approved by U.S.regulators in 2002, according to a study by the Initiative forMedicine, Access and Knowledge, a consumer group that's blasteddrugmakers over high drug prices.

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A low-cost copy of the medicine will be available in Europe inOctober, while the U.S. version won't be allowed until 2023, underthe terms of a settlement AbbVie reached last year with Amgen Inc.The patent on the active ingredient for Humira expired in 2016.

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