Patient groups file amicus brief in imported HIV drug scheme

Urge Court to Protect Patients Against Unscrupulous “Alternative Funding Programs” for Prescription Drugs

Five patient groups led by the HIV+Hepatitis Policy Institute filed an amicus brief in litigation between Gilead Sciences and a number of drug supply middlemen, including a vendor owned by CVS Health, that are forcing patients to bypass their employer sponsored insurance and use illegally imported HIV drugs.  CVS is one of the largest health care enterprises in the country.

 “Forcing a person who has employer sponsored health insurance to sign up with an unknown third-party vendor to receive their life-saving drug supplied by a foreign country not only is illegal but jeopardizes the health and safety of patients,” commented Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute. “In an effort to evade actual coverage of specific prescription drugs that the health insurance plan states it covers, middlemen are profiting by scheming to set up so-called ‘alternative funding programs.’  While federal regulators should be shutting them down, in the meantime, the courts must step in to protect patients.”

The amicus brief filed by HIV+Hep and the other patient groups was filed in the United States Court of Appeals for the Fourth Circuit in Gilead Sciences, Inc. v. Meritain Health, Inc. Gilead filed the litigation after learning that a person living with HIV in Maryland was receiving his HIV medication from Turkey. As described in Gilead’s brief, the wording on the bottle was entirely in Turkish and lacked the legally required FDA “black box” warnings and labeling, including the patient hotline number. The drug, Gilead asserts, was shipped through an insecure drug supply chain not in compliance with U.S. law.

Gilead filed the case against third-party administrator (TPA) Meritain Health, which is owned by CVS Health; ProAct, which acted as the PBM; and affiliated pharmacies Rx Valet and Advanced Pharmacy. According to the allegations made in the case, Rx Valet is not licensed in the U.S. and openly sources its drugs internationally and then ships them to Advanced Pharmacy for patients in the U.S.  Gilead alleges that the scheme being used by the defendants violated its trademark and laws that prohibit the importation of prescription drugs in almost all instances. The District Court in Baltimore, Maryland, ruled in favor of Gilead and granted it a preliminary injunction. The injunction is now the subject of the appeal.

In the amicus brief, the patient groups describe to the Court the serious impact of alternative funding programs and specifically those that rely on imported drugs that are materially different from drugs obtained through the well-regulated and controlled U.S. system. The process creates patient confusion and puts them and their health at risk.

In addition to HIV+Hep, the brief was filed by the ADAP Advocacy Association, the International Foundation for Autoimmune and Autoinflammatory Arthritis (AIArthritis), the Autoimmune Association, and HealthHIV. It was prepared by William Sarraille, Special Counsel for HIV+Hep.

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The HIV+Hepatitis Policy Institute is a national, non-profit organization whose mission is to promote quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions.