Novo Nordisk: NovoSeven Promotion Beyond Hemophilia

In the Novo Nordisk NovoSeven settlement, the company agreed to pay $25 million to resolve allegations that its off-label promotion caused Medicare and Medicaid to pay for prescriptions those programs did not cover. The alleged campaign took a drug approved for certain bleeding disorders in hemophiliacs into trauma care and surgery.

The Department of Justice announced the civil settlement on June 10, 2011. The announcement named Novo Nordisk Inc., the U.S. subsidiary in Princeton, New Jersey, and a campaign aimed at doctors and hospitals throughout the country. Whistleblowers brought the case under the False Claims Act.

What Is Considered Off-Label Promotion?

Off-label promotion means marketing an approved drug for a use outside its FDA-approved labeling. NovoSeven is a blood-clotting drug. In this case, the government described its approved use as treatment of certain bleeding disorders in hemophiliacs. It alleged that Novo Nordisk promoted the drug to healthcare professionals for a much broader set of uses.

The announcement identifies trauma, general surgery, cardiac surgery, liver surgery, liver transplants and intracerebral hemorrhage. A sales presentation about controlling bleeding could reach very different patients depending on which of those settings it addressed.

Someone who worked on the message, chose the physician audience or heard the hospital presentation may recognize that difference more readily than someone looking only at the drug’s name.

How the Promotion Reached Medicare and Medicaid

The government alleged that Novo Nordisk’s campaign influenced doctors and hospitals and caused claims for prescriptions that government health care programs did not cover. Medicare and Medicaid paid those claims across the United States, according to the announcement. Taxpayers were funding the uses the company allegedly encouraged.

A manufacturer can drive the prescription while a pharmacy or physician sends the bill. The government alleged that Novo Nordisk caused the uncovered claims through its promotion.

Drugs commonly move from manufacturer to wholesaler to dispenser. Following that shipment identifies the product and its commercial route. It does not tell us why the patient received the drug.

Coverage depends on the use as well as the product. For Medicaid outpatient drugs, medically accepted indications include FDA-approved uses and uses supported by specified drug reference works, called compendia. In this case, the government alleged that the promoted NovoSeven uses produced claims the programs would not reimburse.

The Indication Can Disappear Between Records

Knowing which drug was dispensed does not tell a payer why it was prescribed. A May 2018 article in Managed Care, Indication-Specific Drug Pricing–Simple in Theory, Complex in Reality, describes this information problem in the context of pricing drugs differently for different uses. A payer needs the indication to administer such an arrangement, but that information may remain in the electronic medical record without being captured when the drug is dispensed.

A product-level sales report may show growth without showing the patient groups behind it. We examine the sales message alongside the clinical use and reimbursement information because each answers a different question.

What Evidence Is Needed to Prove Fraud?

In an off-label promotion case, we work with you to connect the sales message, the prescribed use and the paid claim. In NovoSeven’s case, the government alleged a campaign aimed at doctors and hospitals. We would examine how the company described the drug, which uses it encouraged and how the resulting prescriptions reached Medicare or Medicaid payment.

Other pharmaceutical complaints make those business decisions concrete. They describe sales instructions, materials used inside hospitals and communications about reimbursement. Each can reveal something different about how a manufacturer tries to turn a promoted use into a paid prescription.

Sales Instructions Can Name the Intended Use

In a separate case involving ISTA Pharmaceuticals, a whistleblower alleged that the company grouped off-label uses of Xibrom into sales categories it called buckets. The complaint attributed an internal instruction to the company, tying those categories to the representative’s pay:

The same complaint alleged that representatives could spend their allotted budgets printing preoperative instruction sheets to encourage doctors to prescribe Xibrom before surgery. That allegation reaches beyond what a representative said during a visit. It describes putting the promoted use into a document the practice could hand to a patient.

The comparison matters for a sales insider: a target-use category, a bonus instruction and a patient-facing sheet can connect the commercial objective to the prescribing workflow.

Hospital and Reimbursement Records Show the Next Step

In a complaint against Pacira Pharmaceuticals, a whistleblower alleged promotion of Exparel for bariatric, orthopedic, hernia-repair and spine procedures outside its indications. The complaint also alleged that a hospital’s pharmacy and therapy committee restricted the drug because of overuse resulting from the company’s promotion.

A separate complaint against Endo Pharmaceuticals alleged that the company supplied prescription-writing instructions intended to avoid payer scrutiny of off-label Lidoderm use. The alleged intervention reached the wording used to obtain reimbursement. The sales message, the prescribed use and the information presented for payment were all parts of the accusation.

These parallels give an insider a more concrete way to describe what they saw. A sales employee may know the intended audience. Hospital staff may know the procedures for which the drug was promoted. A reimbursement employee may know what the payer was told. Our work brings those accounts together around the government’s payment.

The Civil Settlement and Whistleblower Award

Novo Nordisk’s settlement allocated approximately $21.4 million to the federal government and approximately $3.6 million to state Medicaid programs. The Justice Department also announced that the whistleblowers would receive more than $3.5 million from the federal share of the civil recovery.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

Novo Nordisk also agreed to a corporate integrity agreement with the Department of Health and Human Services’ Office of Inspector General. It put the company’s compliance program under independent monitoring to help prevent future off-label promotion.

What the NovoSeven Case Shows

The NovoSeven allegations connected a narrow approved use, a broader promotional campaign and government payments for the resulting prescriptions. That connection is what makes the case useful to someone inside pharmaceutical sales, medical affairs or reimbursement.

The drug’s name stayed the same as the alleged campaign reached different patients and treatment settings. The promoted use changed. An insider who understands what the company wanted physicians to prescribe may hold the part of the story that a payment record alone cannot explain.

You Know the Use the Company Was Selling

You know the campaign from inside the business. Speak with our whistleblower experts about how the sales message reached uncovered prescriptions. We stay beside you to build your strongest pharmaceutical whistleblower case and bring in pharmaceutical fraud whistleblower lawyers who understand promotion, clinical indications and government reimbursement.