Alexion: The Soliris Fund That Reported Back

In the Alexion Soliris copay settlement, Alexion Pharmaceuticals Inc. agreed to pay $13 million over alleged copay charity kickbacks involving Soliris. The government’s account paired a fund Alexion allegedly wanted restricted to its drug with a referral portal that told Alexion which Soliris patients the foundation had approved for assistance. For someone inside patient access, the revealing detail is the information coming back.

The Department of Justice announced the civil settlement on April 4, 2019. The alleged conduct ran from January 2010 through June 2016. This pharmaceutical fraud case follows decisions that patient-support and foundation employees can recognize: which treatment qualified for help and what the manufacturer learned about the people receiving it.

Soliris Cost and the Copay Incentive

The Justice Department put Soliris’s annual cost at approximately $500,000 based on its list price and indicated dosing recommendation. At that price, help with the patient’s share could keep an expensive prescription moving while Medicare paid the rest.

The USC Schaeffer Center’s 2020 paper, The Association Between Drug Rebates and List Prices, found that increases in estimated rebates were associated with increases in list prices across branded drugs. It also explained why patients whose deductibles or coinsurance depend on list prices can remain exposed to those higher prices. With different prices across the transaction, discounts can leave the patient’s immediate affordability problem intact.

That is where a manufacturer-funded copay can become commercially valuable. The patient gets help with the share that stands between a prescription and a purchase. Medicare remains in the transaction paying for the drug. Congress intended copays to help check health care costs. In the alleged scheme, the manufacturer funds the patient’s share to secure the sale, and Medicare and taxpayers carry the rest.

What Did the Soliris Referral Portal Do?

The Soliris referral portal allegedly returned information to Alexion confirming which Soliris patients the foundation had approved for copay or other financial assistance, and detailed the foundation’s payments to them. The manufacturer could see an approval attached to its own product, beyond simply knowing that it had supported a charity.

That information mattered because of the alleged fund restriction. According to the government’s account, Alexion asked the foundation in January 2010 to create a fund for Soliris patients, became the fund’s sole donor and told the foundation it wanted assistance for patients with the diseases Soliris treats limited to Soliris therapy. The disease supplied the category, but the manufacturer’s drug allegedly supplied the condition for help. A patient with the diagnosis could still fall outside the assistance Alexion wanted funded. Alexion allegedly noted internally that it needed to be diligent in telling the foundation when a patient stopped taking Soliris, so that its donations would not be used on patients who were not starting or maintaining Soliris therapy.

For a patient-access employee, an approval report is familiar operational information. In this case, the government alleged that information flowed back to the same company seeking the product restriction. Who requested a coverage rule and who received the results belong in the same account of how the assistance worked.

The foundation side drew a separate settlement. Patient Services Inc. settled in January 2020 over allegations that it served as a conduit for manufacturer payments of Medicare patients’ copays. Alexion was among the manufacturers identified as counterparties. The company funding the assistance and the organization administering it each faced allegations about its part in the arrangement.

Why the Fund’s Independence Mattered

The Office of Inspector General’s November 2005 guidance called for charities to award assistance independently of a donor’s interests or the patient’s choice of drug. It also said manufacturers should not receive information that let them match donations to subsidized prescriptions for their products.

Those principles explain the significance of the alleged Soliris restriction and approval feedback. Eligibility can reserve help for a particular product before an application arrives. Returning product-specific approvals can then let the donor see the result. Calling the payment a charitable donation leaves both business decisions unexplained.

Why Free Drugs and Copay Assistance Produce Different Revenue

Giving medicine away generates no drug sale. Funding a patient’s copay can leave Medicare paying the rest and generate manufacturer revenue. That difference explains why the choice of assistance route matters in pharmaceutical kickback cases. The government alleged that Alexion generally kept Medicare patients out of its free drug program, which was open to other financially needy patients, even when they could not afford their Soliris copays, and instead referred them to the foundation through the referral portal to generate revenue from Medicare.

United Therapeutics provides a close comparison. In its December 2017 settlement announcement, the government alleged that the company used foundation spending data for its drugs to decide how much to donate. It also alleged that the company excluded needy Medicare patients from its free-drug program, while allowing other financially needy patients to participate.

The Alexion portal allegation concerns approval information coming back to the manufacturer. The United Therapeutics allegation shows spending information feeding the next donation decision. Both put the flow of information inside the assistance arrangement. To an employee handling those reports, the connection between patient support and the company’s commercial decisions can be visible in ordinary work.

Why Did Alexion Avoid a Corporate Integrity Agreement?

The Office of Inspector General did not impose a corporate integrity agreement on Alexion because of sweeping organizational changes, according to the explanation included in the Justice Department’s settlement announcement. The agency pointed to a new executive leadership team of eight members, replacement of half the board, 40% new employees and a relocated headquarters.

What Evidence Is Needed to Prove Fraud?

For an assistance arrangement like the one alleged here, the useful evidence connects the manufacturer’s funding and instructions to the fund’s eligibility decisions, the information returned to the donor and the Medicare claims that followed. We work through them with the person who saw the decisions inside the business.

A healthcare employee may know who requested a product restriction or what an approval report allowed the manufacturer to see. Someone handling patient support may know how free-drug and foundation-assistance routes were chosen. Those perspectives give meaning to eligibility rules, donation communications and patient-support records that otherwise show only separate transactions.

Our work with pharmaceutical whistleblowers brings those parts together: what the company intended to fund, what it knew about the result and how the prescription reached Medicare.

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

You Saw What Came Back Through the Portal

If you know who shaped a fund’s eligibility or what patient information went back to its donor, speak to one of our whistleblower experts. We turn your knowledge of the assistance operation into a focused case and bring in pharmaceutical kickback whistleblower lawyers who understand foundation funding and Medicare payments. We stay beside you as partners throughout the case.