Federal Trade Commission Sues The Three Largest Pharmacy Benefit Managers

Friday, the FTC filed an administrative lawsuit against UnitedHealth Group Inc's Optum unit, CVS Health Corp's Caremark unit and Cigna Corp's Express Scripts unit, claiming they exclude lower cost insulin products from lists of drugs covered by insurers.  The suit also names Zinc Health Services, Ascent Health Services, and Emisar Pharma Services, the purchasing subsidiaries of the three PBMs.

This lawsuit was filed at the FTC Office of Administrative Law Judges, rather than a U.S. District Court.  In 2023, the U.S. Supreme Court permitted constitutional challenges to the FTC’s administrative law process in Axon Enterprises, Inc. v. FTC.  This administrative action is likely to be challenged in U.S. District Courts.  Defendants in administrative law cases can now challenge the FTC’s in-house proceedings immediately, in a U.S. District Court:

https://www.reuters.com/business/healthcare-pharmaceuticals/us-ftc-sues-drug-gatekeepers-over-high-insulin-prices-2024-09-20/

US FTC sues drug 'gatekeepers' over high insulin prices
By Jody Godoy and Ahmed Aboulenein - September 20, 2024

Sept 20 (Reuters) - The U.S. Federal Trade Commission sued the country's three largest pharmacy benefit managers on Friday, accusing them of steering diabetes patients towards higher priced insulin in order to reap millions of dollars in rebates from pharmaceutical companies.

The case accuses UnitedHealth Group Inc's (UNH.N), opens new tab Optum unit, CVS Health Corp's (CVS.N), opens new tab CVS Caremark and Cigna Corp's (CI.N), opens new tab Express Scripts of unfairly excluding lower cost insulin products from lists of drugs covered by insurers.

Driving down drug prices has been a key goal for the Biden administration, and Vice President Kamala Harris, the Democratic nominee, has emphasized her work for patients, and in particular on lowering insulin prices, on the campaign trail.
The conduct hurt patients, such as those with coinsurance and deductibles, who were not eligible for the rebated price, the FTC said. The three companies together administer 80% of all prescriptions in the U.S., according to the case, which was filed in the FTC's in-house court.

The three companies said in statements that the suit was baseless and defended their business practices, saying that they had lowered insulin prices for businesses, unions and patients.

KFF health policy expert Larry Levitt described the FTC action as a "shot across the bow."

"Insulin is an extreme case of PBMs extracting bigger and bigger rebates from drug manufacturers and driving list prices up at the pharmacy counter, but this is a dynamic that plays out with many medications," he said.

CVS shares fell 1.4% in midday trading, while UnitedHealth and Cigna shares were flat.

The suit also named Zinc Health Services, Ascent Health Services, and Emisar Pharma Services, purchasing organizations created by the companies in recent years.

CVS spokesman David Whitrap said in an emailed statement that the company has worked to make insulin more affordable for Americans and described the FTC as being "simply wrong." It said it provided insulin at $25 through a reduced price program.

Cigna Chief Legal Officer Andrea Nelson said if the FTC were to succeed in forcing it and others to include drugs that have higher total net costs for health plans, drug prices would rise.

Optum Rx spokesperson Elizabeth Hoff said the company has lowered insulin costs for its health plan customers and members to an average of less than $18 per month.

'MEDICATION GATEKEEPERS'

Rahul Rao, Deputy Director of the FTC's Bureau of Competition, said in a statement that the three pharmacy benefit managers are "medication gatekeepers" that have "extracted millions of dollars off the backs of patients who need life-saving medications."
"Millions of Americans with diabetes need insulin to survive, yet for many of these vulnerable patients, their insulin drug costs have skyrocketed over the past decade thanks in part to powerful PBMs and their greed," he said.

The case will be heard by one of the FTC's three administrative law judges.

The FTC did not sue the three major makers of insulin, Eli Lilly, Sanofi, and Novo Nordisk, but it did criticise their role in what it called a broken system, and said it reserves the right to sue the pharmaceutical companies later.

The drugmakers' shares did not react on Friday afternoon.

Sanofi and Lilly said the FTC’s lawsuit addressed aspects of the U.S. healthcare system they had long advocated to reform and that they had programs to reduce the out-of-pocket cost of their insulins to $35.

CVS Caremark said in its statement that any attempt to curtail pharmacy benefit managers' ability to negotiate drug prices will only benefit pharmaceutical companies.

The three PBMs have criticised the FTC's approach to the industry, accusing it of bias. Express Scripts sued the FTC earlier this week seeking to force it to withdraw a report that said PBMs enrich themselves at the expense of smaller pharmacies.

James Harlow, Senior Vice President at Novare Capital Management said PBMs have withstood previous criticism.

"Despite intense scrutiny, negative headlines, and attempts to pass legislation targeting PBMs, this business continues to be sticky and generates solid growth and margins," he said. Novare owns UnitedHealth and CVS shares, regulatory filings show.