USA – The Federal Trade Commission (FTC) has kicked off an inquiry into the operations of pharmacy benefit managers, and what the agency calls the “prescription drug middleman industry,” that control access to medications for millions of Americans.

The consumer protection agency has said that it will order the nation’s largest pharmacy benefit managers, or PBMs, to provide a range of information and records detailing how they do business.

PBMs run prescription drug coverage for big clients that include health insurers and employers that provide coverage.

They help decide which drugs make a plan’s formulary, or list of covered medications. They also can determine where patients go to fill their prescriptions.

These businesses, the biggest of which are run by companies that also operate health insurers, have been criticized by doctors and patients over their formularies and other concerns about drug access.

Pharmacy benefit managers (PBMs) negotiate with drugmakers for rebates and lower fees on behalf of employers and other clients, and reimburse pharmacies for prescriptions they dispense.

The FTC said in a statement it will ask about fees charged to independent pharmacies and reimbursements that are then clawed back from them, efforts to steer consumers to PBM-owned pharmacies and about their specialty drug policies.

As part of the inquiry, the antitrust body sent orders to CVS Health Corp’s Caremark, Humana Inc, Cigna Corp’s Express Scripts and UnitedHealth Group’s OptumRx, among others

Officials from CVS and Prime Therapeutics said in statements that they intended to cooperate. Other companies did not respond to requests for comment.

We are confident that any examination of pharmacy benefit managers will validate that PBMs are reducing prescription drug costs for consumers,” said PCMA President JC Scott in a statement.

Drug manufacturer price-setting is the root cause of high drug costs. The most effective study of issues around drug costs for consumers would examine the entire supply chain,” Scott added.

Commenting on this development, Federal Trade Commission Chair Lina M. Khan said in a statement, “Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the US prescription drug system.”

This study will shine a light on these companies’ practices and their impact on pharmacies, payers, doctors, and patients.”

The FTC said it will seek to learn more from PBMs about drug manufacturer rebates and how they affect formulary design and the cost of drugs.

FTC Commissioner Alvaro Bedoya said on Twitter that the practices of these intermediaries are “cloaked in secrecy and opacity,” adding that for most Americans, “pharmacy middlemen control what medicine you get, how you get it, when you get it, and how much you pay for it.”

The study is expected to take months and should make companies’ practices more transparent, Chair Lina Khan said.

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