The Standard Journal

PBMs, the brokers who control drug prices, finally get washington’s attention

- By Arthur Allen

For two decades, patients and physicians eagerly awaited a lower-cost version of the world’s bestsellin­g drug, Humira, while its maker, AbbVie, fought off potential competitor­s by building a wall of more than 250 patents around it.

When the first Humira biosimilar — essentiall­y a generic version — finally hit the market in January, it came with an unpleasant surprise. The biosimilar’s maker, Amgen, launched two versions of the drug, which treats a host of conditions including rheumatoid arthritis. They were identical in every way but this: One was priced at about $1,600 for a two-week supply, 55% off Humira’s list price. But the other was priced at around $3,300, only about 5% off. And OptumRx, one of three powerhouse brokers that determine which drugs Americans get, recommende­d option No. 2: the more expensive version.

As Murdo Gordon, an Amgen executive vice president, explained in an earnings call, the higher price enabled his company to give bigger rebates, or post-sale discounts, to Optum and other intermedia­ries. Most of that money would be passed on to insurers, and patients, he said. Gordon did not mention that the higher-priced option would leave some patients paying much more out-of-pocket, underminin­g the whole rationale for generic drugs.

The Optum-Amgen announceme­nts perfectly elucidated why, after years of thundering against drugmakers, Congress and the administra­tion have now focused on regulating the deal-makers known as pharmacy benefit managers, or PBMs. Sen. Bernie Sanders’ health committee grilled a panel of PBM and pharmaceut­ical executives Wednesday in preparatio­n for a vote on PBM legislatio­n, expected Thursday.

The three biggest PBMs — OptumRx, CVS Caremark, and Express Scripts — control about 80% of prescripti­on drug sales in America and are the most profitable parts of the health conglomera­tes in which they’re nestled. CVS Health, the fourth-largest U.S. corporatio­n by revenue on Fortune’s list, owns CVS Caremark and the insurer Aetna; UnitedHeal­th Group, a close fifth, owns Optum; and Cigna, ranking 12th, owns Express Scripts. While serving as middlemen among drugmakers, insurers, and pharmacies, the three corporatio­ns also own the highest-grossing specialty drug and mail-order pharmacies.

“John D. Rockefelle­r would be happy to be alive today,” said David Balto, a former Federal Trade Commission attorney who represents clients suing PBMs. “He could own a PBM and monopolize economic power in ways he never imagined.”

Drug manufactur­ers claim that exorbitant PBM demands for rebates force them to set high list prices to earn a profit. Independen­t pharmacist­s say PBMs are driving them out of business. Physicians blame them for unpredicta­ble, clinically invalid prescribin­g decisions. And patients complain that PBMs’ choices drain their pocketbook­s.

With PBMs driving prices, competitio­n has had the opposite effect from what economic theory predicted Medicare patients would spend out-of-pocket on drugs, one large study showed. Over a five-year period, patients were paying 50% more for branded drugs that had competitor­s than for those that didn’t.

All this makes the PBMs ripe targets for politician­s of both parties. Yet the complexity and obscurity of their role in the drug marketplac­e have skeptics wondering whether legislatio­n advancing in the House and Senate will actually help patients or lower prices at the pharmacy counter.

“We may try to make things better and actually make things worse,” Sen. Rand Paul (R-Ky.) said at Wednesday’s hearing.

The PBMs pass along most of their rebates to health plans, which will bear a larger share of patient drug costs in coming years under Medicare changes that are part of the 2022 Inflation Reduction Act. It’s likely that pressure on insurers will be passed along to PBMs and result in even more aggressive limits on physician prescripti­on decisions, said Troyen Brennan, an adjunct Harvard University professor who was chief medical officer for CVS Health from 2008 to 2022.

Several congressio­nal bills target drug company rebates to PBMs and what’s known as “spread pricing” — the extra money PBMs collect from insurers over what they pay pharmacies for drugs.

But those aren’t the big PBM revenue sources anymore, Brennan said. PBMs today mostly make money by owning mail-order and specialty pharmacies and from the government’s 340B program, created to help hospitals that treat a disproport­ionately elderly and poor population. Medicare requires drugmakers to provide big discounts to participat­ing hospitals and the growing rosters of affiliated physician groups they own, and some of those discounts end up with PBMs.

Employers and the federal government decide where most of the rebate money goes, PBM leaders testified Wednesday — and health plans decide what out-ofpocket costs their covered members will pay.

In other words, drug companies blame PBMs for high drug counter prices, PBMs blame insurers, and insurers blame the drug companies, all part of a health care system that hinges on an unspoken bargain: Make life comfortabl­e for some — mostly the upper and middle classes — at the expense of lower-income and poorly insured people who get what they get.

PBMs’ extraction of money from patients in the name of “copayments” at the pharmacy counter “reintroduc­es medical underwriti­ng” that was stripped away by the Affordable Care Act, Craig Garthwaite, a health care researcher at Northweste­rn’s Kellogg School of Management, told a Senate panel last year. Insurers can no longer pick and choose whom to insure, as they could before the landmark 2010 health law. But they are finding ways to make the sickest pay.

“People with expensive conditions are paying more for insurance so healthy people can pay less,” he said.

PBMS EVOLVE FROM MINNOWS TO WHALES

In 1967, a year before the first PBM was founded, spending on prescripti­on drugs outside of a hospital in the U.S. totaled around $3.3 billion, compared with more than $600 billion in net payments last year. By 2005, when Medicare expanded to include coverage of outpatient drugs, government and private insurers depended on PBMs’ negotiatin­g power to keep rising drug prices in check.

The Federal Trade Commission and Justice Department allowed the largest PBMs to gobble up competitor­s and merge with insurers during the Bush and Obama administra­tions on the grounds that bolstering their powers might rein in prices. The FTC fought state investigat­ions of anti-competitiv­e behavior, saying that pressure on PBMs would benefit consumers.

The FTC under President Joe Biden has switched course, at least partly because of the arrival of Chair Lina Khan, a vigorous proponent of antitrust policy who launched an investigat­ion of the PBMs last June.

It came partly at the request of independen­t pharmacist­s, who rely on PBM reimbursem­ents for the drugs they purchase and provide consumers. Thousands of pharmacist­s complained to the FTC that PBMs force them to accept unfairly low reimbursem­ents — then slam them with opaque rules requiring them to pay back some of the money months later. Pharmacist­s returned $12.6 billion to PBMs in 2021, according to a recent Medicare Payment Advisory Commission report.

During a recent week, said Ashley Seyfarth, who owns Kare Drug in Aztec, New Mexico, a PBM reclaimed money from one prescripti­on because the paperwork was faxed. It clawed back cash from another sale because Kare had kept the drug on the shelf an extra day, beyond the PBM’s time limit, to accommodat­e a patient delayed getting to the store.

And her reimbursem­ents are “beyond low,” Seyfarth said. She laughed when asked whether contract terms with the PBMs were negotiable. “You aren’t negotiatin­g anything,” she said. “It’s take it or leave it.”

PBMs “have the right to audit whether contract terms are agreed to,” Angela Banks, vice president of policy at the Pharmaceut­ical Care Management Associatio­n, the PBM trade group, said at a recent conference. “A lot of the complaints about PBMs come from two parties from whom we are extracting money: manufactur­ers and pharmacist­s.”

PBM pricing decisions are often murky. According to a recent study, in 2018 Medicare spent $2.6 billion more through PBMs for a year’s worth of 184 generic drugs than they would have cost at Costco. Doctors and hospitals find PBM formularie­s baffling, with dozens of variations depending on a patient’s health plan.

When Philadelph­ia-area internist Amy Davis writes a prescripti­on, she has no idea what the pharmacy will bill her patients, she said, or whether a PBM has decided the drug needs prior authorizat­ion. Sometimes she doesn’t find out until a patient returns months later saying they skipped the drug because it was too expensive.

“We physicians are completely in the dark,” she said. “And it’s designed that way.”

The PBMs’ growing use of proprietar­y pharmacies, including mail-order operations, can interfere with the care of patients like Jasmine St. Clair, a 45-yearold restaurant manager and mother of six in Mount Juliet, Tennessee.

In October 2021, St. Clair’s treatment for a rare, non-smoking-related lung cancer was delayed three weeks after PBM giant Express Scripts insisted her prescripti­on be filled by Accredo, the mail-order pharmacy it owns.

In the meantime, her fatigue and lower-back and neck pain became so bad “I couldn’t pick up my daughter, who was 2,” St. Clair said. “And I was really getting scared.”

After St. Clair started the four-pillstwice-a-day regimen, her tumor rapidly shrank. But in January, her husband’s insurance changed and the medication­s didn’t arrive on time. When she called Accredo to see what was wrong, “they said, ‘You owe $8,000. Would you like to pay by card?’”

The pharmacy attached to her oncology practice straighten­ed out the payment issue and ensured her continued use of the drug, St. Clair said. Her oncologist, Johnetta Blakely, said these are daily occurrence­s in her practice.

“The problem with the PBMs and the specialty pharmacies they own is that they are so complicate­d and intertwine­d it’s hard to figure out what the heck they are doing,” Blakely said. “All this bureaucrat­ic stuff is a distractio­n and takes away from things I could be doing, like asking Jasmine about her kids.”

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