Drug Pricing

Retail prescription drug spending is expected to grow moderately throughout the next decade. But per capita out-of-pocket retail drug costs may decrease starting in 2024 due to the Inflation Reduction Act (IRA), a recent Peterson-KFF Health System Tracker study predicted.

Using National Health Expenditures Accounts historical and projection data from 2021, researchers found that per capita spending on retail prescription drugs has skyrocketed over the past three decades— from $101 in 1960 to $1,147 in 2021. Meanwhile, out-of-pocket prescription drug spending has been declining since the mid-2000s and is anticipated to drop by 8% by 2031.

A Sept. 26 potential class action lawsuit brought by independent pharmacists accuses CVS Health Corp. of charging excessive direct and indirect remuneration (DIR) fees for Medicare Part D claims administered by the firm’s Caremark PBM division. The suit, filed in the U.S. District Court for the Western District of Washington, calls the DIR fees charged by Caremark “unconscionable,” and says that the vertically integrated managed care, retail and pharmacy giant breached “the covenant of good faith and fair dealing.” In a Sept. 27 press release, the National Community Pharmacists Association (NCPA) — a trade group of independent pharmacists that has recently lobbied in favor of strict regulation of PBMs — backed the lawsuit. “It’s payback time,” said NCPA CEO B. Douglas Hoey. “Finally, community pharmacies have a chance to recover DIR fees that were unfairly taken. PBMs have been gaming the system for a long time, and it’s time to turn the tables.”

As PBMs continue to face an onslaught of regulatory scrutiny, their main trade group — the Pharmaceutical Care Management Association (PCMA) — has been arguing that attempts to alter the industry’s dominant business practices would do nothing but hand Big Pharma a victory and erode PBMs’ ability to bring down drug prices.

Now, however, a new coalition of smaller PBMs that promote a “transparent” business model has entered the scene and is aligning itself not with PCMA, but with attempts to overhaul the PBM industry.

PBMs are increasingly deriving profits from collecting fees and from their specialty pharmacies as opposed to manufacturer rebates and spread pricing, according to an analysis published on Sept. 18 from Nephron Research. Eric Percher, the report’s author and a Nephron research analyst, tells AIS Health, a division of MMIT, that the findings suggest PBMs have shifted their business model in recent years even as they receive scrutiny from state and federal government officials for old tactics.

Nephron received compensation for the survey design and independent data analysis from the Pharmaceutical Research and Manufacturers of America (PhRMA), the leading trade group for drug manufacturers. Percher maintains that Nephron had full editorial control of the report.

Although CMS has released its list of the first drugs to be negotiated under the Inflation Reduction Act (IRA), questions surrounding the process, as well as other provisions of the law, still exist. During a recent webinar, Mark McClellan, M.D., Ph.D., the Robert J. Margolis Professor of Business, Medicine, and Policy, and founding director of the Duke-Margolis Center for Health Policy at Duke University, addressed some of those issues, including the real-world evidence that CMS is looking for and how the redesign of Medicare Part D will play out.

The Sept. 18 webinar was the second in a series presented by Innopiphany on navigating the IRA, following the initial one held June 20.

Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.

Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of adults with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis, people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 years old with active psoriatic arthritis.

List prices for the 25 branded drugs associated with the highest Medicare Part D spending in 2021 have increased by an average of 226% since they first entered the market, according to a recent report from AARP’s Public Policy Institute. These drugs were responsible for $80.9 billion in total Medicare Part D spending in 2021.

Overall, lifetime price increases among the 25 drugs ranged from 20% to 739%, with all but one of them greatly exceeding the annual rate of inflation over the same period. The list price of Enbrel (etanercept), a treatment for rheumatoid arthritis and psoriatic arthritis, skyrocketed by 701% since entering the market in 1998.

The FDA recently granted another approval to Taiho Pharmaceutical Co., Ltd. Division Taiho Oncology, Inc.’s Lonsurf (trifluridine/tipiracil) in combination with another agent for a type of colorectal cancer. The decision provides another treatment option for a condition that respondents to a Zitter Insights survey regard as in need of more effective therapies.

On Aug. 2, the FDA approved Lonsurf as a single agent or in combination with bevacizumab for the treatment of adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) drug and, if Rat sarcoma (RAS) wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. Bevacizumab originally was available as Avastin from Genentech USA, Inc., a member of the Roche Group, but now four biosimilars of it are also on the market: Celltrion USA, Inc.’s Vegzelma (bevacizumab-adcd), Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly), Pfizer Inc.’s Zirabev (bevacizumab-bvzr) and Amgen Inc.’s Mvasi (bevacizumab-awwb).

A bill that “delinks” PBM pay from drug list prices and utilization in Medicare Part D could “shift billions of dollars annually from patients and taxpayers to drug manufacturers and retail pharmacy companies,” according to a new paper funded by the PBM industry’s main trade group. However, some experts argue that the research may not offer a completely accurate assessment, even if it makes some valid points.

“I’m a little bit of two minds on this paper,” says Matthew Feidler, a senior fellow at The Brookings Institution’s Schaeffer Initiative on Health Policy. Feidler, who was not involved in the National Bureau of Economic Research (NBER) paper, recently coauthored an issue brief assessing the current landscape of PBM reform proposals.

New PBM regulations are one step closer to becoming a reality, as leadership of the U.S. House of Representatives released their draft package of health care reforms on Sept. 8. Lobbyists representing plan sponsors tell AIS Health, a division of MMIT, that the House package is not as aggressive as possible legislation in the U.S. Senate, but they point out that much could change when both chambers consider floor versions of their PBM bills.

The House legislation, called the Lower Costs, More Transparency Act, would, according to a summary of the bill prepared by House staffers: