PBMs/Pharmacy Benefit Managers

U.S. patients paid an estimated 278% more for prescription drugs than patients in other high-income countries did for the same drugs in 2022, according to a RAND Corp. study. U.S. gross prices for brand-name originator drugs were 422% higher than drugs in the comparison countries, RAND found; after rebates were applied, brand-name drugs still cost more than three times the amount paid in other countries. Unbranded generics were the only category that were not “substantially higher” in price than drugs in other countries. As RAND pointed out, unbranded generics account for 90% of U.S. drug volume but just 8% of total drug spending at manufacturer gross prices.

A Johnson & Johnson employee sued the firm over allegations that the medical manufacturing giant overpaid for prescription drugs dispensed by the firm’s employee health plan — which she alleges is a violation of J&J’s fiduciary duty under the Employee Retirement Income Security Act of 1974 (ERISA). The suit is part of what some legal experts have predicted will be a “” of litigation against plan sponsors that may have paid more than they should have for certain health care services and products, potentially including prescription drugs or pharmacy benefits. The plaintiff in the suit is Ann Lewandowski, a health care policy and advocacy director at J&J, STAT reported.

Blue Shield of California’s plan to replace its traditional pharmacy benefit arrangement with what it hopes will be a more transparent assemblage of services won’t go into full effect until 2025, but it has already generated a lot of hope and criticism across the healthcare landscape. The insurer, though, is aiming to inspire as much at it aiming to succeed on its own.

“It’s going to take more than just one plan, or one employer group or one manufacturer. It’s going to take all of us to look at our business model and think about how it can be simpler, more sustainable, more affordable, with higher quality care,” Alison Lum, Blue Shield of California’s VP-Pharmacy Services, said in an interview with the Pink Sheet on 6 February.

An ongoing lawsuit over the use of copay accumulators is drawing to a close following the defendants’ and plaintiffs’ motions to dismiss their appeals. The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court judge’s ruling, which states that manufacturer assistance must be counted toward patients’ out-of-pocket responsibility unless a brand-name drug has a medically appropriate generic equivalent.

Health plans and PBMs several years ago began implementing copay accumulators — and then a new iteration known as copay maximizers that declare certain drugs non-essential health benefits to avoid covering them per the Affordable Care Act (ACA) — to counter manufacturer copay assistance programs. Before these tools, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators and maximizers, patients can still use that assistance, but it does not help reduce those out-of-pocket costs.

Capping off months of rumors that such a deal was brewing, The Cigna Group on Jan. 31 said it has agreed to sell its Medicare business to Health Care Service Corp. (HCSC). Industry observers say that given the near-term headwinds Medicare Advantage is facing, it’s wise for Cigna to leave a market in which it struggled to compete and focus on more promising growth opportunities.

The $3.7 billion purchase will transfer nearly 600,000 Medicare Advantage members, more than 450,000 Medicare Supplement lives and 2.5 million Medicare Part D lives from Cigna to HCSC, the companies said. The Blue Cross Blue Shield licensee will also acquire Cigna’s CareAllies business, which offers “management services to support value-based care arrangements” and works with providers to form accountable care organizations and independent physician associations.

PBM and drug pricing regulation will continue to be hot topics at the state level after several years of busy lawmaking, experts predict, even as PBM reforms are diluted and stalled in Congress. They predict that more states than ever will continue to embrace or pursue policies like drug affordability review boards.

“I do think the momentum is still strong, because states have the ability to do a lot more,” Kate Sikora, associate principal at Avalere Health, tells AIS Health, a division of MMIT. “Federal bills typically get a little bit watered down by the time they actually pass. So some of these state laws are a little bit heartier — a little bit more robust — in terms of what they attempt to do.”

Biosimilar uptake is higher for Medicare Advantage beneficiaries than their traditional Medicare (TM) counterparts, with MA members up to 2.3 times more likely to be prescribed a biosimilar, according to new research published in JAMA Health Forum. The FDA has approved 45 biosimilars so far, with more approvals expected this year.

Researchers from CMS, the FDA and policy research firm Acumen LLC studied claims and encounter data to calculate market share for 20 biosimilars across seven product categories. Biosimilar uptake was higher for MA members in every category but bevacizumab, the generic name for Genentech’s targeted cancer therapy Avastin. Avastin currently has four biosimilars available, with a fifth approved last month.

Although 2023 was a banner year for biosimilars hitting the U.S. market, uptake of these near-copies of biologic drugs remains low. Manufacturers of biologics also commonly file lawsuits or take other measures to extend their patents and have successfully delayed the introduction of FDA-approved biosimilars. Pharmaceutical industry experts tell AIS Health, a division of MMIT, that the slow adoption of biosimilars has an impact on payers that would prefer patients receive lower-cost biosimilars rather than expensive biologics.

In fact, a recent study offers evidence that private insurers are increasingly embracing biosimilars. Uptake of biosimilar medications was higher in Medicare Advantage plans than in traditional, fee-for-service Medicare from May 2015 through September 2022, according to a recent study published in JAMA Health Forum. However, biosimilars had less than a 50% market share in six of the seven product classes the authors examined, suggesting providers and patients often still opt for biologics.

PBM and drug pricing regulation will continue to be hot topics at the state level after several years of busy lawmaking, experts predict, even as PBM reforms are diluted and stalled in Congress. They predict that more states than ever will continue to embrace or pursue policies like drug affordability review boards.

“I do think the momentum is still strong, because states have the ability to do a lot more,” Kate Sikora, managing director at Avalere Health, tells AIS Health, a division of MMIT. “Federal bills typically get a little bit watered down by the time they actually pass. So some of these state laws are a little bit heartier — a little bit more robust — in terms of what they attempt to do.”

Tyson Foods, Inc. dropped CVS Health Corp.’s Caremark PBM in favor of Rightway, a fee-based PBM partnered with Mark Cuban Cost Plus Drug Co. Rightway promises to save employers 15% on their pharmacy benefit costs. Tyson’s head of benefits, Renu Chhabra, told CNBC that concerning jumps in specialty drug spending were a key reason behind the move. CVS withheld data that Chhabra hoped to use to manage costs, she said. “We were going anywhere between 12% to 14% increases for pharmacy — and on a $200 million spend that’s quite a bit,” said Chhabra. “I wanted to look at Humira, and I wanted to see what the acquisition cost was…it was very difficult to get to those numbers. Part of this was to really get a partner who can help us organize the information, make sure we understand how to manage specialty, and really looking at how to get the best net cost.”

Last year, as the country’s three dominant PBMs faced an unprecedented amount of scrutiny, smaller firms saw an opportunity to step into the spotlight. Thus, they founded Transparency-Rx, a coalition of PBMs with “transparent” business models and a shared goal of pushing for the reform their larger rivals were resisting.

One of the members of that new coalition, SmithRx, announced on Jan. 23 that it closed a $60 million Series C financing round led by the health care venture capital firm Venrock. The latest funding infusion, which builds on a $20 million Series B round raised in 2022, positions SmithRx to continue fixing a “broken” pharmacy pricing system, according to its founder and CEO, Jake Frenz.