Although the FDA has approved five biosimilars of Regeneron Pharmaceuticals, Inc.’s best-selling Eylea (aflibercept), patent infringement lawsuits by the drugmaker have kept those competitors off the U.S. market — until now. Following a successful defense of its Pavblu (aflibercept-ayyh), Amgen Inc. recently launched the drug at risk. The agent is entering an increasingly crowded therapeutic class, but it’s one that’s also costly for payers, which may be seeking some savings, say industry experts. But is its price good enough to pull market share?

Pavblu has approval for all of Eylea’s indications — neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) — except for retinopathy of prematurity. Among the vascular endothelial growth factor (VEGF) inhibitors approved for ocular use, Eylea is the only one with that indication on its label.

A recently approved treatment for psoriatic arthritis (PsA) brings a new mechanism of action to the therapeutic class. And while payers and rheumatologists varied in their expectations of what the drug’s impact on coverage of and prescribing for the class will be, almost half said they expect it to have at least some effect, according to a survey by Zitter Insights.

On Sept. 20, the FDA approved three more indications for UCB, Inc.’s Bimzelx (bimekizumab-bkzx) for the treatment of adults with active PsA, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis. Two months later, on Nov. 20, the FDA gave the drug another approval, for the treatment of moderate-to severe hidradenitis suppurativa.

All of the Big Three PBMs have added private-label subsidiaries into their fold that are working closely with some manufacturers. And while industry experts say that the companies offer certain benefits to the U.S. health care system overall, questions about them remain. Still, the entities could offer benefits to their pharma partners, including better formulary positioning and potentially even moving away from rebates.

Two of the companies, both based in Ireland, seem to be mainly, if not exclusively, focused on biosimilars, starting with those of AbbVie Inc.’s best-selling Humira (adalimumab).

Last month’s FDA approval of a drug to treat atopic dermatitis brings a new agent to a growing class of medications that payers say they consider a high priority to manage.

On Sept. 13, the FDA approved Lilly’s Ebglyss (lebrikizumab-lbkz) for the treatment of people at least 12 years old who weigh at least 40 kg with moderate-to-severe atopic dermatitis that is not well controlled despite treatment with topical prescription medications or when those medications are not advisable. Dosing for the interleukin-13 (IL-13) antagonist is 500 mg via two 250 mg subcutaneous injections at weeks zero and two and then 250 mg every two weeks until week 16 or later, when an adequate clinical response is achieved. At that point, maintenance dosing is 250 mg every four weeks. The drug’s WAC is $3,500 for a 250 mg/2 mL single-dose prefilled pen or prefilled syringe.

Employers expect their health care costs will increase next year at a higher rate than in previous years, as they continue to deal with inflation and other headwinds, according to recent surveys and database analyses from major benefits brokers. Actuaries from two of those firms tell AIS Health, a division of MMIT, that the increases are being driven by a few factors, including higher reimbursement for hospitals and providers, a rise in care utilization now that the coronavirus pandemic is over, and a higher percentage of people using expensive specialty medications and GLP-1 drugs.

Aon predicts the average cost for employer-sponsored health plans will increase by 9% in 2025, up from a 5.8% increase this year. Meanwhile, WTW projects a 7.7% increase in health care costs next year compared with a 6.9% increase this year and a 6.5% increase last year. Mercer anticipates a 7% increase in costs for employer plans in 2025.

The last of the so-called Big Three PBMs recently joined the others in offering a new private-label subsidiary when it unveiled upcoming changes to its commercial formularies. Those units, which are largely focused on biosimilars and generics, may offer benefits to pharma companies partnering with them, but such arrangements also pose potential risks as the offerings are already drawing scrutiny.

On Jan. 1, 2025, UnitedHealth Group’s Optum Rx will place Nuvaila-labeled biosimilars of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine and AbbVie Inc.’s Humira (adalimumab) on various tiers of three of its commercial formularies for a zero-dollar copay. In partnership with Amgen Inc. for its interchangeable Wezlana (ustekinumab-auub), Wezlana for Nuvaila will be available in both high-wholesale acquisition cost and low-WAC versions.

Most industry experts would agree that paying for costly cell and gene therapies (CGTs) is one of the top issues facing payers. And with more than 4,000 gene, cell and RNA therapies in the pipeline, the issue isn’t disappearing any time soon. One relatively new company is taking a slightly different approach to tackling the issue.

Quantile Health is focused on increasing patient access to CGTs, explained Yutong Sun, co-founder and CEO, during AHIP’s 2024 Medicare, Medicaid, Duals & Commercial Markets Forum, held earlier this year in Baltimore. As almost one-third of self-insured plans have dropped their coverage of gene therapies, the company is focused on this sector of the health care marketplace, which faces “quite different challenges” than other entities, she said. While CGTs may be “a drop in the bucket” for major national plans with annual budgets of a few billion dollars, one CGT could represent half of the annual budget for a self-insured plan with 100 to 500 employees.

Overall satisfaction with PBMs is at a decade-long low this year, according to the 2024 Pharmacy Benefit Manager Customer Satisfaction Report, published by Pharmaceutical Strategies Group, an EPIC company. The report also showed that payers were seeking improvements in the PBM industry and were willing to be part of the disruptive change.

The report is based on responses from 248 benefits leaders at employers, unions/Taft-Hartley plans, health plans, and health systems, and it was conducted from May 10, 2024, through June 7, 2024.

Amid reports of increasing prior authorization (PA) requests and coverage denials, dozens of hospitals and health systems are exiting or threatening to exit insurers’ Medicare Advantage networks. Although some departures have already taken effect, many will impact the 2025 plan year, which MA insurers have begun promoting in advance of the Annual Election Period (AEP). While on the surface the disputes reflect providers’ growing frustrations with insurers’ PA policies, two industry experts say hospitals’ latest round of muscle-flexing may reflect a trend of health systems looking more strategically at their markets and seeking the best deals.

As of Oct. 1, Becker’s Hospital Review had counted at least 27 health care providers nationwide that have unveiled MA network departures this year. And that is not an exhaustive list, as additional reports of providers joining the exodus continue to pour in from local news outlets across the U.S.

Overall satisfaction with PBMs is at a decade-long low this year, according to the 2024 Pharmacy Benefit Manager Customer Satisfaction Report, published by Pharmaceutical Strategies Group, an EPIC company. The report also showed that payers were seeking improvements in the PBM industry and were willing to be part of the disruptive change.

The report is based on responses from 248 benefits leaders at employers, unions/Taft-Hartley plans, health plans, and health systems, and it was conducted from May 10, 2024, through June 7, 2024.