Spotlight on Market Access

As manufacturers continue to bring more advanced therapies onto the U.S. market, payers are grappling with how to afford these agents. And while the products may be life-changing for some patients, they may not have the desired outcome in others, leaving payers on the hook for an unsuccessful treatment. This has resulted in various contracting opportunities, including warranties.

While such agreements can make payers more confident in their coverage of treatments, particularly high-cost ones and products whose effectiveness or durability are uncertain, they also are beneficial for pharma companies, which are seeing utilization of their therapies.

Select Health is the wholly owned health insurance unit of Intermountain Healthcare, a Salt Lake City-based health system of 33 hospitals. Select Health is the largest insurer in Utah and also has a presence in Idaho, Nevada and Colorado. The majority of Select Health’s members are enrolled in commercial risk-based products, with the insurer holding a robust Affordable Care Act exchange presence in Utah and Idaho, leading both states' exchange markets. Select Health also holds a Medicaid contract in Utah and has expanded its Medicare Advantage presence in recent years. Intermountain successfully merged with Colorado system SCL Health in 2022 and spearheaded the founding of Civica Rx, a nonprofit generic drug manufacturer that focuses on drugs in short supply or those with high mark-ups.

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.

Small-molecule drugs and biologics may produce similar health benefits, but because small molecules tend to be priced lower than biologics, they often represent better value, according to a recent Health Affairs study. And the study authors argued those findings suggest it could be worth revising how the Medicare Drug Price Negotiation Program is set up.

The Inflation Reduction Act of 2022 requires that Medicare negotiate a Maximum Fair Price for selected small-molecule drugs nine years after they were approved by the FDA. Whereas for selected biologics, the negotiated price takes effect after 13 years.

The second administration of Donald Trump may well run the gamut as far as its impact on health care and pharma. Biotech companies may benefit from a good business environment, prompting more mergers and acquisitions, but they may also experience challenges in working with what could be somewhat unconventional leaders of federal agencies, such as Robert F. Kennedy Jr., whom President-elect Trump tapped on Nov. 14 to run HHS.

RFK Jr., a politician and environmental activist who has questioned the safety and efficacy of vaccines and spread misinformation about them, has said that “there are entire departments, like the nutrition department, at FDA that have to go, that are not doing their job.”

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.

With Donald Trump set to be the 47th president and Republicans in control of both chambers of Congress, 2025 is shaping up to be a year in which the GOP has enough political might to pass PBM reform — if it has the political will.

Yet two pharmaceutical industry trade groups do not appear to be counting on Republicans’ ability to quickly prioritize a health care issue. Instead, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Association of Manufacturers (NAM) are both launching ad blitzes aimed at pressing Congress to target PBMs before the year is over.

Copay maximizer programs are gaining popularity among payers while copay accumulators appear to be losing some of their appeal, according to the annual Copay Accumulator & Maximizer Programs Special Report published by AIS Health’s parent company, MMIT. The report was based on surveys of 35 commercial insurers and PBMs representing 121.0 million lives.

About 39% of people were enrolled in plans with copay accumulators in 2024 on average, down from 47% in 2023. And 47% of enrollees were in plans with copay maximizer programs. On average, payers anticipated that about 48% and 57% of plan members will be covered by plans with copay accumulators and maximizers within the next 12 months, respectively.

While changes to the Medicare Part D benefit resulting from the Inflation Reduction Act (IRA) are already underway, Part D plans and manufacturers still face a good deal of uncertainty as to how the Medicare landscape is going to shake out. Changes to Medicare Part D plans in 2025 will almost certainly impact a large swath of beneficiaries, as well as manufacturers’ contracting strategies for 2026, said industry experts at a recent webinar hosted by Avalere.

“We are at an interesting moment for Part D,” observed Ethan Hall, associate principal on the client solutions team for Avalere, during an Oct. 30 webinar that he moderated.

CVS Health Corp.’s Aetna is the third-largest health insurer in the U.S., serving more than 25 million lives across all market sectors. Nationally, Aetna ranks No. 3 in administrative services only (ASO) non-risk contracting, No. 4 in the group risk commercial market and No. 3 in Medicare Advantage (MA). Under CVS's banner, Aetna has been at the forefront of the industry's movement toward increased payer, PBM and provider integration. But 2024 has been a tough year for the insurer, fueled by higher-than-expected medical costs, particularly in the public sector, and earnings underperformance. CVS is reportedly considering breaking up its enterprise into separate businesses, partially due to Aetna's poor performance. The company in October appointed David Joyner, then president of CVS-owned PBM Caremark, as CEO, ousting former Aetna president Karen Lynch.