Court Cases

Even at 10% Discount, Eylea Biosimilar Pavblu Offers Lower-Cost Option

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.

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More Commercial Health Plan Enrollees Have Copay Maximizers Than Accumulators in 2024

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.

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Will Supreme Court Review Preventive Services Coverage Case?

On Sept. 19, the Biden administration filed a petition asking the U.S. Supreme Court to review the case Braidwood Management, Inc. v. Becerra, which challenges the legality of the Affordable Care Act’s requirement that nearly all health insurers must cover a slew of preventive services without cost sharing.

Legal experts tell AIS Health, a division of MMIT, that the case could have significant ramifications for patients and the health care industry alike. And they say how it plays out may partly depend on who wins the upcoming elections.

“We’re getting close to four years in terms of when it was filed, but the stakes of this case remain really significant for tens of millions of Americans,” says Zachary Baron, director of the Health Policy and the Law Initiative at the O'Neill Institute. More than 150 million Americans have benefited from no-cost coverage of preventive services, he says, including lung cancer screenings, statins used to lower cholesterol, mammograms, vaccines and birth control.

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State Senator Launches Probe Into Controversial Arizona Medicaid Awards

In the latest twist in Arizona’s controversial quest to implement new statewide long-term care contracts with Centene Corp. and UnitedHealth Group, a Republican state senator said he is looking into the potential mismanagement of state taxpayer dollars by Gov. Katie Hobbs (D). That includes the questionable procurement of Medicaid contracts serving approximately 26,000 elderly and disabled members conducted by the Arizona Health Care Cost Containment System (AHCCCS).

The agency on Dec. 1, 2023, said it selected subsidiaries of Centene and UnitedHealth for contracts that would begin on Oct. 1, 2024. The contracts are worth an estimated $15 billion over seven years. An administrative law judge (ALJ), however, last month agreed with three local not-for-profit plans that the request for proposals process was flawed and should be redone. In a move that sources say is extremely rare, the state ignored the ALJ ruling and said it intends to move forward with the contracts after a one-year delay.

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News Briefs: HHS OIG Seeks $11M in Medicare Overpayments From Humana, Aetna

The HHS Office of Inspector General (OIG) is asking Humana Inc. and a division of CVS Health Corp.’s Aetna to refund the federal government a combined $11 million for estimated overpayments, according to two reports posted on Sept. 25. OIG is seeking $6.8 million from Humana and $4.2 million from Aetna’s HealthAssurance based on extrapolated audit findings. For the Humana audit, the agency examined a random sample of 240 enrollee-years for which Humana submitted high-risk diagnosis codes in 2017 and 2018. It found that for 202 enrollee-years, the claims submitted by Humana to CMS “were not supported by the medical records and resulted in $497,225 in overpayments.” HHS OIG performed a similar analysis for HealthAssurance and found the medical records did not support the diagnosis codes for 222 of the 269 sampled enrollee-years and resulted in $657,744 in overpayments. Humana and Aetna both disagreed with the findings, according to the report.

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News Briefs: Sanders Touts PBM Promise in Pushing for Wegovy, Ozempic Price Cut

Sen. Bernie Sanders (I-Vt.) said during a Senate hearing that major PBMs promised to expand access to Ozempic and Wegovy if Novo Nordisk agrees to lower the list price. In a tense hearing on Sept. 24 held by the Senate Health, Education, Labor and Pensions Committee, Sanders, the committee chair, sought answers from Novo CEO Lars Jorgenson as to why the company’s semaglutide list prices top $1,000 a month in the U.S., noting that the drugs can cost anywhere from $130 to even $59 in other countries. Ozempic and Wegovy, both GLP-1 drugs, treat Type 2 diabetes and obesity, respectively. Sanders challenged Jorgenson to lower the U.S. list price, noting that The Cigna Group’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx pledged to expand coverage of the diabetes and obesity medications. Jorgenson did not commit to a price reduction, saying “I don’t know under which conditions such a promise comes,” but he seemed to remain open to the idea if it helps patients access more affordable medicine. Jorgenson also noted that the $1,000 drug list price is a starting point for payer negotiations and said the company pays 75 cents per dollar received due to discounts, fees and rebates.

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Mileage of FTC Suit Against PBMs May Vary, Experts Suggest

When the Federal Trade Commission (FTC) officially accused the three largest PBMs of artificially inflating insulin prices, it marked the latest move in what has become a protracted effort by federal regulators to rein in the industry’s business practices.

However, experts who spoke to AIS Health say it’s unclear how much of an impact the FTC-driven litigation will have on the market — or whether the complaint itself will survive once the White House gains a new occupant.

Even if the FTC’s lawsuit is “robustly successful,” says Joe Shields, managing director of Transparency-Rx, it is focused on only one drug category. “That’s not meant as a criticism, but the reality is, what that means to the broader aspects of formulary or pharmacy benefit management, it’s an open-ended question,” adds Shields, whose organization of smaller PBMs is pushing for industry reform.

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Transgender Women File Discrimination Lawsuit Against Aetna

Three transgender women filed a lawsuit on Sept. 10 against CVS Health Corp.-owned Aetna alleging the insurer denied them coverage of gender-affirming facial reconstruction (GAFR) surgeries and procedures in violation of an Affordable Care Act statute. David Kaufman, a lawyer who is not involved in the case, tells AIS Health the plaintiffs made a “pretty persuasive argument” in the lawsuit, although he points out that court proceedings are “often a tedious, drawn-out process” and it remains to be seen whether a judge will certify the case as a class action.

The plaintiffs — Binah Gordon, Kay Mayers and an individual identified as S.N. — alleged the surgeries and procedures they sought were medically necessary and that Aetna violated “the prohibition on discrimination on the basis of sex in federally funded health programs and activities under Section 1557” of the ACA. Gordon, a 42-year-old Nebraska resident who works as a language curriculum specialist at a community college, was covered under an Aetna plan in the federal employee health benefits program. Mayers, a 52-year-old Alaska resident who works in information technology, and S.N., a 48-year-old physical therapist from Pennsylvania, were enrolled in Aetna employer-sponsored plans.

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FTC, Express Scripts Trade Legal Salvos

Just days after The Cigna Group’s Express Scripts sued the Federal Trade Commission over an interim report that criticized PBMs, the FTC revealed that it is suing Express Scripts, UnitedHealth Group’s Optum Rx, and CVS Health Corp.’s Caremark for “artificially inflating” insulin prices.

The FTC said its administrative complaint also names the “Big Three” PBMs’ affiliated group purchasing organizations that serve as prescription drug rebate aggregators: CVS’s Zinc Health Services, Cigna’s Ascent Health Services, and UnitedHealth’s Emisar Pharma Services.

The FTC alleges that the three PBMs, which together processing 80% of all prescription drug claims, “created a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices.”

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Twice-Yearly PrEP Shows Promise in Clinical Trials

When the FDA approved the first injectable treatment for HIV pre-exposure prophylaxis (PrEP), the agency hailed the therapy as “an important tool in the effort to end the HIV epidemic” due to its every-two-months regimen, lessening the burden of oral treatments that were taken every day. But a new injectable agent may soon be approved that reduces that treatment burden to twice a year.

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