A Medicare Part D policy forbidding plan sponsors’ formularies from excluding nearly all drugs in six “protected” classes hinders payers’ ability to negotiate prices and may lead to significantly higher costs to the health care system, according to a recent analysis published in Health Affairs. The study’s lead author notes this is the first peer-reviewed trial suggesting Part D plans “can’t negotiate as high of rebates as they might otherwise be able to” for drugs in the protected classes.

HealthCare.gov enrollees have more health plan options in 2025 compared to previous years, yet the average benchmark plan premium in states that use the federal enrollment platform increased modestly, according to CMS.

In most states, the open enrollment period for Affordable Care Act marketplace coverage runs from Nov. 1, 2024, to Jan. 15, 2025. Out of the 31 states that are using HealthCare.gov, eight have more Qualified Health Plan (QHP) issuers in 2025 than in 2024, and 97% of enrollees have access to three or more issuers, compared to 78% in 2021. Seven HealthCare.gov states have counties with a single QHP issuer in 2025, compared to nine states in 2024. Georgia stopped using HealthCare.gov in 2024 and transitioned to a state-run exchange, and Illinois is scheduled to move to a state-based marketplace for the 2026 plan year.

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.

In the seven years since the approval of the first chimeric antigen receptor T-cell (CAR-T) therapy, the agents have proved to be effective in the treatment of non-Hodgkin lymphoma. But the one-time-use agents come with risks, including the potentially fatal cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), so the FDA requires patients remain near their treatment center for four weeks after administration, which can be onerous for patients. But a recent study finds that side effects were rare after the first two weeks post-infusion, perhaps helping lead to less of a burden for patients.

An article in Blood Advances, a journal of the American Society of Hematology, revealed the findings of a retrospective study of 475 patients who received three CD19-directed CAR-Ts at nine different centers: Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. subsidiary Kite Pharma, Inc., Novartis Pharmaceuticals Corp.’s Kymriah (tisagenlecleucel) and Breyanzi (lisocabtagene maraleucel) from Juno Therapeutics, Inc., a Bristol Myers Squibb company.

Premiums for many stand-alone Medicare Part D Prescription Drug Plans will go up moderately in 2025, while the number of PDP options for beneficiaries will drop significantly, according to AIS Health’s analysis of the recently released CMS Medicare Advantage and Part D landscape files.

The Inflation Reduction Act, passed in 2022, ushered in a host of policy changes to the Part D benefit that will take effect in 2025: Most notably, Medicare Part D beneficiaries’ out-of-pocket drug costs will be capped at $2,000 annually and Part D plan sponsors will be responsible for 60% (up from 20%) of any costs their enrollees incur beyond that cap. As a result, the Medicare Part D national average monthly bid amount (NAMBA) is projected to increase by $115, nearly 180%, to $179.45 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.

Founded in the 1930s by a Washington, D.C.-based hospital association, CareFirst BlueCross BlueShield is now one of the largest insurers in the Washington metropolitan area, leading the Maryland market and earning the No. 2 spot in the District. It largely offers commercial health products, including plans sold on the Affordable Care Act exchanges in D.C., Maryland and Virginia, as well as Medicare Advantage and Medicaid plans in Maryland. The insurer is relatively new to the public sector — it began offering MA products for the first time in 2021 and entered the Medicaid space via its 2020 acquisitions of Trusted Health Plan and the University of Maryland Medical System's Health Partners. CareFirst later lost its D.C. Medicaid contract in 2022, following a hotly contested bidding process. CareFirst is also the second-largest participant in the Federal Employee Health Benefits Program, behind Elevance Health, with about 635,000 members.

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.