Medicare Part D

HHS Floats Trio of Drug Pricing Models, Some More Ambitious Than Others

In response to an executive order issued last fall, HHS recently unveiled three new prescription drug pricing models that it wants the CMS Innovation Center to test. The models — which target low-cost generics, cell and gene therapies and drugs that received accelerated approval — are likely to diverge considerably when it comes to industry reception and likelihood of speedy implementation, experts say.

“One of the things I really like about the three models that have been proposed is that they touch on really different aspects of affordability and access, and different programs that CMS oversees,” says Stacie Dusetzina, Ph.D., a health policy professor at the Vanderbilt University School of Medicine. “So it was encouraging to me to see, for example, a model that was focused on gene and cell therapies and Medicaid programs, in addition to two very different groups within the Medicare programs: one being high-cost drugs approved through accelerated approval, and the other being drugs that we typically think of as being low-cost, but that maybe we could be...making more affordable to seniors — including high-value generic drugs offered on Part D.”

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Evercore ISI Addresses Some IRA Issues, Unveils List of Potential Negotiated Drugs

On Sept. 1, CMS will publish its list of 10 Medicare Part D drugs that it has chosen for negotiations for 2026, the first year that negotiated prices will be in effect via the Inflation Reduction Act (IRA). But a lot of unknowns exist around the law, including how CMS will determine the drugs up for negotiation. During an Evercore ISI webinar held Jan. 30, analysts broke down this aspect of the IRA and shared the drugs and manufacturers they expect to be impacted.

“We are looking at an escalating number of drugs subject to negotiation starting in 2026,” noted Tobin Marcus, policy analyst at Evercore ISI. “There’s been some misunderstanding about the fact that these numbers are cumulative.” So while 2026 will have 10 drugs up for negotiation, 2027 will have an additional 15 Part D drugs for a total of 25 for the year. The following year will see an additional 15 Part D and Part B drugs, and then starting in 2029 and later years, 20 more Part D and Part B agents will be up for negotiation.

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Medicare Price Negotiation Simulation Shows Substantial Savings, Despite Restrictions

The U.S. will likely save billions of dollars in the first few years of Medicare drug price negotiation — a provision of the Inflation Reduction Act (IRA) — suggests a recent study published in JAMA Health Forum. Acting as though the IRA had been implemented from 2018 to 2020, researchers from Harvard Medical School and Brigham and Women’s Hospital created a simulation of the drug selection process, and found that Part D and Part B drug spending would have been reduced by 5% — $26.5 billion — over those three years.

Overall, 40 drugs were selected. CMS’s criteria are strict — spending on each drug must exceed $200 million in the year prior to its selection, and products must have been on the market for at least nine years (or 13, if the drug is a biologic). Selected therapies cannot have any generic or biosimilar alternatives, and orphan drugs and plasma-derived products are also ineligible. Then, the negotiated price must fall below a drug’s “ceiling price,” which is determined by the lesser of two figures: the average net price of a drug after its existing rebates and discounts, or between 40%-75% of the drug’s nonfederal average manufacturer (non-FAMP) price, depending on the drug’s age.

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Economy, IRA, Pharma Competition May Impact Industry in 2023

The pharmaceutical industry likely will continue to battle challenges posed by a variety of factors in 2023, including global economic issues, competition and the Inflation Reduction Act (IRA). The biosimilars space in particular is expected to undergo a change as the world’s top selling drug, AbbVie Inc.’s Humira (adalimumab), finally faces competition from a number of companies. But industry experts tell AIS Health, a division of MMIT, that they expect a number of positive developments in the space in 2023.

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Medicare Enrollees May Still Face Affordability Issues After Part D Benefit Redesign

About 800,000 Medicare beneficiaries in 2024 and 200,000 in 2025 could see their out-of-pocket (OOP) medication costs exceed 10% of their annual income, even with the Part D drug benefit reforms passed via the Inflation Reduction Act (IRA), according to an Avalere analysis.

The IRA will establish a beneficiary OOP cap at the catastrophic threshold, which is estimated to be $3,233 in 2024. Avalere estimated that 1.5 million Part D enrollees without low-income subsidies (LIS) are projected to reach OOP drug spending levels above the catastrophic threshold in 2024. Among them, about 18% of beneficiaries will reach the catastrophic phase in the first three months. Greater shares of beneficiaries who are younger than 65 years old or who are Hispanic will face affordability challenges compared to the average non-LIS enrollees. The analysis also suggested that non-LIS enrollees taking asthma drugs, blood thinners, immunology therapies, cancer treatments and HIV drugs are more likely to reach the OOP cap in 2024.

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Testing New Modules

As part of a sweeping new Medicare Advantage rule, CMS recently proposed a policy aimed at reforming a reimbursement system that local pharmacies have long claimed is straining them to the breaking point. PBMs, on the other hand, argue that the proposal could hamper value-based contracting in Part D and potentially increase Medicare spending.

At issue are arrangements in which Part D plan sponsors can recoup money from pharmacies for dispensed drugs if the pharmacies do not meet certain metrics. Generally speaking, these payments to plan sponsors are known as price concessions, and when assessed retrospectively — as they currently are — they are counted as direct and indirect remuneration (DIR).

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Diabetes Patients Fare Better With Medicare Advantage, Study Suggests

New research conducted by Avalere on behalf of the Better Medicare Alliance (BMA) suggests Medicare Advantage plans aid in earlier detection of type 2 diabetes and that seniors diagnosed with type 2 diabetes generally fare better than similar patients in fee-for-service (FFS) Medicare. Specifically, lower medical spending and rates of inpatient hospitalizations/emergency department visits observed by researchers may be particularly compelling for policymakers as they consider the overall value of the MA program.

With MA serving more seniors than ever before — having just reached a milestone of enrolling more than 30 million Medicare-eligible beneficiaries — and one-third of seniors estimated to have a diagnosis of type 2 diabetes, it is important to look at how these patients’ care differs in MA vs. traditional Medicare, asserted Matt Kazan, managing director with Avalere, during a Jan. 12 webinar hosted by BMA. In many cases, there are “major differences,” he noted.

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Medicare Enrollees May Still Face Affordability Issues After Part D Benefit Redesign

About 800,000 Medicare beneficiaries in 2024 and 200,000 in 2025 could see their out-of-pocket (OOP) medication costs exceed 10% of their annual income, even with the Part D drug benefit reforms passed via the Inflation Reduction Act (IRA), according to an Avalere analysis.

The IRA will establish a beneficiary OOP cap at the catastrophic threshold, which is estimated to be $3,233 in 2024. Avalere estimated that 1.5 million Part D enrollees without low-income subsidies (LIS) are projected to reach OOP drug spending levels above the catastrophic threshold in 2024. Among them, about 18% of beneficiaries will reach the catastrophic phase in the first three months. Greater shares of beneficiaries who are younger than 65 years old or who are Hispanic will face affordability challenges compared to the average non-LIS enrollees. The analysis also suggested that non-LIS enrollees taking asthma drugs, blood thinners, immunology therapies, cancer treatments and HIV drugs are more likely to reach the OOP cap in 2024.

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MA, Part D Plans Face New Premium Calculus With Drug Price Negotiation

The coming year is unlikely to see any major new policy developments come out of the split Congress, but health insurers and other stakeholders will have their hands full figuring out the implications of the Inflation Reduction Act’s (IRA) Medicare drug price negotiation policy, according to a Jan. 18 panel of Avalere Health experts.

Last November’s election led to divided control of Congress, with Republicans in control of the House of Representatives and Democrats in control of the Senate. Given that, “the activity this year, over the next two years, is going to look quite a bit different than we saw in Congress from the previous two years,” said Matt Kazan, managing director at Avalere.

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Industry Will Continue to See 340B, Patient-Paid Prescription Impact as IRA Looms

The pharmaceutical industry and the broader health care services market currently are experiencing a series of trends that are likely to persist into 2023, said Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a Dec. 16 webinar titled Drug Channels Outlook 2023. These include pressure on insurers’ traditional coverage of generics from patient-paid prescriptions, ongoing 340B litigation and providers’ increased presence within the specialty pharmacy market. But the impact of the biggest disruption, the Inflation Reduction Act (IRA), is yet to come. In this second of a two-part series, AIS Health highlights these trends projected by the longtime industry expert.

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