Medicare Part B

News Briefs: KFF Poll Finds Voter Awareness of IRA Drug Pricing Is Low but Improving

Most U.S. voters are unaware of the Medicare drug pricing provisions resulting from the Inflation Reduction Act, although awareness among older voters has improved since November. That’s according to a new KFF poll tracking voters’ perceptions of major health and entitlement programs and how they align with presidential candidates’ views. Of voters aged 65 and older, nearly half (48%) indicated awareness of drug price negotiation — compared with 36% in November — and 40% knew about the annual limit on Part D out-of-pocket prescription drug costs, up from 27% in November. Meanwhile, large shares of voters indicated support for extending some of the prescription drug provisions to all adults with private insurance, which President Joe Biden has proposed, reported KFF.

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News Briefs: Fresenius Kabi Launches First Actemra Biosimilar

Fresenius Kabi AG launched Tyenne (tocilizumab-aazg), the first biosimilar of Roche Group member Genentech USA, Inc.’s Actemra (tocilizumab) to become available in the U.S., the company revealed April 15. The FDA approved the interleukin-6 inhibitor on March 5 in both intravenous and subcutaneous formulations, making it the only Actemra biosimilar approved so far in both. On Sept. 29, 2023, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) as an intravenous formulation only. Fresenius says Tyenne is available now in an intravenous formulation only. The agents are approved for several autoimmune conditions.

Sandoz reached an agreement with Amgen Inc. resolving all patent litigation related to denosumab, Sandoz revealed April 30. The FDA approved Sandoz’s Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) on March 5 as biosimilar to and interchangeable with Amgen’s Prolia (denosumab) and Xgeva (denosumab) for all of their indications. They are the first FDA-approved denosumab biosimilars. The agreement will allow the agents to launch on May 31, 2025, or earlier “under certain circumstances if customary acceleration provisions are triggered.”

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Stelara Formulations, White Bagging Bring Complexity to IRA Negotiated Drug List

As CMS engages in the initial round of Inflation Reduction Act (IRA)-mandated drug price negotiations with manufacturers, one of the agents on the list of Medicare Part D drugs to be negotiated has certain aspects that make it a not-so-straightforward candidate. Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson has particular qualities that could result in unintended consequences, asserts one industry expert.

Stelara is unique among the first drugs to be negotiated in that it is available in both subcutaneous and intravenous formulations. The human interleukin-12 and -23 antagonist is approved for subcutaneous use for the treatment of people at least 6 years old with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 with active psoriatic arthritis. It also is approved for the treatment of adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis, for whom treatment is initiated with a single intravenous dose, followed by subcutaneous maintenance dosing.

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Alternative Payment Policies May Help Medicare Part B Reap Greater Savings From Biosimilars

The growing use of biosimilars has reduced spending in the Medicare Part B program, but there are opportunities to further reduce costs — through greater use of more affordable biosimilars and through the implementation of different payment policies, according to a study published by the HHS Office of Inspector General (OIG).

The OIG analyzed the average sales prices, utilization and costs of 21 biosimilar drugs and their reference biologic products in the Medicare Part B program between 2015 and 2021. The agency found that overall use rate of biosimilars in Part B jumped from 18% in 2015 to 62% in 2021. While the adoption of biosimilars has lowered both the prices of biologics and biosimilars, Part B spending could have been reduced by $179 million in 2021 if the five biosimilars that cost less than their reference products — epoetin alfa, infliximab, bevacizumab, rituximab and trastuzumab — had been used at the same rate as the most widely used biosimilar, filgrastim.

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Coding Intensity, Favorable Selection Fuel MedPAC’s Push for MA Pay Reform

In its latest report to Congress, the Medicare Payment Advisory Commission (MedPAC) asserted that the federal government now pays approximately 22% more for Medicare Advantage enrollees than it would if they were enrolled in traditional fee-for-service (FFS) Medicare, for projected higher spending of $83 billion in 2024. That figure came in slightly below projections provided at a January meeting but higher than MedPAC’s previously estimated differences in spending, largely because it accounted for favorable selection. And while the commission said it “strongly supports the inclusion of private plans in the Medicare program,” it maintains that the current payment system is ripe for reform.

According to MedPAC’s latest Report to the Congress: Medicare Payment Policy, released March 15, the federal government in 2023 paid MA plans roughly $455 billion for serving approximately 31.6 million enrollees — 52% of Medicare beneficiaries with both Parts A and B coverage.

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Alternative Payment Policies May Help Medicare Part B Reap Greater Savings From Biosimilars

The growing use of biosimilars has reduced spending in the Medicare Part B program, but there are opportunities to further reduce costs — through greater use of more affordable biosimilars and through the implementation of different payment policies, according to a study published by the HHS Office of Inspector General (OIG).

The OIG analyzed the average sales prices, utilization and costs of 21 biosimilar drugs and their reference biologic products in the Medicare Part B program between 2015 and 2021. The agency found that overall use rate of biosimilars in Part B jumped from 18% in 2015 to 62% in 2021. While the adoption of biosimilars has lowered both the prices of biologics and biosimilars, Part B spending could have been reduced by $179 million in 2021 if the five biosimilars that cost less than their reference products — epoetin alfa, infliximab, bevacizumab, rituximab and trastuzumab — had been used at the same rate as the most widely used biosimilar, filgrastim.

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Stelara Formulations, White Bagging Bring Complexity to IRA Negotiated Drug List

As CMS engages in the initial round of Inflation Reduction Act (IRA)-mandated drug price negotiations with manufacturers, one of the agents on the list of Medicare Part D drugs to be negotiated has certain aspects that make it a not-so-straightforward candidate. Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson has particular qualities that could result in unintended consequences, asserts one industry expert.

Stelara is unique among the first drugs to be negotiated in that it is available in both subcutaneous and intravenous formulations. The human interleukin-12 and -23 antagonist is approved for subcutaneous use for the treatment of people at least 6 years old with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 with active psoriatic arthritis. It also is approved for the treatment of adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis, for whom treatment is initiated with a single intravenous dose, followed by subcutaneous maintenance dosing.

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‘Sleeper Issue:’ How Part B Drugs May Be Impacted by Medicare Part D Redesign

Physician-administered drugs could catch some windfall due to the Inflation Reduction Act’s Medicare Part D redesign.

Much time and energy has been focused on thinking about how drug pricing, rebating and Part D plan design may shift due to changes set to finish taking effect in 2025, including new caps on enrollee out-of-pocket spend and more liability falling on plans rather than taxpayers.

But a “sleeper issue here is what all of this is going to mean for Medicare Part B drugs,” said Avalere’s Kesley Lang on a January webinar on the health policy outlook for the new year.

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Troubled by Too Many Plan Options, MedPAC Agrees to Pursue MA Benefits Standardization

To help overwhelmed seniors make better Medicare Advantage plan comparisons, the Medicare Payment Advisory Commission (MedPAC) nearly a year ago began discussing the concept of standardizing a limited number of common supplemental benefits in MA. During its September public meeting, MedPAC agreed to devote a chapter of its June 2024 report to standardizing select MA benefits, while several commissioners echoed previous sentiments about striking a balance between standardization and flexibility.

At its November 2022 public meeting, the independent congressional agency considered two different approaches: (1) standardizing a limited number of common supplemental benefits, such as dental, hearing and vision, and (2) standardizing Medicare Parts A and B services, whereby plans use a limited number of benefit packages. But some commissioners at the time expressed concern about potentially hampering MA plan innovation.

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House Inches Closer to Passing Hospital-Feared, Payer-Loved ‘Site-Neutral’ Reforms

The House is reportedly poised to vote soon on legislation that consolidates a host of previously introduced health care measures — including a step toward site-neutral payment reform. Aimed at stopping “price gouging” by hospital outpatient departments (HOPDs), those provisions are enthusiastically supported by payers but opposed by the hospital industry, which argues that they would result in payment reductions.

The legislation also would codify existing regulations that lay out new price transparency requirements for health plans and hospitals, and it would implement modest PBM reforms.

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