Medicare Part B

Over half of Medicare Advantage enrollees were in plans that applied step therapy to the 10 most commonly used rheumatoid arthritis (RA) medications covered by Medicare Part B in 2023, according to a recent Avalere analysis.

Since 2019, CMS has given MA plans the ability to use step therapy protocols — meaning a patient may be required to try a less expensive drug before moving to the more expensive one — for physician-administered and other Part B medications. Avalere analyzed MA plans’ annual medical policy and formulary restrictions for 22 RA drugs from 2018 to 2023 and found that the percentage of MA beneficiaries in plans that use step therapy has increased steadily since 2019. For two of the drugs studied, 78% of enrollees were in MA plans that applied step therapy in 2023.

Over half of Medicare Advantage enrollees were in plans that applied step therapy to the 10 most commonly used rheumatoid arthritis (RA) medications covered by Medicare Part B in 2023, according to a recent Avalere analysis.

Since 2019, CMS has given MA plans the ability to use step therapy protocols — meaning a patient may be required to try a less expensive drug before moving to the more expensive one — for physician-administered and other Part B medications. Avalere analyzed MA plans’ annual medical policy and formulary restrictions for 22 RA drugs from 2018 to 2023 and found that the percentage of MA beneficiaries in plans that use step therapy has increased steadily since 2019. For two of the drugs studied, 78% of enrollees were in MA plans that applied step therapy in 2023.

While home infusion has been an option for patients for decades, the space continues to evolve. Within this landscape, providers must successfully execute the contracting process with PBMs and government and commercial insurers, navigating various pitfalls along the way.

Attorney Jesse Dresser, a partner in law firm Frier Levitt’s life sciences department who heads the firm’s pharmacy practice group and frequently helps pharmacies and pharmacy providers on issues with payers and PBMs, moderated a panel discussion titled “Strategies for Successful Payer and PBM Contracts in Home Infusion” at the National Home Infusion Association’s (NHIA) annual conference, held March 23 through 27 in Austin, Texas.

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.

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.”

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.

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.

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.

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.

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.