Radar on Specialty Pharmacy
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News Briefs: Draft NBPP Did Not Address Accumulators
HHS did not address copay accumulators in the 2026 proposed Notice of Benefit and Payment Parameters (NBPP), as patient advocacy groups had hoped it would. Rather, the agency said that it and the Departments of Labor and Treasury plan to issue a future notice of proposed rulemaking that addresses “the applicability of drug manufacturer support to the annual limitation on cost sharing.” Posted online on Oct. 4 and published in the Federal Register on Oct. 10, the proposed NBPP also did not align the use of copay maximizers, which declare certain drugs non-essential health benefits, in large group market plans and self-funded group plans with HHS’s stance barring the use of maximizers in nongrandfathered individual and small group market plans, as stated in the final 2025 NBPP. -
Optum Subsidiary Nuvaila Will Offer Biosimilars of Stelara, Humira
Optum Rx recently revealed that Optum Health Solution’s new biosimilars-focused, private-label subsidiary will join the other two big PBMs’ similar offerings. On Jan. 1, 2025, two Nuvaila-labeled biosimilars will be added to three of its commercial formularies — and for a $0 copay.
Amgen Inc.’s Wezlana (ustekinumab-auub), an interchangeable biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine, will be added to Optum Rx’s commercial formulary on Jan. 1, 2025, the PBM revealed. The agent will be provided as a private-label product from Nuvaila — known as Wezlana for Nuvaila — and will be available in both high-wholesale acquisition cost and low-WAC versions.
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Evernorth Reveals Stelara Biosimilar Strategy, but Will Others Get Same Discount?
Ahead of the much-anticipated launch of the next wave of biosimilars for a high-cost specialty drug, The Cigna Group’s Evernorth Health Services has said that it will roll out a program to manage the drugs that is similar to one it first began offering this summer. But several aspects of the upcoming launch remain unclear, including whether the discount provided for the new drug will be available to all payers.
Evernorth revealed on Sept. 5 that it will offer an interchangeable biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine for $0 for “eligible patients” of Accredo starting “early next year.” The agent will be produced by Quallent Pharmaceuticals, Cigna’s private-label subsidiary.
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As Biden Admin Winds Down, Will It Address Accumulators, Maximizers as Promised?
As President Joe Biden’s administration nears its end, two promised rules on copayment accumulators and maximizers have yet to be released. They stand to have a huge impact on whether pharma manufacturer-provided patient assistance — much of which is provided for specialty drugs — must be counted toward patients’ out-of-pocket responsibility.
The first concerns a lawsuit over the 2021 Notice of Benefit and Payment Parameters (NBPP) and its stance toward copay accumulators.
Health plans and PBMs several years ago began implementing accumulators to counter manufacturer copay assistance programs. Traditionally, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.
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Quantile Health Wants to Help Self-Insured Plans Access CGTs
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.
