Biosimilars

Studies: IRA Will Spur Medicare Biosimilar Adoption — and Shift Costs to Part D Plans

Medicare Part D plans are likely to revise their biosimilar formulary management policies as a result of recent regulatory changes, not least the Inflation Reduction Act (IRA). Part D payers will also be on the hook for a greater share of the cost of biosimilars going forward.

A study in Health Affairs released in May makes the case that the longstanding gap in the coverage of biosimilar products between employer-sponsored insurance plans and Medicare Part D plans is likely to shrink in 2025, when several key components of the IRA take effect.

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2023 Drug Trends Included GLP-1s, Humira Biosimilars, $0 Cost Share

Notable pharmacy benefit trends in 2023 claims data included increased use of GLP-1s for weight loss, shifting market dynamics amid high demand for AbbVie Inc.'s Humira (adalimumab) and its biosimilar competitors and increasing approval of expensive gene therapies. All this took place amid “persistent price inflation” across most drug categories, according to a new report by PBM analytics firm Xevant.

According to Xevant’s 2023 Drug Trend Report, which analyzed pharmacy claims data from its commercial plan clients, 2023 plan-paid amounts across all brand and generic non-specialty and specialty drugs went up an average of 20% from 2022. In addition, the number of specialty prescriptions processed by plans increased by 11% in 2023. GLP-1 utilization increased by 400%, while claims for Humira and its biosimilars increased by 25%.

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News Briefs: Optum Rx Unveils New Pricing Model Starting in 2025

Optum Rx announced on May 20 a new program, Clear Trend Guarantee, that will combine guarantees into a single per member cost metric. The PBM will make Clear Trend Guarantee available to plan sponsors starting on Jan. 1, 2025. In a press release, Optum Rx described Clear Trend Guarantee as “an alternative, guarantee-based pricing model that combines retail, home delivery, specialty drug and rebate components into one per member guarantee” and said the program would “ultimately deliver value to individuals and families who want predictability in their premiums and drug costs.” Meanwhile, Patrick Conway, Optum Rx’s CEO, wrote in a May 22 LinkedIn post that Clear Trend Guarantee “means plan sponsors will have another option to manage their pharmacy spend with greater predictability and choice to help manage lowest net cost.” Optum Rx last year announced other alternative pricing models, including a pass-through model using average ingredient costs.

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Specialty Drug Benefits Survey Spotlights Gene Therapy, Biosimilar Strategies

While over 90% of health plans receive specialty medication rebates under the pharmacy benefit, the receipt of medical-benefit rebates has risen in the past one to two years, according to the 2024 Trends in Specialty Drug Benefits Report, published by Pharmaceutical Strategies Group, an EPIC company. The report also covered topics like the management strategies of Humira biosimilars and the financial risk associated with cell and gene therapy.

The report is based on responses from 185 benefits leaders from employers, unions/Taft-Hartley plans and health plans representing plan sponsors of approximately 86.6 million covered lives, conducted from Sept. 18, 2023, through Oct. 13, 2023.

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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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Specialty Drug Benefits Survey Spotlights Gene Therapy, Biosimilar Strategies

While over 90% of health plans receive specialty medication rebates under the pharmacy benefit, the receipt of medical-benefit rebates has risen in the past one to two years, according to the 2024 Trends in Specialty Drug Benefits Report, published by Pharmaceutical Strategies Group, an EPIC company. The report also covered topics like the management strategies of Humira biosimilars and the financial risk associated with cell and gene therapy.

The report is based on responses from 185 benefits leaders from employers, unions/Taft-Hartley plans and health plans representing plan sponsors of approximately 86.6 million covered lives, conducted from Sept. 18, 2023, through Oct. 13, 2023.

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PBMs’ 1Q Earnings Calls Are All About Biosimilar, GLP-1 Programs

During their first-quarter earnings calls, the companies that own the three largest PBMs shared a wealth of details about how the market is responding to their new programs targeting GLP-1 and biosimilar drugs. Wall Street analysts noted that those remarks offered a welcome highlight amid decidedly mixed results in the firms’ health insurance divisions.

The Cigna Group CEO David Cordani opened his prepared remarks during the company’s May 2 earnings call by spotlighting the company’s “focus on biosimilars to drive greater affordability,” calling it one of Cigna’s key strategic growth drivers.

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New FDA Approvals: FDA Approves AstraZeneca’s Voydeya

March 29: The FDA approved Alexion, AstraZeneca Rare Disease’s, Voydeya (danicopan) as an add-on therapy to ravulizumab (currently available as the company’s Ultomiris) or eculizumab (currently available as the company’s Soliris) for the treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria. The agent is a first-in-class factor D inhibitor, and it has breakthrough therapy designation. Initial dosing for the tablet is 150 mg three times a day, which can be increased to 200 mg three times a day. Drugs.com lists the price of 180 50 mg-100 mg tablets as more than $4,359.

April 5: The FDA expanded the patient population of AstraZeneca’s Fasenra (benralizumab) to include the add-on maintenance treatment of people aged 6 to 11 with severe asthma with an eosinophilic phenotype. The agency first approved the interleukin-5 receptor alpha-directed cytolytic monoclonal antibody on Nov. 14, 2017. Dosing for the newest indication for pediatric patients weighing less than 35 kg is 10 mg via subcutaneous injection every four weeks for the first three doses and then once every eight weeks; for those at least 35 kg, dosing is 30 mg every four weeks, followed by once every eight weeks. The list price for one 30 mg/mL solution is $5,511.41.

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AMCP Panel Details Barriers to Broad Biosimilar Adoption

For biosimilar use to truly take flight, health plans need to focus on easing switches between original products and reference products — and policymakers should consider expanding interchangeability, according to expert presenters at the Academy of Managed Care Pharmacy (AMCP) annual conference in New Orleans.

There is a lot of "promise" and "optimism" around biosimilars, said Cate Lockhart, Pharm.D., Ph.D., executive director of the Biologics and Biosimilars Collective Intelligence Consortium, during an April 17 panel at the AMCP conference, but there is more that could be done to increase systemic savings and improve patient access.

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Payers Continue to Employ Array of Specialty Drug Management Strategies

Rebates continue to be a huge part of the specialty pharmacy space, with 93% of respondents to a recent survey receiving them for drugs in the pharmacy benefit. Meanwhile, 44% of respondents said their firm received rebates for medical benefit drugs, representing an increase from 39% in the prior year’s survey. Those are just some of the findings in the Trends in Specialty Drug Benefits Report from Pharmaceutical Strategies Group (PSG), an EPIC company.

The 11th annual survey, which reflects 2023 information, was fielded from Sept. 18 through Oct. 13, 2023. The primary source of respondents was PSG’s proprietary database of drug benefit decision makers, and they included people from employers, health plans (or third-party administrators or insurance companies) or union/Taft-Hartley plans. There were 185 benefits leaders from plan sponsors with an estimated 86.6 million lives.

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