Radar on Specialty Pharmacy
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Cell and Gene Therapies Pose Multiple Challenges but No Easy Solutions
While health care payers are facing a variety of issues, paying for multimillion-dollar cell and gene therapies (CGTs) is one of the most pressing, as evidenced by sessions at two recent AHIP conferences. Multiple speakers discussed various approaches to the agents, as well as challenges payers need to tackle, but all acknowledged that a truly successful model has yet to be implemented.
Many CGTs are in the pipeline, impacting potentially millions of patients and prompting many questions around affordability and accessibility, stated Sean Dickson, senior vice president of pharmaceutical policy at AHIP, during a session in Baltimore titled “Cell and Gene Therapies: Regulatory Updates and Coverage Policies.” “Oncology is where it will get really interesting,” and these agents will have the greatest impact on Medicare payers.
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New FDA Approvals: FDA Expanded Mircera’s Patient Population
April 30: The FDA expanded the patient population of CSL Vifor’s Mircera (methoxy polyethylene glycol-epoetin beta) to include the treatment of anemia associated with chronic kidney disease in pediatric patients 3 months old to 17 years old on dialysis and not on dialysis who are converting from another erythropoiesis-stimulating agent after their hemoglobin level was stabilized with an ESA. The agency also approved a subcutaneous route of administration for pediatric patients. The FDA first approved the long-acting ESA on Nov. 14, 2007. Dosing for the newest use is once every four weeks based on total weekly epoetin alfa or darbepoetin alfa dose at the time of conversion. The agent is available in both intravenous and subcutaneous formulations, and patients younger than 6 years old should maintain the same route of administration as the previous ESA. Drugs.com lists the price of one 75 mcg/0.3 mL injectable solution as more than $237.
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News Briefs: Multiple Developments Around Biosimilar Humiras Occurred
Multiple developments around biosimilar versions of AbbVie Inc.’s Humira (adalimumab) have occurred. Teva Pharmaceuticals, a unit of Teva Pharmaceuticals Industries Ltd., and Alvotech launched Simlandi (adalimumab-ryvk) in the U.S., the companies disclosed on May 20. The FDA approved the interchangeable, high-concentration, citrate-free drug on Feb. 23 for nine of its reference drug’s indications.…Boehringer Ingelheim said on May 13 that it had signed an agreement with Quallent Pharmaceuticals, a private-label pharmaceutical distributor that is a wholly owned subsidiary of The Cigna Group, to offer both high- and low-concentration, citrate-free versions of adalimumab-adbm through a copay assistance program. The tumor necrosis factor (TNF) inhibitor’s interchangeable designation applies to the low-concentration version. Boehringer will continue to commercialize that agent and its branded version, Cyltezo, which has approval for nine of Humira’s indications.…Celltrion USA has made its high-concentration, citrate-free adalimumab-aaty available at a low wholesale acquisition cost that is an 85% discount to Humira’s WAC, the company revealed on May 9. Its branded version, Yuflyma, remains available at a 5% discount to Humira’s WAC. The agent is approved for eight of Humira’s indications.
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PBM Moves Spur Humira Biosimilar Uptake but Raise Questions
The FDA has approved 10 biosimilars of AbbVie Inc.’s Humira (adalimumab), with nine of them launching in the U.S. since last year, but uptake of them has been relatively slow. Recently, though, a formulary change by CVS Health seems to have spurred uptake of the agents, and an upcoming change by The Cigna Group should boost their use again. However, some industry experts question whether those changes were made with an eye on increasing biosimilar access — or boosting their own profits.
On April 25, Evernorth Health Services, a subsidiary of Cigna, revealed that it will have a high- and low-concentration interchangeable Humira biosimilar for zero dollars in out-of-pocket costs for “eligible patients” of its specialty pharmacy, Accredo, starting in June. The product, according to a press release, “will be produced for Evernorth’s affiliate private label pharmaceutical distributor, Quallent Pharmaceuticals, through agreements with multiple manufacturers.”
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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 report, 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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