Specialty Pharmacy SmartBrief
Dozens of generic drugs recalled
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April 18, 2025
Specialty Pharmacy SmartBrief
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Leading News
President Donald Trump signed an executive order that contains elements that could lower and increase the cost of prescription drugs. The order calls for changes in the Medicare drug price negotiation program, and it directs the FDA to make it easier for states to import drugs from Canada and to recommend ways to streamline approvals for generic drugs and biosimilars, among other actions.
Full Story: Axios (4/15),  The New York Times (4/15) 
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Specialty Pharmacy Update
According to a Drug Channels Institute report, the 2024 US specialty pharmacy market was dominated by pharmacies affiliated with the three largest pharmacy benefit managers, together making up two-thirds of specialty drug dispensing revenues, led by CVS Specialty with $77.2 billion. The total specialty prescription dispensing revenue for 2024 was valued at $265 billion, representing an 8% increase from the previous year.
Full Story: Drug Channels (4/16) 
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Glenmark Pharmaceuticals is recalling 39 different generic drugs produced at a facility in India that failed to meet manufacturing standards. Recalled drugs include diltiazem hydrochloride, ranolazine, clindamycin hydrochloride, voriconazole, cetirizine hydrochloride, lacosamide and gabapentin.
Full Story: Health (4/17) 
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Mark Cuban's Cost Plus Drug Co. has partnered with Morris & Dickson to improve the distribution and affordability of injectable drugs across the US, aiming to mitigate drug shortages and include more drug categories moving forward. 
Full Story: Becker's Hospital Review (4/16) 
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The FDA has designated Celltrion's Yuflyma as an interchangeable biosimilar to adalimumab, marking it as the fourth biosimilar to receive this status. Yuflyma is indicated for ulcerative colitis and adult Crohn's disease, along with other conditions.
Full Story: Healio (free registration) (4/15) 
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Legislation & Regulation
Alabama Gov. Kay Ivey signed the Community Pharmacy Relief Act, which restricts harmful practices by pharmacy benefit managers such as directing patients to mail-order or affiliate pharmacies and implementing spread pricing. The law, supported by pharmacy employees across the state who staged a walkout, addresses the recent closures of local pharmacies due to PBM practices.
Full Story: Becker's Hospital Review (4/16) 
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Twelve Republicans sent a letter to House Speaker Mike Johnson, R-La., warning they would not vote for a budget reconciliation package that significantly cuts Medicaid. The House, which previously passed a resolution requiring $1.5 trillion in cuts, is negotiating the extent of reductions amid pressure from the Freedom Caucus for deeper cuts. "We cannot and will not support a final reconciliation bill that includes any reduction in Medicaid coverage for vulnerable populations," the letter said.
Full Story: Axios (4/16) 
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Clinical & Research News
The majority of a CDC work group supports ending universal COVID-19 vaccine recommendations in favor of guidance based on individual risk of severe disease. The proposed change would recommend at least two doses annually for adults 65 and older and those with underlying health conditions. A formal vote by the Advisory Committee on Immunization Practices is expected in June.
Full Story: CBS News (4/15) 
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AZD0780, an investigational drug, shows promise in lowering LDL cholesterol levels in patients who are unable to reach target levels with statin therapy. The oral drug targets PCSK9, a protein involved in cholesterol metabolism, offering a convenient alternative to injectable PCSK9 inhibitors.
Full Story: Medscape (4/16) 
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Trends & Technology
The introduction of AI into the prior authorization process could either improve or complicate the system, experts say. AI has the potential to streamline and accelerate prior authorizations, but it may also increase denial rates and further delay care, especially if the existing system isn't reformed to be more transparent and patient-centered. "The danger of layering AI on top of a broken system is that, while it offers a lot in terms of efficiency, if you introduce more efficiency and speed into that system, you just speed up the rate at which you do bad things," said attorney Amy Killelea, an assistant research professor at Georgetown University's Center on Health Insurance Reforms.
Full Story: Medscape (4/16) 
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One can't fight with oneself, for this battle has only one loser.
Mario Vargas Llosa,
writer, journalist, politician, Nobel Prize in Literature recipient
1936-2025
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