Highlights

• Cyltezo (adalimumab-adbm) is launched as the first interchangeable biosimilar to Humira.
• Centers for Medicare and Medicaid Services (CMS) outlines coverage plan for new Alzheimer’s drugs
• FDA and Novo Nordisk take steps to address unauthorized acquisition of GLP-1 drug semaglutide
• CVS Caremark partners with GoodRx to launch the Caremark Cost Saver program

FDA Approvals and Launches

• Cyltezo (adalimumab-adbm) is launched as the first interchangeable biosimilar to Humira.
• Roctavian (valoctocogene roxaparvovec-rvox) is approved as a one-dose treatment for patients with hemophilia A.
• The list price for this gene therapy treatment is expected to cost around $2.5 million per dose.
• Opill (norgestrel) is approved as the first over-the-counter (OTC) oral contraceptive.
• Leqembi (lecanemab-irmb) is approved to treat patients in the early stages of Alzheimer’s disease.
• Ycanth (cantharidin) is approved to treat molluscum contagiosum, a type of viral skin infection.

News

Centers for Medicare and Medicaid Services (CMS) outlines coverage plan for new Alzheimer’s drugs

• The press release is likely in response to the approval of Alzheimer’s drug Leqembi (lecanemab) which received traditional FDA approval.
• Coverage for Aduhelm (aducanumab) differs due to being approved under the accelerated approval process.

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FDA and Novo Nordisk take steps to address unauthorized acquisition of GLP-1 drug semaglutide

• Novo Nordisk has filed lawsuits against several spas and wellness clinics for selling products claiming to contain semaglutide, the active ingredient in Ozempic, Rybelsus, and Wegovy.
• The FDA published public guidance warning against purchasing semaglutide from unauthorized sources.

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CVS Caremark partners with GoodRx to launch the Caremark Cost Saver program

• The program allows members to leverage GoodRx’s prescription pricing when it is lower than pricing through their own pharmacy benefits plan.
• The program will be offered to CVS Caremark clients at no charge and will be effective starting in January 2024.

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Optum publishes Summer 2023 editions of its “Drug Pipeline Insights” and “Regulations to Watch” reports

• Three “drugs to watch” include treatments for depression, geographic atrophy, and atopic dermatitis.
• Several laws on both a state and federal level have addressed pharmacy benefits topics such as spread pricing, pass-through rebates to plan sponsors, and steerage towards preferred pharmacies and pharmacy networks.

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Drug wholesaler indicted on charges of fraud involving the distribution of HIV drugs

• Diversion of drugs occurred through “buyback” schemes in which cash payments were used to purchase dispensed HIV drugs from patients and subsequently redistributed.

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Senator Bill Cassidy publishes op-ed proposing strategies for lowering drug prices

• The senator is a former practicing physician and the current ranking member of the Senate Health, Education, Labor, and Pensions (HELP) committee.
• Topics discussed include the “parking” of 180-day exclusivity status for generics, the 340B program, and PBM pricing incentives regarding rebates.

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Drug Channels examines the Humira biosimilar market

• The article discusses the connection between rebates and list prices as well the incentives that each stakeholder in the distribution chain may have when deciding which products to prefer.

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International Foundation of Employee Benefit Plans (IFEBP) publishes 2022 employee benefits survey results

• The survey includes data from 502 organizations around the country and reports on a “wide range of benefit offerings.”
• 22% of surveyed employers reported coverage of prescription drugs for weight loss.

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Investigational weight loss drug retatrutide produces up to 17.5% mean weight reduction in phase 2 trial

• The drug combines different mechanisms of action in a once-weekly, subcutaneously dosed treatment.
• Four phase 3 trials, known as the TRIUMPH program, are currently underway to evaluate safety and efficacy in a larger sample size of patients.

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