Newsletter
Pharmacy Briefing | July 2023
29 August 2023
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.
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.
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.
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.
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.
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.
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.
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.
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.