Highlights
- Pfizer-BioNTech COVID-19 Vaccine, marketed as Comirnaty, is approved to help prevent COVID-19 infection
- Semglee (insulin glargine) is approved as the first interchangeable biosimilar product to treat diabetes
- President Biden signs executive order addressing prescription drug pricing
- Alzheimer’s treatment Aduhelm (aducanumab) remains non-covered by some plans and providers
- EvaluatePharma publishes “World Preview 2021, Outlook to 2026” Report
FDA Approvals and Launches
- Pfizer-BioNTech COVID-19 Vaccine, marketed as Comirnaty, is approved to help prevent COVID-19 infection.
- Semglee (insulin glargine) is approved as the first interchangeable biosimilar product to treat diabetes.
- The product is interchangeable with Lantus (insulin glargine) and will have biosimilar exclusivity for one year.
- Vaxneuvance (pneumococcal 15-valent conjugate vaccine) is approved to help prevent pneumococcal disease.
- Bylvay (odevixibat) is approved as first drug to treat progressive familial intrahepatic cholestasis.
- Saphnelo (anifrolumab) is approved to treat moderate to severe systemic lupus erythematosus.
News
President Biden signs executive order addressing prescription drug pricing
- The order includes direction on importing prescription drugs from Canada, supporting the development of generic and biosimilar drugs, combatting high prescription drug prices, and banning “pay for delay” agreements.
Alzheimer’s treatment Aduhelm (aducanumab) remains non-covered by some plans and providers
- Blue Cross Blue Shield plans in North Carolina, Pennsylvania, Michigan, Western New York, and Kansas have announced they will not cover the newly approved drug.
- The plans determined the drug to be investigational, citing insufficient evidence of clinical benefit.
- Hospital systems Cleveland Clinic and Mount Sinai have also announced that their providers will not prescribe the drug.
EvaluatePharma publishes “World Preview 2021, Outlook to 2026” Report
- The report covers many topics including drug pricing reform, worldwide prescription drug sales, drug pipeline developments, and patent expirations.
FiercePharma report summarizes upcoming patent expirations
- Products with highly anticipated patent expirations over the next two years include Humira (adalimumab), Januvia (sitagliptin), and Victoza (liraglutide).
CVS Health publishes “Specialty Pharmacy Pipeline | Drugs to Watch”
- The report summarizes products with anticipated launches in Q3 or Q4 of 2021.
Blue Cross Blue Shield plans launch pharmacy solutions start-up Evio
- Evio will use real-world data collected from five health plans to support outcomes-based contracting with drug manufacturers.
Delaware State Auditor estimates $24.5 million in excess costs to PBM
- The Office of Auditor of Accounts published a report faulting poor contracting and lack of transparency as major reasons for the overpayments on behalf of the state employees’ pharmacy benefits plan.
- Over fiscal years 2018-2020, the State Auditor estimated a 20.1% increase in total plan costs despite flat enrollment numbers.
FDA Advisory Committee votes against the approval of roxadustat
- The investigational drug treats anemia associated with chronic kidney disease and has been approved in several other countries.
Clinical Trials
Investigational drug for treating age-related far-sightedness produces positive results in phase 3 trial
- The drug, currently designated as AGN-190584, would reduce the need for contact lenses or glasses for patients with presbyopia.
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About the Author(s)
Pharmacy Briefing August 2021
Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.
Marc Guieb