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.
- FDA issues emergency use authorization for remdesivir for the treatment of COVID-19
- National Council for Prescription Drug Programs (NCPDP) issues guidance for pharmacy-led COVID-19 testing
- Eli Lilly introduces Lilly Insulin Value Program allowing those with commercial insurance or without any insurance to fill monthly insulin prescriptions for $35
- Express Scripts publishes “America’s State of Mind Report” examining recent utilization of mental health medications
FDA Approvals and Launches
- Generic version of Proventil HFA (albuterol sulfate) is approved to prevent and treat bronchospasms.
- Koselugo (selumetinib) is approved to treat neurofibromatosis type 1 (NF1), a rare genetic disorder.
- Ontruzant (trastuzumab-dttb) is launched, the fifth biosimilar to Herceptin (trastuzumab).
- Ongentys (opicapone) is approved as an add-on therapy to treat Parkinson’s disease.
FDA issues emergency use authorization for remdesivir for the treatment of COVID-19
- Preliminary data showed faster recovery times and increased clinical improvements associated with the investigational drug.
National Council for Prescription Drug Programs (NCPDP) issues guidance for pharmacy-led COVID-19 testing
- Guidance includes directions for billing COVID-19 testing under the pharmacy benefit.
Eli Lilly introduces Lilly Insulin Value Program allowing those with commercial insurance or without any insurance to fill monthly insulin prescriptions for $35
- Participation in the program requires use of a manufacturer assistance card obtained through the Lilly Diabetes Solution Center.
Express Scripts publishes “America’s State of Mind Report” examining recent utilization of mental health medications
- Prescriptions for antidepressant, anti-anxiety, and anti-insomnia medications increased 21% between February 16 and March 15.
- 78% of these prescriptions filled during the week ending March 15th were for new prescriptions.
FDA cautions against outpatient use of hydroxychloroquine or chloroquine to treat COVID-19
- The agency emphasizes that these drugs can cause serious heart conditions and have not been shown to be safe and effective in the treatment of COVID-19.
CDC launches COVIDView weekly COVID-19 surveillance summary
- Summary includes preliminary data on lab testing, outpatient and emergency department visits, hospitalization rates, and mortality.
- For the week ending on May 9, visits to outpatient providers and emergency departments for care related to influenza-like illness and COVID-19-like illness decreased.
Harvard researchers observe a decrease in ambulatory care visits
- In March, visits to ambulatory care offices decreased almost 60%.
- This decrease is likely to reduce costs associated with outpatient care including the amount of claims for new prescriptions.
- Decreases were greatest in the New England and Mid-Atlantic region, the area hit hardest by the COVID-19 pandemic.
Nationwide pediatric vaccination rates decrease as Americans avoid physician office visits
- Many Americans are avoiding routine care visits to avoid potential COVID-19 exposure, causing a decrease in vaccination rates.
American College of Allergy, Asthma, and Immunology reports shortage of albuterol inhalers
- The shortage is caused by an increased utilization of albuterol inhalers in response to COVID-19.
United States District Court rules in favor of generic companies in Vascepa (icosapent ethyl) patent litigation
- The ruling creates the opportunity for generic releases of the product.
- Currently, there are no FDA-approved generic formulations.
Clinical Trials and Research
Study of employer-sponsored plans finds a five-fold increase in dispensing of schedule II stimulants such as amphetamines over the period 2004 to 2019
- Overall dispensing rates of schedule II narcotics and schedule IV depressants decreased between 2014 and 2019.