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.
- The United States sends withdrawal notice to the World Health Organization (WHO)
- Several Blue Cross Blue Shield (BCBS) insurers sue CVS Health over its Health Savings Pass drug discount program
- Employer and Patient Protection and Affordable Care Act (ACA) health plans required to cover the cost of HIV PrEP
- Remdesivir list price set to be $3,120 for a five-day course of therapy
FDA Approvals and Launches
- Lyumjev (insulin lispro-aabc) is approved as an ultra-rapid acting insulin for the treatment of both type 1 and type 2 diabetes.
- Phexxi (lactic acid/citric acid/potassium bitartrate) is approved for use as an on-demand contraceptive applied before sexual intercourse.
- Amivas (artesunate) is approved to treat malaria.
- Taltz (ixekizumab) and Cosentyx (secukinumab) receive additional approval to treat spondyloarthritis.
- Oncology drug Nyvepria (pegfilgrastim-apgf) is approved as the fourth biosimilar to Neulasta (pegfilgrastim).
United States sends withdrawal notice to the World Health Organization (WHO)
- The withdrawal would become effective on July 6, 2021, if all withdrawal conditions are met.
- The notice cites failures to appropriately address the COVID-19 pandemic, but the withdrawal could impact research and access to COVID-19 treatment and vaccines.
Several BCBS insurers sue CVS Health over its Health Savings Pass drug discount program
- The lawsuit alleges that CVS Health set higher reimbursement rates from health plans than the cash prices it charged patients through discount programs.
Employer and ACA health plans required to cover the cost of HIV PrEP
- Requirement applies to plans with renewals effective on or after July 1, 2020.
- Mandate is the result of a recommendation by the U.S. Preventive Services Task Force made in June 2019 and covers at least one of two options: Truvada (emtricitabine/tenofovir disoproxil) and/or Descovy (emtricitabine/tenofovir alafenamide).
Remdesivir list price set to be $3,120 for a five-day course of therapy
- For U.S. private insurance companies, the list price will be set at $520 per vial with an expected six-vial course of therapy for most patients.
- The FDA issued emergency-use authorization for remdesivir in May 2020.
Several independent pharmacies sue OptumRx over alleged price discrimination
- In addition to price discrimination, the pharmacies accuse the pharmacy benefit manager (PBM) of charging health plans brand prices while paying pharmacies generic prices, using differing brand/generic definitions to generate extra revenue.
FDA reports shortages of generic versions of Zoloft (sertraline)
- Shortages could be caused by increased utilization of anxiety drugs due to the COVID-19 pandemic as well as manufacturing difficulties associated with obtaining active pharmaceutical ingredients (APIs).
Joint lawsuit involving 51 states and territories sues 26 generics companies, alleges price-fixing
- Lawsuit involves alleged price-fixing of generic dermatological drugs.
Milliman publishes article detailing the prior authorization process as a tool for utilization management
- While the article details prior authorizations in the context of Medicare Part D, many concepts are shared with its use in commercial plans.
Man pleads guilty in $50 million healthcare fraud scheme involving compound prescriptions
- The scheme recruited others to fill claims for unnecessary compound prescriptions to receive reimbursements from PBMs.
U.S. District Court invalidates Tecfidera (dimethyl fumarate) patent
- The decision would allow the marketing of a generic version of the multiple sclerosis drug. However, no generics are currently FDA-approved.
Clinical Trials and Research
RECOVERY trial team discovers reduced mortality rates associated with dexamethasone treatment in patients with COVID-19
- The investigators found benefits in patients receiving mechanical ventilation as well as those receiving oxygen without mechanical ventilation.
- No evidence of benefit was observed in patients not receiving any respiratory support.
Citing ongoing analysis of data, FDA revokes emergency use authorization for chloroquine and hydroxychloroquine
- The FDA has determined that the drugs are ineffective in treating COVID-19 while also endangering patients with serious side effects.
JAMA analysis observes widespread drug utilization peaks in March 2020, followed by declining utilization
- The analysis describes a large increase in hydroxychloroquine/chloroquine claims, a drug hypothesized to treat COVID-19.
- Declining utilization of maintenance drugs may have been due to a combination of reduced acute care visits, restricted access to pharmacies, drug inventory rationing, loss of insurance, and early drug stockpiling.