Denise Myshko

Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.

Advisory panel endorses Pfizer vaccine booster for some, Brukinsa gets third indication, oral migraine med makes headway and other FDA-related news this week.

The vaccines advisory committee voted late on Friday, September 17, 2021, to provide emergency authorization of Pfizer’s COVID-19 vaccine as a booster for those over the age of 65, as well as for those at high risk of developing severe disease.

Tezepelumab, which is being currently reviewed by the FDA, provides small improvements in daily symptoms and quality of life but is only modestly cost-effectiveness at the anticipated price, according to the cost-effectiveness group's calculations.

To date, Pfizer has not received reports of adverse events related to this recall, but is making the move as a precaution.

The combination of bamlanivimab/etesevimab can now be given to both treat and prevent COVID-19 infection after exposure.

Regeneron also announced an expanded contract with the U.S. government for the purchase of additional doses of REGEN-COV.

Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.

Clinical appropriateness, not the cost of a drug, is the first consideration in formulary decisions, said Katie Thompson and Katie Deckelbaum of Express Scripts.

Confidio VP Thatcher Sloan described how applying formulary and utilization management effectiveness calculations to drug costs managed by PBMs may paint a truer picture of their economic value to their clients.

Alinia and Sutent have been removed from the drug lists because of the introduction of generic therapies.

WellDyne executives David Skomo, RPh, and Nick Page told PBMI Annual Conference attendees that matching communication channels and messages with patient preference is the way to engage patients and increase adherence.

The affected lots of this rare disease therapy have been contaminated with yeast, mold, and bacteria, which could lead to life-threatening infections.

Amazon is gearing up for an era that includes telehealth and home testing, but the former FDA commissioner says the new model is more than a logistics challenge and that healthcare companies will prevail.

Point32Health is the name of the not-for-profit health care organization formed by the merger of Harvard Pilgrim Health Care and Tufts Health Plan.

Investigators found patients with COPD taking Anoro Ellipta had low overall on-treatment exacerbation rates, which can reduce medical costs due to increased adherence to therapy.

ICER’s updated analysis uses observational, real-world data for three therapies — Takhzyro, Haegarda, and Cinryze.

Patients faced with high out-of-pocket costs sometimes delay seeking care for appendicitis or diverticulitis, which can result in higher overall costs, increased risk of mortality, and a worse quality of life.

The CDC and the FDA have updated their recommendations for the 2021-2022 flu season.

Approvals for a twice-yearly schizophrenia therapy and a seizure drug for infants, a full approval for Keytruda, and a revised EUA for a COVID-19 therapy round out the week.

The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.

Mobile devices for patients to report symptoms associated with immune checkpoint inhibitors address an unmet need.

The full results from the Emperor-Preserved trial show Jardiance reduces the risk of hospital and death from heart failure.

Greater uptake of hepatitis C medication may help improve the health of Medicaid enrollees and reduce the economic burden of untreated hepatitis C on the U.S. healthcare system, the authors said.

The combination bamlanivimab and etesevimab can resume use and distribution to treat mild-to-moderate COVID-19 but only in states where variants resistant to the therapy are low.

Tecentriq loses indication, Xarelto is approved for reduce risks of cardiovascular events, Tibsovo is approved for rare cancer, Skytrofa is a new, once-weekly growth hormone, and supplemental application is filed Orencia graft-versus-host disease.

Bluebook Rx is a new solution that helps employers and plan sponsors better understand and optimize their prescription drug spending.

The new model indicates a small initial impact on new drugs coming to the market, but an impact that grows over time.

Study results reported in JAMA Network Open show that financial incentives are only modestly effective in getting more people to get way screened for colorectal cancer.

ICER’s policy recommendations suggest payers establish step therapy with less expensive systemic agents to allow patients and clinicians to choose from multiple options.