Denise Myshko

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.

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.

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.

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.

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.

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.

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

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.

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.

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 calculations using real-world data would result in major price cuts of three therapies — Takhzyro, Haegarda, and Cinryze — if they were to meet commonly used cost-effective thresholds.

FDA approves Opdivo, Jardiance for new indication, Jemperli gets accelerated approval for solid tumors, and Lilly’s rapid-acting insulin, Lyumjev is approved for administration via an insulin pump.

At a placeholder price of $75,000 per year for mavacamten used along with standard first-line treatment for symptomatic obstructive hypertrophic cardiomyopathy was above the threshold of $150,000 per QALY.

Positive trial results were reported in The Lancet last year. The FDA is scheduled (the PDUFA date) to make a decision on the application for approval early next year.

Another FDA approval and two additional applications for Keytruda have been submitted; a generic for Chantix and a sleep disorder treatment is approved; and a complete response letter has been issued for an anemia therapy.

AstraZeneca gets FDA nod for Saphnelo, BMS pulls indication for Istodax, Merck to seek another use for Keytruda, Tecentriq is granted priority review for NSCLC and COVID-19 cocktail gets expanded EUA.

Newly approved drugs put the brakes on particular “driver mutations,” that when unimpeded, rev up the runaway cell growth and division that characterizes cancer.

Approval of the first interchangeable biosimilar; new indications for Keytruda, Botox, and Nucala; Shingrix label's expanded to a new patient population; and Ardelyx’s Complete Response Letter round out this week's FDA news.

New vaccine for pneumococcal disease, an sNDA approved based on real-world data, a new therapy for skin and muscle disease, Keytruda combination receives full approval in endometrial cancer, a new diabetes therapy is approved, and another JAK inhibitor misses PDUFA date round out this week’s FDA news.

An advisory committee recommends against approving an anemia drug. Darzalex Faspro receives another indication, Bayer receives approval for Kerendia for chronic kidney disease, and FDA delays its decision on sNDAs for JAK inhibitor therapies for atopic dermatitis.

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.

Merck will withdraw Keytruda's advanced gastric indication after an FDA panel vote, a drug with supply problems gets a new indication, NDAs for an HIV therapy, and other news.

Regulatory actions for drugs for children, a combination cancer therapy, launches of two generic therapies for COPD, and cancer and Alzheimer’s therapies receive Breakthrough Designation round out this week’s FDA news.

Positive findings for Tepmetko and Tabrecta reported at ASCO.

A new indication, a nonprescription switch, a recall, and new guidances round out this week’s FDA news.