Denise Myshko

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.

The report found that mavacamten offers benefits but was above the threshold of $150,000 per quality-adjusted life-years.

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.

Including patients in the decision-making process, the authors said, is an important component of patient-centered health care.

The monoclonal antibody had been given an emergency use authorization to treat COVID-19, but the recent spike in cases is driving a shortage in supply.

The move, effective July 15, was the result of a generic now being available.

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.

All stakeholders together incur about $93.3 billion in costs for implementing, contesting, and navigating drug utilization management.

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.

This is the first approval of generic version of Chantix, and it comes just weeks after a recall of the brand-name drug.

The potassium-lowering agent was associated with a 20% relative reduction in costs related to outpatient, inpatient, and emergency department visits.

Four products on the preferred list this year will be excluded next year.

A decision on the plaque psoriasis therapy is expected in the second quarter of 2022.

Current drug shortages based on FDA data, prepared by Formulary Watch.

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.

A single application targets the infection without entering the circulatory system.

The sickle cell disease therapy will now be on the Preferred Drug List.

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

This is the first new approval for lupus in a decade.

Pharmacies will need to obtain pre-dispense authorization for clozapine.

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.

Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.

Drugs that provide only incremental benefit may not be included on clinical pathways.

The approval allows for substitution at the pharmacy counter for Lantus, its reference product.

The findings were similar in people with or without diabetes.

Competition among branded products did not substantially curb annual spending increases.

A substantial discount would be needed to meet cost-effectiveness thresholds.

The FDA would like to see additional data on clinical benefit for patients with anal cancer.

Current drug shortages based on FDA data, prepared by Formulary Watch.