Denise Myshko

Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.

Hospitalization, disability, having private high-deductible, Medicare Advantage, or no coverage were risk factors associated with medical debt.

The applications are based on progression-free survival data even though the FDA has recommended that the company wait for more mature overall survival data.

Terlivaz is the first approved therapy to treat hepatorenal syndrome, a rare form of kidney disfunction related to advanced liver disease.

Jeffrey A. Shaman, Ph.D., chief science officer at Coriell Life Sciences, talked about how pharmacogenomics can inform medication management.

If approved, Perrigo’s Opill could be the first-ever over-the-counter birth control pill. The advisory committee meeting is scheduled for Nov. 18, 2022.

Kali Panagos, Pharm.D., at ARMSRx, discusses the growing trend of copay assistance programs and alternative funding solutions that can help provide access to expensive specialty therapies.

Because of a generic is now available, Toviaz has been removed and up-tiered on Prime’s Medicare formularies.

Although Xeljanz, Olumiant and Rinvoq are in the same drug class, the risk of serious adverse events from these three products to treat rheumatoid arthritis and other inflammatory conditions may not be similar.

In a second committee meeting, FDA advisors supported approval of AMX0035 after the company presented additional analysis of phase 2 data of AMX0035 to treat patients with ALS. The Prescription Drug User Fee Act (PDUFA) target action date is Sept. 29, 2022.

Prime Therapeutics’ predictive model was able to identify members with high breast cancer pharmacy and medical claims to help clients better manage drug spend.

If approved, NOV03 would be the first prescription eye drop to address excessive tear evaporation. The FDA has assigned a PDUFA action date of June 28, 2023.

PSG’s latest Artemetrx specialty spend report finds that, as with 2020, claim utilization continues to drive the trend.

Survey participants said their drug costs have gone up and almost a third had trouble paying for food and housing because of high drug costs.

The PBM is removing four products and adding one product back to its standard control formulary.

Out-of-pocket costs decreased for those with insurance but rose for those without insurance, finds RAND study.

After a failed trial in advanced breast cancer, Sanofi has stopped all studies of amcenestrant, including in early-stage breast cancer.

Bluebird bio has set a wholesale acquisition cost of $2.8 million for the gene therapy beti-cel, now with the brand name Zynteglo, and is offering an outcomes-based contract with an 80% risk sharing.

Shabbir J. Imber Safdar, executive director, Partnership for Safe Medicines, talks about efforts to address counterfeit drugs in the U.S. supply chain.

Genentech has updated the warnings section of the label for the MS therapy Ocrevus to include information about cases of immune-mediated colitis and a serious brain infection in the post-marketing setting.

Those who spoke at a recent webinar discussed the prescription drug elements of the Inflation Reduction Act, which recently passed in the House, and the impact it will have on Medicare and its beneficiaries.

Susan Lang, CEO and founder of XIL Health, talks about the shifting trends and pressures that have led to a misalignment between the PBMs, their clients and consumers.

The Inflation Reduction Act also allows Medicare to negotiate prices on some drugs and caps out-of-pocket costs for Medicare beneficiaries.

The FDA has requested Acadia conduct an additional trial of Nuplazid to support an indication in patients with Alzheimer’s disease.

Coherus’ Cimerli has been approved to be interchangeable for all five indications, including age-related macular degeneration and diabetic retinopathy. It will be available in early October 2022.

Investigators found that socioeconomic and financial barriers can affect patients’ access to oral cancer medications. They suggest that addressing these barriers could improve adherence.

Prime has removed six drugs from its formularies because generics are now available. One has been removed because it has been discontinued.

Optum has teamed up with Sanofi to provide savings cards for six insulins through the Optum Store.

Kelly Stanton, director of quality at Qualio, talks about the impact on patients of prescription drug recalls.

This follows a move by Bayer to import Ultravist with non-U.S. labeling also to address pandemic-related shortages of iodine-containing contrast media used in imaging procedures.