Denise Myshko

Drugs that the FDA has approved on its fast-track accelerated approval basis are making up an increasingly larger share of Medicaid spending on pharmaceuticals.

The agency needs more time to review new information on the analytical method used.

EmsanaRx, the new PBM, aims to provide large employers with flexibility and transparency on drug spending.

An understanding of hemoglobin levels in patients with COPD could help guide disease management.

In COVID-19 news, FDA issues EUA for Pfizer vaccine for children. The FDA approved a therapy for macular edema and a novel pain treatment. And Novartis submits application for new indication for Kymriah.

Specialty drug prices are rising as these therapeutics replace lower-cost therapies.

The label now includes new data from the trial that supported Cyltezo’s application for interchangeability with Humira.

Cigna plans to remove 45 drugs from its Standard Prescription Drug List and add restrictions for other therapeutics.

Cumulative spending on drugs without overall survival data was $1.8 billion in 2018 and surpassed that of drugs with such data.

Specialty medicines are now 53% of spending, up from 27% in 2010 and driven by growth in autoimmune and oncology therapies.

Recently approved for children 6 to 11 years, Dupixent reduces severe asthma attacks and improves lung function.

In COVID-19 news, the FDA issues EUA for both Moderna’s and J&J’s COVID-19 booster. In new drug approvals, there is a novel therapy for macular degeneration, new therapies for eye disease and opioid overdose, as well as new therapies for asthma and HIV in children.

Treating and managing patients with paroxysmal nocturnal hemoglobinuria is expensive and requires constant surveillance by the provider and health plan.

AmerisourceBergen/Xcenda survey finds payers believe biosimilars provide costs savings, and they are expected to continuing contracting with manufacturers.

The tools for formulary management for atopic dermatitis need flexibility to take into account quality-of-life issues and patient access.

Most of the solutions have established systems to track patient outcomes over time, and several include performance guarantees as part of their solution.

Boehringer Ingelheim will make Cyltezo available when its commercial license begins on July 1, 2023.

In COVID-19 news: An advisory committee recommends both J&J's and Moderna’s booster, Regeneron seeks full approved for its treatment and Merck seeks EUA for treatment. In cancer, the FDA approves Verzenio for early breast cancer, Keytruda for advanced cervical cancer, and Tecentriq in early nonsmall cell lung cancer.

This European study enrolled patients with more severe cases of spinal muscular atrophy than a similar study conducted in the U.S.

A new method for delivering this treatment drug for spinal muscular atrophy offers an option for patients with advanced cases of the disease. But investigators found that the new method may also carry risks of mechanical failure and infection.

The product contained N-nitrosoirbesartan impurity, a probable human carcinogen.

Hikma, which makes the broad-spectrum antibiotic, has experienced manufacturing delays.

The FDA has approved Tavneos, a first-in-class, oral therapy to treat a group of autoimmune diseases characterized by inflammation and damage to small blood vessels.

Drugs with accelerated approval represent a larger amount of Medicaid drug spending relative to their use.

Compared with Keytruda, Libtayo resulted in an incremental gain of 3.44 life-years and incremental cost-effectiveness ratio of $130,329 per quality-adjusted life-year.

Pfizer officially seeks EUA for pediatric COVID vaccine, AstraZeneca seeks EU for COVID-19 prevention, J&J submits data for COVID-19 booster, a gene therapy is approved for leukemia, and Janssen submits Stelara for psoriatic arthritis in children.

Rinvoq, a JAK inhibitor, is still under review at the FDA as a treatment of atopic dermatitis.

Incyte will be required to conduct postmarketing study and set up patient registry to monitor whether the topical JAK inhibitor has adverse effects on mothers, fetuses and infants.

Investigators found only small differences in the change in LDL-C levels in the incentive groups versus the control group

The labeling of Trikafta, which treats cystic fibrosis, has been updated to warn about the possibility of liver failure that could lead to the need for transplantation.