Denise Myshko

The safety labeling for the beta interferons that are used to treat multiple sclerosis have been updated to include warnings about injection site reactions.

The high cost and limited clinical evidence for cell and gene therapies have led U.S. health plans and countries outside the United States to limit access.

At a placeholder cost equal to Ozempic, tirzepatide scored lower in a measure of cost-effectiveness compared with Ozempic but higher than Jardiance.

CVS Caremark has removed 10 branded products from its formulary and added about 30 additional products.

The studies conducted to support Verzenio’s most recent approval for the treatment of high-risk early breast cancer provided additional safety data.

In COVID-19 news, Merck receives UK authorization for oral antiviral, its first approval, and the FDA rejects EUA for COVID-19 respiratory failure therapy. In cancer news, the FDA has approved a novel therapy for chronic myeloid leukemia and extended the review of Janssen’s CAR T therapy for multiple Myeloma. The agency also approved a therapy for age-related blurry vision.

ICER’s analysis finds that Tezspire, which is under review at the FDA, provides clinical benefit for patients with severe asthma, but with increased costs to the healthcare system.

Safety concerns may limit JAK inhibitors as treatment for the common skin condition.

UK regulatory authorities approved molnupiravir to treat patients with mild-to-moderate COVID-19.

This Tufts study has found that plans that restrict orphan drugs do so by narrowing the patient population who can receive them.

Prime’s formularies will include the insulin biosimilar over the reference product Lantus beginning in January 2022.

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.