Denise Myshko

The FDA needs additional time to assess information about proposed risk revaluation mitigation strategy for the treatment for obstructive hypertrophic cardiomyopathy.

People from racial and ethnic minority groups had higher risks of COVID-19 infections, but outcomes varied based on access to primary care physicians and insurance.

Collaboration among stakeholders is needed to increase transparency of pharmacy payment programs and to better align the design of these models with good patient care.

A reimbursement policy similar to that used for branded and generic drugs would have saved $1.6 billion from 2015 to 2019.

Investigators in Japan have developed a new, noninvasive method for screening for spinal muscular atrophy using saliva analyzed with conventional PCR as an alternative to blood-based genetic screening.

President Biden nominates new FDA commissioner, and the agency has approved a liquid form of a seizure medication and a new treatment for a rare blood disease. The FDA also accepted a supplemental NDA for Jardiance this week.

Smaller PBMs are rated higher by health plans in terms of satisfaction because of their ability to offer more customized solutions.

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.