Denise Myshko

The warnings section of Inrebic, a JAK inhibitor to treat a bone marrow cancer, now includes information about the cardiovascular risk associated with Xeljanz, another JAK inhibitor to treat arthritis.

ICER’s first scorecard of the barriers to fair access to medications found, of the policies that could be reviewed, most were structured to support fair access to medications.

ICER’s first scorecard of the barriers to fair access to medications found that more transparency is needed to fully assess insurers and their coverage policies.

A new meta-analysis of research finds that a history of previous cardiac events puts children with hypertrophic cardiomyopathy at risk for cardiac death.

The regulatory agency has set a Prescription Drug User Fee Act date during the first quarter of 2022

The study found that nearly half of Americans diagnosed with high blood pressure do not have it sufficiently controlled.

Moderna and Pfizer are assessing their vaccines against the Omicron variant, which was first identified in South Africa.

Across all payers, the use of generic statins has resulted in a savings of $11.9 billion annually.

New research confirms that regardless of age or severity of COVID-19 infection, prolonged effects on cognitive function are possible.

New requirements resulted in long call wait times, which has led to patient access issues.

OptumRx will favor the reference product Lantus on the Premium Formulary. The organization also released coverage information about other newly approved therapies.

In COVID-19 news, FDA expands EUA for Moderna/Pfizer boosters and Pfizer seeks EUA for oral antiviral. Keytruda receives another indication, first therapy is approved for dwarfism, FDA extends review of mavacamten, and Gilead submits application for chronic hepatitis therapy.

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.