Formulary Watch |

FDA approves Corlanor to treat heart failure

FDA has approved ivabradine (Corlanor, Amgen) to reduce hospitalization due to worsening heart failure. Corlanor is an antianginal agent approved for use in patients who have chronic heart failure caused by the lower-left part of the heart not contracting well.

FDA approves changes to hep C drug label to include new warnings

FDA has approved changes to the hepatitis C antiviral simeprevir (Olysio, Janssen) label to include new warnings about serious symptomatic bradycardia-slowing of the heart rate-when co-administered with antiarrhythmic drug amiodarone and antiviral sofosbuvir (Solvaldi, Gilead).

FDA approves Copaxone for MS; problems persist

The FDA today approved the first generic version of Copaxone (glatiramer acetate injection) for treating patients with relapsing forms of multiple sclerosis (MS) on April 16.

Waldenstrom’s drug shows sustained benefit at 2 years

Ibrutinib, a newly approved drug for Waldenstrom’s Macroglobulinemia, a rare form of lymphoma, continued to control the rare blood cancer, with 95% of patients surviving for 2 years, according to a new study, published in The New England Journal of Medicine.

Study: Drug costs for hereditary angioedema tripled in 2 years

Patients with hereditary angioedema (HAE) are accruing specialty drug treatment costs of more than $300,000 annually on average, according to a study presented at the Academy of Managed Care Pharmacy (AMCP) 27th Annual Meeting and Expo, in San Diego.

[BLOG]: Clinical pharmacogenomics: Meeting the needs of the community through a dedicated clinic

BLOG: Pharmacogenomics is the study of how DNA differences affect response to medications. This can explain why similar patients have different reactions to the same medication even if they receive the same dosage. The pharmacogenomics clinic at NorthShore is the first step toward a larger implementation.

New cystic fibrosis drugs may significantly increase pharmacy benefit costs

New cystic fibrosis treatments, that target the gene mutations causing the disease, will significantly increase healthcare costs, according to a study presented at the Academy of Managed Care Pharmacy (AMCP) 27th Annual Meeting and Expo, in San Diego.

Study: Reduce long-term care use among patients with Parkinson’s disease psychosis

Reducing long-term care utilization among patients with Parkinson’s disease psychosis (PDP) may lower overall economic burden, according to data presented at the American Managed Care Pharmacy 27th Annual Meeting & Expo in San Diego.

Study: Babies exposed to narcotic pain relievers more likely to experience drug withdrawal syndrome

Pregnant women are commonly being prescribed opioids - narcotic pain relievers such as hydrocodone - which results in an increased likelihood of neonatal abstinence syndrome (NAS), a drug withdrawal syndrome that opioid-related infants experience shortly after birth, according to a study in Pediatrics.

FDA: Diabetes drugs don’t need death warning

Onglyza, the diabetes medication manufactured by AstraZeneca, may be associated with an increased death rate, according to a preliminary review by the Food and Drug Administration (FDA).

Louisiana bill seeks closed formulary

A Louisiana senator is calling for a closed drug formulary for the state’s Worker’s Compensation program, to help combat the overutilization of opioids and compounded drugs.

Combination BP meds raise risk of mortality in elderly

Researchers raised concerns about the safety of prescribing combination antihypertensive medications in elderly patients with low blood pressure, in a new JAMA Internal Medicine study.

Cancer drug prices not linked to survival rates

The pricing of oncology drugs is not necessarily based on their novelty or effectiveness, according to a new JAMA Oncology study. Instead, researchers found, “current pricing models are not rational but simply reflect what the market will bear.”

Study: Cancer drug prices vary widely depending on who’s paying

Patients without insurance could be asked to pay twice as much or more than insurers pay for chemotherapy, according to a study published in he April issue of Health Affairs.

Study: FDA should warn consumers about chemical in weight loss supplements

Several weight loss and fitness supplements contain the chemical BMPEA, a stimulant similar to amphetamine, according to a new study.

Researchers discover IPF biomarkers

In a large, mutli-center study, researchers discovered potential biomarkers for accurately assessing idiopathic pulmonary fibrosis (IPF) disease progression. The study, published in the March 11 issue of The Lancet Respiratory Medicine, was led by R. Gisli Jenkins, PhD, with the Division of Respiratory Medicine at the University of Nottingham in the United Kingdom. The PROFILE study was funded by GlaxoSmithKline R & D and the Medical Research Council.

FDA approves breath test to help diagnose gastroparesis

The FDA has approved the Gastric Emptying Breath Test (GEBT), manufactured by Advanced Breath Diagnostics, a new, non-invasive test used to help diagnose gastroparesis.

Report: Diabetes drives traditional drug trend, specialty trend increases 20%

According to Catamaran's 2015 Informed Trends Report, diabetes accounted for a major share of the increase in traditional drug trend. The study also found that specialty medications accounted for 28% of drug costs but only 1% of claims.

Study questions use of paracetamol for lower back pain and osteoarthritis

Paracetamol is ineffective in reducing pain, disability or improving quality of life for patients who suffer from low back pain or osteoarthritis of the hip or knee, and its use may affect the liver, according to a study published BMJ.

Cigarette smoke makes MRSA more aggressive

Antibiotic-resistant methicillin-resistant Staphylococcus aureus (MRSA) exposed to cigarette smoke become even more resistant to killing by the immune system, according to a study published in Infection and Immunity.

Children’s use of antipsychotics may increase risk of diabetes

Initiating antipsychotics may elevate a child’s risk not only for significant weight gain, but also for type 2 diabetes by nearly 50%, according to a study in JAMA Pediatrics. Moreover, among children who are also receiving antidepressants, the risk may double.

Gilead sues to stop Actavis' generic bid for Letairis

Actavis plc on Friday said it filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) seeking approval to market Ambrisentan Tablets, a generic version of Gilead Sciences, Inc.'s Letairis®, a treatment for pulmonary arterial hypertension.

DVT patients taking rivaroxaban had fewer hospital admissions, costs, similar subsequent hospital visits vs. standard of care

Patients diagnosed with deep vein thrombosis (DVT) and treated with rivaroxaban (Xarelto) were admitted to the hospital less frequently than those treated with the standard treatment of low-molecular-weight heparin (LMWH) and warfarin, according to real-world data presented at the Hospital Medicine 2015 Congress.

FDA drug approvals-April 2015

FDA actions in brief, priority review, breakthrough therapy designation, fast-track designations, orphan drug designations, first-time generic approvals

Specialty drug coverage varies across health plans

Coverage of specialty pharmaceuticals varies widely among health insurers, according to a new report from Atlantic Information Services in Washington, D.C.

FDA should pull diabetes drug ads, group says

Consumer advocacy group Public Citizen said this week that the Food and Drug Administration (FDA) must stop direct-to-consumer advertisements that market several “dangerous” diabetes medications for weight loss or blood pressure reduction.

CEO resignation linked to FDA drug approval process

Sarepta Therapeutics CEO Chris Garabedian resigned earlier this week, a move that may be linked to a dispute with the Food and Drug Administration (FDA) over the approval process for its new drug, according to The Wall Street Journal.

Strep A rapid molecular test gets FDA clearance

FDA has granted marketing clearance for Alere I Strep A Rapid Molecular Test (Alere). The Alere I molecular test initially received marketing clearance in June 2014 for the detection and differentiation of influenza A and B virus, and in January 2015, the test became the first-ever molecular test to receive a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA.

Indiana county “disaster” after HIV outbreak

Indiana Governor Mike Pence declared rural Scott County a public health disaster after it realized a spike in HIV cases linked to intravenous prescription drug abuse.

Study details problems with COPD drug

Roflumilast, a drug recently approved in the U.S. to treat severe chronic obstructive pulmonary disease (COPD), increases the production of a protein that causes inflammation – which possibly results in patients developing a tolerance to the drug after repeated use and renders it ineffective, according to a new study.