Clinical

At least 9 states are considering their own health insurance mandates now that Congress has repealed that of the Affordable Care Act; a senator is calling on the United States to invest $1 billion into developing a universal flu vaccine; physicians believe proposed Florida legislation may be too tough on opioid prescriptions.

New research on breast cancer biopsies and counseling after treatment will allow surgeons to have more meaningful conversations with their patients, according to a study published in JAMA Surgery.

Nat Turner, co-founder and CEO of Flatiron Health, explains how data can be used for finding potential patients to be included in clinical trials.

When a drug becomes first-line, I would like to think that as a clinician I would have access to that, but most importantly that my patients would not have to have a bake sale or take out a second mortgage on their homes to get therapies that are designed specifically for them, said A. Mark Fendrick, MD, director of the Center for Value-Based Insurance Design at the University of Michigan.

Despite years of stability, patients with monoclonal gammopathy of undetermined significance (MGUS) are at risk of progressing to multiple myeloma or another blood cancer, according to a long-term follow-up study published in New England Journal of Medicine. MGUS usually causes no problems, but it is a precursor to cancer.

A study finds that protein markers may be a better predictor of drug response than genetic mutation are in patients with acute myeloid leukemia (AML). As a result, some patients who could benefit from treatment may not be eligible under current approval specifications.

Biomarkers of renal dysfunction, endothelial dysfunction, and inflammation were associated with incident heart failure with reduced ejection fraction. By contrast, only natriuretic peptides and urinary albumin to creatinine ratio were associated with heart failure with preserved ejection fraction (HFpEF), a finding that highlights the need for future studies focused on identifying novel biomarkers of the risk of HFpEF, according to a study in JAMA Cardiology.

The FDA has launched a new pilot program that will evaluate whether disclosing certain information within clinical study reports following approval of a new drug application enhances public access to drug approval information, according to a statement by FDA Commissioner Scott Gottlieb, MD. The agency is also working to add a trial's ClinicalTrials.gov identifier number to the agency’s materials for future drug approvals.

Poor baseline Lung Immune Prognistic Index (combining derived neutrophils ratio greater than 3 and lactate dehydrogenase greater than upper limit of normal), or LIPI, was associated with worse outcomes for immune checkpoint inhibitor (ICI) treatment in patients with non-small cell lung cancer (NSCLC), but not with results of chemotherapy, according to a study in JAMA Oncology.

The trial evaluates the immunotherapy drug durvalumab as maintenance therapy in patients who have successfully undergone R0/R1 resection of pancreatic ductal adenocarcinoma following neoadjuvant chemotherapy and completion of adjuvant chemotherapy.

Regardless of daily exercise and healthy eating, a person’s genes determine their ability to lose or gain weight, and researchers have now identified 14 variations in 13 genes that affect an individual’s body mass index.

The approval expands the use of olaparib to include the treatment of patients with BRCA-mutated HER2-negative metastatic breast cancer. The FDA also expanded the approval of Myriad’s BRCAnalysis CDx, a companion diagnostic to olaparib, to include the detection of BRCA mutations.

More than half of octogenarians and nonagenarians with stage III non–small-cell lung cancer did not receive treatment, according to a study in CANCER. Older age, black race, and living in a lower educated census tract were found to be risk factors for not receiving treatment.

Syapse, a leading precision medicine company, and Roche have joined forces to advance precision medicine in oncology. They will work together to bring real-world data to providers, bring oncology into the value-based care era, advance patient-reported outcomes, and optimize clinical trial recruiment.

Eisai’s multiple receptor tyrosine kinase inhibitor lenvatinib and Merck’s anti–PD-1 therapy pembrolizumab as a combination therapy for patients with renal cell carcinoma received the designation based on results from the renal cell carcinoma cohort in Study 111.

While public funding through the National Institutes of Health has created a foundation for healthcare research, the private sector can benefit from getting more involved, said Bill Gates, philanthropist and co-founder of Microsoft.

Despite recent setbacks, drug makers and investors are still optimistic about finding an Alzheimer disease treatment; the United States' already moderately severe flu season could get worse; a charity that assists patients with out-of-pocket drug costs is suing the government over communication restrictions with drug donors.

A new guideline from the American Psychiatric Association to treat alcohol use disorder focuses on the use of evidence-based pharmacological treatments.

A subset of patients with chronic lymphocytic leukemia (CLL) with highly expressed CD49d have poorer outcomes while on Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib, which antagonizes B-cell receptor (BCR) signals. However, a team of researchers may have found a way to treat these patients.

The fact that you have certain drugs that treat numerous cancers, and that they may treat 1 cancer different or better than another, would suggest that we should probably have differential pricing models, said A. Mark Fendrick, MD, director of the Center for Value-Based Insurance Design at the University of Michigan.

This week, the top managed care stories included an analysis of how healthcare spending has changed in the United States; a study finds people willing to try e-cigarettes smoke less and are more likely to quit; and a new cholesterol test that doesn't require fasting gives more accurate results.

Carfilzomib was associated with higher rates of all-grade and high-grade cardiovascular adverse events (CVAE), and both later trial phase and higher doses of carfilzomib were associated with higher rates of CVAE, according to a study in JAMA Oncology.

A newer method for calculating low-density lipoprotein (LDL) cholesterol is more accurate than the older method that required people fast before blood was drawn.

Patients with chronic obstructive pulmonary disease should be given the pneumococcal conjugate vaccine and influenza vaccines to decrease the risk of exacerbations. However, despite the evidence of vaccine efficacy, improvements are needed in coverage and awareness.

Using data collection means taking the guesswork out of treatment, said Torrie K. Fields, MPH, senior program manager of Palliative Care Program Design & Implementation for Blue Shield of California.