The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $5 million in funding for 24 research projects seeking to develop nontraditional therapeutics for bacterial infections to help address the growing health threat of antibiotic resistance.

The FDA has accepted a new drug application for venetoclax (AbbVie/Genentech/Roche) for the treatment of chronic lymphocytic leukemia (CLL) in adults who have received at least one prior therapy, including patients with the 17p deletion genetic mutation. The application was granted a priority review.

The Centers for Medicare and Medicaid Services (CMS) has announced 121 new participants in Medicare Accountable Care Organization (ACO) initiatives designed to improve the care patients receive in the health care system and to lower costs. Of these organizations, 21 will be the first to join Medicare’s new ACO model, the Next Generation.

The U.S. Preventive Services Task Force has published a final recommendation statement on screening for breast cancer after reviewing the science on the benefits and harms of screening mammography, and after considering the input received from public and health care professionals on its 2015 draft recommendation.

The drug-development pipeline for Parkinson’s disease (PD) offers a more-promising treatment landscape compared with the current market, according to a report from business intelligence provider GBI Research.

Details regarding a “breakthrough medical discovery” with potential for treating patients with serious bacterial infections were presented on January 11 at the 8th Annual Biotech Showcase in San Francisco, California.

Proton pump inhibitors (PPIs), which are commonly used to reduce acid in the stomach, appear to be associated with an increased risk of chronic kidney disease (CKD), but more research is needed to determine whether PPI use causes kidney damage, according to an article published online in JAMA Internal Medicine.

The U.S. Supreme Court has declined to hear an appeal from Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, of a $124 million penalty imposed by South Carolina after a jury found that the company had improperly marketed the antipsychotic medication risperidone (Risperdal) and had concealed its risks, according to a Reuters report.

On January 1, Pfizer raised U.S. prices for more than 100 of its drugs, some by as much as 20%, according to a report from Reuters.

Steady reductions in smoking combined with advances in cancer prevention, early detection, and treatment have resulted in a 23% drop in the cancer death rate since its peak in 1991. The drop translates to more than 1.7 million cancer deaths averted through 2012.

The FDA has expanded the labeling for the Animas Vibe insulin pump and continuous glucose monitoring system (Animas Corporation/Johnson & Johnson) to include the management of diabetes in children and adolescents 2 to 17 years of age. The system was originally approved in December 2014 for use in adults (18 years of age or older).

CHS-0214 (Coherus BioSciences/Baxalta Inc.), a proposed biosimilar of etanercept (Enbrel, Amgen), has met its primary endpoint in a phase 3, double-blind, randomized, controlled clinical trial.

The Centers for Medicare and Medicaid Services (CMS) has issued a final rule regarding the ordering of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), according to a report from FierceHealthFinance.

Cancer screening has never been shown to “save lives” as advocates claim, experts argue in the British Medical Journal. This assertion is based on reductions in disease-specific mortality rather than overall mortality, say Dr. Vinay Prasad, an assistant professor at Oregon Health and Science University, and his colleagues.

Positive results have been reported from HBV-23, a phase 3 trial of the investigational hepatitis B vaccine Heplisav-B (Dynavax Technologies Corporation) compared with a currently marketed vaccine, Engerix-B (hepatitis B vaccine [recombinant], GlaxoSmithKline), in more than 8,000 adults 18 to 70 years of age.

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Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.