Six years ago, federal health officials were confident they could save taxpayers hundreds of millions of dollars annually by auditing private Medicare Advantage insurance plans that allegedly overcharged the government for medical services.

The FDA, after further review of the new drug application (NDA) for valbenazine (Ingrezza, Neurocrine Biosciences), has decided to cancel a meeting of its Psychopharmacologic Drugs Advisory Committee that was scheduled for February 16, 2017.

The FDA has approved ranibizumab (Lucentis, Genentech) 0.5-mg injection for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Ranibizumab is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the United States.

The phase 3, randomized, open-label IGNITE trial was designed to evaluate the use of Contrave (naltrexone and bupropion extended-release tablets, Orexigen Therapeutics) in combination with a commercially available lifestyle-intervention program compared with usual care in a “real world” weight-loss setting.

e39b5075-1687-4e67-85a6-fcec56b4cd4e.pngPeople are just not sure about the ACA. They’re not sure whether they want it repealed, or want it to stay.

Sanofi SA and Regeneron Pharmaceuticals, who partnered to make a new cholesterol-fighting drug called Praluent, cannot sell their product in the United States, a federal judge ruled yesterday.

The comparative, confirmatory REFLECTIONS B538-02 study has met its primary objective by demonstrating equivalent efficacy, as measured by the American College of Rheumatology 20 (ACR20) response rate at week 12, between PF-06410293 (Pfizer) and Humira (adalimumab, AbbVie).

Republicans and Democrats on Capital Hill are fighting to control political messaging as Congress takes its first steps toward dismantling the Patient Protection and Affordable Care Act (PPACA), according to the Wall Street Journal.

In a population-based study conducted in Scotland, the use of commonly prescribed acid-suppressant medications (ASMs), such as proton pump inhibitors (PPIs), has been linked to an increased risk of intestinal infections with Clostridium difficile and Campylobacter bacteria, which can cause serious illness.

Positive data have been reported from a phase 2b study of ribaxamase (SYN-004, Synthetic Biologics, Inc.), a first-in-class oral enzyme designed to protect the gut microbiome from the disruption caused by certain intravenous (IV) beta-lactam antibiotics.

Scientists at the University of North Carolina (UNC) at Chapel Hill have developed a new technique that uses light to activate a drug stored in circulating red blood cells so that the drug is released exactly when and where it is needed.

In a bid to salvage a large part of his political legacy, President Obama is meeting with congressional Democrats to discuss ways to block GOP-led efforts to repeal the Patient Protection and Affordable Care Act (PPACA), according to an article in the Wall Street Journal.

As top Republicans see it, a medical malpractice crisis is threatening U.S. health care, according to an article posted on the Kaiser Health News (KHN) website. They claim that frivolous lawsuits are driving up malpractice insurance premiums and are forcing physicians out of business.

In September, Allergan promised to keep price increases under 10% as part of a “social contract” with patients, and now it’s making good on its word––barely. The company hiked prices on nine of its branded medications for 2017, with the new costs going into effect on January 1.


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.