The primary endpoint has been met in a pivotal phase 3 study evaluating prophylactic treatment with emicizumab (Chugai Pharmaceutical Co./Roche/Genentech) in patients 12 years of age or older with hemophilia A and inhibitors to factor VIII.

The FDA has allowed the marketing of the AeroForm device (AirXpanders), a new tissue-expander system for soft-tissue expansion in two-stage breast reconstruction after mastectomy and in the treatment of underdeveloped breasts and soft-tissue deformities. The patient uses a dose controller to independently inflate the expander.

Some health care providers are worried about what changes to Medicaid under President Trump will mean for their bottom lines and the patients they serve.

As the nation grapples with a devastating opioid epidemic, concerns have primarily focused on young people buying drugs on the street. But America’s elderly also have a problem, according to a report from Kaiser Health News (KHN).

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the biologics license application for ocrelizumab (Ocrevus, Roche) to March 2017. The extension is the result of the submission of additional data by Roche regarding the commercial manufacturing process of ocrelizumab, which required additional time for FDA review.

Two phase 3 studies designed to evaluate the safety and efficacy of switching virologically suppressed patients from a three- or four-drug antiretroviral regimen to the two-drug regimen of rilpivirine (Edurant, Janssen) and dolutegravir (Tivicay, ViiV Healthcare) have met the primary endpoint of noninferiority at week 48.

Inovio Pharmaceuticals has announced that its DNA-based Zika virus vaccine GLS-5700 generated robust antigen-specific antibody responses in a first-in-man phase 1 trial. In initial testing, Zika-naïve subjects in both low-dose and high-dose vaccine groups demonstrated Zika antigen-specific antibody responses after one or two vaccinations.

The man who advises President-elect Donald Trump about nominations to head HHS, FDA, and NIH has been called a visionary who understands how science can alter the future, and a “worrisome outlier” who’s impatience with the way medicine operates could endanger patients.  

Prescription drug prices have gotten out of control for many Americans and many insurers, with some medications costing as much as premium sports cars, according to health-care investments analyst Keith Speights, writing for The Motley Fool. Speights recently reviewed the five most expensive drugs of 2016.

The Department of Health and Human Services has finalized a slew of new regulations to improve how the Patient Protection and Affordable Care Act (PPACA) marketplaces function, even though their future remains uncertain as Donald Trump prepares to enter the White House, according to a report from FierceHealthcare.

It’s no secret that some Americans regularly buy prescription drugs on the internet or while traveling abroad. But the popularity of this approach is underscored by the results of a Kaiser Family Foundation survey conducted in November.

The FDA has granted accelerated approval to rucaparib (Rubraca, Clovis Oncology) to treat women with a certain type of ovarian cancer.

Providing high-quality patient care while trimming costs is a major goal in the current health care reform environment. The Institute of Medicine has specifically called for the establishment of learning health systems (LHSs) to address this challenge.

Hospitalized patients who see a female doctor are less likely to die within 30 days of discharge and are also less likely to get readmitted within a month, according to a study in JAMA Internal Medicine.

Responding to criticism that repealing the Patient Protection and Affordable Care Act (PPACA) would leave millions without health insurance, House Republicans have announced that their goal in replacing the PPACA is to guarantee “universal access” to health care and coverage, not necessarily to ensure that everyone has insurance, according to an article i


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.