The multiple sclerosis (MS) therapy alemtuzumab––marketed in the United States as Lemtrada (Genzyme Corporation)––may trigger severe, unpredictable adverse effects, according to German researchers. Writing in Lancet Neurology, the scientists report on two patients in whom the infusion of alemtuzumab significantly worsened symptoms.

Positive results have been reported from a pivotal phase 3 study of certolizumab pegol (Cimzia, UCB/Dermira, Inc.) in adults with moderate-to-severe chronic plaque psoriasis. Based on the findings from this study, UCB plans to submit a marketing application to the FDA in the third quarter of 2017.

The FDA has approved oxymetazoline hydrochloride cream 1% (Rhofade, Allergan) for the topical treatment of persistent facial erythema associated with rosacea in adults. The product will be commercially available in the United States starting in May 2017.

The FDA has approved ibrutinib (Imbruvica, Janssen Biotech/AbbVie) for the treatment of patients with relapsed/refractory marginal-zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti–CD20-based therapy.

A new position paper from the European Society for Medical Oncology (ESMO) outlines approval standards for biosimilars; how to safely introduce them into the clinic; and the potential benefits for patients and health care systems.

There’s been much heated debate (but isn’t there always with this topic) about just what affect restrictive state abortion laws and the closing of abortion clinics have had on abortion rates, accordging to a report by the Guttmacher Institute, a research group that supports abortion rights It not

The FDA has approved the first generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. The generic product was developed by Roxane Laboratories.

Physician-assisted suicide and euthanasia (PAS/E) is a topic of intense debate in society, not least among critical care medicine specialists, who treat many patients at or near the end of life.

Financial ties between researchers and companies that make the drugs they are studying are independently associated with positive trial results, suggesting bias in the evidence base, according to a new study published in the British Medical Journal.

The FDA has released long-awaited draft guidelines on the interchangeability of biosimilar products with original brands, and the agency’s message is clear: it won’t be easy winning a biosimilar designation, according to an article posted on the FiercePharma website.

FiercePharma has compiled a list of the top 15 cancer medications that are expected to dominate the oncology market in 2022. According to the report, oncology drugs remain the fastest-growing category in pharma, with anticipated sales of approximately $90 billion over the next five years.

Thirty-two million people could find themselves uninsured by 2026 if President-elect Trump and Republican lawmakers don’t have something to replace the ACA with right away.

Results from a pivotal phase 2/3 study of the investigational drug candidate dasotraline (Sunovion Pharmaceuticals) in children 6 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD) have shown a statistically significant improvement in the 4-mg per day arm compared with placebo.

A family of highly drug-resistant and potentially deadly bacteria may be spreading more widely—and more stealthily—than previously thought, according to a new study from Harvard T.H. Chan School of Public Health and the Broad Institute of MIT and Harvard. 

Health care leaders prefer changes to the Patient Protection and Affordable Care Act (PPACA) rather than wholesale “repeal and replace,” according to a survey from HealthLeaders Media. Two-thirds of respondents (66%) said the best option for the health care industry regarding the PPACA is to make some changes but otherwise retain it.


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.