Jack McCain
Contributing Editor

When Gertrude Stein famously wrote, "Rose is a rose is a rose is a rose," she seemed to reveal an ignorance of, if not contempt for, the flowers. After all, any gardener knows some roses look like flabby cabbages and others sport flesh-ripping thorns. Do physicians, MCOs, and PBMs who act as though "statin is a statin is a statin is a statin" display a similarly uncritical attitude toward the drugs — and unwittingly show a certain disregard for their patients? Or are statins (and roses) really rather more similar than not?

Back in the early days of statin therapy, circa 1990, the notion of reducing the risk of morbidity and mortality from heart disease by lowering levels of cholesterol was still greeted with some skepticism. Cholesterol, after all, is a component of every human cell. It was thought that overly aggressive cholesterol reduction might trigger cancer or some kind of central nervous disorder. But since then several large clinical trials (See "Major statin trials" on page 41) seem to have established the overall safety and clinical value of statins. Their best-known effect is reducing the amount of cholesterol carried by low-density lipoprotein (LDL), thereby preventing the accumulation of LDL cholesterol (LDL-c) in atherosclerotic plaque.

Today, LDL-c reduction is well accepted as a means of reducing cardiovascular risk, and the manufacturers of a half dozen statins vie for the attention of physicians, patients, and P&T committees — and a chunk of the $13.5 billion U.S. statin market. The entire market is supported by guidelines issued by the National Cholesterol Education Program (NCEP), which recommends statin therapy for patients at risk for coronary heart disease (CHD), and which physicians ignore at their legal peril. Armed with scientific studies — plus plenty of marketing savvy — each statin manufacturer seeks to demonstrate why its product should be preferred over the competition. If you haven't yet heard presentations about the effects of statins on high-density lipoprotein cholesterol (HDL-c) and inflammation, as measured by high-sensitivity C-reactive protein (hs-CRP), you soon will.

At the same time, all the statin manufacturers keep looking over their shoulder for the coming of the next blockbuster in cardiovascular drug therapy. It probably won't be yet another statin, but it might be one or more products that improve levels of HDL-c. HDL is best known for its ability to transport cholesterol away from peripheral tissues, thereby reducing the cholesterol burden in atherosclerotic plaque.

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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.