Cancer specialists think that the U.S. Food and Drug Administration is too slow to approve new cancer-fighting medications and devices, and that such tardiness hinders physicians' ability to fight the disease.

A Competitive Enterprise Institute survey of 160 cancer specialists found that almost 8 of 10 oncologists think the FDA's approval process has "hurt their ability, at least once in their medical careers, to treat patients with the best possible care."

Specialists also say that society is, for the most part, unaware of the problem; 70 percent believe that the general population doesn't understand the human cost of the FDA approval process and that "Some people may suffer or die waiting for the agency to act."

While this news is somewhat sobering, there is a bright spot, according to Tennessee Republican Sen. Bill Frist, MD, a Harvard-trained surgeon.

"What used to take several years has now been reduced to an average review time of 6 to 10 months for new drugs," he says. "Yet, as many respondents indicated, more needs to be done to improve the drug-review process."

Respondents were asked whether they agree that the additional time it takes the FDA to approve drugs and medical devices costs lives by forcing people to go without potentially beneficial therapies."To what extent does this FDA policy of limiting information make it more difficult for you to learn about new uses for drugs or devices?'"Would you say the FDA's approval process has hurt your ability to treat your patients with the best possible care frequently, some of the time, at least once, or never?

SOURCE: COMPETITIVE ENTERPRISE INSTITUTE, A NATIONAL SURVEY OF ONCOLOGISTS REGARDING THE FOOD AND DRUG ADMINISTRATION

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.