NCI, Drug Companies Unveil Effort Today To Speed Up Approval of Oncologic Drugs

Speed seems to be the theme these days when it comes to approval of medications. The first step is knocking down the obstacles that delay getting new, potentially life-saving medications to the market. That’s especially true in oncology.

As STAT reports, researchers who want to combine therapies made by two drug companies for use in a clinical trial must negotiate contracts with each company. A lot of details must be worked out, including data sharing and intellectual property rights.

To address that problem, the National Cancer Institute today announced a partnership with six drug companies that will allow scientists to more quickly and easily access data to conduct novel research. It’s part of Vice President Joe Biden’s cancer moonshot initiative.

The six drug companies involved are: Bristol-Myers Squibb, Eli Lilly, Genentech, Kyowa Kirin, Loxo Oncology, and Xcovery. They will add 15 therapies to the project. Organizers hope that a lot more drug companies will participate. In fact, that’s crucial to the effort’s success because there needs to be a lot more agents included than the initial 15. Other potential members of the new and hopefully growing coalition will be watching the initial stages closely, STAT reports.

George Demetri, a bone oncologist at the Dana-Farber Cancer Institute and member of the American Association for Cancer Research, tells STAT: “It’s got to work well, it’s got to work fast, it’s got to be frictionless.”

Getting the government involved seems like it could do a lot to speed the approval process. As Managed Care reported last October, clinical trials are becoming more challenging to conduct, as they must comply with often costly and inefficient federal and state regulatory requirements, according to researchers from several universities and institutions. 

As we reported then, when federal and state governments take notice, it can become like the old E.F. Hutton commercial where everybody freezes. That’s because “institutions and sponsors often interpret these requirements conservatively and thereby add to the complexity and perceived (but often highly theoretical) risk of conducting clinical trials,” according to a report issued jointly last year by the American Society of Clinical Oncology and the Association of American Cancer Institutes.

Source: STAT

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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.
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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.