Michael D. Dalzell

Thirteen of the 27 drugs receiving Food and Drug Administration approval in 2013 were biologics and other specialty pharmaceuticals. It’s the first time since 2009 that more than half of FDA approvals were for conventional drugs.

That the number of specialty drugs and biologics making it to market slipped from 25 in 2012 to 13 last year doesn’t mean that small molecules are back in vogue. On the contrary, a report released late last year by the Tufts Center for Drug Development noted that big pharma has made a dramatic shift in its R&D focus from small-molecule drugs to biotechnology.

Cancer continues to be a hotbed of specialty drug development. Of the 13 specialty drugs and biologics approved last year, 9 carry oncology indications and hefty price tags. None were chemotherapies.

Share of specialty drugs among FDA drug approvals, 2009–2013

2013 drug-approval timeline
Trade nameUseCosta
KynamroHomozygous familial hypercholesterolemia$176,000b
PomalystMultiple myeloma$10,500
KadcylaBreast cancer$9,800
TecfideraMultiple sclerosis$55,000b
XofigoProstate cancer$69,000c
MekinistMelanoma$8,700
TaflinarMelanoma$7,600
GilotrifLung cancer$5,500
TivicayHIV$1,175
GazyvaChronic lymphocytic leukemia$41,300d
ImbruvicaMantle cell lymphoma$11,000
OlysioHepatitis C$66,360e
SolvaldiHepatitis C$28,000f
aCost per month, unless otherwise noted.
bPer year.
c6-injection course of therapy.
d6-month course of therapy.
e3-month course of therapy.
fBottle of 28 tablets.
Pricing sources: Bioworld.com, Drug Discovery.com, Fierce Biotech, Huffington Post, Kantar Health, Medical Marketing & Media, Myelomabeacon.com, Nature, PharmExec.com, San Francisco Business Journal, UBC/Express Scripts, WebMD

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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.