Focus on Biosimilars

The Next Generation ACO program has gotten off the ground with 21 organizations agreeing to participate this year.

That’s a solid start for a program that was expected to have between 15 and 20 provider organizations during it’s first two years.

“This level of participation shows that CMS is listening to the experiences of ACOs and refining their program to make it more financially and operationally viable for providers,” says Chris Dawe, a managing partner for policy and transformation at Evolent Health, a consulting firm in Arlington, Va., that provides ACO advice.

The final full text of the Trans-Pacific Partnership (TPP) is out, and it will stir up some debate again over the massive trade deal.

But for those watching how the trade pact might affect the international market for biosimilars, the unveiling of the full text doesn’t seem to mean any big surprises.

Outside of the U.S., the data exclusivity for biologics—which is tantamount to the amount of time before a biosimilar can hit the market—will range from a minimum of five years, with additional years of vaguely defined “other measures,” to a firmer period of eight years of exclusivity.

News reports have said the 12-year standard will remain in effect in U.S., and the summary of the deal that U.S. Trade Representative posted today as part of the release of the full text confirmed that. The trade representative’s summary says that none of the provisions pertaining biologics will “change any U.S. healthcare program or the data protection that’s existing in U.S. Law.”

Everyone seems to agree that one of the main hang-ups during the negotiation of   the Trans-Pacific Partnership (TPP) trade deal was data exclusivity for biologics, a key factor in determining when biosimilars can get on the market.

But there’s a lot less agreement about what the TPP negotiators have actually agreed to. Full text of the agreement is not going to available for several weeks, so in the meantime there’s plenty of room for interpretation.

Biosimilars will probably not take the United States pharmaceutical market by storm but they may find faster acceptance here than they did in Europe, one expert tells the Wall Street Journal. Kate Keeping of the research company Decision Research Group says that U.S. physicians are much more familiar with biosimilars than European physicians had been before biosimilars were launched there. “It’s less likely that you’re going to see restrictions on uptake due to physicians being hesitant,” she tells the WSJ.

Maybe. But maybe it’s a systematic problem. Ronny Gal, an analyst at Sanford C. Bernstein, tells the newspaper that countries with a strong central health care payer tend to take to biosimilars faster than those that lack such central control. In that case, doctors must decide.

Sandoz, a unit of Novartis, this month launched Zarxio, a biosimilar of Amgen’s biologic Neupogen, which fights infections in cancer patients. Zarzio, the European version of Zarxio, has been in that market since 2008. It’s 10% to 30% cheaper than Neupogen, in contrast to 80% to 95% discounts for generics of small-molecule drugs.

Biosimilars supporters argue that they “could still bring significant cost savings since the drugs they copy are so expensive to begin with.”

Again, much hinges on physician buy-in, not always a sure thing, as a recent survey of gastroenterologists illustrates.

Milliman predicts that it will be at least 12 years before biosimilars fully penetrate the market in the United States. But the consulting company tells employers that the U.S. market could possibly evolve the same way that it has in Europe, where biosimilars have a healthy presence.