Keeping you updated on the latest Medicare and Part D news

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FDA Approves First Biosimilar Drug

Last Friday, the FDA approved its first biosimilar drug, Zarxio. The drug is produced by Sandoz, a division of Novartis, and is a close copy of the biologic drug Neupogen, which is used to help prevent infections in cancer patients undergoing chemotherapy.

According to the FDA,

A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

An FDA panel unanimously recommended Zarxio’s approval in January 2015.  The drug was approved in Europe in 2009 as Zarzio but has not been used in the United States, in part because the FDA lacked a regulatory pathway for biosimilars.

Amgen, the manufacturer of Neupogen, is seeking an injunction to stop the sale of Zarxio, claiming that Sandoz’s generics division declined to participate in patent disclosure procedures (more on the legal issues here). The two companies will be in federal court in California on March 13, 2015, and the result of this case will likely set a precedent for other biosimilar manufacturers. Sandoz said it would not start selling Zarxio until a decision was made on the injuction or April 10, 2015, whichever comes first.



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New Federal Data Shows Rising Rates of Heroin-Related Deaths Since 2000

A new CDC study found that rates of drug poisoning deaths involving heroin almost quadrupled between 2000 and 2013, from 0.7 to 2.7 deaths per 100,000. Increases were observed in all age groups, U.S. regions, and race and ethnicity groups. The analysis also uncovered a demographic shift- in 2000, non-Hispanic blacks aged 45-64 had the highest rate of heroin deaths. By 2013, non-Hispanic whites aged 18-44 had the highest rate.

Opioid drug-poisoning deaths are more common (16,235 vs 8,257 in 2013), but death rates have declined slightly between 2010 and 2013, whereas heroin-related death rates nearly tripled during the same period. The study did not explore the reasons for this sharp increase, but a potential explanation could be that expanding prescription drug monitoring programs have pushed opioid users to switch to heroin. The connection between opioid abuse and heroin is supported by a CDC study released last fall, which found that 75 percent of people who started using heroin after 2000 had already abused opioids.

The CDC recommends increasing the availability of naxalone, a drug that reverses the effects of opioid overdose on the brain. Recent price increases for naxalone have made it difficult for police officers and other first responders to stock the drug. The New York Times reported that the cost of a nasal naxolone dose nearly doubled last fall to $40. And Evzio, the hand-held naxalone auto-injector approved by the FDA last year, can cost over $300 a dose. Local officials, members of Congress, and non-profit organizations are all working to negotiate down costs.