FDA proposes system of names, suffixes for biologics, biosimilars | FDA approves new PCSK9 inhibitor | Former Mich. pharmacy CEO sentenced to 10 years for fraud
 
August 28, 2015
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FDA proposes system of names, suffixes for biologics, biosimilars
The FDA has proposed attaching suffixes to the names of biologic drugs and biosimilars, and the agency is seeking feedback about the names of biologics that are currently on the market without a suffix. Bloomberg (8/27)
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FDA approves new PCSK9 inhibitor
Amgen's Repatha, or evolocumab, has obtained approval from the FDA as a treatment for familial hypercholesterolemia, as well as clinical atherosclerotic cardiovascular disease among patients who need additional cholesterol-lowering treatment. "We plan to leverage this competition to achieve the greatest possible discounts for our clients and patients," said Express Scripts Chief Medical Officer Steve Miller. The New York Times (free-article access for SmartBrief readers) (8/27), Reuters (8/27)
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Legislative & Regulatory News
Former Mich. pharmacy CEO sentenced to 10 years for fraud
Kim Mulder, the former CEO of Michigan-based Kentwood Pharmacy, was sentenced to 10 years in prison with three years of supervised release for conspiracy to commit health care fraud. Authorities say Mulder and 17 other employees at the pharmacy ran a drug-repackaging operation, restocking and redispensing unused drugs returned by nursing homes and adult foster homes. False claims worth $79 million were reimbursed by Medicare, Medicaid and private insurers between 2006 and 2010. MLive.com (Michigan) (free registration) (8/27)
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Nev. health insurance co-op closing
Nevada Health CO-OP announced plans to close by Jan. 1, making it the third nonprofit health insurance plan created under the Affordable Care Act to close. The co-op is paying more to cover care than it receives in subscriber premiums and has high administrative costs. Modern Healthcare (tiered subscription model) (8/27)
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Drug Industry Spotlight
Researchers: Cancer drugs' prices aren't linked to their value
An investigational drug for metastasized nonsmall cell lung cancer that could be approved this year extends survival by about 1.6 months and should be priced from $563 to $1,309 for a three-week regimen, according to a study in JAMA Oncology. "Currently, the prices of cancer drugs are increasing, and the prices are not linked to the benefit that the drug provides," said lead researcher and oncologist Daniel Goldstein of Emory University. The Washington Post (tiered subscription model) (8/27)
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SmartQuote
It takes a lot of courage to show your dreams to someone else."
-- Erma Bombeck,
humorist
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About PCMA
PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 216 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.

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