FDA Approves First Biosimilar; Experts Give Payers Advice on How to Manage These New Drugs in AIS Newsletter
Atlantic Information Services, Inc. (AIS) - March 18, 2015 - Washington, DC

The Food and Drug Administration (FDA) issued its first approval for a biosimilar product, Sandoz Inc.’s Zarxio (filgrastim-sndz), earlier this month, and the pharmaceutical industry is expecting more approvals to come: the agency granted the drug’s use for all five indications that its reference drug, Amgen’s Neupogen, has, underscoring the FDA’s confidence in the biosimilar’s safety, purity and potency. Many stakeholders have long touted these products as a way to help drive down the rapidly growing costs of already-expensive biologics, and Zarxio’s approval was the first step in the process. But, how should payers be preparing for this new class of drugs? Industry experts offer their advice in the March issue of Atlantic Information Services, Inc.’s (AIS) Specialty Pharmacy News (SPN).

“Some [payers] may develop a tiering structure similar to brand and generics, or some may implement value- or outcomes-based arrangements,” Mary Jo Carden, senior director of regulatory affairs at the Academy of Managed Care Pharmacy, tells SPN. “Payers will also consider the implications for the pharmacy benefit in comparison to the medical benefit.” That’s the case at Prime Therapeutics, whose chief clinical officer, David Lassen, Pharm.D., tells SPN that the company is “reviewing the drug in our [pharmacy and therapeutics] committee and developing medical utilization management policies, since the majority of coverage will be on the medical benefit.”

Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates, says that where Zarxio lands on a payer’s formulary will come down to price. “It is likely that these decisions will be influenced by [Sandoz’s] pricing/discounting strategy, and the net resulting cost difference to Neupogen.” Other factors that may impact payer preference include “differences in support services, such as patient assistance, differences in drug distribution strategy, and educational support for patients and prescribers vis-a-vis comparison of Zarxio to Neupogen.”

Joshua P. Cohen, Ph.D., a research associate professor at the Tufts Center for the Study of Drug Development, says payers “will likely place [biologics] in lower cost-sharing tiers on the formulary in order to boost their use and reap cost savings” and that drugmakers may sign rebate deals with payers that will allow biosimilars to increase their market share.

Visit http://aishealth.com/archive/nspn0315-05 to read the article in its entirety.

About Specialty Pharmacy News
Specialty Pharmacy News is a monthly newsletter packed with business news and management strategies for containing costs and improving outcomes related to high-cost specialty products. Designed for health plans, specialty pharmacies, PBMs, pharma companies, providers and employers, the hard-hitting newsletter contains valuable insights into benefit design tactics, specialty markets for certain conditions, formulary decisions, merger and acquisition activity, payer-provider partnerships, patient adherence strategies, and new products. Visit http://aishealth.com/marketplace/specialty-pharmacy-news for more information.

About AIS
Atlantic Information Services, Inc. (AIS) is a publishing and information company that has been serving the health care industry for more than 25 years. It develops highly targeted news, data and strategic information for managers in hospitals, health plans, medical group practices, pharmaceutical companies and other health care organizations. AIS products include print and electronic newsletters, websites, looseleafs, books, strategic reports, databases, webinars and conferences. Learn more at http://AISHealth.com.

Contact
Jill Brown, Executive Editor
Atlantic Information Services, Inc.
(202) 775-9008, ext. 3058
jbrown@aishealth.com

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