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Surescripts adds Tom Skelton as CEO

BY David Salazar

Arlington, Va. — Health information network Surescripts has brought on Tom Skelton as its new CEO, the company announced Thursday. Skelton, who has worked in the health IT field for several years, will take his place at the helm of the company on Aug. 25. 

“Surescripts is at a critical point in its growth, so Tom will play a key role as we continue to perfect e-prescribing and expand our clinical network to create a comprehensive, unified healthcare system that improves care outcomes, increases efficiency and decreases costs,” Superscripts’ board of directors co-chairman Douglas Hoey said.

Skelton’s career in health IT reaches back to the 1980s, when he began as VP operations for medical software company Elcomp Systems, where he stayed until 1994. In 2000, he became CEO of Misys Healthcare Systems and founded Confluence Medical Systems in 2007. Mostly recently, he has been CEO of Foundation Radiology group.

“Tom has a deep understanding of the provider workflow, having previously led firms that develop technology products for physicians and clinicians, and brings tremendous operational and management experience, as well as a proven ability to set a clear vision for the development and commercialization of new technologies,” Surescripts’ board of directors co-chairman Steven Miller said. 

Now Skelton moves on to Surescripts, where he’ll oversee the company that connects about 100 different health systems and more than 850 hospitals in the United States.

It also provides electronic prescription services to 95% of community pharmacies.

“The progress Surescripts has made in recent years is a clear indication of the strength of its relationships with pharmacies, providers, payers, pharmacy benefit managers, retail clinics, health information exchanges and many others,” Skelton said.   

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Biologics restrictions result in lost savings

BY Richard Monks

Restricting access to samples of generic biological drugs would lead to nearly $140 million in lost savings for every $1 billion in biologics sales, Matrix Global Advisors said.

(For the full chain pharmacy section of DSN's Aug. 25 issue, click here.)

“This potential lost savings has enormous implications for the large and growing segment of pharmaceutical spending that biologics represent,” Matrix Global Advisors CEO Alex Brill wrote in “Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry,” a report the firm issued last month examining how overuse of risk evaluation and mitigation strategies, or REMS, is slowing the stream of generics into the marketplace.

Biologics are the fastest-growing segment of the pharmaceutical market, he said, growing by 9.6% last year and accounting for 28%, or approximately $92 billion, of the country’s drug spending.

“In light of the forthcoming regulatory pathway for biosimilars and the pending patent cliff among biologics, access to biologic drugs for biosimilar approvals is critically important,” Brill said. “In the current REMS environment, biologics makers will have the same opportunity to restrict access to samples of biologic drugs, with negative consequences to payers and patients.”

Of the 64 approved individual REMS programs in effect today, 15 are for biologics. Brill said some generic drug makers already have reported restricted access to biologics samples.

More restrictions, he noted, are likely to have a dramatic impact on efforts to control healthcare spending.

“To capture the magnitude of the potential lost biosimilar savings from REMS misuse, we use the Congressional Budget Office’s assumptions about the market dynamics following biosimilar market entry,” Brill wrote in his report. “The competitive dynamics of the biologic drug market are not expected to mimic the dynamics in the small molecule market. CBO expects an eventual 40% biosimilar price discount and 35% substitution rate.”

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Abuse of REMS drives up healthcare costs

BY Richard Monks

The generic drug industry — and by extension, patients across the United States — is being adversely impacted by what some are calling branded drug makers’ abuse of risk evaluation and mitigation strategies, or REMS.

(For the full chain pharmacy section of DSN's Aug. 25 issue, click here.)

“When brand manufacturers use these programs to withhold access to drug samples for generic manufacturers’ bioequivalence testing and development, they can delay generic market entry and competition, thereby preserving high drug prices and preventing the cost savings generic drugs are known to deliver,” Matrix Global Advisors CEO Alex Brill noted in “Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry,” a study his firm recently did for the Generic Pharmaceutical Association.

The impact that the growing use of REMS is having on healthcare spending is substantial, the report said. Through a detailed analysis of pricing and utilization data for just 40 drugs, Brill concluded that the delays caused by overusing REMS adds $5.4 billion a year in healthcare costs, with the federal government picking up a third of these costs and private insurers covering $2.4 billion. In addition, consumers pay $960 million in extra out-of-pocket costs, Brill said, and state and local governments foot the bill for $240 million of added healthcare costs.

“These estimates should not be construed as the entirety of the lost savings from REMS misuse,” Brill said. “Not all currently restricted products are included in our analysis, and as the problem of brand drug companies’ misuse of REMS and other restricted access programs grows, this lost savings will increase.”

REMS were created in 2007 to improve drug safety for certain products by ensuring that the benefits for patients outweigh the risks. However, Brill said that in recent years, branded drug makers have stepped up their use of “elements to assure safe use” — the component of REMS programs that mandates restricted distribution. The report noted that in 2009 only about a quarter of REMS programs included these provisions. Today, more than half of the 70 approved REMS programs — 64 individual REMS and six shared system REMS — include elements to assure safe use.

In addition, the report noted that some branded drug manufacturers also have begun applying restricted access programs to drugs for which the FDA has not required a REMS program.

While both houses of Congress and lawmakers in a handful of states across the country have tried to enact legislation forcing branded drug companies to share their bioequivalency data with generic manufacturers, these efforts have so far failed to become law.
 

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