PHARMACY

Report: FDA panel backs Amgen’s Humira biosimilar

BY DSN STAFF
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PhRMA names Stansel EVP, general counsel

BY David Salazar
WASHINGTON —  The Pharmaceutical Research and Manufacturers of America on Tuesday announced that James Stansel would be joining the organization as EVP and general counsel, effective Aug. 1. Stansel will oversee the organization’s legal department. 
 
Stansel has previously served as acting general counsel for the Dept. of Health and Human Services, working as the chief legal officer for it, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, the Health Resources and Services Administration and the National Institutes of Health. He was also the deputy general counsel and counselor to the secretary during his time at HHS. 
 
“With his deep legal expertise in complex health policy and regulatory issues, I am pleased to welcome Jim to the helm of our legal team,” PhRMA president and CEO Stephen Ubl said. “As our members push forward into new and exciting areas of research and development, Jim's experience working with industry and government will enable him to provide valuable counsel and guidance to our industry.”
 
Stansel joins PhRMA from Sidney Austin LLP,  where he is where he is co-head of the global life sciences team and partner in the health care, government strategies and food and drug groups. He has been recognized in The Best Lawyers in America  since 2011 for biotechnology and health care law, and is a member of Law360. 
 
“The biopharmaceutical industry's focus on saving, improving and sustaining lives through new treatments and cures is the backbone of today's health care system,” Stansel said. “I am excited to join PhRMA and its impressive legal team to support the industry as it continues to lead in and redefine innovation.”
 
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IMS Health: Adherence, persistence issues keep diabetes costs high

BY David Salazar
PARSIPPANY, N.J. — The IMS Institute for Healthcare Informatics on Tuesday released a series of reports on type 2 diabetes and the effects of low persistence and adherence on health system. “Improving Type 2 Diabetes Therapy Adherence and Persistence” looked at five health systems, including the United States, Mexico, the United Kingdom, Germany, Brazil and Saudi Arabia. 
 
In the U.S., the report noted that type 2 diabetes cost the healthcare system about $176 billion, with 61% of the cost coming from diabetes-related complications. Of those patients with type 2 diabetes, about 59% are older than 65 years of age, with a majority of them enrolled in Medicare. Among Medicare patients with diabetes, about 46% of them were sub-otpimally adherent, based on an analysis of 2014 patient records. Given these numbers, the IMS Institute estimates that complications from type 2 diabetes will cost about $100 billion annually in the United States, and $4 billion annually will attributable to the medicare population with diabetes. 
 
“The rising prevalence of Type 2 Diabetes and its associated complications is the root of considerable strain on society and an economic burden on healthcare systems,” Murray Aitken, IMS Health SVP and executive director of the IMS Institute for Healthcare Informatics, said. 
 
The IMS Institute notes that one of the biggest challenges is activating patients — helping them understand their role in the care process and getting them to take a more active stance when it comes to managing their disease. Activation can improve adherence and reduce healthcare costs as a result of increased adherence. But patient activation requires collaboration and solutions that can get patients activated and adherent. 
 
“Simple, customized interventions that put patients on the path to optimal adherence and persistence can yield tangible results, but require alignment between healthcare and government leaders, as well as the active involvement of voluntary associations and the private sector,” Aitken said. 
 
Among the recommendations the report makes for the U.S. are using predictive analytics to identify patients who might be sub-optimally adherent, offering educational content aimed at activating patients, incorporating healthcare plan counseling as part of medical appointments and using technology and digital offerings to maintain activation. 
 
“The economic and societal burden of low [type 2 diabetes] therapy adherence and persistence to the U.S. Medicare system is high and rising,” the report says. “With nearly 12 million Medicare [persons with diabetes] in the U.S. today, estimated to grow to 17.2 million by 2025, it is imperative that structured action is taken to improve [type 2 diabetes] therapy adherence and persistence on a war footing.”
 
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