PHARMACY

Concerns over DIR fees top list of concerns for NCPA members

BY Michael Johnsen

ALEXANDRIA, Va. – Ensuring fair compensation and a level playing field are the chief concerns for community pharmacy operators as the 115th Congress begins their deliberations, according to the latest National Community Pharmacists Association member survey.

For the fourth consecutive year, NCPA asked its members to rank their most important legislative and regulatory priorities. The top issue chosen by respondents is to end the retroactive nature of direct and indirect remuneration (DIR) fees by pharmacy benefit managers. The next most important issue is creating greater transparency in generic presrcription drug reimbursements. Rounding out the top three priorities is the inclusion of an any willing pharmacy provision for Medicare Part D ‘preferred pharmacy’ prescription drug plans.

“NCPA’s annual survey of independent community pharmacies helps focus our advocacy efforts, which take on more urgency with a new Congress and president taking office," stated Douglas Hoey, NCPA CEO. "This year’s top priorities are tied to the questionable business practices of lightly-regulated PBM corporations. Complaints about DIR fees have skyrocketed, so it is not surprising that reining in PBM clawbacks would top the list. The second and third highest ranked priorities are long-standing, PBM-generated challenges –  the lack of transparency with generic prescription drug reimbursements and Medicare Part D’s ‘preferred pharmacy’ plans that prevent independent community pharmacy patients from having access to discounted copays," he said.

“Legislative remedies have previously generated bipartisan support, and we will work to get them introduced and passed in the new Congress. In addition, we will work constructively with the Trump Administration, especially officials charged with oversight at HHS, because we believe our solutions are fair-minded and principles they should favor," Hoey added.

Beyond these three leading issues, NCPA will also focus on relaying the value community pharmacists delivery day-in and day-out as both the political landscape, and potentially the healthcare market, change dramatically. "We will make sure the voice of independent community pharmacies is heard," Hoey said. "Our main objective is always to maintain patient access to prescription drug services at community pharmacies and continue pushing for pharmacists to be fully utilized as clinically-trained medication experts who improve health outcomes while reducing costs.”
 

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PHARMACY

FDA issues draft guidance on biosimilar interchangeability

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration recently shared the first draft guidance addressing the interchangeability of biosimilar drugs and their reference products. 
 
The draft guidance outlines that to sufficiently demonstrate interchangeability, the proposed interchangeable product has to be biosimilar and expected to produce the same clinical results as the reference product on any given patients. And interchangeable products that will be administered more than once should have data showing that switching a patient between the biosimilar and the reference product poses no greater risk than the reference product being used continuously does. 
 
“FDA’s high standards for approval should also assure healthcare professionals that they can be confident in the safety and effectiveness of an interchangeable product, just as they would be for a reference product,” Leah Christi, the FDA’s associate director for therapeutic biologics and lead of the Office of New Drugs’s therapeutic biologics and biosimilars staff wrote in a “From our perspective” post on the FDA’s website. “The availability of biosimilar and interchangeable products in the U.S. marketplace will provide more treatment options, which will hopefully drive down costs to give more patients access to treatment.”
 
Christi also notes that once a product is approved as interchangeable, it can be substituted without intervention from a prescriber. 
 
The publication of the draft guidance means that stakeholders can now comment for 60 days after Jan. 18, the day the guidance gets published in the federal register in order for comments to be considered before the final version of the guidance is written. The FDA has promised a finalized guidance on interchangeability before the end of the year. 
 
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Bayer taps Brunn to lead pharmaceuticals business in Americas region

BY David Salazar
WHIPPANY, N.J. — Bayer on Tuesday announced that it had named Carsten Brunn as president of its pharmaceuticals division in the Americas. Brunn will oversee the company’s pharmaceutical arm in the United States, Canada, Central and Latin America, reporting to pharmaceutical division president and board of management member Dieter Weinand. 
 
“Carsten is a strategic and highly respected leader in the pharmaceutical industry and I'm delighted to have him lead the company's largest pharmaceutical business worldwide,” said Dieter Weinand. “Carsten's global perspective and proven track record of successful operational execution at the local level will be a critical asset to us as we continue to build on our current momentum in the U.S. and across the Americas region.”
 
Brunn was previously head of Bayer’s pharmaceutical commercial operations in Japan, serving in that role since 2013. He was chairman of the European Federation of Pharmaceutical Industries and Associations Japan. He joined Bayer in 2011 and based in Beijing, China as global head of primary care. Before joining the company, Brunn held leadership roles at companies that include Eli Lilly & Co., Novartis and Bausch & Lomb. 
 
“It has been an incredibly rewarding experience to lead Bayer's pharmaceuticals organization in Japan, and I am honored to have the opportunity to join such an established team here in the United States,” Brunn said. “The U.S. is one of the most important and innovative pharmaceutical markets in the world, where we are in a solid period of consistent growth with strong performance across all our therapeutic areas. I'm thrilled to bring my experiences from other markets to this organization as we continue to build on our strengths and meet the needs of patients.”
 
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