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NACDS expresses appreciation for CMS’ announcement on AMP-based FULs

BY Antoinette Alexander

ARLINGTON, Va. — The Centers for Medicare and Medicaid Services has announced new timing to implement the Medicaid average manufacturer price-based federal upper limits for prescription medications, a move that has been applauded by the National Association of Chain Drug Stores. The FULs were expected to be finalized in July.

NACDS president and CEO Steve Anderson has issued a statement that reads:
“We are pleased that leaders at the Department of Health and Human Services and the Centers for Medicare and Medicaid Services have acted on the urging of state officials, federal legislators and pharmacy patient care advocates and announced the new timing. To ensure Medicaid beneficiaries’ access to pharmacy services, states need to update reimbursement for both the cost of dispensing and ingredients.

“NACDS also appreciates members of the U.S. Senate and House of Representatives who requested an adequate transition period so that states have the opportunity to make an effective transition.

“In its announcement, CMS cited that ‘further detailed guidance would be provided for states to implement the Affordable Care Act FULs, and we remain committed to ensuring that this guidance is provided to states with sufficient time to implement the FULs.’

“We look forward to learning more from CMS about this guidance and working together to create a reasonable transition period to help states fully implement FULs that create a fair and accurate reimbursement structure, and for the good of Medicaid beneficiaries.”

The full text of CMS’ announcement reads as follows:
This is to notify states and stakeholders that we will not be finalizing the Affordable Care Act Federal Upper Limits (FULs) in July 2014, as we previously announced in the Center for Medicaid and CHIP Services (CMCS) Informational Bulletin issued on November 27, 2013.
 In the November 2013 Informational Bulletin, we stated that further detailed guidance would be provided for states to implement the Affordable Care Act FULs, and we remain committed to ensuring that this guidance is provided to states with sufficient time to implement the FULs. We expect to provide a new finalization date for the FULs when we release this subsequent guidance to states. We will continue to analyze the draft monthly Affordable Care Act FUL data, including the relationship of these FULs to the National Average Drug Acquisition Cost pricing, as we continue to work to implement the FUL provisions of section 1927(e)(4) of the Social Security Act.  We will also continue to post the draft monthly Affordable Care Act FUL files on Medicaid.gov. 

NACDS stated that it first heard about the July deadline in the November 27, 2013 informational bulletin from CMS that was released to states and stakeholders. Since that time, NACDS has engaged in a series of steps, including meeting with CMS staff on numerous occasions and also contacting Health and Human Services and White House staff with its concerns. 

NACDS made an adequate transition period a focus of its NACDS RxIMPACT Day in March and, with its members, met with more than 400 Congressional offices to discuss the issue. Out of those meetings, NACDS was able to generate bipartisan letters signed by 49 Members of the House of Representatives and nine Senators, agreeing with NACDS’ position. 

Following up on the letters, NACDS also asked members of Congress, Senators, and their staffs to call CMS personally to voice their concerns.
 

 

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Teva acquires Labrys in a deal that could reach $825 million

BY Michael Johnsen

JERUSALEM – Teva Pharmaceutical and Labrys Biologics, a privately-held development stage biotechnology company focused on treatments for chronic migraine and episodic migraine, on Tuesday announced that Teva has entered into a definitive agreement to acquire Labrys in a deal for $200 million in upfront payment in cash at closing as well as up to $625 million in contingent payments upon achievement of certain pre-launch milestones.

Potential peak sales for Labrys’ LBR-101, currently under development, are estimated to reach $2 billion to $3 billion, Teva reported.

With the goal of becoming a global leader in pain by 2020, the Labrys acquisition adds a significant migraine prophylaxis dimension to Teva’s extensive pain care franchise, which includes a range of investigational, approved and marketed treatments for migraine, cancer pain and chronic pain, the company noted.

Labrys is developing LBR-101, a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide currently in Phase IIb clinical trials for prevention of chronic and episodic migraine. Teva’s acquisition of the LBR-101 program targeting high frequency episodic and chronic migraine clearly complements the recent addition of Zecuity, a therapy for the acute treatment of migraine, obtained through the acquisition of NuPathe.

“More than 8.5 million people in the U.S., EU and Japan suffer from episodic or chronic migraine requiring preventative treatment, a condition that can destroy their quality of life,” stated  Michael Hayden , Teva’s president of global R&D and chief scientific officer. “CGRP is a well-validated target in migraine, and Labrys has progressed the development of LBR-101 with scientific rigor and excellence. With its long half-life, target specificity and favorable pharmacokinetic profile allowing for infrequent, and convenient, subcutaneous administration, LBR-101 represents a very exciting biologic product candidate, and much needed option, for the management of this truly debilitating condition.”

The closing of this transaction is subject to antitrust clearance and satisfaction of other conditions.

 

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HDMA announces 2014 DIANA Winners

BY Michael Johnsen

ARLINGTON, Va. — HDMA on Tuesday honored pharmaceutical and consumer product manufacturers at its 2014 Business and Leadership Conference in Phoenix, through the presentation of the Association’s annual Distribution Industry Awards for Notable Achievements in Healthcare (the DIANA awards). 

The DIANA awards have recognized supply chain excellence and successful trading partner relationships since 1959. The awards honor pharmaceutical and consumer product manufacturers for developing innovative new product introductions and promotions for the healthcare distribution industry. Manufacturers also are recognized for advancing trade relations by fostering strong trading partner relationships with HDMA distributor members and creating exceptional business practices that benefit the entire healthcare supply chain.

In addition, presented for the second year, the DIANA Manufacturer Partner of the Year recognizes companies for their active participation in the Association. The winning companies have at least five consecutive years of membership, regularly participate in HDMA conferences, serve on Association committees, and show support through event attendance and sponsorships.

2014 DIANA Manufacturer Partner of the Year Winners:

  • HDMA Manufacturer Member With Sales to Healthcare Distributors of More Than $50 Million: Mylan
  • HDMA Manufacturer Member With Sales to Healthcare Distributors of Less Than $50 Million: Upsher-Smith Laboratories.

2014 DIANA Winners:

Best New Product Introduction or Promotion Awards:

  • Branded Pharmaceutical Products: Eisai for Belviq;
  • Generic Pharmaceutical Products: Citron Pharma for duloxetine DR capsules USP; and
  • Over-the-Counter and Home Healthcare Products: Merck Consumer Care, for Oxytrol for Women.

 Best Overall Manufacturer Awards:

  • Branded Pharmaceutical Product Manufacturer with Sales to Healthcare Distributors of Less Than $300 Million: Depomed;
  • Branded Pharmaceutical Product Manufacturer with Sales to Healthcare Distributors of More Than $300 Million: Forest Pharmaceuticals;
  • Generic Pharmaceutical Product Manufacturer with Sales to Healthcare Distributors of Less Than $100 Million: Alvogen;
  • Generic Pharmaceutical Product Manufacturer with Sales to Healthcare Distributors of More Than $100 Million: Actavis; and
  • Consumer Product Manufacturer: BD Medical – Diabetes Care.


 

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