Lupin gets FDA approval for generic Xenazine
The Food and Drug Administration has approved Lupin’s generic Xenazine (tetrabenazine) tablets. The drug is indicated to treat chorea associated with Huntington’s disease.
Lupin’s generic Xenazine will be available in 12.5- and 25-mg dosage strengths. The product had a U.S. market size of roughly $288.1 million for the 12 months ended January 2018, according to IQVIA data.
NACDS applauds Congress’ DIR fee reform letter
The National Association of Chain Drug Stores announced its support for a letter written to Health and Human Services Secretary Azar, which was written and signed by 50 members of the U.S. House of Representatives and led by Rep. Tom Marino and David Loebsack.
The letter is an effort to achieve pro-patient and pro-pharmacy reforms of direct and indirect remuneration, or DIR, fees in Medicare Part D. House members stated that DIR fee reforms could lower out-of-pocket costs for beneficiaries and make medicine more accessible, which could lead to greater adherence and better health outcomes, the Arlington, V.A.-based company said.
“NACDS is committed to helping bring about a solution to unsustainable DIR fee practices. We appreciate the continued leadership of Congressmen Marino and Loebsack on this issue, and the strong engagement of the House members who signed this important letter,” Steven C. Anderson, president and CEO of NACDS, said. “We are hopeful that the Centers for Medicare and Medicaid Services will maintain the momentum that it has signaled to move toward a workable solution.”
Originally created to capture and report rebate amounts paid by manufacturers at the end of the plan year, DIR fees have come to be a catch-all category used increasingly by plans to include various pharmacy price concessions, such as fees related to performance-based or participation in a preferred network, the company said.
The Congressional letter states, “The unpredictable variability in the use of fees provides little visibility for the Medicare program, as well as for participating retail pharmacies, particularly for performance-based fees and the goals necessary to achieve specified targets to ‘earn back’ fee amounts.”
House members are urging the Centers for Medicare and Medicaid Services to pursue the reforms that it has signaled, as well as to consider other policies that promote a quality-driven healthcare system that also have been urged by the NACDS.