Diabetes drug from Lilly, BI hits shelves
INDIANAPOLIS — A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.
The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The Food and Drug Administration approved the drug on Jan. 30.
The companies developed the drug under a partnership started last year that resulted in a dispute between Lilly and Amylin Pharmaceuticals, with which Lilly had developed the injected Type 2 diabetes drugs Byetta (exenatide) and its long-acting version, Bydureon, which the FDA approved also on Jan. 30. Lilly and Amylin terminated their agreement in November.
NCPA applauds call for congressional hearing on PBMs, Medicare Part D
ALEXANDRIA, Va. — Two lawmakers are calling for a congressional hearing surrounding the role of pharmacy benefit managers in the Medicare Part D prescription drug program.
Reps. Cathy McMorris Rodgers, R-Wash., and Mike Ross, D-Ark., sent a letter outlining the request to U.S. House Energy and Commerce Subcommittee on Health chairman Joe Pitts, R-Pa. Rodgers and Ross said such issues as Part D plan’s "maximum allowable cost;" auditing practices of PBMs, which continue to impact independent pharmacies and their ability to serve their patients; and how Medicare Part D preferred networks are undermining seniors’ ability to access their independent community pharmacy and complaints from seniors about the lack of clarity of information in the Medicare Part D plan finder and plans’ marketing materials.
“We are writing to ask that the Health Subcommittee hold a hearing in this Congress on how PBMs operate within the Medicare Part D program to provide prescription drugs to our nation’s seniors,” the lawmakers wrote. “We believe that these, among other issues, warrant a full hearing before the subcommittee [to help improve Medicare Part D].”
(Read the full letter here)
The call to action was praised by the National Community Pharmacists Association, which sent a letter and petition — signed by pharmacists and pharmacy employees of Lancaster County, Pa. — in December 2011 to Rep. Pitts, calling for a hearing to explore the business practices of PBMs and related issues. The letter was presented to Rep. Pitts by NCPA and the Lancaster County Pharmacists Association.
“Community pharmacists and their patients are grateful for the leadership of Representatives McMorris Rodgers and Ross in requesting this hearing,” NCPA CEO Douglas Hoey said. “With Medicare Part D premiums, patient co-pays, drug costs and PBM profits all rising each year while reimbursements to community pharmacies continue to decline, it’s natural to ask, ‘Where’s the money going?’ This hearing could be an important step toward meaningful reform to achieve more robust competition among pharmacies, lower costs and to align the interests of payers, patients and pharmacies. In addition, the proposed mega-merger of Express Scripts and Medco would reduce the competition and choices available to Medicare and other large health programs, making a hearing this year all the more warranted.”
FDA turns down Eisai drug application
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.
Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.
The drug maker said the FDA’s decision was due to the primary study not providing convincing evidence of safety and effectiveness for AML. The drug already is approved for treating myelodysplastic syndromes, a group of cancers that result from damage to the cells in the bone marrow that form blood cells.