FDA approves new hyperkalemia drug
SILVER SPRING, Md. — The Food and Drug Administration Thursday announced that it had approved Relypsa’s Veltassa (patiromer) for oral suspension. The drug is indicated to treat hyperkalemia, which is the presence of too much potassium in the blood and typically occurs among patients with kidney disease, or heart failure.
“We are very excited to bring people with hyperkalemia the first new medicine in more than 50 years,” Relypsa president and CEO John A. Orwin. “The FDA approval of Veltassa represents approximately a decade of research by dedicated scientists and doctors, and underscores Relypsa's commitment to developing polymer-based treatments for people with conditions that are often overlooked and undertreated.”
Veltassa, which is powdered, is mixed with water and taken by mouth. The drug works by binding potassium in the gastrointestinal tract, and the potassium is then excreted through the body through the normal excretion process. Veltassa was approved with a boxed warning, which recommends taking Veltassa and another oral medication six hours apart because it can bind to orally taken drugs and reduce their absorption, the FDA said.
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Rite Aid, Rx orgs make case for expanded MTM
WASHINGTON — On Wednesday the U.S House of Representatives’ Committee on Energy and Commerce Subcommittee on Health convened a hearing called “Examining Medicare Part D Medication Therapy Management Program.” The hearing was aimed at figuring out the best ways to strengthen MTM model as the Centers for Medicare and Medicaid roll out an overhaul of it. Among those testifying was pharmacist and Rite Aid’s director of field clinical services Jesse McCullough, who spoke in favor of expanding MTM to include more patients.
McCullough focused on how MTM services aid in senior health care and highlighted recent efforts to expand the program, which include the introduction of a bill in the senate, the Medication Therapy Management Empowerment Act that would increase access to MTM for patients with such chronic conditions as diabetes, cardiovascular disease, high cholesterol and COPD. McCullough also noted that, given community pharmacist’s unique role as an easily accessible healthcare provider, they could be at the center of the expansion of MTM programs.
“Rite Aid has participated in MTM programs since their inception, and we have helped thousands of patients get more out of MTM to optimize their medication therapy,” McCullough said. “The fact of the matter is that we can do more.”
McCullough also spoke about the potential savings to the healthcare system that an MTM expansion would provide — especially given that “poor medication adherence alone costs the nation approximately $290 billion annually — 13 percent of total healthcare expenditures — and results in avoidable and costly health complications.”
In light of the hearing, both the National Association of Chain Drug Stores and the National Community Pharmacists associations submitted statements to the subcommittee calling for an expanded MTM model for Medicare patients.
“NCPA believes that prevention is the best medicine, and whether it's catching a medication error before it leads to a hospitalization or effective chronic disease management, MTM services present an opportunity to improve patient care while providing greater efficiencies within the health care system,” NCPA CEO B. Douglas Hoey said. “NCPA strongly supports Medicare's recent efforts to improve MTM services and will continue to work with Medicare officials and Congress toward that end.”
Similarly, the NACDS emphasized the role MTM can play in improving patient outcomes and called for expansion.
“Pharmacist-provided services such as MTM are important tools in the effort to improve medication adherence, patient health and healthcare affordability,” the statement said. “Reforming the Medicare Part D program should be accomplished through efficiently targeting beneficiaries who can most benefit from the services that will improve medication adherence and overall program effectiveness. … We urge Congress to build on this earlier action and strengthen the MTM benefit in Medicare Part D.”