PHARMACY

Prescription drugs lower Medicare costs, CBO study finds

BY Alaric DeArment

WASHINGTON — Increasing the prescriptions filled by Medicare beneficiaries by 1% would reduce the program’s spending on medical services by about 0.2% by reducing costs in such areas as hospitalizations, according to a new report by the Congressional Budget Office.

The report, "Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services," contrasted with previous CBO studies that found insufficient evidence of an "offsetting" effect of prescription drug use on medical services spending.

In response to the report, the National Community Pharmacists Association, a trade group representing independent pharmacies, highlighted what it called pharmacists’ role in reducing costs in the Medicare program through services like using generics and helping to ensure compliance and adherence.

"We commend CBO for acknowledging the growing body of evidence verifying what community pharmacists have known for some time," NCPA CEO B. Douglas Hoey said. "Namely, that the more patients have their prescriptions filled and adhere to medications their doctors prescribe, the healthier they will be, and the likelihood of costlier interventions — including hospitalizations — diminishes, reducing healthcare costs."


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PHARMACY

FDA approves new medullary thyroid cancer drug

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

The FDA announced the approval of Cometriq (cabozatinib) to treat medullary thyroid cancer — a cancer that develops in cells in the thyroid gland that make calcitonin, a hormone that helps maintain a healthy level of calcium in the blood — that has spread to other parts of the body. Another drug to treat medullary thyroid cancer, AstraZeneca’s Caprelsa (vandetanib), was approved last year.

"Cometriq is the second drug approved to treat medullary thyroid cancer in the past two years and reflects the FDA’s commitment to the development and approval of drugs for treating rare diseases," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "Prior to today’s approval and the approval of Caprelsa in April 2011, patients with this rare and difficult-to-treat disease had limited therapeutic options."

The National Cancer Institute estimated that 56,460 Americans will be diagnosed with thyroid cancer — and 1,780 will die from it — in 2012.


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PHARMACY

User fee re-authorization 
fuels generics’ outlook

BY Jim Frederick

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


The enactment in July of the Prescription Drug User Fee Act, or PDUFA, which by law must be re-authorized every five years, provides the Food and Drug Administration with much of the funding the agency needs to review and approve manufacturers’ new-drug applications.


This year, for the first time, the law included Generic Drug User Fee Amendments, thus creating a system of user fees for generic drug companies. The fees, which are projected to raise about $299 million per year over five years, will go toward hiring extra staff to help clear the agency’s estimated backlog of 2,500 generic drug approval applications awaiting review.


The new funding also will spur development of bioengineered and biosimilar medicines by providing the FDA “with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation,” according to Castellani.

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