PHARMACY

Study: $4 generic programs could help save society close to $6 billion

BY Allison Cerra

PITTSBURGH — Patients that opt to fill their prescriptions through a $4 generic program could help garner societal savings of nearly $6 billion, a new study found.

Conducted by the University of Pittsburgh Graduate School of Public Health and published in the March 14 issue of the Archives of Internal Medicine, the study examined a nationally representative sample of nearly 31,000 people in the "2007 Medical Expenditure Panel Survey" and identified patients who could have saved money had they filled their medications through a discount generic drug program.

After comparing those who used generic medications or their brand-name counterparts for such drugs as lovastatin or prescription-strength ibuprofen, GSPH researchers found that less than 6% used the $4 generic medication programs in 2007 — although average prescription drug coverage plans asked patients to pay about $10 per 30-day supply for generic drugs and about $25 per 30-day supply for brand-name medications — and noted that if all eligible patients had used the discount programs in 2007, the societal savings would have been $5.8 billion.

"Although just half of the potential users of the $4 programs would have saved more than $22 a year in out-of-pocket expenses, the societal savings are great. This suggests the majority of savings comes from a small proportion of individuals," said the study’s lead author, Yuting Zhang, assistant professor of health policy and management at GSPH.

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Study: Metformin best first-line diabetes treatment

BY Allison Cerra

NEW YORK — While several drugs to treat Type 2 diabetes are on the market, researchers have found that the best first-line option is metformin.

Led by Wendy Bennett, an assistant professor of medicine at Johns Hopkins University School of Medicine in Baltimore, researchers reviewed 140 trials and 26 observational studies of head-to-head comparisons of monotherapy or combination therapy that reported intermediate or long-term clinical outcomes or harms of six oral diabetes medications.

Despite the fact that all of the drugs — metformin, second-generation sulfonylureas, thiazolidinediones, meglitinides, dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists — reduced hemoglobin A1C levels as either a monotherapy or combination therapy, metformin proved to be the most efficacious for posing the least amount of risks.

The other treatments, study authors noted, posed a higher risk of such conditions as hypoglycemia, congestive heart failure and bone fractures.

"Metformin continues to be an inexpensive medication, and it’s very efficacious," Bennett said.

The study was published in the Annals of Internal Medicine.

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Aegerion’s lomitapide granted orphan-drug status by FDA

BY Alaric DeArment

CAMBRIDGE, Mass. — A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

Aegerion Pharmaceuticals announced that it received the designation for lomitapide as a potential treatment for familial chylomicronemia. The drug currently is in phase-3 trials as a treatment for homozygous familial hypercholesterolemia, and Aegerion said it expects to start a separate clinical trial to evaluate the drug for familial chylomicronemia in the second half of this year.

“The FDA’s grant of orphan-drug designation to lomitapide for the treatment of FC represents an important milestone in the overall development and commercialization plan for the compound, and it underscores the unmet need that exists,” Aegerion CEO Marc Beer said. “With this announcement, we are another step closer toward our goal of [treating] patients with these rare lipid disorders that currently have inadequate treatment options available.”

The FDA gives orphan-drug designation to treatments for diseases that affect fewer than 200,000 people in the United States. The designation includes tax incentives, possible exemption from the FDA user fee and a seven-year market exclusivity period upon approval, compared with the usual five years.

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