CMS authorizes claims data collection from Part D program
WASHINGTON The Centers for Medicare and Medicaid Services has published a final rule authorizing the collection of claims data under the Medicare Part D drug benefit program for research and other public health functions.
The rule, for instance, will permit the automated population (i.e., users do not have to enter information themselves) in personal health records, upon an individual’s consent, of medication histories and the physicians who prescribed drugs.
CMS is seeking Medicare beneficiaries in South Carolina to participate in a pilot program to assess the benefits of using PHRs. But absent this rule, the program was to start with beneficiaries entering their own prescription and over-the-counter medications into the PHR, because CMS believed present law limited its use of Part D data.
“We note that because this final rule applies to all Part D sponsors, it applies to any entity offering a Part D plan, including both prescription drug plan sponsors and Medicare Advantage organizations offering qualified prescription drug coverage,” according to the rule.
Takeda could see Alogliptin approval in near future
OSAKA, Japan Japanese pharmaceutical manufacturer Takeda’s new diabetes drug could get approval soon, according to Bloomberg.
According to the financial news agency, reports by analysts showed that the drug, alogliptin, had promise after the American Diabetes Association released parts of nine studies of the medication that were submitted for marketing approval in the U.S. in January, last week. They show the drug lowered blood sugar levels as much as Merck’s Januvia without serious side effects.
Alogliptin, also known as SYR-322, will compete with Merck’s Januvia and Novartis’ Galvus, which is also up for approval at the Food and Drug Administration. All three drugs are in a new class of diabetes treatments known as DPP4 inhibitors that signal the pancreas to produce more insulin and the liver to make less glucose, or blood sugar.
Assuming approval by the Food and Drug Administration, Alogliptin will succeed Actos, which generates about 29 percent of Takeda’s current revenue. Actos will lose patient approval in 2011.
Accutane ingredient linked to increased risk of depression
NEW YORK A study published in the Journal of Clinical Psychiatry has shown a link between use of the acne drug isotretinoin and increased risks of depression.
The drug was shown to more than double the risk of depression in a study of more than 30,000 people in Quebec who had received at least one prescription for it between 1984 and 2003.
Roche Pharmaceuticals’ drug Accutane has isotretinoin as its main active ingredient. The FDA originally granted approval to the drug in 1982.