News

FDA actions in brief

Hepatitis B immune globulin (HepaGam B, Cangene) was approved for the treatment of acute exposure to blood containing the hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to mothers who are positive for HbsAg, sexual exposure to individuals who are HbsAg-positive, and household exposure to individuals with acute HBV infection.

Amitiza

By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with constipation. Lubiprostone was approved on January 31, 2006, for the treatment of chronic idiopathic constipation (CIC) in adults.

Ranexa

The anti-anginal and anti-ischemic properties of ranolazine are not dependent on reductions in heart rate or blood pressure. Ranolazine was approved on January 27, 2006, for the treatment of chronic angina. Because ranolazine prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs.

The challenges of medical versus pharmacy benefits faced by payers are unique and vary by category, say industry watchers (See Desktop Resource, March 2006). Some of the following drug classes can fall under both benefit arrangements.

News that Blue Cross and Blue Shield affiliates have begun funding the formation of Regional Health Information Networks (RHIOs) should serve as a wake-up call for all managed care organizations (MCOs).

Advanced specialty pharmaceuticals are increasingly used to treat a wide range of conditions. They require close clinical monitoring. With a relatively short shelf life and limited stability, they call for special handling and timely distribution.

In the United States today, 10 million people have osteoporosis (bone density that's about 25% less than a healthy young adult). In addition, 34 million more people have low levels of bone mass, placing them at increased risk. Osteoporosis is responsible for more than 1.5 million fractures annually, including 300,000 hip fractures, approximately 700,000 vertebral fractures, 250,000 wrist fractures, and more than 300,000 other fractures. About 68% of those affected by osteoporosis are women.

As the U.S. healthcare industry continues its evolution from paper toward electronic medical record-keeping, a trend is emerging: The payers are leading the way, but the consumer ultimately will benefit from -- and actively participate in -- the shift toward industrywide computer-based medical-record databases.

Healthcare allowance

The tools may have changed -- from cookie jars and ledger books to electronic spreadsheets -- but keeping a family household budget is nothing new. As healthcare costs rise and traditional cost-sharing disappears, consumers need to wear the hat of a healthcare financial planner.

Practically every service-oriented business in America today talks about how in tune they are with their customers. Terms like "caring" and "compassion" often are tossed about in their advertising collateral. For Summa Health System, an organized delivery system situated in the heart of Northeast Ohio, and its health plan, SummaCare Inc., these aren't just clever lines crafted by a copywriter.

When health insurers buy an existing book of business, they often effect the acquisition through an asset purchase transaction known as assumption reinsurance. There are many accounting and financial issues to consider in pursuing such a transaction.

WASHINGTON, D.C. -- The main Bush administration proposal for dealing with the high cost of healthcare and rising number of uninsured is to create a new commission. In his State of the Union address in January, President Bush called for a new bipartisan panel to propose changes that will equip Medicare, Medicaid and Social Security to deal with the millions of baby boomers headed for retirement.

The Medicare Prescription Drug Plan, which began January 1, 2006, makes the federal government the largest purchaser of pharmaceuticals in the United States, and probably in the world. It is projected that the Centers for Medicare and Medicaid Services (CMS) will spend more than $1 trillion on medications over the next decade, a volume that will influence the pharmaceutical market more broadly and generate new initiatives to encourage utilization of more cost-effective treatments.

Although experience tells us that formulary conversion programs are commonplace, they are discussed fairly infrequently in the literature. A recent MEDLINE search did not identify any conversion programs similar to a human growth hormone (HGH) program implemented at HIP Health Plan of New York (HIP-NY).

In an attempt to improve patient outcomes and control costs, a guide to empiric antimicrobial therapy, including a urinary tract infection (UTI) algorithm, was distributed to hospital physicians at an academic medical center. A retrospective study was conducted to assess the impact of the guide on physician prescribing of empiric antimicrobial therapy for UTIs. Prior to the implementation of the guide, 45% (n=55) of patients with UTIs were treated consistently with the algorithm. Although not statistically significant, consistency increased to 51% (n=45) after implementation of the guide. The initial publication of a guide to empiric antimicrobial therapy did not significantly influence physician prescribing patterns regarding UTIs. Educational sessions at the time of implementation along with reinforcement of the guidelines may further impact prescribing habits and influence algorithm compliance.

Pipeline Preview

Approvable designations, Fast-track designations

FDA actions in brief

FDA approved ranolazine extended-release tablets (Ranexa, CV Therapeutics) on January 31, 2006, for the treatment of chronic angina. A more thorough review of the agent will appear in the FDA Drug Approvals section of Formulary's March issue.

Exubera

New inhalable insulin formulation approved

Sutent

Kinase inhibitor approved for GIST and advanced renal cell carcinoma