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THE BEST STEP therapy programs first consider medical evidence regarding patient outcomes when identifying drug classes for inclusion, according to industry experts.

IN THE PAST TWO DECADES, the progress of pharmacy benefit management has brought about sophisticated strategies including formularies, utilization management and generic substitution. David B. Snow Jr., CEO of Medco Health Solutions, is bargaining that the next decade of pharmacy benefit management will bring enhanced patient therapy, personalized medicine and dramatic opportunities in the generic market-points all pharmacy benefit teams will have to ponder.

What makes the high cost of a drug worth it? Does the intervention have to save a life? Or prevent the onset of a more expensive condition? Or add six months to patient survival? It's all in the eye of the beholder-whether you are a payer, patient or provider.

Washington, D.C.-Sierra Health Services recently disclosed a $2 million monthly loss from its Medicare full donut-hole-coverage prescription drug plan (PDP), blamed the financial problem on a competitor, and decided to sell out to the leader in the field. Sierra executives say they will drop the Sierra Rx Plus plan, which pays for brand-name drugs through the Medicare coverage gap for its 42,000 members, and the new owner, UnitedHealth Group is unlikely to question that decision.

Washington, D.C.-The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires Sept. 30, 2007, has set the stage for Congressional action on broader legislation to enhance government regulation of drug safety. Bills under consideration aim to expand Food and Drug Administration (FDA) oversight by establishing new requirements for postmarket risk assessment, for posting information on active clinical trials and the resulting study data, and for completing agreed-upon postmarketing studies.

Surgical site infections are a significant problem in hospitals today. They occur in 2% to 5% of patients who have clean operations outside the abdomen, and in up to 20% of patients with intra-abdominal procedures. They account for about 15% of hospital-acquired infections.

Over the next few years, more health plans and employers will investigate covering the physician-administered injectable drugs under the pharmacy benefit as a way to control the costs and manage appropriate utilization, says Kathryn Lindhorst Canaday, PharmD, director of pharmacy analysis, Pharmaceutical Strategies Group (PSG), based in Dallas.

New drug delivery methods have potential to improve compliance through ease of use, but have brought up some new questions. Is reconfiguring an injected insulin into an inhaled version, for example, just a way to relaunch a product, or does the invention provide more than a "me-too" product?

It would seem that any healthcare entity able to introduce lower costs and greater convenience would be welcomed with open arms, if not a genuine ticker-tape parade. Yet, walk-in retail clinics, new players built on low cost and convenience, are struggling to gain a national foothold, and experts aren't sure the new guy will even make it in the end.

Attention-deficit/hyperactivity disorder (ADHD) is marked by patterns of inattention, careless mistakes, difficulty waiting, forgetfulness and restlessness. People who have ADHD are distracted most of the time. Even when they try to concentrate, they find that it's hard to pay attention. They have trouble organizing things, listening to instructions or remembering details. Someone with this condition is impulsive. They often fidget, don't wait for their turn and interrupt others. In school, children with ADHD may blurt out answers and move around a lot; they seem to be "always on the go."

Although as many as 48% of seniors were subject to some type of drug-coverage deficiency in 2006, only an estimated 4 million of the 22.5 million enrolled in Medicare drug plans were actually expected to hit the infamous donut hole. There could still be financial woes, however, for the 10.8 million Medicare beneficiaries who at least have the potential for out-of-pocket costs in the donut hole gap because they do not qualify for a subsidy, are not covered outside Part D, or did not pay for enhanced gap coverage.

National Reports-The recent merger move by retail pharmacy chain CVS and pharmaceutical service company Caremark Rx is not likely to have much near-term significance to the managed care industry, say experts, but over time, MCO customers are likely to experience some change as a result of the two entities' combining their PBM operations.

Washington, D.C.-While global sales of pharmaceuticals are slowing, the generic drug market continues to grow. The latest report from IMS Health predicts generic drug sales will rise 13% to 14% to $65 billion next year, almost 10% of projected worldwide drug sales of $685 billion, compared with a 5% to 6% increase in the global pharmaceutical market.

The influenza immunization rate is a closely watched HEDIS measure among plans. Influenza vaccine is about 80% effective in preventing infection in general, although its effectiveness is lower in the elderly. In addition, its effectiveness can vary from year to year, depending on the match between the vaccine and the particular strains of influenza circulating that year.

Recent studies on diabetes control are wrangling for attention with some confirming the National Health and Nutrition Examination Survey (NHANES), which suggests that diabetes control declined through the late 1990s, while others indicate that diabetics are maintaining better control.

Skyrocketing pharmaceutical costs. A still-evolving Medicare prescription drug coverage program. An influx of generic drugs. The prescription drug arena was characterized by a host of complex issues in 2006 that are certain to carry over into 2007. Managed Healthcare Executive tapped a panel of pharmacy experts to discuss big-picture issues in the United States.

The emergence of pharmacy benefit management companies (PBMs) as major players in drug benefit design and pricing has generated criticism as well as praise. PBMs previously served as drug benefit administrators for employers and other payers. But as sponsors of Medicare Prescription Drug Plans (PDPs), they now assume risk and design coverage and payment options.