News

An extensive systematic review published in the Annals of Internal Medicine demonstrated that older oral drugs for type 2 diabetes are just as, if not more, effective than newer agents for gylcemic control, lipid control, and other intermediate end points.

Angiotensin II receptor blockers (ARBs) have been demonstrated to reduce morbidity and/or mortality in patients with chronic heart failure (CHF), acute myocardial infarction (AMI), type 2 diabetes, and hypertension. Although as a class ARBs share a common mechanism of action, potency among the agents varies. Higher-potency ARBs (candesartan, irbesartan, olmesartan, and telmisartan) may demonstrate improved 24-hour blood pressure control, suggesting that these agents may have superior clinical event reduction potential versus lower-potency agents (eprosartan, losartan, and valsartan). We conducted a meta-analysis of randomized, controlled trials that evaluated the effect of ARBs on clinical outcomes. A systematic literature search of MEDLINE from 1966 through December 2006 was conducted using specific search terms. Studies that met the following criteria were included: randomized; not angiotensin-converting enzyme (ACE) inhibitor-controlled; incorporation of monotherapy with ARBs in 1 or more of the treatment..

First-time generic approvals: Carvedilol tablets; famciclovir tablets

The latest FDA action (through October 2007) related to valrubicin (Valstar), pancrelipase (Creon), raltegravir (Isentress), mifamurtide (L-MTP-PE, formerly Junovan), recombinant human antithrombin (Atryn), picoplatin, T4N5 liposome lotion (Dimericine), oral azacitidine, ANX-510 (CoFactor), vincristine (Marqibo), sorafenib (Nexavar), bendamustine (Treanda), MB07133, ALS-357, and MGCD0103

FDA has approved a new indication for risperdal. The drug is now indicated for the treatment of schizophrenia in adolescents aged 13 to 17 years and for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in children and adolescents aged 10 to 17 years.

FDA has approved Somatuline Depot, an analog of natural somatostatin, for the treatment of acromegaly

What if MCO payers could measure providers' costs and outcomes in a single top-down program? What if they could standardize regulations, and immediately test their effectiveness? What if payers could actually help facilities and providers strike a balance between business efficiency and quality patient care-without shutting anyone down?

Today's standard of care has morphed from comprehensive to catastrophic care. As the number of uninsured Americans has increased, so has the percentage of emergency room cases that aren't emergencies. As many as one-half of ER patients are there for routine treatment because they have nowhere else to go.

Consumers tend to seek the best combination of price, features and quality when shopping for medical services, just as in other market transactions. Today, employers are relying on health plans to fill the value-information void with Web-based decision support tools.

Clinical depression is a major problem in the United States, affecting an estimated 5% to 10% of all adults. Costs for medical care and lost productivity related to depression are estimated at more than $40 billion per year.

As patients take more ownership of their disease management regimens, hospitals are beginning to re-evaluate their processes-clinically, administratively and culturally.

National reports-Marketing and distribution of health insurance products continue to evolve, as does the movement toward creating flexible, innovative products to attract new members.

Managed Healthcare Executive recently surveyed readers and gathered your predictions for some of managed care's biggest issues in 2008, including drug safety, technology integration and competition. Answers from the more than 500 respondents indicate that an increasing number of you are uncertain about what the next year will bring, but you remain optimistic about your opportunities and your core capabilities. Comprehensive indicators suggest that the industry is becoming more granular, that is, more customized and more focused on one-off strategies, further stratified populations and differentiation in the market. Preparing for another year of regulatory changes, political influence and industry self-governance will clearly call for greater collaboration, which is another recurring theme throughout this Special Report. We've also included in-depth analysis from an authoritative panel of experts to help you forecast the turning points for 2008.

Disease management-or, what we have known as disease management-stands at a crossroads, as changing demands in the marketplace and a growing emphasis on wellness and prevention recast our thinking on chronic care. Can DM survive?

Health plans are looking for a more integrated approach to managing specialty therapies so they can effectively and efficiently manage the quality of care for the member, as well as the cost to the plan sponsor, say industry experts.

There are as many as 75 million Americans who are either uninsured or underinsured, and the rate will continue to grow. Access to healthcare for all Americans was a hot topic during the early years of the Clinton administration, and has resurfaced recently in anticipation of the 2008 presidential election.

There has been a lot of good news about the Medicare drug benefit lately. Surveys show a substantial increase in coverage, particularly among low-income seniors. Costs are less than expected; employers continue to offer retiree benefits; major insurers are sticking with the program; and product coverage remains fairly broad. Beneficiaries seem generally satisfied with the program, and the much-feared "donut hole" appears less lethal than anticipated.

Every time I look through the sales fliers in the Sunday newspaper, I'm amazed by all the stuff we can buy. Toys, such as satellite radios and video game systems, are just the beginning. Today, you can even buy high-end cleaning products for your bath or shower at more than 10 times the price of a simple sponge and some cleanser.

Washington, D.C-Employer-sponsored health-insurance plan premiums increased only 6% in 2007, less than the last four years. However, insurance costs are rising much faster than inflation and wages, according to a leading survey of employer health benefits. Premiums now average more than $12,000 for family coverage (almost $4,500 for individuals), pricing many workers out of the market.

Denver-A UnitedHealthcare initiative underway in Colorado and a handful of other states allows high-deductible PPO plan members to cut their deductibles as much as $4,000 by meeting certain wellness benchmarks. Called Vital Measures, the program launched June 1 in Colorado, Pennsylvania, Ohio and Rhode Island, and is drawing employer interest, says Cheryl Randolph, UnitedHealthcare spokesperson.

Washington, D.C.-House legislation that proposed to fund expanded coverage for children by cutting payments to Medicare Advantage (MA) plans was put on hold last month in an effort to reach a speedy compromise for reauthorizing the State Children's Health Insurance Program (SCHIP). The legislators agreed to adopt the less-costly Senate proposal, which increases tobacco taxes to expand SCHIP into a $60 billion program over five years. The House bill sought $75 billion for SCHIP and proposed to cut payments to MA plans to offset a lower increase in cigarette taxes. Both plans are much more costly than the $30 billion program proposed by the White House.

Washington, D.C.-House and Senate leaders finally agreed on compromise legislation to renew prescription user fees late last month, just a few days before the funding program was set to expire. The Food and Drug Administration legislation increases drug user fees by $225 million over five years, in addition to adopting user fee agreements negotiated with pharmaceutical, biotech and medical device companies that already raised fees considerably. There's also a new fee program to support FDA pre-review of DTC television ads.

Washington, D.C.-Democratic presidential hopeful Sen. Hillary Clinton scored points with the business community in pledging to retain the nation's public-private healthcare system while promising universal coverage, improved quality and lower costs. In an effort to distance herself from previous efforts to establish a single-payer system, Clinton offered a more centrist plan that touts the "share responsibility" of all parties and builds on the existing employer-based system. There is a mandate for large employers to provide health coverage, which most already do, along with a tax credit for small employers (fewer than 25 workers possibly) to offset premium costs.

Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis

Telavancin is a novel semisynthetic lipoglycopeptide antibiotic undergoing FDA review for complicated skin and skin-structure infections; this agent is also in phase 3 clinical trials for the treatment of hospital-acquired pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Streptococcus pneumoniae. Telavancin exerts its antibacterial action via a dual mode of action involving both inhibition of peptidoglycan synthesis and disruption of the bacterial cell membrane; the latter of these effects is believed to improve the rate of killing observed with telavancin compared with other glycopeptides. In vitro, telavancin exhibits good activity against a variety of gram-positive organisms, including drug-resistant S pneumoniae, MRSA, vancomycin intermediate-susceptible and vancomycin-resistant S aureus, and vancomycin-resistant enterococci. Clinical data have demonstrated that telavancin is at least as effective as comparator agents for a variety of infectious processes...

In response to the recent FDA warnings about an increased risk of suicidal ideation/suicide attempt among children and adolescents using antidepressants, investigators performed a meta-analysis to assess the efficacy and risk associated with antidepressants among pediatric patients.

Legislation to reauthorize the Prescription Drug User Fee Act (PDUFA) IV has been expanded, as expected, via a host of provisions designed to shape drug development and ensure the safe use of medications.

Initial combination therapy with sitagliptin and metformin is more effective than either agent alone in lowering glucose values in patients with type 2 diabetes, according to the results of a recently published study.