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In response to criticism about the composition of its independent advisory committees, FDA announced it would modify its procedures dealing with committee appointments and clarify the circumstances under which waivers for conflicts of interest occur.

Anidulafungin (Eraxis, Pfizer) is a new echinocandin approved for the treatment of Candida infection in adults. Like other echinocandins, anidulafungin acts on the fungal cell wall by inhibiting 1,3 beta-D glucan synthesis. Studies suggest that among the echinocandins, anidulafungin may have more potent in vitro activity against Candida spp and Aspergillus spp. Further, phase 2 and 3 clinical studies with anidulafungin have supported a high end of therapy success rates for invasive candidiasis, including esophageal candidiasis. Anidulafungin appears to be well tolerated, with headache, nausea, vomiting, phlebitis, neutropenia, and hypokalemia being the most commonly reported adverse effects. Importantly, as anidulafungin is chemically degraded, it has no clinically significant drug interactions and does not require any dose adjustment for renal or hepatic impairment.

The role of cost- and pharmacoeconomic-related criteria in formulary decision-making was assessed in a literature review of 31 studies of hospital (n=18) and managed care (n=13) pharmacy and therapeutics (P&T) committees. In both settings, cost was important, although the elements of cost considered varied. Acquisition cost was mentioned more frequently than pharmacoeconomic or cost-effectiveness information. Other factors, including drug characteristics, quality of life, supply-related issues, and physician demand, also influenced decisions.

Metronidazole topical gel, 0.75% (equiv to Metrogel topical gel)

Hepatitis B immune globulin (human) (Nabi-HB, Nabi Bio-pharmaceuticals) for the treatment of hepatitis B infection

FDA approved the etonogestrel 68-mg implant (Implanon, Organon), a single-rod implantable device that prevents pregnancy for up to 3 years.

This fixed-dose combination tablet contains: efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, a synthetic nucleoside analog of cytidine; and tenofovir disoproxil, which is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.

Dasatinib is an inhibitor of multiple tyrosine kinases and is active in vitro against leukemic cell lines representing variants of imatinib-sensitive and -resistant disease.

This inhibitor of human immunodeficiency virus type 1 (HIV-1) protease selectively inhibits the cleavage of HIV-encoded Gag-Pol polyproteins in infected cells, thereby preventing the formation of mature virus particles.

This recombinant humanized IgG1 monoclonal antibody fragment binds to the receptor-binding site of active forms of human vascular endothelial growth factor A (VEGF-A).

A review of agents in late-stage development for the treatment of generalized anxiety disorder and sleep disorders (August 2006).

An ongoing issue among insurers is how to determine "usual and customary" (U&C) charges for medically necessary services that are provided by out-of-network providers. While some state laws require an insurer to pay U&C charges, there often is limited guidance as to how to calculate those charges. Case law from various jurisdictions, as well as several treatises, suggest that U&C may be based on the prevailing rates for similar services in the community and that actual charges billed by the provider are not determinative.

Every year, the poor quality of provider data costs healthcare payers an estimated $26 billion and sabotages their quest for efficient operations. Even the most highly automated plans remain vulnerable to the drain on resources caused by inaccurate provider data, rightly called "the Achilles' heel" of healthcare.

The aging baby-boomer population most likely is driving the health consumerism trend. Baby boomers now have more disposable income than any similar age group in the history of the United States. Now, as patients or care-providers for children and elderly patients, baby boomers are visiting physician offices armed with more information about medical conditions, but also are dissatisfied with the "interruption" to their lives caused by long waits in doctors' offices. They also are more interested in managing their own health and are investing heavily in health management aids including health club memberships, vitamins, herbal medicines, fad diets-virtually anything that will prolong or provide a healthier life.

Since the new San Francisco Health Access plan, approved in July, only covers preventive and catastrophic care, everyone who will receive coverage still needs to learn how to become an astute buyer, according to Chini Krishnan, founder and CEO of Healthia Inc., an integrated comparison-shopping portal for healthcare products and services, headquartered in Mountain View, Calif.

The top five HMO enrollment states also have high immigrant populations, says Cynthia Marcotte Stamer, a member of Glast, Phillips & Murray, PC, Dallas, Texas. "Among the top 20 HMO enrollment states, California, New York, Texas and Florida also are on the list of states qualifying for special Emergency Medical Treatment and Active Labor Act (EMTALA) Medicare reimbursements for undocumented aliens under MMA Section 1028."

The educational and professional qualifications of health coaches is relative to the type of health coaching that is being done, according to industry experts.

If you have not already added Medicare Advantage (MA) as part of your health plan's offerings, you are missing a key business opportunity. MA offers increased reimbursement, the chance to expand your product line, the ability to protect your senior business and a strategy for maintaining your membership base. It is worthwhile to recognize, though, that launching any new line of business always involves a certain amount of risk. The key to success is learning about and preparing for the opportunities and impacts of MA.

There's no doubt that HMO enrollment has been declining in recent years, experts say. Various factors explain this enrollment decline.

The issues have been framed brilliantly, debated enthusiastically and examined closely. While it might not resemble the California Gold Rush, employers that implement wellness programs can still find significant rewards.

Heart failure is a serious condition in which the heart doesn't pump enough blood throughout the body. It may be caused by several different diseases that damage or overwork the heart muscle; the leading causes include coronary artery disease, high blood pressure and diabetes.

Physicians insist that pay-for-performance programs should be voluntary and include risk-adjustments.

Not many CEOs would wish for a massive upheaval in their industries. Georganne Chapin, president and CEO of Hudson Health Plan (HHP), minces no words when she says the United States should transition to universal coverage, and HHP, a not-for-profit managed-care Medicaid plan that covers 60,000 members in New York state, should evolve to play a new role.

NATIONAL REPORTS-The San Francisco health access plan raises challenges for MCOs, say industry experts.

Gut instinct always used to tell me that America would never go for universal healthcare coverage. In the back of my mind, I kept picturing either a healthcare free-for-all with everyone and their uncle running to the doctor for every little paper cut, or just as bad, everyone and their uncle waiting in line for months to receive their ration of healthcare. You might have envisioned those alarming circumstances, too.

A salmeterol/fluticasone combination (SFC) surpassed a formoterol/budesonide combination (FBC) in reducing the rate of moderate-to-severe exacerbations in patients with persistent asthma, according to a study published by the journal Respiratory Medicine.

Potassium-sparing diuretics reduced the risk of Alzheimer's disease (AD) by >70% in patients aged >64 years while other antihypertensive (AH) medications, including all diuretics, beta blockers, and dihydropyridine calcium channel blockers, were linked with somewhat smaller decreases in Alzheimer's risk.

An observational case-control study of 1,384 adults presenting with coronary disease for the first time found that patients who presented with acute myocardial infarction (MI) received statins and beta blockers less often than patients who presented with stable exertional angina.

Bupropion extended-release tablets

Ambrisentan, a propanoic acid type-A selective endothelin receptor antagonist, improved exercise capacity and delayed clinical worsening in patients with pulmonary arterial hypertension (PAH) in phase 3 clinical trial results presented at the annual international conference of the American Thoracic Society in San Diego, Calif.