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Chronic hepatitis B is a common disease worldwide with significant morbidity and mortality. Early diagnosis is essential but difficult, as most patients with chronic hepatitis B do not have specific symptoms until the symptoms of advanced disease occur. The main goal of therapy is to prevent cirrhosis and hepatocellular carcinoma by suppressing hepatitis B virus (HBV) DNA levels. The decision to treat and the choice of therapy require careful consideration of both patient and drug characteristics, as stated in both an expert panel consensus recommendation and the American Association for the Study of Liver Diseases (AASLD) treatment guidelines. Lamivudine, once the mainstay of oral antiviral treatment, has been supplanted by newer agents such as adefovir, entecavir, and telbivudine, which produce less drug resistance overall; these oral agents often require long-term treatment. Pegylated interferon alfa-2a, which has a predefined treatment course but is often poorly tolerated, is now the main option in..

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic drug approval: amlodipine/benazepril capsules

The latest FDA action (through July 2007) related to tramadol (Labopharm), SPD465 (Shire), continuous erythropoiesis receptor activator (Roche), fosaprepitant (Merck), ACAM2000 smallpox vaccine (Acambis), repository corticotropin injection (Questcor), rimonabant (Sanofi-Aventis), tamibarotene (Innovive), mycophenolate (Aspreva), romidepsin (Gloucester), aripiprazole (Otsuka/Bristol-Myers Squibb), AMT 011 (Amsterdam Molecular Therapeutics), aminolevulinic acid (Dusa), cyclosporine A (Novagali), and ARD-07 (Ardana)

Temsirolimus is now approved by FDA as an antineoplastic agent for the treatment of advanced renal cell carcinoma.

Rotigotine transdermal system is now approved by FDA as a nonergoline dopamine agonist for the treatment of for the treatment of signs and symptoms of early-stage idiopathic Parkinson disease.

Doxorubicin liposome injection, an anthracycline topoisomerase inhibitor, is approved by FDA in combination with bortezomib for the treatment of multiple myeloma

A new formulation/dosing regimen for levonorgestrel 90 mcg/ethinyl estradiol 20 mcg, a continuous-use combination oral contraceptive approved by FDA for the prevention of pregnancy.

Medical Professionals are taking to heart the old saying that necessity is the mother of invention. Now more than ever, they're putting their knowledge and experience to work in developing IT innovation.

As the concern about the long-term fiscal viability of Medicare continues to grow, so has the recognition that some of the services ordered by physicians-and subsequently billed to Medicare-might not be warranted.

If managed care executives can't get accurate information and honest opinions, they can't make the right decisions, according to Allan Baumgarten, author of annual state managed care reviews and an independent research consultant in policy, finance and local market strategies.

Healthcare organizations must begin leveraging the value of the products they deliver and infuse customer service into every interaction to remain competitive in this changing market.

Washington, D.C.-Despite earlier promises that consumer-directed healthcare (CDHC) programs would reduce healthcare spending by encouraging more efficient purchase of health services, consumer confusion and higher out-of-pocket costs seem to be slowing enthusiasm for these plans.

Ann Arbor, Mich.- In the past, plans provided electronic explanation of benefits to consumers, which reflected a major customer service innovation. Today, innovations involve enabling consumers to connect their physicians and other care providers with a comprehensive information repository enriched by the data managed by the plan-including medical and drug claims, lab results, and health risk information, industry experts say.

Washington, D.C.-Medicare pays private fee-for-service (PFFS) plans 19% more than prevailing fee-for-service spending, according to the June 2007 report of the Medicare Payment Advisory Commission (MedPAC). At the same time, beneficiaries are complaining of misleading promotional tactics by these plans.

As payers have been increasingly impacted by rising drug costs, they have become more creative in plan design by introducing different copay tiers and member incentives to change drug purchasing behavior, say industry watchers.

While your pharmacy benefit program has no doubt been managing utilization for years with core strategies, it's important to review effectiveness often. Below are the proven strategies that payers should analyze frequently in the current market of increasing utilization.

Grace seems an unlikely acronym for a study of acute coronary events, but given the findings of the Global Registry of Acute Coronary Events published in the Journal of the American Medical Association, the name may be apropos.

More than half of all state Medicaid programs incorporate a financial incentive encouraging providers to deliver better quality care, according to a study by the Commonwealth Fund. In addition, the study finds that 70% of existing Medicaid P4P programs operate in managed care or primary care management environments. Nine Medicaid programs are joining with other payers, employers and providers in statewide or regional P4P efforts, which is an indicator that the Medicaid plans are keeping pace with HMOs-half of which are offering P4P programs of their own.

If managed care executives can't get accurate information and honest opinions, they can't make the right decisions, according to Allan Baumgarten, author of annual state managed care reviews and an independent research consultant in policy, finance and local market strategies.

As far as Michael Howe is concerned, the healthcare community should no longer question whether retail clinics are here for the long haul. The way he sees it, the criticisms about quality and continuity remain theoretical and spoken by a vocal minority. But even more so, the millions of consumers who are driving demand for retail-clinic services seem to have answered the question already.

The practices of some California insurers have recently come under attack in lawsuits brought by private litigants and in administrative actions brought by state regulators. The practice involves the rescission of health insurance policies due to misrepresentations made in the policy application form.

Typically not a big fan of movies, I was surprised by how much I enjoyed my DVD rental of "Man of the Year." The basic premise of the movie has a quirky, independent-party candidate winning the popular vote in a presidential race.

Experts say that 5% of all claims are fraudulent or abusive. If the total spent on U.S. healthcare annually is approaching $2 trillion, that 5% would add up to nearly $100 billion a year in fraudulent or abusive claims. And the percentage may be higher, perhaps as high as 10% of claims.

Payers and employers can pay up to $350,000 per patient for just one year of treatment for high-cost conditions such as rheumatoid arthritis. Patients, too, share the burden, in some cases shouldering 50% of the bill in deductibles and co-pays.

A summary of case management adherence guidelines and online-based case management systems.

The investigational vasopressin receptor antagonist tolvaptan had no long-term impact on clinical events in patients hospitalized with acute decompensated heart failure (ADHF), but the agent did improve symptoms and volume status over the short term, according to results presented at the 56th annual ACC scientific session.

Succinobuccol, an investigational monosuccinic acid ester of probucol, was not associated with a reduction in a composite end point of major cardiovascular events in patients diagnosed with acute coronary syndrome (ACS), but use of the agent did result in improvements on certain secondary end points.

Initial combination therapy for early rheumatoid arthritis (RA) provides earlier clinical improvement and less progression of joint damage at 2 years compared with initial monotherapy, according to a randomized, controlled trial.

Results of a systematic review demonstrated that high doses of aspirin for >10 years may help reduce the incidence of colonic adenoma and colorectal cancer.