News

Pipeline Preview for January 1, 2002

FDA Actions in Brief as reported January 1, 2002

Although sensitivity analysis is a widely used technique for testing the uncertainty in pharmacoeconomic modeling parameters, it does have limitations. This month's column introduces probabilistic sensitivity analysis as an alternative method for examining uncertainty.

Tenofovir disoproxil fumarate (Viread) recently gained accelerated FDA approval. It is the first member of a new antiretroviral class and also the first antiretroviral approved on the basis of efficacy trials conducted almost exclusively in treatment-experienced patients. This Focus article reviews these studies and considers how other pending and planned trials may refine tenofovir's role.

Like their older counterparts, the newer anticonvulsants gabapentin, lamotrigine, and topiramate show promise for treating various off-label psychiatric and neurologic disorders. This review examines the quality of current evidence for these new uses, identifies where gaps in the evidence lie, and discusses which emerging uses of individual agents appear most justified.

Clinicians at Nebraska Methodist Hospital, a not-for-profit acute care facility, developed and implemented an automatic interchange program for the ACE inhibitor class of drugs. This article presents the ACE inhibitor review upon which the formulary decisions were based as well as the initial clinical and economic results of the interchange program. (This pdf version includes an appendix that was not included in the print issue)

Despite the bad reputation from consumer publications, MCOs should be proud of their successes

Perhaps the greatest criticism leveled at America's healthcare system is the fact that millions of people have no healthcare insurance at all. Our physicians are among the best trained in the world, and the equipment and technology they work with is state of the art. But those things are meaningless to patients who fall between the cracks of the system and can't access that care.

Part 2 follows certain projects through to conclusion while providing more advanced concepts to those considering the application of Six Sigma principles at their organization.

Ranked by consumer response to NRC study, 2001

Fondaparinux, the first in a new class of antithrombotics that selectively target factor Xa, has been deemed approvable by the FDA for prevention of venous thromboembolism following orthopedic surgery. Four phase III trials have suggested that it may be more effective than enoxaparin in this setting with little to no additional bleeding risk. This Focus review examines data from these trials and others in an effort to sketch out this pending agent's likely therapeutic role.

New Formulations/Combinations: Pediatric-specific albuterol formulation; fixed-dose bronchodilator combination

New Indication: Light-activated ophthalmic cleared for CNV due to two additional causes

New Indication: Injectable PPI cleared for hypersecretion due to Zollinger-Ellison syndrome

NMEs/biologics: 5-HT receptor agonist for Tx of migraine

Uncle Sam is poised to authorize more than $1 billion to buy medicines and vaccines for the national pharmaceutical stockpile, and federal agencies are gearing up to spend millions more on research related to infectious disease. In response, the pharmaceutical industry is assessing how these developments may alter the way it does business.

Pipeline Preview for December

How diabetes works and who it targets.

Third-party physician credentialing could keep providers focused on their core businesses

MCOs and voluntary health agencies collaborate to improve care, perception

Achieving clinical excellence has always been the goal of the U.S. healthcare industry, even on the payer side.

Ranked by total HMO enrollment as of July 1, 2000

Third-party physician credentialing could keep providers focused on their core businesses

In less than 2 weeks after the launch of generic fluoxetine in August, Merck-Medco had switched 85% of its mail-order Prozac prescriptions to generic versions of the antidepressant. It says its generic switch rate for retail Prozac scripts was 69% over the same time period.

The September 11 terrorist attacks and October's wave of anthrax cases have forced hospitals and health systems to examine their emergency preparedness from a new perspective. When it comes to planning for possible shortages of critical drugs and the need for biodefense, experts say the right mix of federal guidance and local implementation is key.

Harvard Pilgrim HealthCare, Wellesley, MA-It's well accepted that the provision of drug samples influences physician prescribing practices. Annually, the pharmaceutical industry provides billions of dollars worth of drug samples to physicians' offices and studies have shown the effectiveness of sample medications in shaping physician prescribing patterns.

New Formulations/Combinations: Hormonal vaginal contraceptive ring

New Formulations/Combinations: Oral form of corticosteroid for Tx of mild to moderate Crohn's disease

New Indication: Hepatitis B indication expanded to pediatric patients

NMEs/biologics:Cephalosporin for various infections