Urology

New molecular entities

Just mentioning "contract negotiations" can put plans and providers on the defensive or maybe even the offensive. The sometimes-contentious relationship between the two, triggered by the high cost of healthcare and complaints from providers about not being paid enough, escalates while both parties try to come to some kind of agreement.

Men who have used 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors to reduce their cholesterol levels may be at less risk of developing prostate cancer, according to a case-control study published in the American Journal of Epidemiology.

The high cost of emergency department (ED) care is a concern for commercial and government insurers, hospitals, physicians and patients. Two-thirds of EDs operate at full capacity or over capacity, a situation exacerbated by increased ED visits from both insured and uninsured patients. Software applications that automate the ED can help improve patient outcomes and reduce costs. Payer organizations should be aware of four key adoption trends in ED automation.

While healthcare is highly competitive from a business perspective, when it comes to the actual delivery of care, everyone is on the same team. The ultimate goal is to provide the best possible care at the lowest possible cost, and that's exactly why the Cleveland Clinic created its Disease Management Project.

Critics contend that DTC promotion boosts medical costs.

A study was conducted to evaluate the clinical and economic burden of overactive bladder (OAB) among patients <60 years of age in a managed care population, especially with regard to the prevalence of related comorbidities and associated annual medical costs.

Dapoxetine (Alza/Ortho-McNeil) is a novel oral medication undergoing FDA review for premature ejaculation, one of the most common disorders of sexual dysfunction in men. Dapoxetine is a fast-acting inhibitor of the serotonin reuptake transporter. It has a short half-life and is structurally related to the antidepressant fluoxetine, allowing for on-demand dosing.

Kidney transplant recipients on an immunosuppressive regimen of sirolimus plus cyclosporine who had their cyclosporine withdrawn at an early stage had significantly better graft survival than patients who remained on cyclosporine. The advantage appeared to be related to significantly improved kidney function in the patients in whom cyclosporine was withdrawn, reported Graeme Russ, MD, at the American Transplant Congress 2005 in Seattle, Wash.

About three years ago I asked a large group of health plan executives if they knew how much they spend annually for ?specialty pharmacy? products. Few could respond, and virtually none had launched any efforts to control the then unknown rapid increase in these costs.Today, this is not the case.

Benign prostatic hyperplasia (BPH) is a common chronic disease, with the incidence of BPH increasing with age. Histopathologic features are present in almost half of all men aged >60 years. The disease can have a profoundly negative impact on patients' quality of life, often causing them to limit or avoid basic activities of daily living. Many patients who develop BPH will seek treatment for bothersome lower urinary tract symptoms (LUTS).

New entities and actions in brief

New molecular entities

Fibromyalgia is real and prevalent, yet many physicians and employers may inadvertently ignore or demean sufferers, not only at the cost of those with the condition, but at the cost of productivity and healthcare expenditures.

FDA actions and new molecular entities

Washington, D.C. - Last month, the House approved legislation that would make it easier for Americans to obtain prescription drugs from Canada and other countries, similar to action it took last year. This time the legislators voted overwhelmingly to add to FDA's 2005 budget bill a provision that blocks FDA from enforcing a ban on drug reimportation. The drug import language is not expected to survive House-Senate negotiations on a final FDA spending bill, but it allows members of Congress to portray themselves as import advocates at election time.

The parasympatholytic action of trospium reduces the tonus of smooth muscle in the bladder by antagonizing the effect of acetylcholine on muscarinic receptors. Trospium was approved on May 28, 2004, for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Darifenacin (Enablex, Novartis) is a muscarinic antagonist in phase 3 clinical trials for the treatment of overactive bladder (OAB). Darifenacin demonstrates relative selectivity for the M3 muscarinic receptor subtype over the M1 and M2 subtypes. In clinical trials, darifenacin has been compared to placebo for the treatment of symptoms of OAB in adult men and women. Patients treated with darifenacin experienced significantly greater reductions in the number of incontinence episodes per week, nocturnal awakenings, and warning time before micturitions. It appears to have similar efficacy to available anticholinergic agents for the treatment of OAB. Commonly reported adverse events include dry mouth and constipation, and preliminary data suggest that darifenacin may be associated with decreased impairment of salivary flow versus oxybutynin. Darifenacin has not been found to have an effect on the cardiovascular system or cognition in clinical trials. Further research is needed to determine the efficacy of darifenacin compared to other available anticholinergic agents such as oxybutynin and tolterodine, as well as emerging therapies. In addition, further investigation of the adverse effect profile in elderly patients is warranted.

Erectile dysfunction (ED) is now recognized as a common problem in men. Several medical problems, including diabetes mellitus, coronary artery disease, hypertension, and hyperlipidemia are known to increase the likelihood of developing ED. Diagnosis depends on an adequate history and physical examination. Several therapies are now available for the treatment of ED. With the advent of the phosphodiesterase type 5 (PDE5) inhibitors, therapy for ED has become more acceptable for many men. Oral therapy is usually the first-line treatment due to the ease of use and the effectiveness of this therapy. For men who do not respond to or have a contraindication to PDE5 therapy, intrapenile injection therapy, intraurethral therapy, and vacuum devices are effective alternatives.

New molecular entities, new biologics and new formulations

Our recent "ER is a Hit With Insured Americans" news item stirred up some reader response.

New PDE5 inhibitor approved for erectile dysfunction

Recent approvals and FDA actions

Phosphodiesterase inhibitor for the treatment of ED

Data allow MCOs to evalutate their pharmacy services and which drugs should or should not be covered

New HEDIS measures for 2004; President&s New Freedom Commission on Mental Health report; The Commonwealth Fund's report on eroding retiree benefits

Providers and payers benefit from efficient scheduling,vbalanced utilization and adequate staffing

Vardenafil (Levitra, Bayer AG/GlaxoSmithKline) is a selective inhibitor of phosphodiesterase 5 (PDE5) currently under review by FDA for the treatment of erectile dysfunction (ED). If approved, vardenafil will become the third PDE5 inhibitor to be marketed in the United States and the fourth oral agent approved for the treatment of ED. Vardenafil has been studied in subjects of various ages (<45 and >65 years of age), with different etiologies and different baseline severity of ED. Studies evaluating vardenafil have determined it to be safe and effective at doses of 5 mg to 40 mg, including subjects with diabetes mellitus and subjects who have undergone radical prostatectomy. Vardenafil has a pharmacokinetic profile similar to that of sildenafil (Viagra, Pfizer). The drug appears to be well tolerated. In clinical trials, headache, dyspepsia, and flushing were the most common adverse effects reported by subjects taking vardenafil. No adverse hemodynamic or visual effects have been reported during clinical trials of vardenafil; however, further investigation, including post-marketing surveillance, will be required. Further research and clinical experience with the newer PDE5 inhibitors (vardenafil and tadalafil [Cialis, Lilly/ICOS]) will be needed before their roles in the treatment of ED can be determined.

Ranked by total of all payers, 2001

Expert analysis of a debate on cancer screening reveals 63 permutations on points of view. Is it any wonder, then, that the nation has trouble achieving consensus on health care policy?