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FEDERAL AND STATE GOVERNMENT ACTIONS AND THEIR IMPACT ON DRUG DECISION-MAKERS

The growing trend for women to wait later in life before having their first child has placed many women at a higher risk for difficult conception. There are numerous classes of medications available to assist women who have been diagnosed with infertility.Agents that are used in the treatment of infertility include: clomiphene citrate, aromatase inhibitors, gonadotropins, chorionic gonadotropins, gonadotropin-releasing hormone, gonadotropin-releasing hormone agonists, gonadotropin-releasing hormone antagonists, follitropins, and other miscellaneous agents. Medications chosen for a patient will vary depending on the identified cause of the infertility. Additionally, economic factors will play a role. It is important for healthcare professionals to be aware of treatment options and have a basic understanding of the role these medications play in the treatment of infertility. (Formulary. 2005;40:329–341.)

Ranolazine (Ranexa, CV Therapeutics) is a partial fatty acid oxidase inhibitor that increases the amount of ATP produced from glucose and increases the ability of the myocardium to retain functionality despite a reduced oxygen supply. Ranolazine is under FDA review for the treatment of chronic stable angina (CSA). Ranolazine was first reviewed in the August 2003 issue of Formulary. Since the initial review of ranolazine by FDA, additional data have emerged that merit an update in this journal. Clinical trials have demonstrated the efficacy of ranolazine as both monotherapy and combination therapy in patients with CSA. Recently published clinical trials (MARISA and CARISA) have shown an improvement in symptom-limited exercise duration. The results of the ERICA trial demonstrated a reduction in weekly anginal attacks when ranolazine was added to maximum-dose amlodipine therapy. Headache and generalized weakness were the most commonly reported adverse events in clinical trials. Prolongation of the QT interval has raised concerns; however, a lack of development of ventricular tachyarrhythmias-specifically Torsade de Pointes-remains an important safety finding. (Formulary. 2005;40:323–328.)

Initiating therapy with the ACE inhibitor quinapril within the first 7 days after coronary artery bypass graft (CABG) surgery does not lead to better outcomes among patients already receiving optimal therapy, said Wiek H. van Gilst, MD, lead investigator of IMAGINE (Ischemia Management with Accupril Post Bypass Graft via Inhibition of Angiotensin Converting Enzyme).

Early use of clopidogrel, started prior to rather than at the time of angioplasty, reduces the risk of death, MI, or stroke by nearly half, reported Marc S. Sabatine, MD, MPH, lead investigator of PCI-CLARITY (Clopidogrel as Adjunctive Reperfusion Therapy).

An antihypertensive regimen of amlodipine with added perindopril significantly reduces all-cause mortality and most major adverse cardiovascular outcomes compared with a regimen of atenolol with the addition of a diuretic, according to the final results of ASCOT-BPLA (Anglo-Scandinavian Cardiac Outcomes Trial Blood Pressure Lowering Arm).

The factor Xa inhibitor fondaparinux prevents death, MI, and refractory ischemia at 9 days as well as the low-molecular-weight heparin enoxaparin in patients with acute coronary syndromes (ACS), while reducing the incidence of bleeding.

A beta blocker first strategy appears to be as safe and effective as an ACE inhibitor first strategy for the treatment of older patients with heart failure, and may confer an early survival advantage.

The ACE inhibitor perindopril significantly reduced left ventricular remodeling in a well-treated population of older patients with acute myocardial infarction (MI) and preserved ejection fraction, said Roberto Ferrari, MD, PhD, lead investigator of the Perindopril Remodeling in Elderly with Acute Myocardial Infarction (PREAMI).

FDA approved a new influenza vaccine (Fluarix, GlaxoSmith-Kline) for adults aged 18 years and older.

Clonazepam orally disintegrating tablets 0.125, 0.25, 0.5, 1, and 2 mg (equiv to Klonopin rapidly disintegrating tablets).

Nelarabine (Arranon, GlaxoSmithKline) injection for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in pediatric and adult patients whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.

This non-benzodiazepine hypnotic is delivered in 2 stages through the use of a bi-layered tablet.

Infliximab, a chimeric monoclonal antibody, exerts its effect through inhibition of human tumor necrosis factor alpha (TNF alpha).

Read more about backing up your data.

Specialty pharmaceutical spending continues to grow at almost 20% per year and more aggressive payer organizations are applying tighter controls on utilization and access to keep costs in check, according to industry experts.

Case Study: Turn data into knowledge.

Case Study: Compass Health is the state's largest provider of comprehensive behavioral health programs for children and adults from a variety of income levels and ethnic cultures.

Specialty pharmaceutical drug coverage by managed care plans

Heal thcare is in desperate need of disruption. Much of our nation's innovation spending is directed at the most complex, challenging and sophisticated problems in healthcare. Much less is being spent on learning how to provide the healthcare that most of us need, most of the time, in a way that is simpler, more convenient and less costly.

Healthcare is an industry perhaps more complex, fragmented and difficult to comprehend than any other. When we try to understand the dynamics that make our industry such a challenge in which to work, we inevitably underestimate the impact of one force or overlook a series of other competing agendas altogether. It's a slippery slope to think we can understand it all, let alone control it.

In a case that likely will be appealed, a San Antonio jury recently awarded $7.4 million in actual damages resulting from the alleged negligence by a health maintenance organization and several providers. In the lawsuit, a deceased woman's family accused Humana, two physicians, and a physician practice group of negligence in a wrongful death action. The jury decision resulted from a three-week trial presided over by a Republican-appointed judge with an insurance defense background. In accordance with Texas law requiring the apportionment of liability, the jury found Humana liable for 35% of the actual damages and the entire $1.6 million in punitive damages.

Last Month brought us news of the indescribable aftermath of Hurricane Katrina. I consumed all the information I could find at first, but then, like many Americans, I had to step away from the media for a while. I had to let the reality sink in without the narration of a news anchor.

Summarizing the Healthcare industry and the state of the precarious union between providers and payers is like trying to balance a gallon of fresh gelatin in your hands. Every time you think you've got it all together, it begins to slip to one side or right through your fingers. Healthcare is an industry perhaps more complex, fragmented and difficult to comprehend than any other. When we try to understand the dynamics that make our industry such a challenge in which to work, we inevitably underestimate the impact of one force or overlook a series of other competing agendas altogether. It's a slippery slope to think we can understand it all, let alone control it.

Small towns are known for close-knit communities, home cooking and home-grown enterprise. In Champaign-Urbana, Ill., even the CEO of the local managed care plan is a hometown native. Jeff Ingrum grew up in the Champaign area and says he never saw himself as the CEO of any health plan other than Health Alliance because of his long-standing familiarity with the people, the providers and the community.

This NSAID is believed to exert its therapeutic effect through inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). Celecoxib was approved on July 29, 2005, for the relief of the signs and symptoms of ankylosing spondylitis (AS).

Review of agents in late-stage development for the treatment of epilepsy and migraine (September 2005).

Muraglitazar (Bristol-Myers Squibb/Merck) is a new agent under investigation for the treatment of patients with type 2 diabetes. It belongs to a novel class of drugs that target the peroxisome proliferator-activated receptors, both alpha and gamma subtypes. Available clinical data describe improvements in glycemic parameters similar to available thiazolidinediones. In addition to improvements in blood glucose and hemoglobin A (HbA 1c), muraglitazar treatment is associated with a substantial reduction in triglycerides (TGs), an increase in HDL-C, and a modest decrease in LDL-C levels. Safety data are limited, but in available abstracts, there are reports of moderately elevated rates of edema, weight gain, and hypoglycemia with muraglitazar compared with placebo or pioglitazone. When used in combination with metformin or glyburide, chronic heart failure events have been reported with muraglitazar. If approved, muraglitazar will provide a convenient alternative for the treatment of type 2 diabetes. (Formulary. 2005;40:285–293.)

One year of bisphosphonate therapy maintains the gains in bone mineral density (BMD) experienced after 1 year of full-length parathyroid hormone (1–84) in postmenopausal women at risk of osteoporotic fracture. The findings were published in the New England Journal of Medicine (2005;353:555–565).

This study compares the cost-effectiveness of the 4 most common empiric antimicrobial regimens used for the treatment of adults with community-acquired pneumonia (CAP) at a community health system during a 6-month period. Associations between initial antimicrobials and total hospital costs were determined. Cost-effectiveness ratios were determined by dividing the total hospital costs by the percent survival. A total of 415 patients met criteria for the Pneumonia Severity Index (PSI) risk class IV or V. Costs (adjusted for inflation) were as follows (median, 25th and 75th percentile): total hospital costs ($5,078 [$3,218–$8,144]), pharmacy costs ($753 [$455–$1,357]), and antibiotic costs ($139 [$82–$229]). The most favorable cost-effectiveness ratio was observed for patients who received levofloxacin monotherapy ($4,635 per life saved), followed by ceftriaxone plus a macrolide ($5,278), ceftriaxone monotherapy ($5,368), and ceftriaxone plus levofloxacin ($6,317).