News

Although use of the cyclooxygenase (COX)-2 inhibitor celecoxib has demonstrated benefit in preventing premalignant colorectal adenomas, generally the agent should not be recommended for this purpose due to the risk of cardiovascular events, according to 1 recent trial. In a second study of celecoxib use and adenomas, treatment with celecoxib 400 mg/d markedly lowered the incidence of colorectal adenomas within 2 years after the removal of polyps.

In a randomized, double-blind, placebo-controlled trial recently published in Lancet, the thiazolidinedione (or "glitazone") rosiglitazone statistically significantly reduced the incidence of new-onset diabetes when given to patients diagnosed with prediabetes but lacking a prior history of cardiovascular disease. The benefits of using thiazolidinediones in the treatment of patients with diabetes are well known, but the current finding that thiazolidinediones can prevent prediabetics from progressing to diabetes is novel.

So far this year, Formulary has examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members through our "Focus on" articles. Because many readers have expressed that this information is useful when making formulary decisions for their hospitals, health systems, or managed care organizations, Formulary has compiled this late-year review of these new and emerging agents, along with updates on the regulatory status of each.

Lisdexamfetamine (NRP104, Shire/New River Pharmaceuticals) for the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD)

FDA Actions in Brief

FDA granted 2 additional indications for rituximab (Rituxan, Genentech/Biogen Idec) in the treatment of patients with CD-20-positive, B-cell non-Hodgkin's lymphoma (NHL). The agent is now approved as first-line treatment of previously untreated patients with follicular NHL in combination with cyclophosphamide, vincristine, and prednisolone (CVP) chemotherapy, and in the treatment of patients with low-grade NHL with stable disease, or in those with partial or complete response following first-line treatment with CVP chemotherapy.

Infliximab

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Vorinostat

This agent targets the overexpression of histone deacetylase (HDAC) or the aberrant recruitment of HDACs to oncogenic transcription factors in cancer cells. Vorinostat was approved on October 6, 2006, for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease following 2 systemic therapies.

Many new web-based decision support tools and care management solutions have emerged, aimed specifically at the member to complement other resources available at plan web sites. Forward-thinking health plans already have begun launching online support tools within their member portals or are actively planning to do so. Even those who have already begun to roll out such tools are thinking of new, more powerful ways to integrate them into their overall member platform. Here is a quick review of what the field looks like:

Many new web-based decision support tools and care management solutions have emerged, aimed specifically at the member to complement other resources available at plan web sites. Forward-thinking health plans already have begun launching online support tools within their member portals or are actively planning to do so. Even those who have already begun to roll out such tools are thinking of new, more powerful ways to integrate them into their overall member platform. Here is a quick review of what the field looks like:

The influenza immunization rate is a closely watched HEDIS measure among plans. Influenza vaccine is about 80% effective in preventing infection in general, although its effectiveness is lower in the elderly. In addition, its effectiveness can vary from year to year, depending on the match between the vaccine and the particular strains of influenza circulating that year.

Insurance fronting arrangements are more commonly utilized in the property and casualty industry. However, MCOs also have uses for these structures in certain circumstances. For example, many HMOs discover that they have a need to offer products on insurance paper (PPO plans) but do not have the resources to form a separate insurance company. Or, a provider organization may ask an HMO to front for it with respect to a particular product line or sector.

Insurance fronting arrangements are more commonly utilized in the property and casualty industry. However, MCOs also have uses for these structures in certain circumstances. For example, many HMOs discover that they have a need to offer products on insurance paper (PPO plans) but do not have the resources to form a separate insurance company. Or, a provider organization may ask an HMO to front for it with respect to a particular product line or sector.

Medication therapy management (MTM) has long been a part of the pharmacy lexicon and is based on the premise that the right medication in the right dose gets to the right patient. This is to ensure that optimal outcomes are achieved with the highest safety. Numerous examples of pharmacy programs in diverse settings utilize the skills of the pharmacist to optimize drug therapy and improve outcomes and assure safety. The Veterans Administration, academia, health plans, as well as community pharmacies have all been settings where medication management of the patient has occurred.

Pay-for-Performance (P4P) provides home health agencies an opportunity to show their value and expertise to the healthcare industry. The primary goal of home health has always been to educate the client and family on how to proactively manage a chronic illness and avoid the reoccurrence of an acute illness. Home health nurses are the eyes and ears of the physician, often recommending modifications to the plan of care based on their knowledge of the patient's medical condition and home environment. With the advancement of healthcare technologies and pending P4P regulations, this knowledge becomes a more important basis for assessing patient and family compliance to care recommendations.

A 0.5-mg/kg dose of a low molecular weight heparin, enoxaparin, resulted in less non-coronary-artery bypass grafting (CABG) bleeding compared with unfractionated heparin in the first 48 hours after elective percutaneous coronary intervention (PCI), according to a prospective, open-label, multicenter, randomized trial reported in the New England Journal of Medicine.

Intensive lipid lowering with high-dose 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) provides a significant benefit over standard-dose statin therapy in preventing nonfatal cardiovascular outcomes and also may reduce the incidence of cardiovascular death, according to results of a meta-analysis published in the Journal of the American College of Cardiology.

Intensive lipid lowering with high-dose 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) provides a significant benefit over standard-dose statin therapy in preventing nonfatal cardiovascular outcomes and also may reduce the incidence of cardiovascular death, according to results of a meta-analysis published in the Journal of the American College of Cardiology.

Infliximab

TNF inhibitor approved for inhibiting joint damage, improving physical function in psoriatic arthritis

Although acting FDA Commissioner Andrew von Eschenbach, MD, has been on the job since September 2005, it was only last month that he received approval from the Senate's Health, Education, Labor and Pension (HELP) committee for his nomination as FDA commissioner to be considered by the full Senate. However, the step was an incremental one at best for Dr von Eschenbach and the agency, which has been without an officially appointed commissioner for all but 18 months over the past 5? years.

A review of adverse event data associated with the synthetic vitamin A retinoid isotretinoin between 1997 and 2002 suggests that the acne treatment is a "probable" cause of inflammatory bowel disease (IBD) and may precipitate its presentation within a certain subset of patients who are either predisposed to the disease or have subclinical symptoms.