March 1st 2022
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
Formulary Decision-makers update P&T policies following COX-2 inhibitors
July 1st 2005Following the voluntary withdrawal of rofecoxib in September 2004 and the subsequent FDA-requested withdrawal of valdecoxib in April 2005, formulary decision-makers are considering options in navigating the changing pain management landscape. With one remaining COX-2 inhibitor available on the market (celecoxib [Celebrex, Pfizer]) and more cardiovascular (CV) risk data available for the class, the efficacy, adverse events, risk/benefit profiles, and costs of both COX-2-selective and nonselective NSAIDs are receiving more attention than ever.
Alvimopan: A peripherally selective opioid mu receptor antagonist
June 1st 2005Post-operative ileus causes significant patient morbidity and is a major contributor to patient discomfort and increased length of hospitalization post-operatively. Alvimopan (Entereg, Adolor/GlaxoSmithKline), a peripherally selective opioid mu receptor antagonist with gastrointestinal (GI) tract-specific activity, is undergoing FDA review for the treatment of post-operative ileus.
California HMOs required to cover all 'medically necessary' drugs
May 1st 2005New regulations proposed by the California state Department of Managed Health Care (DMHC) that are expected to be implemented by the end of this year would require HMOs in California to cover all medically necessary prescription drugs, even if they are excluded from a plan's formulary.
Clopidogrel beneficial during acute phase of MI; metoprolol has no overall effect
May 1st 2005Clopidogrel reduces 28-day mortality in the treatment of patients with acute myocardial infarction (MI) when given on top of standard therapies, but metoprolol has no effect on in-hospital mortality when given during the acute phase of MI.
Ramelteon: A novel melatonin receptor agonist for the treatment of insomnia
May 1st 2005Ramelteon (Takeda Pharmaceuticals) is a selective melatonin receptor agonist awaiting FDA approval for the treatment of insomnia. Unlike the currently prescribed hypnotic agents that work by targeting gamma-aminobutyric acid (GABA) receptors, ramelteon offers a novel mechanism of action, specifically targeting the MT1 and MT2 receptors in the brain, which are thought to play a role in regulating sedation and circadian rhythms. Ramelteon is characterized by undergoing extensive first-pass metabolism along with having high oral bioavailability. Results of phase 2 clinical trials have demonstrated that ramelteon-treated patients had significantly shorter sleep onset latencies and longer total sleep times than placebo-treated patients. Furthermore, ramelteon therapy did not appear to impair patient cognition, memory recall, levels of alertness, or ability to concentrate. Data from animal studies suggest that ramelteon is not likely to cause abuse or physical dependence. Unlike the current FDA-approved..
Exenatide: A novel incretin mimetic hormone for the treatment of type 2 diabetes
March 1st 2005A number of clinical approaches are utilized in managing the overlapping aspects of poor glycemic control in patients with type 2 diabetes. Exenatide (Amylin/Lilly), a novel drug in a new medication class known as the incretin mimetic agents, offers a new mechanism to achieve glycemic control.
Exenatide: A novel incretin mimetic hormone for the treatment of type 2 diabetes
March 1st 2005A number of clinical approaches are utilized in managing the overlapping aspects of poor glycemic control in patients with type 2 diabetes. Exenatide (Amylin/Lilly), a novel drug in a new medication class known as the incretin mimetic agents, offers a new mechanism to achieve glycemic control.
The use of virtual expert panels: formulary decision-making in the 21st century
March 1st 2005Evidence-based medicine is the driving philosophy for pharmacy and therapeutics (P&T) committee decision-making. When the available evidence is incomplete or unclear, the decision-making process becomes complex. Evaluation of the published literature to make sound decisions regarding appropriate medication use can be a time-consuming process. The use of expert panels or subcommittees may facilitate decision-making; however, this process is often limited by the schedules and time constraints of busy clinicians. This article describes the creation and utilization of a "virtual" panel of experts utilizing anonymous electronic communications to assist the P&T committee at a university-based teaching hospital in making medication use policy. The article includes a detailed description of the P&T committee's experience in the selection of virtual panel members, methods used, advantages, potential pitfalls, and the outcomes of a virtual committee used to evaluate the appropriateness of the off-label use of nesiritide (Natrecor, Scios).
Cilansetron: A novel 5-HT3 receptor antagonist for the treatment of irritable bowel syndrome
February 1st 2005If approved, cilansetron (Calmactin, Solvay Pharmaceuticals) would be the second selective 5-HT3 antagonist introduced for the treatment of irritable bowel syndrome (IBS). Based on 2 main clinical trials, cilansetron 2 mg orally 3 times daily appears to be effective in the relief of IBS-D symptoms (abdominal pain/discomfort) and abnormal bowel habits in both male and female patients. Adverse effects were minor, with constipation being the most commonly reported adverse effect. No information is currently available on cilansetron's potential for drug interactions, need for dose adjustments in renal or hepatic insufficiency, long-term safety, or cost. Cilansetron was granted priority review status by FDA on September 1, 2004, for the treatment of diarrhea-predominant IBS in men and women. Currently marketed agents for the treatment of IBS are only approved for use in female patients.
Update on the treatment of benign prostatic hyperplasia
February 1st 2005Benign 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).