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.
Lower oral retinoid dose effective for psoriasis
June 1st 2006A lower dose of the oral retinoid acitretin is effective for moderate-to-severe psoriasis and can minimize adverse effects, according to a study presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Current practice is to administer the maximal tolerated dose of 25 mg to 50 mg acitretin daily.
New monoclonal antibody effective for plaque psoriasis
June 1st 2006CNTO 1275, an anti-IL12p40, maintains efficacy in clearing plaque psoriasis for up to 24 weeks after 1 dose, according to results of a phase 2 study presented by researchers at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. The subcutaneously injected agent targets both interleukin 12 and 23, two key cytokines in type 1 immune responses, said study author Gerald G. Krueger, MD, of the department of dermatology, University of Utah Health Sciences Center, in Salt Lake City, Utah.
Entecavir demonstrates higher rates of improvement than lamivudine in patients with Hepatitis B
June 1st 2006A phase 3 study evaluating the histologic and virologic improvement of hepatitis B antigen positive (HBeAg) patients randomized to either lamivudine or entecavir demonstrated that patients treated with entecavir had a significantly higher rate of histologic, virologic, and biochemical improvement. Researchers also observed less viral resistance with entecavir.
Varenicline: An oral partial nicotine agonist for smoking cessation
June 1st 2006Varenicline (Chantix, Pfizer) is a partial nicotine receptor agonist with a high affinity for the alpha-4 beta-2 nicotinic acetylcholine receptors, modulating dopamine levels associated with nicotine addiction and aiding in smoking cessation. Clinical studies have demonstrated favorable cessation rates compared with placebo and sustained-release bupropion, with an encouraging safety profile. The most common adverse effect seen in clinical trials was mild-to-moderate nausea. In November 2005, a New Drug Application (NDA) was submitted for varenicline, and the drug was subsequently granted a 6-month priority review. On May 10, 2006, varenicline became the first oral medication approved for smoking cessation since bupropion, representing an agent with a novel mechanism of action for smoking cessation.
Analysis of Medicare drug plans reveals variance in value and in formularies' coverage
May 1st 2006A Kaiser Family Foundation study examined formularies, drug costs, and utilization management tools in drug plans offered by 14 national and near-national organizations, which encompass 35 unique prescription drug plans that account for 1,222 of the 1,429 packages available to Medicare beneficiaries.
Clostridium difficile infections on rise in United States at short-stay facilities
May 1st 2006An analysis of data gathered from the National Hospital Discharge Survey (NHDS) shows that Clostridium difficile-associated disease (CDAD) rapidly increased among patients at US hospitals from 2000 to 2003, particularly among patients aged ?65 years.
Natalizumab: FDA is concerned-should managed care be, too?
April 1st 2006FDA officials said the agency "remains very concerned" that patients who take natalizumab (Tysabri, Biogen Idec/Elan) may develop a rare, potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML). So starts a report from Reuters published on February 15, 2006. Should managed care also be concerned? If so, how should managed care formulary decision-makers respond? What is their role in managing patients who are clamoring for even more products to treat their diseases in an era in which it seems that miracles are a daily occurrence in the world of biotechnology? What role should managed care play in refereeing potentially devastating side effects for a disease that frightens patients as much as multiple sclerosis (MS)?
Aspirin resistance: a growing concern
April 1st 2006Aspirin is the cornerstone of therapy in the treatment and prevention of cardiovascular disease. The potential benefit of aspirin therapy may be significantly reduced in patients with aspirin resistance, creating a clinical and economic burden on the healthcare system. The purpose of this article is to clarify the term "aspirin resistance," describe the proposed mechanisms, review the clinical outcome studies with associated resistance testing, and discuss the potential pharmacologic management of this problem. Literature searches were performed using MEDLINE (January 1966 to January 2006) for review articles on aspirin resistance and antiplatelet activity. Aspirin's primary mechanism of action is to irreversibly inhibit cyclooxygenase-1 (COX-1); however, there are reports of alternative biochemical pathways producing platelet aggregation. The addition of thienopyridines to aspirin should be considered for the management of aspirin-resistant patients. (Formulary. 2006;41:192–201.)
ASA ISC 2006: Neuroprotectant reduces disability after ischemic stroke
April 1st 2006An investigational free-radical trapping agent, NXY-059, significantly reduced disability when given within 6 hours of acute ischemic stroke, said Kennedy R. Lees, MD, at the American Stroke Association's International Stroke Conference 2006 in Kissimmee, Fla.
ASA ISC 2006: Statin withdrawal during acute phase of stroke worsens neurologic outcome
April 1st 2006Withdrawing statins during the acute phase of ischemic stroke is associated with worse neurologic outcomes and larger brain injury compared with acute stroke patients who remain on their statins, said Florentino Nombela, MD, at the American Stroke Association's International Stroke Conference 2006 in Kissimmee, Fla.
Incretin hormones in the treatment of type 2 diabetes
March 1st 2006Type 2 diabetes mellitus is a progressive disease affecting more than 18 million Americans. Incretin mimetics and DPP-IV inhibitors are new classes of antihyperglycemic agents that may improve glycemic control in patients with type 2 diabetes. The incretin hormone, glucagon-like peptide 1 (GLP-1), stimulates glucose-dependent insulin secretion, suppresses inappropriate glucagon secretion, and slows gastric motility. GLP-1 levels are decreased in type 2 diabetes. GLP-1 is rapidly inactivated by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in a half-life of <2 minutes. Strategies to increase GLP-1 activity include the development of incretin mimetics that are resistant to DPP-IV degradation and the development of DPP-IV inhibitors. Clinical trials have demonstrated that the incretin mimetics exenatide and liraglutide, as well as the DPP-IV inhibitor vildagliptin, improve glycemic control, reduce weight, and are fairly well tolerated. Exenatide (Byetta, Amylin/Lilly) was approved by FDA in April 2005..
Lubiprostone: A novel chloride channel activator for the treatment of constipation
March 1st 2006Lubiprostone (Amitiza, Sucampo/Takeda) was approved on January 31, 2006, for the treatment of chronic idiopathic constipation in adults when the cause of the condition is unknown. The agent has a unique mechanism of action compared with current therapies on the market in that it locally activates specific chloride channels (ClC-2) in the lining of the small intestines after oral administration, thereby increasing intestinal fluids and softening bowel movements. In double-blind, placebo-controlled trials, lubiprostone demonstrated efficacy in improving the frequency of spontaneous bowel movements and other related constipation symptoms. Lubiprostone was reported to be well tolerated in clinical trials; the most common adverse effects were mild-to-moderate nausea and headache.
ICAAC 2006: Physicians warn of overuse of vancomycin in treating hospital-acquired pneumonia
March 1st 2006Vancomycin may be overused for the treatment of hospital-acquired pneumonia, perhaps because of physicians' perceptions that patients are at high risk for methicillin-resistant Staphylococcus aureus (MRSA), according to a study by Robert H. Eng, MD, and colleagues at the Veterans Affairs New Jersey Health Care System in East Orange, NJ. The study was presented at the 45th ICAAC meeting in Washington, DC.
Patient adherence increases then tier 1 or 2 medications are prescribed by physicians
March 1st 2006A study analyzing pharmacy claims among patients who receive chronic medications via 3-tier prescription drug plans found that patients who were prescribed generic or preferred medications by their physicians were the most likely to adhere with their treatments.
Topiramate safely decreases body mass hypertension
March 1st 2006Topiramate safely decreases body mass, hypertension. Topiramate reduces body weight and blood pressure with generally mild-to-moderate adverse effects, according to a randomized, placebo-controlled trial involving obese subjects with hypertension.
Medicare encourages more drug effectiveness information
February 1st 2006The Medicare Prescription Drug Plan, which began January 1, 2006, makes the federal government the largest purchaser of pharmaceuticals in the United States, and probably in the world. It is projected that the Centers for Medicare and Medicaid Services (CMS) will spend more than $1 trillion on medications over the next decade, a volume that will influence the pharmaceutical market more broadly and generate new initiatives to encourage utilization of more cost-effective treatments.
A growth hormone conversion program and patient outcomes at a not-for-profit HMO
February 1st 2006Although experience tells us that formulary conversion programs are commonplace, they are discussed fairly infrequently in the literature. A recent MEDLINE search did not identify any conversion programs similar to a human growth hormone (HGH) program implemented at HIP Health Plan of New York (HIP-NY).