In the Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA) investigators observed that dronedarone, an anti-arrhythmic agent related to amiodarone, was associated with increased mortality in patients who were hospitalized for symptomatic heart failure (HF) (New York Heart Association [NYHA] class II, III, or IV) and left ventricular systolic dysfunction.
Recent FDA approvals and indications (through August 2008) related to Concerta, Avodart, Prandimet, Trivaris, Reclast, Requip XL, Aciphex, Aptivus, Kinrix, Pentacel, and Durezol.
New indication: Duloxetine (Cymbalta), an SSNRI, was approved on June 13, 2008, for the management of fibromyalgia
Generic drugs approved by FDA (through August 2008) including risperidone tablets.
Recent FDA action (through August 2008) related to long-acting depot preparation of testosterone, pancrealipase capsules, human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant, tolvaptan, etanercept, ustekinumab, and cysteamine hydrocortisone dual-release table.
New indication: Bortezomib (Velcade), an antineoplastic agent, was approved on June 20, 2008, for the initial treatment of multiple myeloma.
Drug Watch: Agents in late-stage development for the treatment of type 2 diabetes mellitus (August 2008)
An important concept surfacing of late is that of patient care navigators, whose goal it is to decrease the number of cancer deaths caused by healthcare treatment disparities.
Employers and health plans are pursuing technologies such as secure email, personal health records (PHR) and home monitoring in hopes of improving compliance with treatment plans and care management programs.
The evolution of consumer-driven healthcare (CDH) has increased the demand for value-added services from health plans. The ability to offer these new services is a prerequisite for those hoping to succeed in the CDH market.
Specialty pharmacy as a managed benefit has arrived at the same place pharmacy benefit management was several years ago (offering open formularies, flat co-pays, etc.). Yet little is being done to address specialty pharmacy as a managed benefit.
National reports - The e-prescribing SureScripts and RxHub network merger reflects the national movement toward interconnected, standards-based technology infrastructures.
Commonwealth Fund State Performance Ranking (2007): 46
Washington, D.C. - Enough Republicans sided with Democrats last month to approve legislation canceling a scheduled 10.6% cut in Medicare fees for physicians.
Consumers want information that's personalized and useful to their specific health problem, according to a recent healthcare consumer study from Deloitte.
E-visits appear to be on the present horizon, but reimbursements are still being worked out.
The continual inability to fall asleep or stay asleep is keeping approximately one-third of the nation up at night. Individuals with insomnia incur $12 billion in direct medical costs and $2 billion in drug costs alone.
Beginning on October 1, 2007, the Centers for Medicare and Medicaid Services (CMS) began posting Corrective Action Plans (CAP) on the public area of its Web site. The goal was to post all review findings for audited conducted on Medicare Advantage and Part D plans for a specific time period that resulted in a CAP.
Personally, I'm concerned about the financial stability of the small physician practices that struggle to cover their costs. Small practices should consider options such as electronic fund transfers or an employment model to streamline financial activities.
The civil False Claims Act is the principal weapon in the government's arsenal to combat healthcare fraud. The Senate and the House are considering bills that would further expand the scope of liability under the Act and eliminate two of the key defenses to meritless lawsuits filed by qui tam plaintiffs.
To improve the quality, safety, efficiency and effectiveness of the healthcare system, the U.S. Agency for Healthcare Research and Quality (AHRQ) is tasked with a mission to gather research and disseminate valuable findings to those who can translate information into practice. Carolyn Clancy, MD, an internist with decades of experience in fact finding and analysis, directs the agency.
In enacting legislation to delay a reduction to Medicare physician fees, Capitol Hill Democrats demonstrated their intent to undermine the role of private insurers in providing care to seniors. Although all sides agreed to avoid a big cut in Medicare payments to doctors, Republicans fought efforts to fund the fees by reducing payments to Medicare Advantage plans.
The US orphan drug program has demonstrated that economic incentives and regulatory flexibility can spur development of treatments for small patient populations. Since enactment of the Orphan Drug Act (ODA) in 1983, FDA has approved >300 medicines for approximately 12 million patients around the world. However, there are approximately 6,000 to 8,000 rare diseases, so “we still have a very long way to go,” commented Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), at a May conference commemorating ODA’s 25th anniversary, which was sponsored by the Drug Information Association (DIA).
Hospital-acquired pneumonia (HAP) is a frequently occurring complication of endotracheal intubation and hospitalization that is associated with a significant increase in morbidity, mortality, and cost of care.
Tolvaptan is an oral selective vasopressin V2 receptor antagonist that works to produce aquaresis (water diuresis without electrolyte excretion) by blocking the effects of AVP. This effect makes tolvaptan a viable treatment option for patients with acute decompensated heart failure (ADHF) and hyponatremia.
Generic drugs approved by FDA (through July 2008) including fluoxetine capsules and calcipotriene topical solution.
Recent FDA action (through July 2008) related to tigecycline, bazedoxifene, balsalazide tablet, tacrolimus, fospropofol injection, bivalirudin, 13-valent pneumococcal conjugate vaccine, pirfenidone, LX1032, palifosfamide, SB1518, oral tetrathiomolybdate, and terguride.
New indication: Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor, was approved on May 7, 2008, for the maintenance treatment of ADHD in children and adolescents.
NME: Alvimopan (Entereg), a peripherally acting mu-opioid receptor antagonist, was approved on May 20, 2008, to accelerate the time to upper and lower GI recovery after partial large or small bowel resection surgery with primary anastomosis.
According to the results of an extended follow-up of the African American Study of Kidney Disease and Hypertension (AASK), long-term reduction of blood pressure to a lower goal than the standard demonstrates no significant effect on the progression of chronic kidney disease (CKD) in nondiabetic hypertensive patients, except in patients with baseline urinary protein/creatinine ratio >0.22, said Jackson Wright, MD, professor of medicine and director of the hypertension program at Case Western Reserve University, Cleveland. These results were presented at the 23rd Annual Scientific Meeting of the American Society of Hypertension, New Orleans, May 14–17, 2008.