News

May FDA Pipeline

New medical devices, FDA actions and first-time generics

The jury is still out on tiered provider networks. While effectiveness is frequently a criterion for including a specific drug on a preferred drug list, thus far, quality is only playing a small part in designing provider tiers.

The Need for Speed

A veteran of nearly 25 years in the managed care industry, as well as a decorated veteran of the Vietnam war, Paul Caliendo is the founder and president/CEO of Preferred Medical Claim Solutions (PMCS).

Aggressive lipid-lowering with high-dose atorvastatin initiated immediatelyafter hospitalization for an acute coronary syndrome (ACS) significantlyreduces the risk of long-term adverse cardiovascular outcomes compared withlipid-lowering with standard-dose pravastatin. As such, target levels oflow-density lipoprotein cholesterol (LDL-C) may need to be lower than theones currently recommended in patients at risk of cardiovascular events,said Christopher Cannon, MD, at the 53rd annual scientific session of theAmerican College of Cardiology in New Orleans.

Chronic obstructive pulmonary disease (COPD) is a major public health problem, with inhaled anticholinergic agents being the treatment of choice. The disadvantage of currently approved therapies for the treatment of COPD is that agents such as ipratropium (Atrovent, Boehringer Ingelheim) must be administered numerous times daily. Tiotropium (Spiriva, Pfizer/Boehringer Ingelheim) is a new, recently FDA-approved, long-acting anticholinergic drug that requires only once-daily dosing. Tiotropium displays selective receptor kinetics by dissociating more slowly from M1 and M3 receptors than M2 receptors. In patients with COPD, tiotropium 18 mcg inhaled once daily results in significant improvement in lung function. Furthermore, improvements appear sustained for up to 3 weeks after discontinuing tiotropium. Tiotropium is well tolerated with minimal systemic absorption resulting in a favorable adverse effect profile. The most common adverse effect associated with tiotropium is dry mouth. Given the longer duration of action, once-daily dosing, minimal adverse effects, and documented improvements in lung function, tiotropium is poised to replace ipratropium as the inhaled anticholinergic of choice.

One of the most common ophthalmic conditions that directs a patient to a primary-care physician or eye-care practitioner is the red, itchy eye. The highest percentage of conjunctivitis is noninfectious or inflammatory, and frequently these cases are allergic in nature. The ophthalmic armamentarium is now filled with a number of pharmaceutical compounds that act specifically at different points along the inflammatory cascade. Formulary decision-making should be based on sound knowledge of the ocular inflammatory cascade and the pathways through which the various ophthalmic antiallergic preparations exert their anti-inflammatory effects.

The growth of healthcare spending slowed in 2003-7.8% compared with 9.3% in 2002-but according to the Centers for Medicare & Medicaid Services (CMS), employers are not impressed.

Global Perspective

Raised in Trinidad and Tobago, West Indies, Dr. Valerie Beckles, a pediatrician and medical director for Aetna's Southeast Region, graduated from medical school in Jamaica then trained in London and Nassau, Bahamas, before practicing in Texas and transitioning into administration in recent years. Her broad background has allowed her to bring perspective to patient care and the diversity issues that arise in healthcare today.