
Will generic drugs, patent expirations, safety issues and a dry pipeline for high-incident diseases make room for a new drug paradigm?

Will generic drugs, patent expirations, safety issues and a dry pipeline for high-incident diseases make room for a new drug paradigm?

Disease registries are gaining in popularity as electronic tools designed to give physicians clinical support to deliver appropriate care.

The cost of imaging procedures tops $100 billion a year and is expected to double in the next four years. MCOs hope managed care strategies will contain the increases.

As far back as 1971, Mickey Herbert has believed that a market-based system of healthcare delivery is the only option for America. Now president and CEO of ConnectiCare, a commercial and Medicare Advantage insurer, Herbert still believes in the market-based system.

More than three years after Minnesota-based HealthPartners drew national attention after stating it would no longer pay hospitals for costs of treatment related to never events Medicare and private health plans are jumping on the never-event bandwagon.

Healthcare leaders must begin forecasting where Americans will draw the line on their generosity when it comes to the healthy subsidizing the sick, the insured subsidizing the uninsured, and the wealthier subsidizing the less wealthy.

Commonwealth Fund Ranking (2007): 24

Erythropoietin, a humoral factor produced predominantly in the kidney, stimulates red blood cell production in the bone marrow. Erythropoiesis-stimulating agents (ESAs) have been used for years in the treatment of anemia, with extensive experience and benefits in anemia of chronic kidney disease. Recent data have suggested adverse consequences with use of ESAs, perhaps relating to inappropriate use, and prompting release of guidelines to ensure safe use and maximize benefit. When prescribing ESAs, indications, requirements to monitor laboratory parameters (hemoglobin levels and ferrokinetics), and clinical status need to be stringently followed.

FDA has launched the Sentinel Initiative to expand and improve medical product risk detection and evaluation. Instead of relying on passive, voluntary adverse event (AE) reports sent to FDA by physicians and pharmacists, the agency would be able to detect safety signals much more quickly through links to health information databases containing information about millions of patients.

Two randomized, double-blind, phase 3 clinical trials demonstrated that raltegravir plus optimized background therapy was more effective than optimized background therapy alone in suppressing resistant HIV-1.

In a nested, case-control study published in the Archives of General Psychiatry, investigators observed that the use of selective serotonin-reuptake inhibitors (SSRIs) increased the risk of upper gastrointestinal (GI) tract bleeding; this increased risk was also observed with the serotonin and norepinephrine reuptake inhibitor (SNRI) venlafaxine. This risk may be increased when the agents are used concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs) and decreased when used concomitantly with acid-suppressing agents.

The first phase of a double-blind, randomized, parallel-group, multicenter, outpatient study demonstrated that treatment with the combination of etanercept and methotrexate was more effective in inducing both clinical remission and radiographic nonprogression than methotrexate alone in patients with early moderate-to-severe rheumatoid arthritis (RA).

A recent multinational, randomized, double-blind, placebo-controlled clinical trial demonstrated that administration of aliskiren provides additional renal protection to patients with hypertension, type 2 diabetes mellitus, and nephropathy who are already receiving optimal antihypertensive therapy and renal protective therapy with the angiotensin receptor blocker (ARB) losartan.

Among the new data presented at the 68th Scientific Sessions of the ADA were the results of phase 3 trials of the investigational agents liraglutide, ABT-335, saxagliptin, and alogliptin.

Tocilizumab, an investigational agent for the treatment of moderate-to-severe rheumatoid arthritis, is a humanized anti-IL-6 receptor monoclonal antibody. Because tocilizumab contains a mouse monoclonal antibody grafted onto human immunoglobulin, the grafted antibody is less antigenic and has a longer half-life than the mouse antibody. When administered, tocilizumab inhibits IL-6 activity by competing for both the membrane-bound and soluble types of IL-6 receptors, thus eliminating IL-6 transduction into the cell.

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.