News

Abatacept (Orencia, Bristol-Myers Squibb) is the first T-lymphocyte co-stimulation modulator to be approved by FDA. The agent is indicated for use in patients with moderate-to-severe, active rheumatoid arthritis who have not had an adequate response to methotrexate, tumor necrosis factor (TNF) inhibitors, or other disease-modifying anti-rheumatic drugs (DMARDs).

A number of clinical approaches are utilized in managing insomnia. Indiplon (Pfizer) is a selective non-benzodiazepine sedative hypnotic under consideration by FDA for the treatment of insomnia. Like other agents in its class, indiplon binds selectively to the GABA-A receptors in the brain, promoting sleep.

Colestipol for oral suspension, 5 g/packet or scoopful (equiv to Colestid)

Approvable designations

FDA approved prednisolone orally disintegrating tablets (Orapred ODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.

A review of agents in late-stage development for the treatment of depression (July 2006).

Appropriate benefit design-copay structures and tiers-is an important factor in providing members and patients with access to treatment that is affordable. Meanwhile, cost sharing with consumers continues to increase because of pressures on maintaining competitive premium costs and the lack of innovative means to manage utilization, say experts.

Pay for performance (P4P) is touted as the magic bullet du jour for our healthcare cost concerns. In mid-2005, CMS released its "Quality Roadmap" aimed at delivering "the right care for every person every time." Consistent with this initiative, CMS has published quality measurements and information directed toward the beneficiary, the provider and, ultimately, the purchaser audiences.

In the past two years, not-for-profit hospitals have faced increasing scrutiny from a variety of sources. Lawsuits alleging unfair billing practices for the uninsured, congressional hearings regarding hospitals' tax-exempt status, federal and state legislative policies regulating hospitals' provision of charity care and front-page articles in major newspapers outlining overly aggressive efforts to collect payments from uninsured patients have all conspired to put this healthcare sector on red alert.

The era of rising healthcare costs created a new discipline in the business world. Large employers such as industrial giant General Electric (GE) wanted to know why healthcare costs were disproportionately eroding profits, how to spend wisely, how to design worker benefits that made sense and how to reduce waste. In the early 1990s, self-funded GE was spending $800 million annually on healthcare, so a cost reduction of just 5% would equal $40 million, or the equivalent of 800 jobs.

In a unanimous decision (Sereboff v. Mid-Atlantic Med. Svcs.) released on May 15, 2006, the U.S. Supreme Court permitted a health insurer to enforce a reimbursement provision against a participant. The plan had paid approximately $75,000 for the treatment of injuries suffered by the participant, Marlene Sereboff, and her spouse, who subsequently received $750,000 pursuant to a third-party tort settlement. The health plan provided that a participant who is injured by another person and receives benefits under the plan for such injuries must reimburse the plan from any amount recovered, without reduction, for failure to receive the full damages claimed. When the participant refused to comply with this reimbursement provision, the insurer obtained an injunction requiring the Sereboffs to set aside sufficient funds from the settlement, pending a final ruling in the case.

NATIONAL REPORTS-Medical tourism is a fast-growing movement in which American consumers are choosing to travel outside the country for a variety of healthcare procedures and treatments.

WASHINGTON, D.C.-Government officials have been talking about more "transparency" in health information to better inform consumers and practitioners of the cost and quality of hospital and medical services. As a first step, the Centers for Medicare and Medicaid Services (CMS) is disclosing data about what Medicare pays hospitals for 30 common elective procedures and other hospital admissions. Patients now can find out how costs vary across counties in the United States for heart operations, hip and knee replacement, kidney and urinary tract operations, and cardiac defibrillator implants.

About two hours after a colleague and I lamented over breakfast about Americans' shortcomings in wellness, I heard the news that the vaccine for human papillomavirus (HPV) had received the final nod from FDA. Now there was something Americans were actually doing pretty well: immunizing.

Widespread adoption of electronic medical record (EMR) systems in the future is a noble objective, however it has distracted policy makers from enabling true Health Information Technology (HIT) reform now. While others continue to champion EMR systems as former U.S. Department of Health and Human Services National HIT Coordinator David Brailer, MD, did, many in the health sphere confuse the advancement of EMRs with overall HIT reform. As industry pundits debate potential clinical benefits and cost reductions that EMR systems could deliver, there is too little discussion about how HIT can improve the single largest payer of medical claims-Medicaid.

Healthcare executives face an uphill struggle to reduce costs, grow revenues within a shifting payment landscape and ensure that patients receive quality, life-saving care. A tough assignment, especially when a critical shortage of workers sabotages those efforts.

According to Robert Taketomo, president and CEO of Ventegra, an example of a three-tier injectable benefit design (all tiers subject to a standard deductible and out-of-pocket maximum) would be:

Some health plans are partnering with public health departments and statewide services to develop disaster plan to help avert the potential catastrophic effects of a flu pandemic. As an integrated delivery system, SelectHealth in Salt Lake City is working with the Utah Department of Health, which developed the Utah Pandemic Influenza Response, a preparedness plan in coordination with efforts by WHO and the U.S. Department of Health & Human Services. The state's primary goals are to minimize serious illness and deaths, societal disruption and economic loss.

Care management and pay-for-performance (P4P) programs couldn't be more popular in the industry. Although often thought of and managed separately, their goals are really the same: to focus attention and dollars where they will have the greatest impact on patient care. With care management, the focus is on finding and providing specialized services to those who either have chronic illnesses or who might be heading down the path toward them. P4P merely casts the net wider with its assumption that tying physician payments to standards of care will deliver optimal care along the healthcare continuum.

Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.

A review of agents in late-stage development for the treatment of atherosclerosis and thrombosis (June 2006).

Federal Trade Commission (FTC) officials say they are concerned about an increasing trend of pharmaceutical companies paying makers of generic medications to delay marketing competitive products. FTC commissioner Jon Leibowitz, JD, has criticized "reverse payment" settlements, which involve a branded manufacturer compensating a generic medications manufacturer for agreeing to delay marketing efforts for a generic product until the innovator's patent expires.

The blockbuster drugs of the 1990s came off-patent, became generic, and now several of them have become available OTC. Others are expected to join the ranks in the next few years.

A 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.

CNTO 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.

A 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.

Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.

A cross-sectional study of the agendas and transcripts of FDA drug advisory committee meetings from 2001 to 2004 found that conflict of interest disclosures occurred at 73% of the meetings examined, but that the recusal of advisory committee members from decision-making as a result of those conflicts occurred only 1% of the time.