News

A review of selected antibiotics in late-stage development (May 2006).

A 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.

As part of its Critical Path initiative, FDA has released a list reporting 76 high-priority research projects designed to modernize and advance medical product development. This program's goal is to bring medical innovations to patients more quickly and at a lower cost.

In response to ongoing industry and beneficiary concerns about the Medicare Prescription Drug Plan, the Centers for Medicare and Medicaid Services (CMS) is clarifying the rules and reviewing the formularies of insurers who are applying to provide Part D coverage for next year. CMS is simultaneously crafting guidance and procedural improvements that aim to make the program operate more smoothly.

An 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.

Early statin use was associated with a lower risk of congestiveheart failure (CHF) development and in-hospital death in patientstreated for acute myocardial infarction (AMI), according to arecent observational study published in the International Journalof Cardiology.

The 55th Annual Scientific Session of the American College of Cardiology (ACC) assembled from March 11 to March 14, 2006, in Atlanta, Ga, to exchange new and continuing research in cardiovascular disease. The program featured more than 1,600 oral and poster presentations of original research and hundreds of invited lectures and interactive sessions, with many offering the opportunity to update attendees' knowledge of available and investigational pharmaceuticals.

Full-length or intact parathyroid hormone [rDNA origin] for injection (PTH [1-84], Preos, NPS Pharmaceuticals) is currently under FDA review for the treatment of postmenopausal osteoporosis. If approved, parathyroid hormone (1-84) will join teriparatide (PTH [1-34], Forteo, Lilly), the truncated N-terminal (1-34) form of the hormone, as the only anabolic therapies available for osteoporosis treatment.

Approvable designations

Every time a new stop light goes up in a growing neighborhood,BlueCross BlueShield of South Carolina (BlueCross) wants to have acustomer within a block of it. This health plan, nested withsubsidiary businesses, has prioritized growth through an aggressivebranching out from its core competencies. Half of its totalbusiness comes from selling products to other healthcareorganizations.

Traditionally, pharmaceutical step therapy ensured the use of themost appropriate and clinically sound drug therapy for patientswith specific diseases or conditions. More recently however, steptherapy has been used as a cost containment tool by health plansand hospitals alike.

It's not the fig leaf that some would advocate for a fragmentedhealthcare system. But even though the jury appears deadlockedabout the value of the health savings account (HSA), the movementtoward consumer-directed healthcare (CDHC) is accelerating. In themidst of this fracas there is good news for the savvy healthcareconsumer: The tax incentives for HSAs are compelling.

Under a new medicare program to expand coordinated care forvulnerable seniors, insurers and managed care plans across thecountry are offering a range of Special Needs Plans (SNPs, or"snips") to beneficiaries who are dual eligibles, in nursing homesor suffer from chronic conditions. Most of the 275 SNPs approved bythe Medicare program so far aim to provide care to low-incomeseniors who now receive prescription drug benefits from Medicareinstead of state Medicaid programs; special needs plans for othergroups are emerging slowly.

Every time a new stop light goes up in a growing neighborhood,BlueCross BlueShield of South Carolina (BlueCross) wants to have acustomer within a block of it. This health plan, nested withsubsidiary businesses, has prioritized growth through an aggressivebranching out from its core competencies. Half of its totalbusiness comes from selling products to other healthcareorganizations.

Blogs: Inappropriate at work, a protected right for employees

Everyone runs into troublesome customer service now and then. Youknow how frustrating it can become, and it probably inspires you tobe that much more careful when conducting business with your owncustomers. Certainly as consumers, we know the caveat emptorwarnings, but there is nothing so valuable as great service.

All projections of rising healthcare costs assume that advances inmedical science will add to the cost. This is a reasonableassumption, since it has been uniformly true in the past.Antibiotics are a great advance, but bacteria develop resistanceand newer and more expensive antibiotics must be developed. Peoplewho would have died at home in the pre-antibiotic era now survive,but after the greater cost of antibiotics and, possibly,hospitalization. The same is true for advances in cardiac stents,cancer treatment, imaging with CT scanners and MRIs, etc. Thetechnology can be life-saving but is typically expensive.

If one word describes the nearly 150,000 square miles of Montana,it's "vast." And while Montana residents value their state's openspace and its natural beauty, all that space makes healthcarecoordination and delivery difficult at best, as Tom Brewer with theMansfield Health Education Center (Mansfield Center) in Billings,Mont., explains.

A review of selected agents in late-stage development for the treatment of acute and neuropathic pain (April 2006).

FDA 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)?

Last month FDA unveiled a long-awaited list of collaborative projects to streamline and accelerate the development of new medical treatments. Then Health and Human Services (HHS) Secretary Mike Leavitt joined Andrew von Eschenbach, MD, and Deputy Commissioner Janet Woodcock, MD, in urging implementation of the Critical Path initiative. Dr von Eschenbach, who hopes to oversee this effort as permanent FDA head following his official nomination to the position, says he is committed to fully implementing the initiative in order to "dramatically increase the success rate in moving products from the lab to the patient."

Aspirin 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.)

In a post-hoc analysis, raloxifene (Evista, multiple manufacturers) appeared to attenuate stroke risk caused by high estradiol levels in postmenopausal women, said Jennifer S. Lee, MD, at the American Stroke Association's International Stroke Conference 2006 in Kissimmee, Fla.

An 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.

Withdrawing 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.

An observational study of 51 outpatient practices found that about7 in 1,000 outpatients were administered a prescription thatviolated an FDA black box warning and that <1% of those patientshad an adverse drug event (ADE) as a result.

Cyclobenzaprine tablets 5 mg (equiv to Flexeril tablets)

Parathyroid hormone (rDNA origin) (Preos, NPS Pharmaceuticals) for the treatment of osteoporosis.