News

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.

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.

Naltrexone extended-release injectable suspension (Vivitrol, Alkermes/Cephalon) was approved for the treatment of alcohol dependence in patients who can abstain from drinking in an outpatient setting and who are not actively drinking at the time treatment is initiated.

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.

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.

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.)

FDA actions in brief

Sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous tablets (OsmoPrep, Salix) were approved by FDA for cleansing of the colon prior to colonoscopy in patients aged 18 years or older.

Despite systemic challenges in caring for stroke patients, a care program developed by the American Stroke Assn. has shown promise in improving outcomes.