News

Disease management-or, what we have known as disease management-stands at a crossroads, as changing demands in the marketplace and a growing emphasis on wellness and prevention recast our thinking on chronic care. Can DM survive?

Health plans are looking for a more integrated approach to managing specialty therapies so they can effectively and efficiently manage the quality of care for the member, as well as the cost to the plan sponsor, say industry experts.

There are as many as 75 million Americans who are either uninsured or underinsured, and the rate will continue to grow. Access to healthcare for all Americans was a hot topic during the early years of the Clinton administration, and has resurfaced recently in anticipation of the 2008 presidential election.

There has been a lot of good news about the Medicare drug benefit lately. Surveys show a substantial increase in coverage, particularly among low-income seniors. Costs are less than expected; employers continue to offer retiree benefits; major insurers are sticking with the program; and product coverage remains fairly broad. Beneficiaries seem generally satisfied with the program, and the much-feared "donut hole" appears less lethal than anticipated.

Every time I look through the sales fliers in the Sunday newspaper, I'm amazed by all the stuff we can buy. Toys, such as satellite radios and video game systems, are just the beginning. Today, you can even buy high-end cleaning products for your bath or shower at more than 10 times the price of a simple sponge and some cleanser.

Washington, D.C-Employer-sponsored health-insurance plan premiums increased only 6% in 2007, less than the last four years. However, insurance costs are rising much faster than inflation and wages, according to a leading survey of employer health benefits. Premiums now average more than $12,000 for family coverage (almost $4,500 for individuals), pricing many workers out of the market.

Denver-A UnitedHealthcare initiative underway in Colorado and a handful of other states allows high-deductible PPO plan members to cut their deductibles as much as $4,000 by meeting certain wellness benchmarks. Called Vital Measures, the program launched June 1 in Colorado, Pennsylvania, Ohio and Rhode Island, and is drawing employer interest, says Cheryl Randolph, UnitedHealthcare spokesperson.

Washington, D.C.-House legislation that proposed to fund expanded coverage for children by cutting payments to Medicare Advantage (MA) plans was put on hold last month in an effort to reach a speedy compromise for reauthorizing the State Children's Health Insurance Program (SCHIP). The legislators agreed to adopt the less-costly Senate proposal, which increases tobacco taxes to expand SCHIP into a $60 billion program over five years. The House bill sought $75 billion for SCHIP and proposed to cut payments to MA plans to offset a lower increase in cigarette taxes. Both plans are much more costly than the $30 billion program proposed by the White House.

Washington, D.C.-House and Senate leaders finally agreed on compromise legislation to renew prescription user fees late last month, just a few days before the funding program was set to expire. The Food and Drug Administration legislation increases drug user fees by $225 million over five years, in addition to adopting user fee agreements negotiated with pharmaceutical, biotech and medical device companies that already raised fees considerably. There's also a new fee program to support FDA pre-review of DTC television ads.

Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis

Telavancin is a novel semisynthetic lipoglycopeptide antibiotic undergoing FDA review for complicated skin and skin-structure infections; this agent is also in phase 3 clinical trials for the treatment of hospital-acquired pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Streptococcus pneumoniae. Telavancin exerts its antibacterial action via a dual mode of action involving both inhibition of peptidoglycan synthesis and disruption of the bacterial cell membrane; the latter of these effects is believed to improve the rate of killing observed with telavancin compared with other glycopeptides. In vitro, telavancin exhibits good activity against a variety of gram-positive organisms, including drug-resistant S pneumoniae, MRSA, vancomycin intermediate-susceptible and vancomycin-resistant S aureus, and vancomycin-resistant enterococci. Clinical data have demonstrated that telavancin is at least as effective as comparator agents for a variety of infectious processes...

In response to the recent FDA warnings about an increased risk of suicidal ideation/suicide attempt among children and adolescents using antidepressants, investigators performed a meta-analysis to assess the efficacy and risk associated with antidepressants among pediatric patients.

Legislation to reauthorize the Prescription Drug User Fee Act (PDUFA) IV has been expanded, as expected, via a host of provisions designed to shape drug development and ensure the safe use of medications.

Initial combination therapy with sitagliptin and metformin is more effective than either agent alone in lowering glucose values in patients with type 2 diabetes, according to the results of a recently published study.

Splitting statin tablets does not negatively affect patient satisfaction, medication adherence, or lipid level control, according to the authors of a randomized, controlled study

In a randomized, placebo-controlled trial, topiramate was demonstrated to be an effective add-on treatment to lifestyle changes in obese patients with type 2 diabetes.

Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.

Proton-pump inhibitor (PPI) use moderately increases the risk of community-acquired pneumonia (CAP), particularly among younger patients and those who recently initiated treatment, according to the results of a population-based, case-control study.

Parkinson disease (PD) is a chronic progressive neurodegenerative disorder that affects >1 million people in the United States. PD causes both motor and nonmotor disturbances; common symptoms include resting tremor, rigidity, and bradykinesia. The current goals of treatment are to slow disease progression and to reduce disability without inducing long-term complications. The classes of agents currently approved for the treatment of PD include levodopa/carbidopa, dopamine agonists, catechol-O-methyl-transferase (COMT) inhibitors, monoamine-oxidase type B (MAO-B) inhibitors, anticholinergics, and agents/ combinations from other drug classes. Newer agents, such as rasagiline and rotigotine, offer additional treatment options to healthcare professionals. Despite these advances in the treatment of PD symptoms, current therapies do not prevent neuron degeneration. Research into new treatments is focused on neuroprotective drugs, new dopamine agonists, and nondopaminergic agents; the goal of these investigative..

In the large cohort study referred to as the "The Million Women Study," the use of hormone replacement therapy (HRT) in postmenopausal women was demonstrated to increase the risk of ovarian cancer and death from ovarian cancer by 20% and 23%, respectively, compared to nonuse of HRT.

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic approvals: fosphenytoin for injection; pantoprazole delayed-release tablets; cefotetan for injection; cefepime for injection.

The latest FDA action (through September 2007) related to satraplatin, ropinirole (Requip CR), sumatriptan/naproxen (Trexima,) desvenlafaxine (Pristiq), eprodisate (Kiacta,) raloxifene (Evista), natalizumab (Tysabri), bifeprunox, fluticasone/salmeterol inhalation powder (Advair Diskus 500/50), LX211, TZP-101, Alferminogene tadenovec, Ad5FGF-4 (Generx), tramiprosate (Alzhemed), rilonacept, aripiprazole (Abilify), sapropterin (Kuvan), oral topotecan (Hycamtin), mifepristone (Corlux), vitiligo-derived IgG (VitiGam)

A new formulation for rivastigmine; a transdermal formulation of cholinesterase inhibitor approved for the treatment of mild-to-moderate dementia of the AD type and mild-to-moderate dementia associated with PD.

A new formulation for immune globulin intravenous (human), 10% liquid, a polyvalent human immunoglobulin G approved for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.

FDA has approved a new molecular entity for for use in combination with other antiretroviral agents for the treatment of adults with only CCR5-tropic HIV-1 who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

WASHINGTON, D.C.-Instead of going back to academia, former FDA Commissioner and Medicare Administrator Mark McClellan, MD, is setting up his own shop to tackle health reform and drug safety more actively. Dr. McClellan will head the Engelberg Center for Health Care Reform at the Brookings Institution, starting with $20 million in funding from Alfred Engelberg and Leonard Schaeffer.

Private fee-for-service (PFFS) plans are the fastest growing, and most controversial, aspect of the Medicare Advantage (MA) program. They account for approximately 18% of total enrollment, and according to MedPAC, they are receiving payments that average 19% more than payments to traditional Medicare.