News

Anticoagulants and antiplatelet agents in late-stage development

Towards the end of 2009, FDA launched a new medication safety initiative.

Heart failure (HF) guideline-recommended aldosterone antagonist therapy was received by less than one-third of eligible patients participating in a quality improvement registry who had been hospitalized for HF.

New formulation: Diclofenac sodium topical solution (Pennsaid) was approved on November 5, 2009, to treat the signs and symptoms of osteoarthritis of the knee.

In early November 2009, FDA approved revisions to the drug label for exenatide (Byetta, Amylin Pharmaceuticals), an injectable glucagon-like peptide-1 agonist for the treatment of type 2 diabetes mellitus.

Roflumilast is a novel, orally active phosphodiesterase 4 inhibitor currently under review by FDA for the treatment of patients with moderate-to-severe COPD.

Recent FDA action (through January 2010) related to testosterone undecanoate injection, telavancin, Ampligen, doxepin, everolimus, aztreonam lysine, erlotinib, TG4010, BSI-201, midazolam, Aimspro, Motorgraft, BHR-100, dextran sulfate

A systematic review into the comparative effectiveness of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), or both, for patients with stable ischemic heart disease and preserved left ventricular (LV) function found that adding an ACE inhibitor to standard treatment can improve outcomes.

New molecular entity: Pralatrexate injection (Folotyn) was approved on September 24, 2009, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

The new team heading up FDA will be firmly established and eager to implement new policies and programs. Payers, plans, and formulary committees will be watching key trends that will shape drug development and coverage in 2010:

Generic drugs approved by FDA (through January 2010): Nizatidine oral solution in the 15 mg/mL strength

Dabigatran, a new oral direct thrombin inhibitor, given to patients with atrial fibrillation at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.

Recent FDA approvals (through January 2010) related to Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate

Need for public coverage is increasing while state budgets are squeezed even tighter

BCBSA will cross promote with the American Board of Medical Specialties

Don't get caught up in the technology and devices; focus on the workflow and end user

Smoking is the number-one preventable health risk, but quit rates have stalled

Changing times can mean strategic changes in executive leadership

Coordination of care helps decrease costs and ensures effect use of resources

Patent expirations are slowing and other tools are needed to manage costs

Tricky regulations stir up questions about what constitutes overpayment and when disclosure is needed

Design policies carefully to attract members shopping around in the individual market. This growing segment is sure to boost enrollment figures in 2010.

Compared to other countries, U.S. patients are more likely to forgo care because of cost

Healthcare market dynamics don't adequately drive quality, but that bubble will eventually burst, according to Francois de Brantes of Bridges to Excellence. Plans need to take more risks and upset the status quo.

Administrative spending supports care coordination, prevention and technology investment

The industry spends trillions each year, and another $1 trillion is needed to fix it

A new says rising obesity rates will continue to be an increasing burden on the health care system over the next decade.

Media coverage and confusion over the guidelines prompted Kathleen Sebelius, the secretary of Health and Human Services, to speak up.