FDA notified providers and patients that they are continuing to review available data suggesting an increase in the risk of diabetes, heart attack, stroke, and sudden death in men treated with gonadotropin-releasing hormone agonists as androgen deprivation therapy for prostate cancer.
FDA appears to be requesting some kind of Risk Evaluation and Mitigation Strategy on most new drug products.
Pulmonary arterial hypertension (PAH) is a rare but progressive condition characterized by abnormal proliferation and remodeling, vasoconstriction, and thrombosis of the pulmonary vasculature, leading to elevated pulmonary arterial pressure, increases in peripheral vascular resistance, and ultimately to right heart failure and death. Recently, the therapeutic armamentarium for PAH has expanded.
Obesity is a prevalent disease that has reached epidemic proportions in both the developed and developing world. In the United States, it is estimated that 66% of the adult population is overweight or obese. There are several available pharmacologic treatments for obesity used as an adjunct to diet, exercise, and behavioral therapy. However, weight loss with these agents is modest and usually reversible when the drug is discontinued, and novel, more-effective anti-obesity agents are desperately needed.
Recent FDA Approvals (through May 2010) related to Vimovo, CIP-Tramadol ER, Zymaxid, Lumizyme, Rapamune, Sprix
New Molecular Entity: Estradiol valerate/dienogest (Natazia) was approved in May 2010 for the prevention of pregnancy.
Recent FDA action (through, May 2010) related to BMS-224818, Roflumilast, Prostvac, Naltrexone, IL13-PE38QQR/IL13-PE, Prochymal, AEZS-108, SBC-102, Pralatrexate, RG2833
According to the Academy of Managed Care Pharmacy (AMCP) and software partner Dymaxium Healthcare Innovations, the AMCP eDossier System is catching on among decision makers and drug companies alike.
New Formulation: Miconazole buccal tablets (Oravig) was approved in April 2010 for the local treatment of oropharyngeal candidiasis in adults.
Comparative effectiveness research is suddenly flush with fundings. Tucked in last year's American Recovery and Reinvestment Act was $1.1 billion to accelerate CER.
This month keep an eye out for the National Association of Insurance Commissioners recommendations to the Department of Health and Human Services on how health insurers might calculate their MLRs to satisfy the new regulations.
How can plans know they're getting the most value for their money in disease management and wellness programs?
The Patient Protection and Care Act will allow health insurance coverage through state-based health insurance exchanges, expand Medicaid eligibility, and subsidize insurance premiums, all of which involve state implementation.
It's likely that most major health insurers will participate in the insurance exchanges that must be up and running in each state by 2014, according to experts.
Although the most revolutionary health reform provisions do not go into effect until 2014, insurers and payers are scurrying to implement a number of big changes required this year.
People over the age of 80 is the fastest-growing population sement in the United States, and they are also the most susceptible to falling through the cracks in the healthcare system.
Pamela Morris, president and CEO of Dayton-Ohio-based CareSource is operating the nation's fourth-largest Medicaid managed care plan in the recession-plagued state of Ohio.
While not a panacea, emerging financial tools that facilitate members' interaction with the healthcare system--such as online treatment-cost estimators--hold the potential to become a truly effective technology that will help improve those problem areas.
As healthcare moves from a broader clinical mentality to more personalized, tailor medicine, pharmacogenomics is emerging as a best-practice therapy.
A recent national sampling of 34 insurers' EOBs by DALBAR, a third-party communications evaluation firm, gave 68% of the EOB statements it analyzed a failing grade.
It is no surprise that the passage of the Patient Protection and Affordable Care Act has sparked several legal challenges. States already have insurance laws and regulations. But what happens to these now?
Despite advances in behavioral health management, managed care persistenently incurs significant costs for members with a diagnosis of substance dependence.
White House staffers are praising plans that cover young adults before the September deadline.
California voters, regardless of their political party affiliation or income level, are worried about and feel unprepared for the costs of long-term care, according to a new poll from The SCAN Foundation and the UCLA Center for Health Policy Research.
The American College of Physicians' High-Value, Cost-Conscious Care initiative will assess benefits, harms, and costs of diagnostic tests and treatments for various diseases to determine whether they provide good value.
At the Managed Care Executive Group?s (MCEG) recent annual forum, the group released its annual top 10 issues list. This year the Top Ten is dominated by the role of government.
Low-dose oral colchicine is just as effective as high-dose colchicine in reducing pain associated with early acute gout flare, but with a safety profile statistically indistinguishable from placebo, according to a study published in the April issue of Arthritis & Rheumatism, the official journal of the American College of Rheumatology.
Anticonvulsant agents have important therapeutic benefits. However, both the healthcare provider and patient need to remain cognizant of associated risks, according to results of a study published in the April 13, 2010, edition of the Journal of the American Medical Association.
The Board of Trustees of the Foundation for Managed Care Pharmacy (FMCP), the educational and philanthropic arm of the Academy of Managed Care Pharmacy (AMCP), announced the winners in the 10th Annual AMCP/FMCP National Student Pharmacist Pharmacy & Therapeutics (P&T) Competition, and FMCP Best Student Pharmacist and Best Resident or Fellow Poster Contests.
Patients with coronary heart disease (CHD) or CHD equivalent on stable statin monotherapy treated with the addition of extended-release niacin have significant decreases in carotid intima-media thickness compared with those who had ezetimibe added to their stable statin treatment, according to a study published online April 14 in the Journal of the American College of Cardiology, as reported by HealthDay News.