After spending 4 years laying a foundation that will streamline clinical testing and drug development, FDA leaders are poised to move the agency's Critical Path Initiative (CPI) from concept to implementation. Despite public concerns about drug safety, dangerous imports, and rising pharmaceutical costs, CPI has not fallen by the wayside.
A study published in the Journal of the American Medical Association reported that use of finasteride, a 5-alpha reductase inhibitor commonly used to treat benign prostatic hyperplasia (BPH), does not appear to be associated with an increased incidence of hip fractures in men; in fact, the agent appears to decrease the risk of hip fracture.
An observational retrospective study published in the American Journal of Respiratory and Critical Care Medicine demonstrated that mortality is reduced when patients with chronic obstructive pulmonary disease (COPD) are treated with cardioselective beta-blockers before major vascular surgery.
As a pharmacologic adjunct to stenting in patients with acute myocardial infarction (AMI), bivalirudin monotherapy outperformed the combination of a glycoprotein (GP) IIb/IIIa inhibitor and unfractionated heparin (UFH) over 1 year of follow-up, reported investigators at the 2008 Transcatheter Cardiovascular Therapeutics conference.
A phase 2 study published in the New England Journal of Medicine reported that alemtuzumab was more effective than interferon beta-1a in treating early, relapsing-remitting multiple sclerosis (MS), but the agent was also associated with higher rates of autoimmunity, including cases of immune thrombocytopenic purpura (ITP).
To effectively gauge the potential clinical and economic impact of drug and biologic therapies that are pending FDA approval, the monitoring of pharmaceutical pipelines has become an essential function of pharmacy benefit management (PBM) companies and managed care organizations (MCOs); one source of pharmaceutical pipeline information is subscription-based pharmaceutical pipeline databases. Examples of some of these databases, along with the types of information provided and advantages and disadvantages of such products, are presented.
This article reviews the 10 newly improved or investigational agents evaluated in this year's "Focus on" column and includes an update on the regulatory status of each drug.
Prasugrel is a thienopyridine prodrug under FDA review for the treatment of acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI). Clinical trials have demonstrated statistically significant inhibition of platelet aggregation with prasugrel relative to placebo and clopidogrel; however, this improved efficacy outcome entails a significantly increased rate of bleeding.
Recent FDA action (through November 2008) related to aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, and artemether/lumefantrine
Generic drugs approved by FDA (through November 2008) including galantamine extended-release capsules and carbidopa/levodopa orally disintegrating tablets
Agents in late-stage development for the treatment of insomnia and restless legs syndrome (RLS)
Unfortunately, healthcare's complex business model, dynamic technology and regulatory changes, and potential for market disruptions render conventional strategic planning processes and financial decision-making tools less effective.
The American Medical Group Assn.'s compensation and financial survey indicates trends among surgical specialties, based on compensation RVUs and gross charges over a four-year period
Insurers are not immune to the financial crisis, but because of a positive cash flow and liquidity, they are stillattractive to investors
Healthcare learned lessons about access to patient data during past natural disasters and now are putting those lessons to work during this year's hurricane season
Insurers follow updated CMS rules regarding financial responsibility for egregious medical mistakes, do not pay list and never events
As goes the national economy, so goes healthcare. Unemployment will cause a rise in uninsured and Medicaid enrollment with higher spending ahead.
HHS is giving HIPAA enforcement efforts more teeth with fees and Corrective Action Plans
The Connecticut Department of Social Services launched Charter Oak Health Plan in June, a subsidized, public-private plan with no income limits and guaranteed issue. It's a suitable fit for the working uninsured, a target segment for other health reform coverage proposals nationwide.
Plans can no longer charge higher copays or limit the number of visits for behavioral or mental health benefits, thanks to a new law
Commonwealth Fund State Performance ranking: 26
Boomers have a vested interest in finding solutions to forthcoming long-term care crisis
Coverage expansion is taking a back seat as costly medical advances and the burden of obesity chew up more of the healthcare spending pie
In light of the recent NCQA report, plans should consider adopting emerging collaborative models
As disease management programs have grown in size and scope, the importance of justifying their expense by demonstrating financial savings has become critical.
There are incalculable advantages to be gained from the use of clinical data in studying chronic diseases across communities and larger populations.
Hospital medicine groups yield cost savings of approximately 13% while delivering high quality care and patient satisfaction, irrespective of the business model.
Consumers would rather do their taxes than wade through their health benefits materials, but one managed care plan is offering free assistance to help make sense of it all.
Some brokers say wrap-arounds are helping their clients provide a policy that both employers and employees can afford, but insurers disagree. At least one broker has been terminated.
