News

Recent FDA action (through March 2009) related to cetuximab, prasugrel, risperidone, iclaprim, lasofoxifene, ecallantide, laquinimod, C1 inhibitor, SGN-35, and omacetaxine

Ustekinumab is a novel investigational human monoclonal antibody (mAb) that is pending approval for the treatment of plaque psoriasis. Subcutaneous administration of ustekinumab has demonstrated efficacy in both phase 2 and 3 trials.

New formulation: Calcitriol (Vectical), a Vitamin D analogue, was approved on January 23, 2009, for the treatment of mild-to-moderate plaque psoriasis

New biologic: Antithrombin (recombinant) (ATryn), a recombinant human antithrombin, was approved on February 6, 2009, for the prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin-deficient patients

Agents in late-stage development for the treatment of asthma, COPD, and PAH

The problems exposed in California reveal the need for focus on state rescission guidelines

Organizations need to use levers to build financial value for health investments

Performance registries are designed for data collection in reporting to CMS or potentially other payers

Insist that the expected value of improvements in information quality is expressed in dollar figures

The potential is there if you only seek the benefits

Some employers might need to adjust copay structures overall to achieve adequate compliance.

One way to level the playing field is to offer the public plan through an administered market system.

Payers have vast amounts of data that could be used in so many ways, if only HIPAA would allow it

Research must be actionable, relevant, timely, translated and transparent in its funding sources.

Key provisions include funding for Mediciad, COBRA subsidies, health records, NIH research, health centers, effectiveness research, and wellness programs.

Regina Herzlinger's prescription for reform calls for payment based on episodes of care.

Expected losses of delayed IT projects include improved quality, efficiency and care coordination

Your competitive edge can come from digitizing and automating labor-intensive processes to gain efficiencies

Commonwealth Fund State Performance Ranking (2007): 17

Federally qualified health centers need $248 million to meet plan targets, much more than the proposed $100 million in the appropriations bill

Group sessions can also empower patients to cope with recurrence of painful headaches

Sponsors of Part D legislation believe private Medicare Part D plans have been less effective than the government could be in negotiating price concessions.

Payment structure among stakeholders must be equitable in order to avoid contract disputes and provide the highest quality of care to consumers.

At a joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees on January 30, 2009, advisors voted 14 to 12 that propoxyphene and propoxyphene-containing products should be removed from the market. Propoxyphene (Darvon, Xanodyne; generic propoxyphene) and propoxyphene combinations, including Darvocet (Xanodyne), are used for the treatment of mild-to-moderate acute pain.

In an analysis of fracture risk associated with loop diuretic use among postmenopausal women in the Women's Health Initiative (WHI) study, investigators demonstrated no significant association between loop diuretic use and fractures or changes in bone mineral density (BMD). With prolonged use of loop diuretics, however, the risk of fracture was modestly increased.

Initial results of the Women's Health Initiative (WHI) study demonstrated an increased risk of breast cancer among postmenopausal women treated with estrogen plus progestin. A new long-term analysis of this study published in the New England Journal of Medicine demonstrated that breast cancer incidence decreased markedly after WHI study participants discontinued hormone therapy.

Tom Daschle's (D?SD) withdrawal of his nomination for Secretary of Health and Human Services (HHS) has some speculating whether or not healthcare reform will be derailed. Daschle withdrew after saying that his failure to pay more than $120,000 in taxes could be a "distraction."

Pfizer is discontinuing a phase 3 study of axitinib for the treatment of advanced pancreatic cancer. An analysis by an independent data safety monitoring board demonstrated that there was no improvement in survival among patients treated with axitininb plus gemcitabine versus those treated with gemcitabine alone.

After New York State Attorney General Cuomo's industry-wide investigation of allegations that insurers saddle consumers with too much out-of-pocket costs, UnitedHealth says it will develop a new, independent database. Consultants say this is emblematic of a more persistent problem: the relationship among payers, patients, and providers.

Walgreens’ launch of its employer-centric pharmacy, health and wellness program, exemplifies a move by providers of service innovating their delivery models.