The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires September 30, 2007, has set the stage for congressional action on broader legislation to improve the handling of drug safety issues. Bills under consideration aim to expand FDA oversight by establishing new requirements for postmarket risk assessment, for posting active clinical trials and resulting study data, and for completing postmarket studies.
We propose using the results of pharmacodynamic Monte Carlo simulation studies as a surrogate marker for potential efficacy of antibiotic dosage regimens and applying these end points to the calculation of an incremental cost-effectiveness ratio (ICER).
One of the numerous factors shaping pharmacy and therapeutics (P&T) committees' operations and decisions is the push for electronic health information systems, including electronic prescribing (e-prescribing). E-prescribing is expected to help prescribers comply with plan formularies and formulary policies.
In patients with metastatic renal cell carcinoma, treatment with sunitinib yields longer progression-free survival rates and a better health-related quality of life than does the standard treatment, interferon alfa therapy, according to the results of a phase 3 trial published in the New England Journal of Medicine (NEJM). A total of 750 patients aged ≥18 years participated in this international, multicenter, randomized trial.
Maintaining treatment with imatinib as initial therapy in patients with chronic myeloid leukemia (CML) may yield positive outcomes, including increased overall survival to ≥5 years, according to a study published in the New England Journal of Medicine (NEJM). The follow-up study of the International Randomized Study of Interferon and ST1571 (IRIS), a multicenter, international, randomized, phase 3 trial, included patients aged 18 to 70 years diagnosed with Ph-positive CML in chronic phase within 6 months before the start of the study.
Healthcare professionals assembled at the 56th Annual Scientific Session of the American College of Cardiology (ACC) from March 24 to 27, 2007, in New Orleans, La, to exchange information and updates about new and continuing research in cardiovascular disease.
A discussion of new FDA-approved indications and formulations of drugs
A discussion of generic drugs recently approved by FDA
A discussion of drugs under consideration/review for FDA approval
Recombinant monoclonal antibody approved for reducing the signs and symptoms and inducing and maintaining clinical remission of moderately-to-severely active Crohn's disease
Recombinant monoclonal antibody approved for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
DIABETES, ASTHMA cardiovascular disorders, high-risk pregnancy and chronic obstructive pulmonary disease (COPD), will continue to account for anywhere between 55% and 70% of medical costs, according to industry experts. For these disease states, executives are taking a look at more creative DM programs, but they also are seeing emerging diseases on the horizon.
As healthcare costs continue to increase, information has become its own currency. Payers want to identify high utilizers of services; purchasers demand to know how their money is being spent; and providers seek information on patients' status. Even pharmaceutical companies want in, and consumers who are expected to pay for more of their healthcare want to know about the data available to them.
Disease management as we now define it may be on its last legs, though no one knows it yet. The Disease Management Purchasing Consortium has noticed that the savings in all but a few diseases doesn't offset the costs, and nowhere does it generate the level of return on investment (ROI) that some people think they are getting.
Virtually everyone agrees that properly incentivizing physicians-particularly rewarding the high-level performers-is critical to changing the direction of the U.S. healthcare industry. No single stakeholder can effect much of a change alone, however; if the industry is going to change, it will be with help from every direction and demographic.
Twenty years ago, health insurance was marketed on a wholesale basis. Over the past five years-as managed care turned mainstream-different product designs have surfaced and become more retail oriented.
Most employers and healthcare consumers have traditionally purchased their coverage plans based on price, and with spiraling costs, who can blame them? In recent years, however, the proposition of value-that is, price in relation to quality-has slowly gained traction as a guiding principle.
As healthcare costs continue to spiral out of control, state officials across the country are pursuing creative ways to control the high costs of Medicaid services for low-income women, children, the disabled and the elderly.
The State Children's Health Insurance Program (SCHIP) will expire September 30, 2007, unless Congress approves legislation reauthorizing this popular program offering healthcare services for children and some adults. The deadline puts this issue at the top of the Congressional agenda as an opportunity for Democratic leaders to increase public access to care. Efforts to expand coverage for children and secure the Medicare program are important to the managed care community because the legislators are eyeing "overpayments" to Medicare Advantage plans as a possible source for some $50 billion to fund SCHIP and other healthcare programs.
National reports-Patient advocacy groups have multiplied during the past several years, each creating their own niche, ranging from patient education and support, to lobbying for research funding, to funding research to help patients and their families overcome illness and disease.
Washington, D.C.-Sierra Health Services recently disclosed a $2 million monthly loss from its Medicare full donut-hole-coverage prescription drug plan (PDP), blamed the financial problem on a competitor, and decided to sell out to the leader in the field. Sierra executives say they will drop the Sierra Rx Plus plan, which pays for brand-name drugs through the Medicare coverage gap for its 42,000 members, and the new owner, UnitedHealth Group is unlikely to question that decision.
National reports-While national expenditures on bariatric surgery have increased, the average cost per patient has declined, say industry experts.
Washington, D.C.-While members of the Medicare Payment Advisory Commission (MedPAC) may be willing to go slow on proposals to reduce rates for Medicare Advantage (MA) plans overall, they are leery about the fast growth and high cost of private fee-for-service plans. MedPAC members generally believe that payments to MA plans should be comparable with the cost of the traditional Medicare FFS program and that it is inequitable for seniors to receive better benefits from MA plans. They are unhappy over analysis that shows that Medicare pays MA plans 16% on average more than the cost of care under FFS. This breaks out to 15% excess payment to local HMOs, but 22% higher rates for private FFS plans, a newer type of private plan that is growing fast: PFFS plans have attracted 66% more seniors since last August to serve more than 1.3 million Medicare beneficiaries as of February.
Washington, D.C.-The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires Sept. 30, 2007, has set the stage for Congressional action on broader legislation to enhance government regulation of drug safety. Bills under consideration aim to expand Food and Drug Administration (FDA) oversight by establishing new requirements for postmarket risk assessment, for posting information on active clinical trials and the resulting study data, and for completing agreed-upon postmarketing studies.
Harvard Pilgrim Health Care in Massachusetts has been calling itself "America's highest rated health plan" for the past several years. And it's got industry studies to back it up.
A joint collaboration between a small hospital in Indiana and an Indianapolis-based picture archiving and communications systems (PACS) and complete radiology provider enabled the small hospital round-the-clock access to radiologist services. Upon its opening in October 2006, the Monroe Hospital in Bloomington, Ind., joined forces with the PACS and radiology provider to supply the facility with radiologists to cover all of the hospital's general and subspecialty radiology services through both on-site and remote radiologists.
Most Medicare Advantage and Part D sponsors share a common goal: make Medicare a more profitable line of business. To help alleviate some of the challenges associated with enrollment practices, consider the following tips:
Postmenopausal women with hormone-sensitive early-stage breast cancer who have received at least 2 years of adjuvant treatment with tamoxifen can benefit in overall survival from a switch to anastrozole, according to the results of a meta-analysis published in the journal Lancet.
A review of agents in late-stage development for the treatment of genitourinary disorders (March 2007).
The Institute of Medicine (IOM) issued a report in September 2006 urging FDA to make major changes to better balance the agency's assessment of the risks and benefits of new drugs. FDA commissioner Andrew von Eschenbach, MD, has responded with a report that details the agency's plans to improve procedures for detecting and assessing drug safety problems. "The Future of Drug Safety" describes proposals for developing safety "report cards" on new drugs to better inform prescribers and patients about new safety concerns and to more quickly detect drug safety signals.
