Lansdale, PA—February 12, 2010—Hayes, Inc., the nation’s leading health technology research and consulting company, today announced that Susan A. Levine, DVM, MS, PhD, Vice President of Health Technology Research and Consulting, has joined the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC was established in 1998 to provide independent guidance and expert advice to the Centers for Medicare & Medicaid Services (CMS) on specific clinical topics. Dr Levine will serve a two-year term beginning January 1, 2010.

MEDCAC is utilized by CMS to supplement its own research and allow for additional expert and public input on coverage topics, including those that are highly complex or have a major potential impact on the health of beneficiaries and/or the Medicare program itself. The MEDCAC reviews and evaluates medical literature and technology assessments to determine reasonable and necessary applications of medical services and technology. Advisory in nature, MEDCAC provides an unbiased, external evaluation of the strength of available evidence in a public forum. The committee also provides expert clinical and technical review regarding conclusions about the net health outcomes of a technology under consideration.

MEDCAC members are valued for their background, education, and expertise in a wide variety of scientific, clinical and other related fields. “I am honored to be invited to work with this prestigious group of professionals,” says Dr Levine. “In order to improve the quality of healthcare in the United States, decisions about policy, coverage, utilization, and personal healthcare must be grounded in scientific evidence.”

Dr Levine has extensive experience in health technology assessment, clinical trial methodology and data analysis, and comparative effectiveness reviews, and has held a senior management position at Hayes, Inc. for the past 13 years. Before joining Hayes, Dr Levine earned a PhD in Pharmacology and Doctor of Veterinary Medicine degree from Cornell University, and completed a surgical residency at the University of Wisconsin School of Veterinary Medicine. She has held faculty appointments at the University of Wisconsin-Madison, Johns Hopkins University School of Medicine, and Mayo Graduate School of Medicine.

Hayes, Inc.
Hayes, Inc. is an independent health technology research and consulting company dedicated to promoting better health outcomes through the use of evidence. Hayes performs unbiased, evidence-based health technology assessments of the safety and efficacy of new, emerging, and controversial health technologies, and evaluates the impact of these technologies on healthcare quality, utilization, and cost. Hayes’ worldwide clients include hospitals, healthcare systems, government agencies, employers, and managed care organizations. For more information, visit www.hayesinc.com.

We know that you may be too busy to keep track of the drug and technology market, so the professionals at Hayes, Inc. are tracking new developments for you! For example, the Food and Drug Administration (FDA) recently approved two novel technologies: an oral agent for patients with multiple sclerosis (MS) that may help their walking ability and the first percutaneous heart valve system. Hayes has been monitoring the development of these two first-of-a-kind technologies in Technology Prognosis, our horizon scanning service, and this is what we think about each new development:

Ampyra™ (Dalfampridine, Formerly Fampridine-SR; Acorda Therapeutics Inc.)
Ampyra was approved by the FDA on January 22, 2010, to improve walking in patients with any type of MS. Although Ampyra does not change the course of MS, it does represent an intriguing innovation in MS therapy because it is an oral agent that addresses an unmet treatment need. There is, however, uncertainty regarding the practical “real-world” relevance of pivotal trial results. The research suggested that a significantly higher proportion of patients treated with Ampyra versus placebo were able to walk faster, but the magnitude of improvement in the Ampyra group was so small that the actual walking speed in that group differed from that in the placebo group by less than 1 minute.

Hayes Viewpoint: Ampyra will likely be of great interest to MS patients and clinicians despite a paucity of evidence of practical “real-world” benefits.

Melody® Transcatheter Pulmonary Valve (Medtronic Inc.)
The Melody Transcatheter Pulmonary Valve was approved by the FDA on January 25, 2010, through its Humanitarian Device Exemption (HDE) program. The valve and delivery system are indicated to prolong the longevity of failing prosthetic pulmonary conduits in patients with right ventricular outflow tract (RVOT) dysfunction associated with congenital heart defects. Based on the best available evidence, implantation of the Melody valve may delay open heart surgery in selected patients with failing RVOT conduits. However, the long-term efficacy of this intervention to reduce the lifetime risk for exposure to multiple pulmonary valve surgeries is still being evaluated.

Hayes Viewpoint: The Melody valve is not expected to replace current care open heart surgery for initial placement of a pulmonary conduit, but may reduce the total number of open heart RVOT revision procedures required during a patient’s lifetime.

To learn more about Hayes Technology Prognosis or if you have any questions about our products and services, please click here to complete our inquiry form and we’ll be happy to assist you.

Hayes to offer public webinar to help parents of children with ADHD understand the scientific evidence behind a range of ADHD treatments

Lansdale, PA—November 2, 2009—Hayes, Inc., the nation’s leading health technology research and consulting company, today announced that it is offering a consumer-oriented webinar that will unlock the scientific evidence behind various treatments for attention-deficit/hyperactivity disorder (ADHD). In the webinar, Hayes analysts will provide a clear perspective on the benefits, limitations, and potential side effects of a range of ADHD treatments, including pharmaceutical and behavioral approaches.

Hayes CARE professionals will present the webinar. The Hayes CARE program is an innovative workplace benefit for employees and their families. The information provided by Hayes CARE helps employees to understand treatment options, maintain or regain control over their own healthcare decisions, and cope with disruptive health events.

ADHD impacts 4 to 5 million American children, and its treatment is controversial. During the webinar, Elisabeth Houtsmuller (Ph.D.) will explore the clinical evidence behind ADHD treatments for children and cover the benefits and limitations of each, taking into consideration the severity of the symptoms.

In commenting on the webinar, Dr. Houtsmuller said, “Parents of children with ADHD are often overwhelmed by differing opinions about the effectiveness of the various treatments. It is difficult to find unbiased information about treatments, and the Internet is cluttered with conflicting data, some of which has been provided by drug companies with products to sell. At the same time, ADHD is a “lightning rod” issue, and opinions abound from relatives, friends, and neighbors, adding to the confusion.”

“In our webinar, we will provide an unbiased view of ADHD treatments, including prescription drugs such as Adderall® and Strattera®, behavioral therapies, neurofeedback, and over-the-counter treatments such as St. John’s wort and Ginkgo biloba. Our hope is that parents will have the opportunity to learn about treatment options in a forum that is free from the influence of any drug manufacturers, special interest groups, or other marketing biases.”

The one-hour interactive webinar will be offered on November 12, 2009 at 12:00 PM Eastern time and again at 9:00 PM Eastern time. Participants will be able to ask questions through the web-based software. Participants will also receive easy-to-use take-home guides that summarize the information discussed during the program. The registration fee of $19.95 includes all materials. Click here to learn more and to register.

Dr. Houtsmuller continued, “It is important for parents to be involved in decisions about how to treat their children with ADHD. There are so many options, and most parents don’t have access to the scientific literature. At the same time, finding and calibrating the right treatment for children with ADHD can create family stress. We hope that by offering this webinar we can provide parents with an unbiased and broad perspective to make these challenging and stressful decisions.”

Hayes, Inc.
Hayes, Inc. is an independent health technology research and consulting company dedicated to promoting better health outcomes through the use of evidence. Hayes performs unbiased, evidence-based health technology assessments of the safety and efficacy of new, emerging, and controversial health technologies, and evaluates the impact of these technologies on healthcare quality, utilization, and cost. Hayes’ worldwide clients include hospitals, healthcare systems, government agencies, employers, and managed care organizations.

Hayes products and services include:

• A dynamic, web-based health technology assessment Knowledge Center designed to support professionals who are responsible for strategic planning, technology acquisition, and policy development.
• Consulting services that enhance strategic technology planning and support evidence-based technology acquisition so that hospitals can anticipate and prepare for the financial, clinical, and operational impact of new technologies prior to their adoption.
• Customized services that help payers develop and update coverage policies as well as create clinical guidelines.
• Employee benefit programs that help patients make well-informed decisions about healthcare options.

For more information, visit www.hayesinc.com.

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