After enrolling in Medicare Part D, seniors who previously had limited or no drug coverage spent more on prescriptions and less on other medical care services such as hospitalizations and visits to the doctor’s office, according to a University of Pittsburgh Graduate School of Public Health study. Published in the July 2 issue of the New England Journal of Medicine, the study also found that seniors who had relatively good drug benefits prior to enrolling in Medicare Part D spent somewhat more on prescriptions and, at the same time, increased their spending on other medical care services.

“We found that Part D led to increases in overall pharmacy spending among all beneficiaries,” said the study’s lead author, Yuting Zhang, Ph.D., assistant professor of health economics at the University of Pittsburgh Graduate School of Public Health. “These increases were offset by decreases in spending on other medical care services in those with little or no drug coverage before they enrolled in Medicare Part D, which was one-third of the beneficiary population studied. The majority of Part D enrollees in our study population - those with relatively good prior prescription coverage - spent more on prescriptions as well as other medical services.”

The purpose of Medicare Part D, which took effect in January 2006, is to subsidize the cost of prescription drugs for Medicare beneficiaries, more than 30 percent of whom had limited or no coverage for prescription drugs prior to its implementation.

Dr. Zhang and her colleagues compared prescription drug use and other medical spending among three groups of senior citizens two years before and after Part D was implemented. The groups included beneficiaries with no prior drug coverage, poor prior drug coverage ($600 maximum per year) and relatively good prior drug coverage ($1,400 maximum per year, comparable to Part D). They found that total monthly prescription drug spending increased by 74 percent among the no-coverage group; by 27 percent among the poor-coverage group; and by 11 percent among the good-coverage group. The study also found that the use of both lipid-lowering and anti-diabetic medications rose in the groups with limited or no drug coverage.

When it came to spending on other medical care services excluding drugs, the no-coverage group and poor-coverage group decreased their spending by $33 and $46 per month respectively, while the good-coverage group increased their spending by $30 per month.

“The offset in spending by seniors with limited or no prior drug benefits could be due to improved adherence to medication, especially for those with chronic conditions. Improved access to prescription drugs provided by Part D may enable this population to better control symptoms and cut down on visits to the physician’s office or emergency room,” said Dr. Zhang. On the other hand, the lack of a similar spending offset in the good-coverage group could indicate an overuse of some medications and services by this population, she noted.

Co-authors of the study include senior author Joseph P. Newhouse, Ph.D., Harvard University; Julie M. Donohue, Ph.D., and Judith R. Lave, Ph.D., University of Pittsburgh Graduate School of Public Health; and Gerald O’Donnell, M.S., Highmark Inc., Pittsburgh.

The study was funded in part by a grant to Dr. Donohue from the National Institutes of Health and a grant to Dr. Newhouse from the Alfred P. Sloan Foundation.

Source:
Clare Collins

University of Pittsburgh Schools of the Health Sciences

Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) and Eisai Corporation of North America (Headquarters: Woodcliff Lake, NJ, Chairman and CEO Hajime Shimizu) are currently focusing on three clinical development programs for the company’s major product Aricept(R) (donepezil hydrochloride tablets) to further contribute to patients with Alzheimer’s disease. As progress in those programs has been made, Eisai announces the status as follows:

1. Sustained Release Tablets

Eisai has completed a Phase III study of Aricept 23 mg sustained release (SR) in patients with moderate to severe Alzheimer’s disease. Aricept 23 mg SR is being developed to increase clinical benefits while maintaining a favorable safety profile compared to currently marketed Aricept 10 mg immediate release.

Based on the preliminary review of the data from this Phase III study, Eisai plans to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in August or September 2009.

2. Pediatric Use

Eisai filed a Proposed Pediatric Study Request (PPSR), an application that proposes a rationale and study design for pediatric studies, with the U.S. FDA in February 2009 to evaluate the clinical benefits of donepezil in children with attention impairment following cancer treatment. Eisai received a notice from the U.S. FDA that there were insufficient grounds to issue a Written Request to obtain pediatric exclusivity. Eisai plans to complete the ongoing studies to provide important information on this therapeutic approach for an underserved patient population currently with limited treatment options.

3. Transdermal Patch Formulation

Clinical trials of a once-a-week transdermal patch formulation of donepezil, which include a bioequivalence study compared to the currently marketed formulation of donepezil, are currently being conducted by Teikoku Pharma USA, Inc. in the United States. An NDA submission to the U.S. FDA is planned for the middle of fiscal year 2009 based on the results of the clinical trials. Eisai is working on this new formulation of donepezil based on agreements with Teikoku Seiyaku Co., Ltd. and its U.S. subsidiary, Teikoku Pharma USA, Inc.

About Aricept

Aricept is the first and only prescription medication approved by the U.S. Food and Drug Administration for mild, moderate and severe dementia of the Alzheimer’s type. This indication is supported by evidence-based medicine backed by numerous well-controlled clinical studies of AD in all stages and settings among thousands of patients that demonstrated that Aricept improves cognition and delays functional decline.

Aricept is well tolerated, but may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take Aricept may experience fainting. Some people may have nausea, vomiting, diarrhea, bruising, or not sleep well. Some people may have muscle cramps or loss of appetite or may feel tired. In studies these were usually mild and temporary.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 10,000 employees worldwide.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd. and supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.

Source: Eisai Co., Ltd.

View drug information on ARICEPT.

A low dose of oral interferon alpha shows promise in preserving beta cell function for patients with newly diagnosed type 1 diabetes, or juvenile diabetes, according to researchers at The University of Texas Medical School at Houston.

The results of the Phase II trial are published in Diabetes Care, a journal of the org/” rel=”nofollow”>American Diabetes Association.

“It shows a strong trend in preserving insulin-producing beta cell function that is significantly better than placebo,” said Staley Brod, M.D., principal investigator of the trial, which includes the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “It can extend the ‘honeymoon phase’ of the disease, allowing the body to still produce insulin from beta cells, which correlates with decreased complication rates.”

As many as 3 million Americans may have type I diabetes, formerly called juvenile diabetes, according to the Juvenile Diabetes Research Foundation International. Each year, 15,000 children are diagnosed with the autoimmune disease, in which the pancreas stops producing the insulin needed to transfer glucose from the blood to cells for energy. The result is too much glucose in the blood, which can lead to kidney failure, blindness, nerve damage, amputations, heart attack and stroke.

A honeymoon phase sometimes occurs just after diagnosis as the body tries to rebound. Many patients experience a period when their need for insulin becomes minimal, control of blood sugar improves and beta cells partially recover. If the pancreas is still able to function, the highs and lows experienced by taking manufactured insulin can be decreased.

The Phase II trial included 128 patients from the NIDDK’s Intramural Studies Office, The University of Texas Southwestern Medical Center in Dallas and Children’s Hospitals and Clinics in Minneapolis/St. Paul, Minn. Research was conducted at The University of Texas Clinical Research Center at Memorial Hermann-Texas Medical Center, which is part of the Center for Clinical and Translational Sciences at The University of Texas Health Science Center at Houston.

Research subjects ages 3 to 25 diagnosed with type 1 diabetes within six weeks of enrollment were randomized to receive 5,000 units of interferon alpha, 30,000 units of interferon alpha or placebo once daily for one year. Patients treated with 5,000 units lost only 29 percent of their beta cell function compared to 48 percent for patients receiving 30,000 units and 56 percent for patients receiving the placebo.

Austin resident Jarod Wallquist, 11, was 5 years old when he was diagnosed with type I diabetes and his mother Amy learned about Brod’s study. Jarod received the 5,000 units of interferon alpha, but neither she nor the researchers knew it at the time because of the double-blind nature of the study.

“My husband and I are both scientific-minded so we understood the importance of the research even if we didn’t know whether it would help Jarod,” said Wallquist, whose family made regular trips to Houston for the study. “Jarod is doing really well. He wears an insulin pump but he’s never had to go to the emergency room. To this day, according to his doctor, his amount of insulin needed is much lower than other kids his age and weight. He plays baseball and is on the swim team and he totally has a normal life.”

The research builds on Brod’s earlier studies on oral interferon alpha in animals and a Phase I safety trial. After the results of the safety trial, NIDDK researchers asked to join Brod’s research before the Phase II trial.

Brod’s theory is that autoimmune diseases, which occur when the body is attacked by its own immune system, are actually an alpha interferon immunodeficiency syndrome. Interferons are a group of proteins produced by cells in response to an attack by a virus.

The research was supported in part by two grants from the National Institutes of Heath - one to Brod from the NIDDK and one to the UT Health Science Center at Houston for the Center for Clinical and Translational Sciences. The research also was supported by grants from the Children’s Hospital of Minnesota Foundation and the Diabetes Action Research and Education Foundation.

Co-authors of the study from the UT Medical School at Houston are Philip Orlander, M.D., professor and director of the Division of Endocrinology, and Miriam Morales, B.S., consultant. Corresponding author from the NIDDK is Kristina Rother, M.D., M.H.Sc.

Source:
Deborah Mann Lake

University of Texas Health Science Center at Houston