Issue 19 July 2004
MAP Helps to Provide Over $7.3 Million to Transplant Recipients New Medication: Myfortic (mycophenolic acid) Delayed Release Tablets Medicare-approved Prescription Discount Drug Card Programs
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MAP Helps to Provide Over $7.3 Million to Transplant Recipients

The Medication Access Program (MAP) is a statewide program, available at no cost, for solid-organ transplant recipients in Georgia that offers information about programs that can increase transplant recipients' accessibility to medications (e.g., Medicare, Medicaid, pharmaceutical manufacturer sponsored medication assistance programs). The mission of MAP is to increase access to medications for solid-organ transplant recipients who reside in the State of Georgia. In addition to identifying medication assistance programs, MAP also provides assistance to transplant recipients in the enrollment process necessary to participate in these programs. MAP is available through a grant from the Carlos and Marguerite Mason Trust and the University of Georgia College of Pharmacy.

Financial circumstances resulting from a lack of insurance for medication coverage may force transplant recipients to become noncompliant with medications. Noncompliance with immuno-suppressants and other critical transplant medications may lead to organ rejection, increased health care cost, and decreased quality of life. MAP provides information about and enrollment services into assistance programs concerning immuno- suppressant medications and other medications for concomitant disease states that may develop in transplant recipients. These disease states include, but are not limited to, hypertension, diabetes, pulmonary diseases, and lipid disorders. Additionally, MAP is a valuable resource to healthcare professionals and transplant recipients by providing the most up-to-date information regarding available medication assistance programs.

From October 1999 through June 2004, MAP has aided approximately 450 Georgia solid-organ transplant recipients. Through MAP's services, these recipients have received over $7.3 million in medications, based on average wholesale prices. We encourage all transplant recipients and healthcare professionals to contact MAP. MAP personnel may be reached Monday through Friday from 9:00 AM to 5:00 PM by calling (706) 721-0131 or 1-800-736-2273 ext. 0131.

New Medication
Myfortic (mycophenolic acid) Delayed Release Tablets

In March 2004, Novartis Pharma AG announced that the FDA has approved the use of Myfortic (mycophenolic acid) delayed release tablets, in combination with cyclosporine and corticosteroids, to prevent organ rejection in renal transplant patients. Myfortic is a new enteric-coated formulation of mycophenolic acid that delivers the active moiety mycophenolic acid (MPA), which is the same active moiety delivered by mycophenolate mofetil (MMF, Cellcept ). The introduction of MMF represented a major advance in transplant medicine, and currently, over 80% of new renal transplant patients in the U.S. receive Cellcept as part of their immunosuppressant regimen.

However, optimal use of MMF may be limited by its gastrointestinal side effects possibly causing MMF dose reduction, interruption, or discontinuation. In fact, studies have reported that up to 70% of patients taking MMF required at least one dose change due to drug-related adverse events. In addition, patients who underwent an initial dose reduction in MMF dose were eight times more likely to suffer acute organ rejection than those who had not had a dose adjustment. Myfortic was developed in an effort to enhance upper gastrointestinal tolerability with its enteric-coated formulation, and therefore reduce the risk of acute organ rejection in these patients.

The clinical results for Myfortic come from two randomized, multi-centered, double-blind clinical trials comparing Myfortic to MMF in which more than 700 de novo and maintenance renal transplant patients participated. These results indicate that Myfortic and MMF are therapeutically equivalent in de novo renal transplant patients, and that the conversion to Myfortic from MMF is safe in maintenance renal transplant patients. Adverse events reported in >20% of patients receiving combination therapy with Neoral (cyclosporine, USP) and corticosteroids in the 12-month de novo renal study and maintenance renal studies were similar between patient groups receiving Myfortic and MMF. Although fewer dose reductions, interruptions, and discontinuations were observed with Myfortic , investigators say that additional studies are still needed to further determine the potential clinical benefits of the enteric coating. For more information about these studies, refer to the February 2004 issue of the American Journal of Transplantation.

"Different products work for different patients," commented Robert B. Ettenger, MD, Medical Director of Pediatric Kidney Transplant Program at Mattel Children's Hospital at UCLA. "The availability of more treatment options increases the chances that we can reduce the risk of organ rejection in more patients."

Authored by Lee A. Jenkins

Medicare-approved Prescription Discount Drug Card Programs

On December 8, 2003, the Medicare Modernization Act (MMA) was signed into law.¹ This legislation will provide a prescription drug benefit for Medicare recipients. Medicare-approved prescription discount cards are currently being offered to eligible citizens and are stated to be in effect until at least January 2006 when the Medicare drug benefit is set to begin. Enrollment for the cards began in May 2004 with the cards going active on June 1, 2004. The new cards are intended to provide discounts on medications for Medicare recipients who have no other prescription coverage, such as Medicaid. Centers for Medicare & Medicaid Services (CMS) claims the new cards will offer prescription drug savings between 10% and 25%. Over 7.3 million people are expected to enroll, and save between $1.4 billion and $1.8 billion off of their prescriptions. ¹

To be eligible for the programs, patients must be enrolled in Medicare Part A (hospital coverage) and/or Part B (medical coverage) and not be receiving prescription assistance through Medicaid.1 There are 41 card programs currently available, but patients can only be enrolled in one card at a time. Each card will have a slightly different formulary, varying discounts beyond retail prices, and can have a maximum of $30 annual fee. If annual income is below $12,569 (single) or $16,862 (couple), patients can receive a $600 credit to be used towards medication coinsurance (co-payment), and the patients' annual fee for the card will be waived.¹

Choosing the right card is essential and may be cumbersome. Therefore, MAP is available to help determine if a medication discount card will help decrease medication cost, and find the most appropriate card for the patient. For more information, please contact MAP at 706-721-0131 or 1-800-736-2273 ext. 0131
or by e-mail at map@mapuga.com.

Authored by Josh Marshall

1. Centers for Medicare & Medicaid Services (CMS).
Medicare Prescription Drug Discount Card and Transitional Assistance Program. March 26, 2004. Available at:

http://www.cms.hhs.gov/media/press/release.asp?Counter=990

Accessed June 11, 2004.

Medication Access Program
University of Georgia at the
Medical College of Georgia
Clinical Pharmacy Program
CJ-1020
Augusta, Georgia 30912-2450
706-721-0131 or 800-736-2273 ext. 0131
or e-mail us at: map@mapuga.com

The Medication Access Program (MAP) is a statewide program for solid-organ transplant recipients in Georgia that offers information about medication assistance programs and helps with the enrollment into these programs.

MAP Personnel

Marie Chisholm, Pharm.D., RPh.
MAP Founder / Director

Charlene J. Garrett, CPhT
J. Chinaye Turner, BS
Gene McGinty, BS Pharm., RPh.
Debbie Martin, RN
Kimberly E. Smith, CPhT
Silenda H. Leakes

  
The MAP newsletter is published quarterly to present topics of interest to the transplant
community. If you would like to submit material to be considered for publication in the
newsletter, please contact MAP at:
Medication Access Program
University of Georgia at the Medical College of Georgia
Clinical Pharmacy Program
CJ-1020
Augusta, Georgia 30912-2450
(706) 721-0131 or 1-800-736-2273 ext. 0131
E-mail -
map@mapuga.com
The Medication Access Program is a statewide program for solid-organ transplant patients in Georgia that offers information about medication assistance programs and helps with the enrollment into these programs.