Immunosuppressant Coverage
Gengraf™, Diovan®, Alendronate®, Lasix®, Diabeta®
Protonix®, Once weekly Fosamax®
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| Medicare Immunosuppressant Coverage |
Updates on Patient
Assistance Programs Gengraf™, Diovan®, Alendronate®, Lasix®, Diabeta® |
Recent
FDA Approval Protonix®, Once weekly Fosamax® |
Transplant 2001 Meeting |
| Medicare
Immunosuppressant Coverage In January 2001, HCFA issued a program memorandum implementing section 113 of the Medicare, Medicaid, and Benefits Improvement and Protection Act of 2000. Effective December 21, 2000, the 44-month time limit of Medicare coverage of immunosuppressive drugs for Medicare-eligible transplant recipients was eliminated, meaning that patients who receive Medicare benefits based on age and/or disability are entitled to immunosuppressant coverage for as long as it is needed. Immunosuppressant coverage for transplant recipients whose Medicare eligibility is based solely on end-stage renal disease will terminate 36 months after kidney transplant. For more information contact HCFA at 410-786-4635. |
| Updates
on Patient Assistance Programs Several new patient assistance programs are available. Gengraf™ (cyclosporine capsules, USP Modified), manufactured by Abbott, is an immunosuppressant indicated for the prophylaxis of organ rejection in kidney, liver, and heart transplants. For patients that may benefit from Gengraf™ but may not have the resources to purchase this medication, information concerning patient assistance may be accessed through MAP at 706-721-0131 or Abbott Labs at 1-800-633-9110. Diovan®, an angiotensin II antagonist used in the management of hypertension, is available through an assistance program. Information concerning this program may be accessed through MAP at 706-721-0131 or Novartis at 1-800-257-3273. Alendronate®, a biophosphate used to treat and prevent osteoporosis, is available through an assistance program for the new 35mg and 70mg tablets (see article below). Patient assistance enrollment for Lasix® and Diabeta® is no longer available, however, these drugs have a generic equivalent available. |
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Recent
FDA Approval An unpublished placebo-controlled eight-week trial in 603 patients with GERD found that pantoprozole 40mg per day significantly decreased symptoms of heartburn and regurgitation, and produced endoscopic healing in 93% of patients compared to 40% with placebo. In another eight-week study in patients with GERD, complete healing occurred in 153 of 170 patients (90%) treated with pantoprazole 40mg/day and 81 of 86 patients (94%) treated with omeprazole 20mg/day. Pantoprazole was more effective than nizatidine and ranitidine in healing esophageal erosions and decreasing symptoms of GERD. Pantoprazole was also effective for 12 to 24 months as maintenance therapy for GERD. Pantoprazole was found to be effective in eradicating Helicobacter pylori and treating duodenal and gastric ulcers. Intravenous pantoprazole was well tolerated and effective as oral pantoprazole in suppressing acid secretion and is also effective in treating Zollinger-Ellison syndrome. The recommended adult oral dose of pantoprazole is 40mg once daily for erosive GERD. If healing is not complete, the drug can be given for a second eight-week course. Pantoprazole tablets can be crushed and given with liquid through feeding tubes. Pantoprazole is generally well tolerated. Diarrhea, rash, constipation, nausea, and skin eruptions may occur. A patient assistance program is available for this medication. For more information concerning the patient assistance program contact MAP at 706-721-0131 or Wyeth-Ayerst Laboratories at 1-800-568-9938. Weekly Fosamax®
for Treatment and Prevention of PMO For the treatment of osteoporosis, Fosamax® increases bone mass and reduces the incidence of fractures, including those of the hip and spine. The therapeutic equivalence of once weekly Fosamax® 70 mg and Fosamax® 10 mg daily was demonstrated in a 1-year, double-blind, multicenter study of postmenopausal women with osteoporosis. In the primary analysis, the mean increases from baseline in lumbar spine BMD (bone mass density) at one year were 5.1% in the 70-mg once-weekly group (n=440) and 5.4% in the 10-mg daily group (n=330). The two treatment groups were also similar with regard to BMD increases at other skeletal sites. For the prevention of osteoporosis, Fosamax® may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture. The therapeutic equivalence of once weekly Fosamax® 35mg and Fosamax® 10mg daily was demonstrated in a 1-year, double-blind, multicenter study of postmenopausal women without osteoporosis. In the primary analysis, the mean increases from baseline in lumbar spine BMD at one year were 2.9% in the 35-mg once-weekly group (n=307) and 3.2% in the 5-mg daily group (n=298). The two treatment groups were also similar with regard to BMD increases at other skeletal sites. Similar to daily dosages,
Fosamax® weekly dosages should be taken upon arising
for the day with a full glass of water and patients should not lie down
for at least 30 minutes after administration to prevent adverse effects
of the esophagus. Patients may be more compliant to weekly Fosamax®
than daily dosages. A patient assistance program is available for this
medication. For more information concerning the patient assistance program
contact MAP at 706-721-0131 or Merck at 1-800-994-2111. |
| Transplant
2001 Meeting Held in Chicago May 11-16 The American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (AST) are having the Joint American Transplant Meeting. At the meeting a variety of formats are planned that will encourage the exchange of scientific and clinical information. The meeting will be held at the Sheraton Chicago Hotel and Towers in Chicago, Illinois during May 11-16, 2001. For more information, please contact the Transplant 2001 staff at 856-439-0880 or visit the website at www.transplant2001.org. |
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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. |