Policy & Public Affairs
ASN Expresses Concern over New Proposal for
Vitamin D Therapy
Richard K. Baer, MD
Medical Director, Medicare Part A
AdminaStar Federal
225 North Michigan Avenue
22nd Floor, AFCH-85
Chicago, IL 60601-7601
The American Society of Nephrology (ASN) is an organization of 7,000 scientists and physicians dedicated to the advancement of research on kidney disease and its treatment and prevention. I am writing to express ASN's concern with your proposed restrictions on Vitamin D therapy for patients with secondary hyperparathyroidism.
Nephrologists have observed progress in the treatment of end-stage renal disease. While more needs to be done, thanks to clinical experience, new research and the development of more effective medications, dialysis patients in the United States can now look forward to a better quality of life and a somewhat extended lifespan.
However recent proposals being considered by your agency may not sustain the progress already achieved in certain areas of clinical care. We are deeply concerned and unable to support a policy which suggests that nephrologists must administer either an oral Vitamin D medication which has been virtually abandoned by the renal community due to its lack of effectiveness or an older and/or less effective form of intravenous medication.
This policy under consideration creates two major concerns:
1. Oral vs. intravenous. Currently, 90+% of dialysis patients who require Vitamin D therapy are treated intravenously - for reasons of efficacy, safety and compliance (the peak blood levels necessary to reduce elevated PTH levels consistently and effectively can only be achieved with IV administration). An oral vitamin D product has been available since 1978, but it was not until the introduction of an IV preparation in 1988 that patients were effectively treated for secondary hyperparathyroidism. Significant hypercalcemia was a not infrequent complication of oral vitamin D therapy.
The proposed policy would run contrary to years of experience, training and clinical practice by nephrologists. It would require doctors to prescribe a drug that they believe to be less effective. As we understand, only if the patient "fails" oral therapy, presumably as indexed by predictable continued medical evidence of hyperparathyroidism and its consequences, would AdminaStar "allow" intravenous treatment. It is difficult to defend such a practice.
2. Paricalcitol vs. other drugs. If i.v. therapy were permitted, it would not reimburse for the newer Vitamin D medication, paricalcitol, a preparation favored by most physicians because of distinct clinical benefits.
Paricalcitol is currently prescribed for more than 75 percent of patients who need vitamin D therapy, because of its minimal effect on calcium and phosphorous levels. Other medications, including doxercalciferol, are viewed as less effective. The most frequently prescribed alternative medication, calcitriol, often must be withdrawn from patients to allow time for its unwanted side effects, increased levels of calcium and phosphorous, to subside. Recent research published in the November 2001 issue of the American Journal of Kidney Disease demonstrated that among the patients who were studied, paricalcitol was more effective than calcitriol in maintaining appropriate levels of calcium and phosphorous.
Roland C. Blantz
President