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A recent decision by the U.S. Centers for Medicare and Medicaid Services (CMS) to increase access to high-dose interleukin-2 (IL-2) therapy for certain patients with life-threatening cancers is the result of a study by oncologists at nine centers nationwide, including Columbia University Medical Center at NewYork-Presbyterian Hospital. The reimbursement change, which affects metastatic renal cell carcinoma and metastatic melanoma patients, will take effect on October 1.

The study collected data on the cost to the hospital to administer the drug compared to Medicare reimbursement, documenting the insufficient reimbursement and financial losses to each hospital. The study found that high dose IL-2 therapy required Medicare reimbursement of approximately $25,000, versus the less than $10,000 previously allotted.

"The new reimbursement change will more accurately reflect the cost of administering the drug, providing an important option for patients who could not get this treatment because of the cost," said Howard L. Kaufman, M.D., Co-Director of the Melanoma Center at Columbia University Medical Center and Vice Chairman of Surgical Oncology at Columbia University College of Physicians & Surgeons.

Prior to the policy change, high-dose IL-2 was classified under Medicare's reimbursement code for biological response modifiers. However, unlike most of the ancillary or supportive services under this code, administration of high-dose IL-2 therapy is resource intensive and requires hospital admission.

There are nearly 30 medical centers in the United States that administer high-dose IL-2. With the large discrepancies in Medicare reimbursement, several of those centers discontinued the therapy, limiting access of this potentially lifesaving treatment option.

Interleukin-2 administered in high doses is the only FDA-approved therapy in the United States for the treatment of metastatic renal cell carcinoma and the first therapy approved for the treatment of metastatic melanoma in more than 20 years. Approximately 11,900 new cases of metastatic renal cell carcinoma and 7,800 new cases of metastatic melanoma are diagnosed in the United States each year. IL-2 is a naturally occurring protein that plays an important role in stimulating the immune system.

Interleukin-2 is manufactured by the Chiron Corporation of Emeryville, California.