NHL Drug Threatened by Medicare Fee Cut Raises Progression-Free Survival by 2 Years
Elsevier Global Medical News. 2007 Dec 10, J. Salodof MacNeil
ATLANTA(EGMN) - No sooner did Medicare announce it will cut funding for two approved radioimmunotherapies than an international phase III trial is reporting that one of them, 90Y-ibritumomab tiuxetan, can prolong progression-free survival by 2 years in relapsed follicular non-Hodgkin’s lymphoma.
Patients given consolidation therapy with 90Y-ibritumomab tiuxetan (Zevalin) have so far achieved a median progression-free survival of 37 months compared with 13.5 months in a control group that had no further treatment after achieving a complete or partial response with first-line therapy (P less than .001).
Overall survival data are not yet mature, Dr. Anton Hagenbeek, study investigator, said during a press briefing Dec. 9 at the annual meeting of the American Society of Hematology.
The Zevalin First-Line Indolent Trial (FIT) enrolled 414 patients who had responded to various first-line therapies for relapsed follicular non-Hodgkins lymphoma (NHL) at 77 centers in 12 European countries and Canada. A total of 208 patients were randomized to a consolidation regimen of rituximab and 90Y-ibritumomab tiuxetan, while 206 received standard therapy, which is no further treatment, said Dr. Hagenbeek, professor of hematology, University Medical Center Utrecht/HOVON, the Netherlands.
Other favorable findings in the 90Y-ibritumomab tiuxetan arm include at approximately 2½ years of follow-up: a 77% rate of conversion from partial responses after induction therapy to complete responses, a complete remission rate of 87%, and a molecular remission rate of 97%. Dr. Hagenbeek described the consolidation regimen as well tolerated with no unexpected toxicities and noted that the conversion rate was the same regardless of the first-line therapy received before the patient was randomized.
Bayer Schering Pharma AG in Germany sponsored the trial. It has exclusive worldwide rights to 90Y-ibritumomab tiuxetan except in the United States, where Cell Therapeutics Inc. (CTI) in Seattle recently signed an agreement to acquire the rights from Biogen Idec Inc.
Zevalin is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed forms of B-cell NHL, including patients with rituximab-refractory follicular NHL. A competing radioimmunotherapy agent iodine I 131 tositumomab (Bexxar) has a similar indication.
Despite favorable clinical trials, both radioimmunotherapies are considered underused. Each combines a monoclonal antibody to an antigen expressed on cancer cells with radiation, thereby enhancing the effects of radiation and immunotherapy. Both therapies must be given in a hospital with nuclear medicine capabilities. As a result, only a limited number of facilities, typically in academic centers, can deliver these therapies.
As of Jan. 1, 2008, Medicare will cut hospital payments to approximately $16,000 for Zevalin and Bexxar, which are administered only once. When asked about the Medicare decision, Dr. Hagenbeek said he is “a believer in coming up with good data” that can convince payers to invest in health care treatments. “I am happy that I work in Europe,” he added.
The press conference moderator, Dr. Jane N. Winter, a professor of medicine at Northwestern University in Chicago, said she had just learned that the new Medicare rates would be $10,000 less than it costs her hospital to provide radioimmunotherapy to lymphoma patients. “Just at the time that data are emerging to show this is highly effective, we are being cut off at the knees,” she said, emphasizing that the treatments would not be offered because a nonprofit hospital cannot afford to lose $10,000 for each patient treated.
Dr. Winter said the cost is attributable largely to the extensive technical support required and not the price of the agents themselves. “When you are dealing with radioisotopes, you don’t want to cut your technical support,” she said.
In the long term, the cost of alternative consolidation treatments would prove more expensive, Dr. Winter added in an interview. “It’s absolutely going to be cheaper,” she said, noting that FIT patients required no further treatments during the additional 2 years of progression-free survival, and comparing one-time treatment with Zevalin or Bexxar to an estimated $40,000 for just four weeks of rituximab.
Lymphoma advocacy groups are already organizing to fight the increase, according to Dr. Winter, who noted that she had conducted a number of Zevalin studies sponsored by Biogen. Although NHL is the fifth most common cancer, she observed that advocates “just don’t have the clout of the colorectal cancer and breast cancer lobbies.
“We were hoping this study would give a real boost for use of radioimmunotherapy,” she said.
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