April 15, 2005

Senate mulls bill on clinical trials’ costs

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Mace Rothenberg, M.D., testified this week at the State Senate about a bill that could impact insurance costs for clinical trials for cancer patients.
photo by Dana Johnson

Senate mulls bill on clinical trials’ costs

Requiring insurers to cover routine medical costs associated with clinical trials of potential new therapies would enable more patients to participate and would allow progress in medicine, including cancer care, to move forward more quickly, a leading Vanderbilt-Ingram Cancer Center physician-scientist told state lawmakers earlier this week.

Mace L. Rothenberg, M.D., Ingram Professor of Cancer Research, Professor of Medicine and director of Vanderbilt-Ingram's Phase I Drug Development Program, testified Tuesday before the state Senate Commerce Committee in support of a bill that would require health insurers to cover routine medical costs associated with clinical trials for cancer patients.

“There's been a concern and a lot of misunderstanding over the years that insurance companies are asked to pay for research expenses which they shouldn't,” Rothenberg told the committee. “Additionally, sponsors including the NIH have refused to pay for standard care costs that are incurred in the clinical trials. What this bill tries to do is clearly delineate who pays for what.”

Senate Bill 1706, sponsored by Sen. John Ford (D-Memphis), would require insurance plans to provide coverage for all routine patient care costs related to clinical trials whose enrollees are diagnosed with cancer and are accepted into Phase I, II, III, or IV clinical trials that the patient's doctor has determined could have a meaningful potential benefit to the enrollee. Twenty-two other states have similar legislation. A similar measure in the House is sponsored by Rep. Joe Armstrong (D-District 15).

“Every health insurance policy that is written has the same phrase written in it — that this policy does not cover investigational drug treatment,” Rothenberg said. “Many people who read that say, 'well, I can't participate in a clinical trial.' This is a false perception that prevents more people who are interested and eligible to participate in clinical trials from doing so.

“Hopefully what this legislation will do is make it very clear that insurance companies that write policies in the state of Tennessee will have to adhere to the standard of covering routine clinical care costs that are incurred by patients who are participating in clinical trials.”

Currently, about 450 drugs in are clinical trials for cancer. Routine costs for cancer patients can run into the tens of thousands of dollars, and if they are not covered by insurance, can pose a great financial risk to patients who participate in clinical trials.

“Any progress we are making in terms of cancer treatment is the result of carefully done clinical trials,” Rothenberg said. “So if there is not support for this, what we are saying is that the progress in the treatment would stop where it is in 2005, and we would not make any further progress. And that's unacceptable.”