The Cost of Clinical Trials

The following are common questions people have about the cost of clinical trials:

• Who pays for the costs of a clinical trial?
• What costs do trials involve, and who is usually responsible for paying them?
• What criteria do health plans use to make decisions about reimbursement for trials?
• What does Medicare cover?

Who pays for the costs of a clinical trial?

The trial sponsor usually pays for the cost of the intervention being studied (for example, any drugs not currently approved for your condition). The sponsor may also pay for the cost associated with any special testing or extra doctor visits that are required.

"Routine patient care costs" are the usual costs of medical care, such as doctor visits, hospital stays, clinical laboratory tests and x-rays that you would receive whether or not you were participating in a clinical trial. Some health plans may not cover these costs once you join a trial, even though studies have shown that they are not appreciably higher than costs for patients who are not enrolled in trials. You will know what will be covered and what may not be covered prior to beginning any treatment. In addition, in the state of California, Medicare and most HMO insurance plans are required to cover clinical trials for cancer patients. Again you will know your full coverage prior to beginning treatment.
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What costs do trials involve, and who is usually responsible for paying them?

There are two types of costs associated with a clinical trial: patient care costs and research costs.

Patient care costs fall into two categories:

• Usual care costs, such as doctor visits, hospital stays, clinical laboratory tests, and x-rays, which occur whether you are participating in a trial or receiving standard treatment. These costs have usually been covered by a third-party health plan, such as Medicare or private insurance.
  
• Extra care costs associated with clinical trial participation, such as the additional tests that may or may not be fully covered by the clinical trial sponsor and/or research institution. The sponsor and the participant's health plan need to resolve coverage of these costs for particular trials.

Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests purely performed for research purposes. Such costs are usually covered by the sponsoring organization, such as the National Cancer Institute (NCI) or a pharmaceutical company. These costs are not the patient's responsibility.

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What criteria do health plans use to make decisions about reimbursement for trials?

Health insurance companies and managed care companies decide which health care services they will pay for by developing a coverage policy regarding the specific services. In general, the most important factor determining whether something is covered is a health plan's judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exist in sufficient quantity, the plan may label the service as investigational.

Health care services delivered within the setting of a clinical trial are very often categorized as investigational and not all health plans will cover investigational treatments. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Again, California has laws in place to help ensure that clinical trials for cancer patients will often be a covered benefit. Your individual plan will be contacted for coverage information prior to beginning treatment.

Your health plan may define specific criteria that a trial must meet before extending coverage, such as:

• Sponsorship
  Some plans may only cover costs of trials sponsored by organizations whose review and oversight of the trial is careful and scientifically rigorous, according to standards set by the health plan.
  
  
• Trial phase and type
  
  Some plans may cover patient care costs only for the clinical trials they judge to be "medically necessary" on a case-by-case basis. Trial phase may also affect coverage. For example, a plan may be willing to cover costs associated with phase III trials, which include treatments that have already been successful with a certain number of people. However, the plan may require some documentation of effectiveness before covering a phase I or phase II trial.
  
  Policies vary widely, but we will evaluate your coverage benefits with your insurance company before you start treatment.

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What does Medicare cover?

For up-to-date information about Medicare coverage of clinical trials, go to the
Web site for the Centers for Medicaid & Medicare.

Costs that are normally covered by Medicare

• Anything normally covered is still covered when it is part of a clinical trial. This includes test, procedures, and doctor visits that are ordinarily covered.
  
• Anything normally covered, even if it is a service or item associated with the experimental treatment. For example, Medicare will pay for the intravenous administration of a new chemotherapy drug being tested in a trial, including any therapy to prevent side effects from the new drug.
  
• Anything normally covered, even if it resulted from your being in the clinical trial. For example, a test or hospitalization resulting from a side effect of the new treatment that Medicare would ordinarily cover.

Costs that are normally not covered by Medicare

• Investigational items or services being tested in a trial. Sponsors of clinical trials sometimes provide the new drug free, but make sure you ask your doctor before you begin.
  
• Items or services used solely for the data collection needs of the trial.
  
• Anything being provided free by the sponsor of the trial.
  What kinds of clinical trials are covered?
  In general, cancer treatment and diagnosis trials are covered if:
  
• They are funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other federal agencies that fund cancer research. Other trials may be eligible for coverage and doctors can ask Medicare to pay the patients' costs.
  
• They are designed to treat or diagnose your cancer.
  
• The purpose or subject of the trial is within a Medicare benefit category. For example, cancer diagnosis and treatment are Medicare benefits, so these trials are covered. Cancer prevention trials are not currently covered.

Who should participate in Cancer Trials?

More information about clinical research

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