Dec 18, 2014

The Right Clinical Trial for You--Part 2

What are the Costs of Clinical Trials?  

When you think about the costs of a clinical trial, you may be thinking about the costs of your care in a clinical trial. These costs are called clinical care costs, things like lab tests, scans, etc. As expensive as those may be, these actually are only a fraction of the total costs of the study. The people who work to make clinical trials a reality are the largest expense. Study coordinators, study nurses, and investigators are the folks you are likely to meet. Pharmacists, laboratory technicians who handle your blood specimens, regulatory specialists (who make sure the trial has all the necessary approvals), and all the people who oversee the clinical trial process and make sure it is being done correctly are working in the background; you will probably never meet them. That seems like a lot of people, but that is only the tip of the iceberg. These are just the people working at the one hospital or research center you are visiting.

There is another large group of people at the pharmaceutical company (or subcontracted by the pharmaceutical company) who develop the study procedures, receive, review, and analyze the results, monitor all side effects, disseminate information to all the researchers (for example, new serious side effect information has to be circulated quickly to everyone who is involved), and interact with the FDA. As you can see, behind every clinical trial, there is an army of people and it all costs a small (or even a large) fortune.

So Who Pays for all This?
That might be interesting, but it’s probably a safe bet that you care most about the clinical care costs that will affect you. In general, items that are solely for research (i.e. the study drug and highly specialized tests that would not otherwise be done to take care of you and your cancer) are covered by the study budget and are free to you. All other costs of medical care; the sorts of things that you would generally expect to need even if you were not in a clinical trial, are billed to you and your health insurance. 
The costs of running the study are borne by the pharmaceutical company for trials that are sponsored by a company. Not all studies have an industry sponsor. Some research ideas, although important, are unlikely to be tested by a pharmaceutical company. For example, if we find that a commonly used drug that is generic (and cheap) could have a beneficial use in cancer therapy, there is almost never a pharmaceutical company that is willing to get involved. The lack of patent protection and inexpensive cost of generic drugs makes this type research a lousy business proposition. 

 Such studies are typically designed and led by an individual researcher. The investigator must also find the funding to support it. Sometimes that involves a grant from the pharmaceutical industry, a grant from a federal source (most commonly the National Cancer Institute or Department of Defense), or a grant from a private organization such as the American Cancer Society. Some studies are funded by philanthropic donors or even the hospital itself. And some studies have no funding at all. Normally such studies would just not get done, but what often happens is that the investigator’s team donates their time. University administrators frown on unfunded studies because the people involved still get their salaries‑‑from the university. Academic professors can be quite innovative about these sorts of things when they are truly excited about a new idea.

Costs of Your Care and Insurance Coverage of Cancer Clinical Trials
 Everyone worries about costs
Misconceptions and concerns about healthcare costs during cancer clinical trials are very common. Some patients (and some doctors) think that experimental treatment is always free. This is almost never true. There are some studies that do provide all of the care for free, but in the world of cancer research they are more often the exception than the rule.

For the studies that you would be interested in, those that seek to treat your cancer, your health insurance will be billed for many elements of your care. It is always spelled out in the consent form; but it may be difficult to sort out. Check out the fine print and ask a health professional for help if it seems confusing.

Is your health insurance willing to pay? If so, how much? Is there a chance that you will get stuck with the bill? It could happen, but much can be done to prevent this if you are proactive. Until all patients with cancer can expect a reliable cure, well-designed clinical trials should be part of standard care. Unfortunately there is no single answer that fits everyone. Read on to learn how you can make sure that there are no financial surprises in your clinical trial.

Medicare Comes Through
If you are over the age of sixty-five, chances are Medicare is a part (or even all) of your health care coverage. Many insurance companies follow, to one extent or another, the approach that Medicare takes in deciding what it will cover and what it won’t.

Since the year 2000, Medicare covers the routine costs of qualifying clinical trials. In addition, Medicare covers costs of diagnosing and caring for complications arising from participation in all qualifying clinical trials. As with all legal matters, it is worth understanding the key definitions.

Routine costs are those items and services that are generally available to all Medicare beneficiaries. That would include doctor visits, routine labs, scans, and tests necessary to monitor your condition. Medicare also covers the costs associated with the giving of the experimental agent (not a big deal if it’s a pill but if it’s an IV infusion this can become expensive and it’s good to know it’s covered). If Medicare doesn’t cover something normally (i.e. cosmetic surgery), it would not cover it while you are a part of a clinical trial. Medicare does not cover the experimental drug or device itself (the actual pills, for example) and items or services that are used solely to gather and analyze research data and are not being done to take care of the patient (like blood drug levels or exploratory tests).

Most of the time these definitions are pretty clear. One gray zone is a situation where something that is routinely done is required more frequently during the study than would be done ordinarily. Let’s say a study wants a CT scan twice a year, but if you weren’t in a trial, you’d most likely only get one a year. This is a gray area because, in most cases, there is not an absolute standard for how often patients need blood tests or scans when they are receiving care for cancer. Some situations require more frequent monitoring than others. Some doctors (and some patients) prefer more frequent monitoring than others. The Standard is really a range of how doctors actually practice. There are situations where something that would ordinarily be considered quite routine is done so frequently in a study that it won’t be covered by Medicare. Your research team and the institutional oversight committee (IRB‑‑see chapter 9) are expected to pay attention to these matters and identify situations where Medicare or your insurance won’t pay. In these situations, the trial sponsor would usually be expected to pay; you’ll obviously want to know in advance if it’s going to come out of your pocket.

If you notice that the study you are considering requires very frequent tests, ask about it. Check in with your study team about the costs of those tests and who pays for them. Many institutions develop tables called Costs of Care or Clinical Billing Schedule tables for each study. These tables spell out every planned item and service that is a part of the study and make it clear if that particular item will be provide free of charge or billed to your insurance.

The Bottom Line
·        1 Until standard cancer therapy is much more effective and reliable cancer cures are common, participation in clinical trials should be an option for all cancer patients.
·         2 Medicare covers routine costs of care for patients who participate in qualified clinical trials. The investigational drugs or devices themselves and procedures that are purely for research purposes (not designed to care for you) are not covered. Services that would not normally be covered under Medicare are not covered.
·         3 Many insurers have policies that provide for similar coverage, but this varies from plan to plan and state to state.
·         4 The majority of states have now passed laws that require coverage for clinical trial participants.
·         5 The Health Care Reform Act of 2010 requires all health plans to cover clinical trials by January 1, 2014.
·         6 Large companies that are self-insured are regulated by the federal ERISA law and may not be impacted by state laws. ERISA does not address clinical trials.
·         7 Your research team should communicate with your insurer to gain approval for your coverage before you begin participation.
·          8 If you are denied coverage, work with your doctor and research team to appeal. Appealing with knowledge of your insurer’s policies, your state’s laws, and the particulars of the trial in which you are interested has the best chance of success. A call from your doctor to your insurance company’s Medical Director can also be very helpful.

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(c) 2012 Tom Beer and Larry Axmaker

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