As oncology treatments continue to evolve and change over time, so do various treatment options available. Clinical trials present the opportunity to use new treatment options that are still being studied and not approved by the FDA, clinical trials may compare a new treatment to a treatment that is already available as well. Thanks to science and the fascinating arena of clinical trials, some patients now have a plethora of options available to treat their cancer, should you meet the various inclusion criteria of a trial and are able to find one located near you. Most of the criteria generally relate to diagnosis and tumor mutation types as well as current health status and patient’s ability to tolerate the treatment option.
Clinical trials can be sponsored by organizations, institutions, pharmaceutical and biotechnology companies, the government or nonprofit groups who want to improve current cancer treatments. Some trials are investigator-initiated, which means a researcher or doctor created the trial, these trials still face the same level of scrutiny and criteria as any other clinical trial. There are typically 4 phases to a clinical trial, if the drug successfully passes through Phases I, II, and III, it will usually be approved by the FDA for use in the general population. Phase I trials are smaller enrollment trials that may be open to people with any type of advanced cancer, and usually for those who have already tried other available treatments. Phase I trials are important as they are used to determine how much of the new drug is safe to give or what the dosing schedule should look like. Phase II trials are larger enrollment trials used to determine the efficacy or effectiveness of the new drug, usually more locations and slots are available at this time point for patient enrollment. Phase III is used evaluate how the new medication works in comparison to existing medications for the same condition, and to confirm the findings on efficacy found in the previous phases. Drugs don’t have to go through all phases if they’re seen as being effective early on with substantial improvement, it can go through breakthrough therapy designation (an accelerated approval process) and get approved quicker, or if the opposite happens trials can come to a halt. Phase IV is used for FDA approved drugs in the treatment of another disease that it wasn’t originally approved for.
Another option available to a patient is compassionate use or expanded access. If a clinical trial isn’t available close to where a patient lives and there are no other available treatment options, sometimes the sponsor can allow the provider to essentially create a mini-trial for one patient, following the same criteria and be subject to the same level of scrutiny, of a clinical trial and writing a protocol and regimen for the use of the drug. There is currently some legislation around this called the “Right to Try” Law, which essentially was intended to provide patients further access to experimental therapies that have completed Phase I testing but have not been approved by the FDA.
Federal law requires that most standard and/or routine care costs incurred should be covered by the insurance company. However, what an insurance company considers routine or standard of care does vary, and insurances are not required to cover out-of-network providers or hospitals. Insurance plans also are not required to cover the research costs of a clinical trial. Examples of these costs could include extra blood tests or scans that are done for research purposes, and in this case, the trial sponsor should cover these costs based on how the contract was negotiated.
Many of the specifics on what the sponsor will and will not pay for are housed in the research finance department, or with whoever initiates and negotiates the budget and contract agreement. If you do get billed for a service and your insurance denies the claim, it is important to communicate that to your provider to inquire about whether the service should have been billed to your insurance or to the sponsor. If indeed the service was to be billed to the insurance and the insurance provider deems it is not medically necessary, you should work with your provider’s office to initiate an appeal and document why the service was indeed necessary for your participation in the trial.
Lastly, sometimes the hospital, research center, and the pharmaceutical company will cover the cost of treatment in a clinical trial. Yet oftentimes, clinical trials do require additional tests, doctor visits, travel, childcare costs and other expenses that are not covered by the trial sponsors or the patient’s insurance. Again, it’s important to review your options with the hospital Patient Financial Advocate (PFA), check for relevant third-party foundation funds (PAF, PAN, etc.), and work with your provider’s office to find ways to mitigate these extra costs. If the facility has a PFA or Financial Navigator it would be beneficial to work with them on determining if you can appeal any denials with your insurance plan, and work with your provider to submit that to your insurance. Also, work with your provider to see if you can qualify for any hospital-based charity care or financial assistance as well. If the trial isn’t available near you, work with your provider to see if compassionate use or expanded access use of the trial drug is a worthwhile option.
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