Insurance issues and clinical trials

From Jill Sisco, patient advocate, president of the acromegaly community and PWN contributor comes this commentary on insurance out-of-pocket charges and an update on acromegaly clinical trials.  

As a patient leader, that runs a sizable discussion group of Acromegaly patients, I am extremely concerned with the insurance issues my fellow patients are facing. My concerns specifically pertain to the use of drug co-pay cards and how the insurance companies are refusing to apply the proceeds towards the deductible or maximum out-of-pocket limits for patients.

Acromegaly patients are maxing out their pharmaceutical card benefits, and then the patients are presented with a bill for the balance for the out-of-pocket maximum, minus any other medical expenses they have previously paid for the year. This eliminates any benefits the patients would have received, except for paying later in the year. This payment essentially “double dips” and penalizes the pharmaceutical companies who are trying to help keep the costs to a minimum for rare patients.

I have repeatedly been asked by many Acromegaly patients, “What can I do to stop my insurance company from following this unethical practice?” I have personally contacted NORD, Global Genes and all the other various pharmaceutical companies that support Acromegaly treatments. Patients should always contact their program administrators to confirm, but right now, I am told, that there is not much that can be done other than removing the co-pay assistance info from the specialty pharmacy patient profile and paying the copayment amount out-of-pocket. If patients choose to do this, they can then request reimbursement from the programs directly. However, this must be done before the meds reach the maximum assistance level on the drug co-pay cards, which means it must be processed early in the year to ensure that there will be enough funds to reimburse you. Each program has between a $15,000-20,000 cap for their copay assistance programs. Acromegaly medications can run much higher.

If it is too late to be reimbursed, and a person is near the maximum benefits, another alternative would be to participate in a clinical trial. The added benefit to a clinical trial is that the patient would then be part of a clinic with physicians that specialize in Acromegaly. Typically, the patient’s travel costs to and from the trial site are paid for directly by the clinical trial or reimbursed to the patient. During the clinical trials, physicians run tests regarding acromegaly at no cost to the patient and the patient is given the access to the much-needed medications at no cost!

One of the concerns of Acromegaly patients is that in recent clinical trials, not every patient receives the actual medication. Some are given ‘placebo’, and therefore, some are not receiving the necessary medications. This is a concern, however, please be aware that there are “rescue” plans in place. If the patient’s levels begin to rise, he/she will be put back on their previous therapy, and that medication is then covered by the trial until the end of the study. Regardless of the random placebo issue, we do need dedicated patients to participate in these studies to move forward with new solutions and therapies. Once patients begin a study, it is important that they follow through with the study through completion.  A drop out of the patient from the study leaves a bad mark on the therapy itself, even if you have left the study for reasons other than medication issues.  So dedication is very important.  There are several companies right now in phase I clinical trials that are testing medications on healthy individuals. This also ensures the research teams the safety of the new drug.  This is the first step in the clinical trial process. From there it moves on to phases II and III that bring in actual acromegaly patients into the process. Phase II studies the efficacy of a drug and phase III studies randomized testing using a placebo on patients. Phase IV presents follow up studies once FDA approval has been granted.

Current trials enrolling now.

Please visit for a complete and updated list.

I have personally participated in clinical trials in the past and found them to be a rewarding experience. Through Science and Innovation, these experiences have left me feeling as though I am doing my part to help our Acromegaly family on their journey to better health.

You can reach Jill by visiting the Acromegaly Community website.


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