I started blogging about the clinical trial for elezanumab, when I enrolled as a patient. As I started sharing in my blog, and in vlogs with Damian Washington, I was amazed to get feedback from other patients in the trial. This lead me to sidestep my nervousness, and start a Facebook Group, to not only share my experiences of the clinical trial with others, but to also lift back the curtain of mystery surrounding clinical trials. When I started the group I was scared to be starting something and I had no idea how I, as a patient suffering from Cog Fog, and trying to be a Mom to my two kids, was going to keep up with this. There were a lot of, “What makes you think you can do this moments.” I have been so lucky to also receive so much support from the group, and others began sharing and I was left with the relation that my only responsibility was to share honestly, and I didn’t have to do any of this alone.
It’s a year and a half later, and my participation in the phase 2a Clinical Trial for Elezanumab, is largely completed. However, I still continue to look for more information about the drug, as I hope that it goes on to phase 3, and hope to continue my participation in the trial.
My wonderful moderator to the Facebook group, shared with me a link that elezanumab should be available under the Expanded Access Program under the FDA. I get excited about the progression of any remyelination drug, but this one has become my baby. Of course, when I see this baby meet a developmental milestone, I have to rejoice. (I know this drug isn’t really my baby, its just that I’ve been able to participate and receive it for a time and share about it.)
What does this Expanded Access mean for the advancement of getting it into the hands of those who need it, especially since there are 2.5 million people in the world with multiple sclerosis and without access to a remyelination agent? What does this really do for us, when most of us couldn’t afford any MS medication, without the help of insurance, Medicaid or medicare, or a grant assistance program?
What does this Mean for You?
When I have an idea, I go to google, and type in all my search terms to try to get as much information as possible to figure out what it means for me, and what it may mean for you, my readers. I am not perfect, and I often make mistakes. I apologize in advance for any I make. Always discuss the possibility of any new drug with your doctor, neurologist, or multiple sclerosis specialist.
The Expanded Access Program by the FDA, is a program to give a potential means of access to patients living with a serious or life threatening disease. It is reserved for rare instances because it is a program to gain access to an investigational drug that has not yet received FDA approval, as it is still in the phases of clinical trial. For more information please see the FDA’s explanation of the Expanded Access Program.
Limitations of Expanded Access
If there are circumstances that would mean that you meet the criteria to participate in a clinical trial of the medication, you man not qualify for the Expanded Access Program.
It is always the safest option to be part of a clinical trial, if you qualify. The quality of care I received while in the phase 2a clinical trial of elezanumab, gave me a lot of comfort. The drug had only been tested in phase 1, to determine safety, by giving just four infusions to patients. I was receiving twelve infusions. I needed a lot of extra monitoring, to make sure my health was not any any jeopardy, and I not only received this care free of charge, I was also given snacks, access to wonderful nurses and clinical trial coordinators, free MRIs, and a Debit card for reimbursed travel and a modest monetary incentive. What I’m saying, is there are many perks to being part of a clinical trial, and the most important perk is having extra attention and care paid to the state of your health.
If you do not qualify for a clinical trial, and do want to request use of Elezanumab, or another drug, under the Expanded Access Program, it seems it would be very necessary to have your doctor completely on board with your need for the medication. In addition to this hurtle, you need approval from the Institutional Review Board, and the drug maker to make sure that the drug is appropriate for your needs.
FDA is committed to increasing awareness about the expanded access process and the procedures for getting access to investigational medical products. It is important to note that, even if you meet the criteria under the law and FDA regulations, the licensed physician, the Institutional Review Board (IRB), and the company all need to agree that expanded access is appropriate for you in order for you to receive the investigational medical product. In addition, there may be costs not covered by third-party payers such as private insurance or Medicare.https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients#what-is-it
There is information from Abbvie, the pharmaceutical company that is the sponsor of the clinical trial of Elezanumab, on Pre-Approval Access.
Links to more information on the Expanded Access Program for the Drug Elezanumab: (Click the blue text.)
If a person were to get approval for the Expanded Access Program from the drug manufacturer, many insurance companies, as well as medicaid and medicare may not cover the cost of the medication, as it does not yet have FDA approval. I have no idea what the costs of the drug would be; that would be a conversation to have with your doctor and Abbvie, should it seem that you qualify for approval under Expanded Access.
Questions to Ask Your Doctor About Compassionate Use and Expanded Access:
There is some excellent information from the American Cancer Society, including questions to ask your doctor about Compassionate Use, Expanded Access, and Right to Try programs:
Are there any approved treatments that I haven’t tried?
Is there any evidence to support the use of this drug to treat my
type of cancer(type of MS)?
What makes you think this drug could help me?
In what way do you think this drug is likely to work better than an approved drug?
What are the known risks and benefits of treatment with this drug?
Will the drug company give me the drug for free? If not, how is it to be paid for? What costs will I have to pay to get the drug? Will my insurance cover any costs?
Should we consider expanded access (EAP) or a Right to Try path? What are the pros and cons of each?
What will we have to do to get access to this drug?
How long do you think it will take for me to get access to this drug?http://www.cancer.org
I wish I had more answers on how to fund access to a medication under Expanded Access, Compassionate Use, or Right to Try programs, but unfortunately I have come up short. It’s my Dad’s Birthday today, and the 17th MSversary of my diagnosis, so I’m trying not to exhaust myself on this one, but still get information to you.
I hope to get more information in the Fall of 2021 about Phase 3 of the Clinical Trial for Elezanumab and I promise to share this information when it comes. I am anxious to continue, and to find out if I did receive the drug. I am anxious about what exactly will happen to my body in the time in between trials. I received 12 monthly infusions over the course of the trial. Then there were six months of observation, of which I was only able to have minimal participation (teledoc interviews) because I needed to temporarily relocate due to the pandemic. The amount of questions I have, as well as the new numbness in my head and face, that seems to be sticking around, can drive me crazy at times.
However, I repeat to myself like a mantra, the positives I have felt and observed since my year in the trial:
- I can complete a Tandem Walk, even on a balance beam. That has been the neurological test I have failed for years. This gives me hope that there has been improvement in my cerebellum, as this is the area of the brain that can may have a lesion if you have problems with the Tandem Walk.
- My recorded EDSS went down from a 6 to a 3 in my last evaluation of the Clinical Trial, and this was largely due to the fact that I completed the 500 meter walking test without the aid of an assistive device.
- I have a little better control of my bladder, and more ease on emptying, most of the time. 😊
- My neurologist pointed out my Cognitive Improvements to me, while in the clinical trial.
This gives me so much comfort, especially when I feel like ants or some time of something is crawling over my scalp and face. It helps me, and gives me comfort, to focus on the positives. It has also helped me so much, that you have come on this journey with me. While I was on the trial I would get so nervous. My MS specialist gave me an MRI, just a few months after my clinical trial MRI, when I was having a month of worsening vertigo during the trial, that was actually due to an underlying Urinary Tract Infection. In some ways being in the clinical trial added a whole new layer over the uncertainty of my health, as it seemed to be one more thing to worry about. My MS was being well controlled by Ocrevus, was jumping into a clinical trial and all the uncertainty that goes with it, damning myself to unforeseen damage? The care I received in the clinical trial, and the close attention to any side effects or symptoms I was experiencing, gave me the comfort and reassurance that I was in good hands. You all helped to reinforce that, and helped me to stay positive while giving room for my fears to breathe. I have received so much encouragement and I am so very grateful for that. From the bottom of my heart, thank you.
Well, it is Dad’s Birthday, and my littles are needing my attention. Thank you so much for reading and listening. I hope this information is useful to you. Whether Expanded Access is an option, or not, I hope that it is a step in the right direction, of FDA approval, and access to remyelination and regenerative medication to reverse some of the damage of multiple sclerosis.
May God Be with You Til We Meet Again…