background
PATIENT SPOTLIGHT

Gary L. :

His Battle for Health, Policy, and Treatment Choice for his Son

October 27, 2022
5 min read

The pain of feeling helpless first with his son’s diagnosed illness and pain and then the misconduct of his son’s health insurer was more than he could stand.

Something wasn’t right

While in high school our son began to have stomach and bowel problems. But it wasn’t until shortly after his high school graduation that he explained; eating “often felt like he was swallowing ground glass.” He had frequent bloody diarrhea, sometimes several times a day, multiple days a week, for months on end. Obviously, we knew something was terribly wrong.

The road to diagnosis

After lots of exploration and different doctors, a gastric endoscopy and a colonoscopy, his doctor confirmed that our son had severe Crohn’s disease with lesions throughout his entire gastrointestinal system. Later, when we obtained a second pathology study from a leading university hospital we learned that the year before his first pathologist had missed the signs of our son’s Crohn’s disease. He had suffered an extra year without proper treatment. Though he had just graduated high school and was about to start college in another city several hours away, his doctor advised us that he should not go off to college, that instead he should stay home and be treated and observed in Dallas. That doctor also told us that the reason our son had stopped growing was most likely because of his body’s reduced absorption of nutrients, a common side effect of untreated Crohn’s, which in his case had gone misdiagnosed for at least a year.
When we learned about our son’s newly diagnosed Crohn’s, we also learned that the disease if not properly and successfully treated, would most certainly continue to interfere with his body’s absorption of nutrients and fluids, causing scar tissue, and even permanent damage to his intestines. We learned that many Crohn’s patients had sections of their intestine surgically removed and had permanent Ostomies. We worried for his future and quality of life. His illness affected many life decisions, including attending medical school – which no longer seemed like the best option.
When my son’s gastroenterologist said our son should not leave town to attend the college he had been accepted to, that he should stay in Dallas to be regularly monitored, and that his Crohn’s might even interfere with his ability to work, we were looking at a very dim future. Like so many other Crohn’s disease patients and their families, we were terrified, and we hoped and prayed for a miracle for a better future for our son. Our son was prescribed some standard medications for his Crohn’s, but they did little if anything to alleviate his symptoms.

Treatment and Hope

Then, his gastroenterologist suggested that our son might be able to go off to college if he was treated with a relatively new infusion drug, Remicade, provided he came back to Dallas every 8 weeks for repeated infusions and to be monitored by that doctor.
Though we were still scared of some very serious risks, including cancer, that were then seemingly associated with this new drug, our son wanted to go to college and we agreed with him to take these risks in order for him to hopefully get better and to be able to pursue a hoped for near normal college education and maturing experience.
For his four years of college, he traveled back to Dallas every 8 weeks for his infusions.

Hope from Treatment

Today our son is 32 years old and for the last 13 years , he has received a Remicade infusion in a clinical setting once every 8-weeks without fail. As a result of his Remicade treatments, he has been in 100% remission. He has never had to be hospitalized, never had to be put on steroids, and other than the few days a year when he must go in for his infusion for a few hours, he has never missed a day of school or work due to his well-controlled Crohn’s disease.
Our son has been fully employed since college graduation and living a healthy, independent and productive life. His college degree and much improved health have afforded him the opportunity to have a rewarding career and to live a normal adult life.

What would happen if he stopped his prescribed treatment?

Before receiving his Remicade infusion treatment for his Crohn’s disease, finding a bathroom was often frantic and embarrassing when confronting multiple uncontrolled daily bowel movements and bloody diarrhea. Even when he went off to college we submitted a special medical request to his school regarding his likely need for unrestricted bathroom access whenever the need might arise and other special accommodations.
Stopping his infusions could cause him to have a flare in his disease which may involve serious complications of debilitating pain, frequent if not near constant diarrhea, bloody discharge, severe weight loss, and the inability to deal with normal daily activities such as working. The real risk of hospitalizations and surgeries was clearly something to be avoided, at all costs.
I’m a football player, a quarterback with the NFL’s Jacksonville Jaguars. I’m used to pain. You get hit, you get up and keep going. But I’d never felt anything like the pain that ripped through my gut that January afternoon in 2004. One minute I was sitting in my lounge chair at home watching TV, the next minute I was doubled over. Not even Ravens linebacker Ray Lewis hitting me from the blind side hurt that bad.

Threat to Treatment

In April 2021, our son’s employer’s health insurer wrote him a form letter and said that Remicade would no longer be a “preferred medication” under his then health benefit plan. The letter further told him that he must take a “biosimilar” drug. The insurer misleadingly claimed in its letters that these specific biosimilars were medications made from the “same natural sources, provide the same treatment benefits, and have the same strength and dosage.”
We were then and still are terrified that he may lose the quality of life provided by the right medical treatment.
His doctors strenuously disagreed with the health insurance company. Our son has been consistently advised by each and every doctor who has ever treated him, including the head of pediatric gastroenterology at a local children’s hospital, despite the availability of other drugs on the market, to continue with his prescribed Remicade treatment because this specific infusion was effective for him for the last 13 years and that switching to another (even similar) infusion treatment or medication might not have the same results. He was also told that a nonmedical switch could lead him to develop an adverse drug reaction, which could then result in future Remicade infusions becoming either less effective or potentially dangerous to continue taking.
We felt dumbfounded at the risks being imposed on our son by his health insurance company. They are not medical professionals. They are not the patient. They are not the medical treating specialists. And yet here we were. After his treatment being fully covered by insurance for over 12 years, our son was suddenly being forced to switch treatments for nonmedical reasons. When medical decisions are made for nonmedical reasons, it is at the expense of a patient’s health.

Next Steps

Background of a biologic

Remicade is an original medication in a class of drugs called biologics, meaning it is not manufactured by mixing chemicals in a beaker, vat, or test tube. Rather, biologic drugs such as Remicade are synthesized in living organisms, such as bacteria, yeast, and even mammalian tissue and cells. Biologic drugs are complex. Remicade for example has tens of thousands of atoms and it is composed of 597 amino acids. There is no true generic of Remicade because there are not “ingredients” that are mixed together in the same way that could be found in a pill – like aspirin. Instead, the medications developed to act like Remicade must be called “biosimilars” because they are developed to have similar chemical profiles and to act like Remicade, but are not 100% exactly the same as the chemical makeup of Remicade.

Numerous Appeal Letters:

We appealed the insurer’s repeated denials so that our son would not have to roll the dice with his health and be forced to treat his illness with drugs that are not the same and may not be as effective. Worse, if a nonmedical switch to this new biosimilar didn’t work as well, my son could be prevented from going back to his successful treatment which kept him totally healthy and in 100% remission for now almost 13 years.

Response

His current treating gastroenterologist wrote the insurer several times asking them to reconsider their mandated non-medical switch. Our son’s treating board certified gastroenterologist’s letter was directly in line with medical journals that discuss real-world evidence of treatment patterns between Remicade and biosimilars in patients who continued with their regular treatment of Remicade and those that switched to a biosimilar.
First the insurer would approve, sometimes only a day before his next infusion and then deny the very next infusion. My son’s doctor explained in her multiple appeals that it remains unknown if patients with active disease or with multiple switches across a biosimilar and originator drug can experience the same efficacy, safety, and immunogenicity findings as the insurance company was citing as their reason for denial. The insurers could point to no studies supporting their claims that a single or multiple switches was without risk to their insured, our son.
In addition to his treating doctor, we obtained the advice of a prominent national board certified gastroenterologist who reviewed our son’s medical records and provided an affidavit trying to convince the insurer to continue our son’s Remicade infusions. We also repeatedly offered to pay whatever the difference was between what the insurer might negotiate as the cost they would pay for any biosimilar and the added cost (if any) of his Remicade. However, the health insurer refused to accept any offer to pay the difference. They in fact never responded to this offer at all.

Process Flaws

The appeal process was also flawed from the start. We followed the rules set out in the Texas step therapy appeals law.  Two of the appeals were reviewed and denied not by the insurer’s hired gastroenterologist, experienced with treating patients with Crohn’s, but instead by the insurer’s hired doctor whose area of expertise was physical medicine rehabilitation. During one of her purported “peer reviews” with our son’s board certified gastroenterologist the health insurer’s hired “peer” doctor admitted to our son’s doctor that she, the insurer’s hired expert, had not only not spoken with our son, but she had also not even reviewed his medical records.
Therefore, we filed a grievance with the Texas Medical Board but they have done nothing about this. We complained to the Texas Dept of Insurance, and they too have done nothing.
The insurance company repeatedly ignored written requests for expedited review from our son’s treating board certified gastroenterologist, asking the health insurer to reinstate approval for our son’s Remicade medication. The insurer ignored requests for qualified peer-to-peer reviews, despite having twice hired unqualified, inexperienced and unprepared physicians to review the appeal requests.
Then in the final external appeal, the health insurer and the supposedly independent external review organization that the insurer chose, ignored all Federal Affordable Care Act (CMS) appeal guidelines. We sent in the appeal through the health insurer. We requested that when it was assigned to the independent reviewer that the “independent” reviewer contact us so that we could send in, unfiltered by the insurer, the supporting medical evidence to keep our son on Remicade. A week later when we had not yet heard from anyone, we contacted the health insurer to inquire and they said that the independent medical reviewer had already reviewed our appeal and denied it. That was a violation of the law. The issuer must provide all documents related to the adverse benefit determination within five business days.  We were never allowed to submit information supporting our appeal to this agency, nor were we notified that our son’s claim was forwarded to the review agency, in accordance with the law and in accordance with the cover letter that accompanied the insurer’s IRO form.

Consequences and Intermittent Success

The insurer’s actions in failing to properly consider our son’s appeals caused our son and our family tremendous distress and anxiety. The insurer effectively repeatedly threatened our son’s health and livelihood. The stress this placed on our son and our entire family was unconscionable. After all, insurance is based on the fundamental concept of all the insureds pooling their risks, risk sharing. The notion that once some insured has that short straw, is unfortunate enough to be struck by some injury or illness, that the agency that they all relied upon to spread that risk, the insurer, goes back on its word and tries and force medication changes for non-medical reasons, one that only serve to increase corporate profits is unconscionable.
Frustrated by the lack of progress and ignorance of process and law, in February 2022 I reached out to the President of the health insurance company with a LinkedIn “invitation.” Composing a very condensed note, I explained his company’s denial of my son’s medication. To my great surprise, although he never replied directly, someone from the insurer “coincidentally” called me later that week. After a lot of discussion, the insurer finally agreed to extend continued coverage for my son’s Remicade for 13 months – until the expiration of his Cobra benefit continuation period.
In March 2023, just a few months away, when my son’s Cobra continuation coverage ends, he will be dealing with the same or an even worse situation when his new (for the past year) employer’s self-insured plan begins because this particular for-profit health insurance company has a history of denying coverage for Remicade.

What’s Next?

We keep fighting. My son has a strong support system, but many others just like him do not have the same resources we have to fight. That privilege isn’t lost on me. I fight not just for my son, but for every single person out there that is unnecessarily sick because, despite having insurance, despite finding successful treatment, their health is threatened by harmful insurance company policies like Nonmedical Switching and Step Therapy, and unnecessary Pre-Certification reviews that put short-term profits over peoples’ health. We need to share our stories so lawmakers are forced to understand the true costs and implications of these insurance company practices that put people’s health at tremendous risk every day.

Your support means the world to us.