I ended up in the Emergency Room in 2017 because, unbeknownst to me, my health insurance dictated a course of treatment that was not my best option.
Prior to undergoing open-heart surgery in 2016, the hospital required clearances for any abnormalities in my bloodwork. My iron levels were far too low for the surgeon to feel comfortable operating, and I was diagnosed as anemic. So, I made an appointment with a Hematologist.
The Hematologist was a fellow ex-New Yorker who was knowledgeable, thorough, and told it like it was…exactly the kind of doctor I like. Oral iron supplements and eating red meat were not going to solve my problem, certainly not in time for me to have surgery a couple of months later.
“You need to come in once a week for the next three weeks for an IV iron infusion,” he said. He went on to explain that the iron product was called Venofer, and he would have to give me a dose of Benadryl before starting each infusion, just to be sure I didn’t have an allergic reaction.
“OK,” I said, agreeing to the treatment plan much more quickly than I normally would without asking additional questions. It sounded like I didn’t really have a choice; that was the protocol if I wanted this problem resolved within my existing time constraints.
I settled into the infusion room at the Hematologist’s office on the prescribed schedule, reclining in my assigned vinyl-covered chair next to an IV pole. I spent about 15 minutes receiving the Benadryl preparation, followed by 45 minutes more of the Venofer.
After each of the three treatments, my feet turned a little bit red, but I emerged otherwise unscathed.
Two weeks after the final dose, I returned to the Hematologist for bloodwork, which showed that my anemia was under control.
He cleared me for surgery.
A few months post-open-heart surgery, I returned to the Hematologist for a follow-up. My bloodwork showed that I was anemic again. That came as no surprise, given the amount of blood loss I had during the surgery and the two blood transfusions I received in the hospital about five days post-op. So, I casually scheduled a new set of three Venofer iron infusions.
The day of my next dose began just as the others had: Benadryl, Venofer iron infusion, go home. My feet were mildly tinged with red splotches again, but it was similar enough to my previous experience that I was not concerned.
A few hours later, though, the redness began to spread. My legs started to look a little pink, and so did my hands. I really started to get nervous when the pink tinge spread to my face.
I called the Hematologist’s office for guidance.
The doctor on call said “You need to go to the Emergency Room, just in case you are about to have an anaphylactic reaction.”
I resisted.
“You can’t afford to risk it,” he said.
I let out an exasperated sigh but relented anyway, wondering how and why this could be happening, when I had no previous issues with this medication.
Although I announced my potentially urgent situation upon my arrival in the ER, I seem to have landed at the bottom of the list of priorities in the waiting room. So, I waited, impatiently, while monitoring the level of redness in my feet, hands, and face to see if there were any changes.
When I was finally brought back to a patient bay, the nurse asked if I felt like my tongue was swelling.
“Maybe a little,” I said. “My mouth felt a little tingly earlier, but nothing that was preventing me from breathing.”
“Let’s give you some more Benadryl,” she said. “We’ll continue to monitor you for a few hours.” That sounded kind of passive to me, but sure, we can try something I could have done at home.
About three more hours passed, and it was late into the evening. I didn’t feel any worse, so the nurse decided to discharge me.
Since I had not met my hospital deductible yet that year, I owed somewhere in the vicinity of $1500 for the privilege of being given an over-the-counter medication and sent home.
Annoyed, I returned to the Hematologist, who seemed non-plussed.
“That happens all the time,” he said. “Insurance companies will only cover Venofer because it is the cheapest option for them. If you have an allergic reaction to it, then they will approve you for Injectafer, which is the more expensive product.”
“What’s the difference between the two?” I asked.
“Injectafer,” he said, “is very well tolerated by just about everyone. You don’t need to take Benadryl beforehand, and the infusion itself only takes about 15 minutes.”
“Are you kidding?” I retorted. “I had to have a near-anaphylactic reaction in order to get the iron product that I should have been given to begin with because my insurance company cares more about money than about patients?”
“Correct,” confirmed my straight-shooter Hematologist.
“The system stinks, but that is what we are dealing with,” he continued. “I will add a note to your file that you had a reaction to the Venofer. The insurance needs that documentation so they can approve the Injectafer.”
Apparently, I had failed up. Crashing out of the baseline medication was now giving me access to better treatment.
But why did I have to go through that to begin with? Shouldn’t everyone have access to the best possible medication?
It wasn’t until much later that I learned this practice is called Step Therapy:
…it means that a patient can be required to try a lower cost prescription drug that treats a given condition before “stepping up” to a similar-acting, but more expensive drug. The health plan won't cover the more expensive drug until the lower-cost medication has failed to treat the patient's condition. Other names for step therapy are ‘step protocol’ and ‘fail first requirements.’1
Fail first requirements?!
Look, I can appreciate the goal of cost-savings for patients and health insurance companies alike, but not when it comes at the potential expense (pun intended) of the patients’ health.
Upon further investigation, it turns out that I was very lucky. Outside of being red, itchy, and inconvenienced for a few hours, my story ended well.
But there is enormous potential for negative ramifications on patient health.
To be clear, in this case, I am talking about medications that have a known difference between the safety and efficacy of the cheapest drug, as opposed to the best drug. Using generic prescription medications in lieu of brand names technically also falls under step therapy, but their safety and efficacy is meant to be comparable. (To learn more about what happens when they are not comparable, read my fellow HCM Warrior Dawn Levitt’s recent post: Pill Rhymes With Kill For a Reason).
In the case of Psoriatic Arthritis (PA) patients, the American Medical Association found that step therapy can:
…delay efficacious treatment and potentially worsen a patient’s disease prognosis. They may also experience undesired adverse reactions from drugs in the intermediary stages or hospitalizations from not obtaining optimal therapy in a timely manner for disease flares. According to the American Medical Association (AMA) PA physician survey, 33% of physicians indicated that [step therapy] resulted in a significant adverse event, and 25% stated that it led to a patient’s hospitalization.2
Those numbers feel significant to me, when other drugs are readily available.
Neurologists expressed similar concerns for Multiple Sclerosis (MS) patients, saying:
Our concerns are not just about the wasted hours of appealing arbitrary and uninformed decisions by insurance companies. Insurance companies are interfering with the shared decision-making of patients and their physicians that is at the center of compassionate and ethical health care. This interference can harm patients.3
I think we can all agree that no one, other than a patient and their doctor, should be making decisions about the patient’s health, least of all an external company with no direct knowledge of their individual case. And yet, we see it here with Step Therapy (as well as in a growing number of claim denials being decided by AI, an issue for another day).
The American Academy of Neurology goes deeper, offering these sobering facts:
82% of patients abandon treatment due to authorization struggles with health insurers
Step Therapy requirements delay care 2-3 months per step requirement – multiple requirements can lead to months and months of delay for the appropriate treatment
Nearly 40 percent of drug coverage policies are subjected to step therapy requirements
If a patient switches insurance, they may be forced to step through treatments they’ve already failed – forcing the physician to fill out paperwork again
There is no standardized process or timeline for receiving step therapy exceptions
Payers, manufacturers, physicians, and patients incur nearly 93.3 billion in costs annually due to utilization management requirements4
To me, it’s clear that the practice of Step Therapy is ripe for legislative reform. Especially if the intended goal is to save time and money, and it is not achieving either of them. Currently, there is a hodge-podge of different rules in each state (click here for a useful tool to learn more about the rules in your state), while the Step Therapy Act at the Federal level has been in the pipeline, in one form or another, for many years (you can read more about a recent proposal here).
Over the last few years, I have returned to my Hematologist’s office for a few Injectafer infusions. I require them much less frequently now than I used to. Each time, his office has to resubmit the documentation about my failed attempt at Venofer in order to provide me with the Injectafer.
Now, I spend more time waiting for the in-house pharmacist to prepare my IV bag of Injectafer than I do for the infusion itself. It is just that much quicker and easier than the Venofer was. And, knock on wood, I have not had any kind of adverse reaction to the Injectafer.
My frustration with the process remains. When health insurance companies put profits over patient safety, we should all question that approach.
Each issue of "What's Her Problem?" includes questions for further discussion. You can Leave a Comment publicly below, or become a Paid Subscriber to join the conversation in the private community Chat.
This week’s question:
Have you participated in a step therapy program (knowingly or unknowingly)? Were there any adverse effects to your health as a result?
Shan DM, Greenzaid JD, Greene E, Feldman SR. Analyzing the Benefits and Costs of the Safe Step Act on Patients, Physicians, and Insurers. J Psoriasis Psoriatic Arthritis. 2024 Jul;9(3):115-120. doi: 10.1177/24755303241253203. Epub 2024 May 7. PMID: 39301213; PMCID: PMC11361492.
https://www.neurology.org/doi/pdfdirect/10.1212/CPJ.0000000000000208 /https://doi.org/10.1212/CPJ.0000000000000208
Bourdette, D. N., Hartung, D. M., & Whitham, R. H. (2016). Practices of US health insurance companies concerning MS therapies interfere with shared decision-making and harm patients. Neurology. Clinical Practice, 6(2), 177–182.
I'm sorry to hear that you had to experience that Debra, but I've heard of this numerous times. It's our wonderful healthcare system.
As long as health insurers run the show and maintain their big DC lobbies, that Step Therapy legislation doesn't have much of a chance and you have to hope you don't need an Rx that is part of step therapy.