In December 2021, I was diagnosed with Stage-4C Colon Cancer. The following September, I had several reasons to celebrate: chemotherapy (FOLFIRINOX) was behind me, radiation therapy (IMRT) was complete, my colostomy had been reversed, and I was on the road to living a cancer-free life. Although treatments were over, my doctors warned me about the long-term effects of chemo and radiation on my body. I was already familiar with the usual suspects of neuropathy, joint pain, and cognitive issues, among a few other non-life-threatening effects specific to my particular type of treatment.
At 48, I was closing in quickly on 50, the proverbial end of my youth. All those years of taking vitamin and calcium supplements while watching my dietary intake of calcium should, under normal, no-chemo, circumstances give me an advantage against the degenerative bone disease my grandmother had. But chemotherapy has a funny way of destroying healthy cells along with the diseased cells. My oncologist, gynecologist, and primary physician were all warning me about the possibility of osteoporosis after chemo.
I would have to have a bone density scan. Lying in the machine, trying to stay still and calm as the arm moved slowly over my body, I could feel it in my bones that no good news was going to come out of this scan (pun intended).
I have always been fit, active, healthy, and energetic. Cancer was not going to change this about me. But, in a one-two punch, chemotherapy and IMRT came along and put me to the test. The expected aches and pains of a woman in her late-40s were being overshadowed by more pronounced joint pain in my hips, shoulders, and lower back. No longer able to jump up off the sofa and be at the other end of the house in under 3 seconds, I was feeling the effects of these powerful treatments on my body. Receiving the news that the bone scan showed the onset of osteoporosis due to my cancer treatments was neither shocking nor worrying. There are so many treatments available for this condition, so I believed my doctors would prescribe the correct one for me and I would soon be on my way to wellness.
My oncologist decided that Prolia (denosumab) injections would be the best course of action for me. Women my age, and who have had chemotherapy, respond well to the drug. I was feeling optimistic. My oncologist has been right about every treatment plan so far. Through my cancer treatments, I literally trusted him with my life, so I trusted him now with this secondary treatment. Whatever he said was the right medicine was obviously the right medicine.
I was beginning adjuvant chemotherapy with two new drugs: Xeloda (capecitabine) and Avastin (bevacizumab). Adjuvant treatments come after your primary treatments and, in my case, are used to maintain an inhospitable environment, making growth difficult for any microscopic cancer cells that the heavy chemotherapy and IMRT may have missed. My oncologist submitted the care authorization for the Avastin (infusion) and Prolia to my insurance company at the same time. The Avastin was approved; the Prolia was not.
“This letter is to notify you that we will not cover all or part of the services requested because it is Not medically necessary.” (I did not appreciate how they poorly capitalized for emphasis) The letter went on to explain the rationale for the denial which included the expected review of my medical notes and test results. “You have osteoporosis. This is a weakening of the bones. You have colon cancer. There are no notes that show this treatment is for the prevention of skeletal-related events because of cancer that has spread to your bones. There are no notes that show that you cannot tolerate other therapies. These can include other oral or intravenous drugs. Based on this, the request is not medically needed.”
All indignation aside, the most important sentence of this denial letter is this one: “There are no notes that show you cannot tolerate other therapies.” What this refers to is something in the insurance industry known as “Step Therapy.” It is one of the main ways that insurance companies attempt to keep down their costs when covering specialty and prescription drugs. In general, our physicians can prescribe us whatever drugs they want, and as long as it is not categorized as a “Specialty drug,” we can pick up the little white paper bag from our local pharmacy and go on with our lives. But if you have a more serious condition (let’s stick with me and my colon cancer), you will undoubtedly be prescribed a Specialty drug along the way. Xeloda, the oral chemotherapy pill that I was to begin taking in October 2022, was quickly approved by my insurance. Although it had to go through the same approval process as the Prolia, thankfully there are no "Step Therapy" drugs leading up to chemotherapy.
Prolia was another story. My oncologist’s initial prescription for the more effective drug was denied in favor of a cheaper drug. I could get Fosamax at my local Rite Aid with just a prescription, but it was not the drug my doctor had decided was best for my treatment, and it came with many more side effects. Denial of the Prolia by my insurance essentially carried the message, “Your oncologist is asking for an expensive drug. We don't trust his financial judgment. You have to try our list of cheaper drugs first.”
With thinly veiled grumbling, my oncologist wrote a prescription for Fosamax. I retrieved it from the pharmacy on my way home and the next morning I took the new pill. Within hours, I was hit with waves of nausea, acid reflux, and constipation (a serious side effect for someone like me who has just come through extensive surgeries and treatments for colon cancer). I called my oncologist the next morning, and sure enough, I had now fulfilled the insurance review requirement: “There are no notes that show you cannot tolerate other therapies.” Now there would be notes stating my failure on the drug, which means my oncologist’s original treatment plan may actually be approved this time. We’re eagerly awaiting the next envelope with the results of their decision.
My experience with Step Therapy is a mild one compared to what others endure. While patients are being forced to try lesser effective drugs/treatments because of their insurance company, their doctors and specialists are wringing their hands, knowing precious time is being wasted when they could have been properly treating their patients from the beginning.
In cases of ulcerative colitis (UC), patients may have to try several lesser effective, and less expensive, drugs before finally being granted permission to go on the original drug prescribed by their doctor. Because of the delayed treatment, these patients become open to developing other serious conditions resulting from untreated UC. The patient must “fail” on the step drugs outlined by the insurance company first, and like my letter clearly stated, the insurance company needs to see proof of that failure in your medical notes.
Obviously, this is not a practice unique to just digestive diseases, but I use this example because my colon cancer falls into this category. By delaying treatment for patients, insurance companies are playing a risky game. How many patients’ conditions progress to life-threatening or turn deadly while they wait for the proper treatment? In the case of people with UC, things may get to a point where whole stretches of their colon need to be removed, which could have been prevented if the patient had been able to have the first drug the doctor prescribed.
The effects of these delays on the daily lives of patients, and their inability to go about their normal activities, are not things that can be easily expressed in lab notes. The doctor has to report that the patient failed on the drug. As in my case with Fosamax, he may write “experienced constipation, GERD, and nausea.” But what he cannot convey is how those side effects prevented me from functioning for three days – I could not do my usual exercise routine, I could not eat my normal meals, and I had to take three extra drugs to counter each of those side-effects. I'm certain the side effects hit me harder because my body is still recovering from chemotherapy and radiation. My experience may be mild compared to what other patients go through, but I think it illustrates the point well: even the slightest side effects make a big difference to the quality of life.
This month is Colorectal Cancer Awareness Month, and there is a big push to get the “Safe Step Act” through the House (H.R. 2163) and Senate (S.464). This bill, which would protect patients from having to "fail first" according to insurance company requirements, was introduced in 2021 with bipartisan support but has yet to be passed. The Digestive Diseases National Conference (DDNC) on March 4-6, the United Ostomy Associations of America (UOAA), and many other patient advocacy groups have been advocating and meeting with lawmakers to push this bill over the finish line. Patients and advocacy groups may not be as powerful as the insurance industry, but we have the numbers and the sentiments of the majority of voters on our side.
What can you do? Learn more about patient advocacy and the Safe Step Act by visiting: https://www.ostomy.org/wp-content/uploads/2023/01/DDNC_Safe_Step_Act_Toolkit.pdf
Patients Rising Now: https://patientsrisingnow.org/safe-step-act-protect-patients/
S.464 -- https://www.congress.gov/bill/117th-congress/senate-bill/464/text
H.R. 2163 -- https://www.congress.gov/bill/117th-congress/house-bill/2163/text