But that all changed after Rynearson gave birth to her daughter in 2014. “Pregnancy had put me in remission, but when my daughter was 9 months old, I started to get really sick,” she says. “It was clear that my disease went from mild to severe pretty quickly.” Her doctor suggested that she go on a biologic, a type of drug that can prevent inflammation. The medication, according to her doctor, showed great results in people who had similar disease progression. First, though, her doctors had to get approval from her insurance company. Three weeks after doctors reached out, her insurance replied and said she first had to prove that steroid therapy wouldn’t help her. Six weeks later, a CT (computed tomography) scan showed what her healthcare team expected: Steroids were not effective. So, they reapplied for approval for the biologic. Another three weeks passed, only for her insurers to tell her she needed to try another medication. So she did — and had an allergic reaction to it. And yet, she still needed to wait longer. During that time, Rynearson’s symptoms worsened. “I had been flaring uncontrollably with no relief for eight months and made multiple trips to the emergency room,” she says. “My intestines were getting more damaged every single day without the right treatment.” Finally, she received the approval she needed, albeit too late, in her belief. Despite starting the biologic, there was so much scar tissue that she needed a bowel resection, a surgical procedure to remove 12 inches of her intestines. “I believe that, had I gotten the right medication sooner, I could have prevented all these complications,” she says. The process that Rynearson went through is called step therapy, a protocol used by some health insurance companies that requires patients to try and fail at lower-cost medications, according to the Crohn’s & Colitis Foundation. Another name for this is “fail first.” Crohn’s can be difficult to treat without these hoops to jump through. “Even our best medications only have a success rate of 60 percent,” says Dr. Lewin. “Those who do not respond have to then go on a different medicine to see if that treatment type is a better fit. Each medication trial for Crohn’s disease can take up to four months to know if it’s a success or not, so if it takes two or three medication trials, patients can be experiencing symptoms of Crohn’s for quite a while.” Adding insurance authorization to the mix costs patients even more time, leading to an increase in symptoms and suffering, notes a February 2019 article in Inflammatory Bowel Diseases. “There are a lot of short- and long-term implications of not being on the right therapy,” says Angela Sandell, MD, cochair of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee’s Government & Industry Affairs Committee. “If the inflammation in the bowel is not brought under control, people may end up with surgical resection of a bowel that’s damaged beyond repair. They may also become malnourished.” Research on biologics prescribed for children with IBD shows that insurance authorization delays the time they can start on these drugs by three weeks and increases the likelihood of hospitalization, surgery, or a trip to the emergency department, according to a study published in February 2022 in the journal Pediatrics. The conclusion from researchers: Step therapy is bad practice for everyone, harming patients and costing insurance companies a lot of money in the long run, to boot. A survey from the Crohn’s & Colitis Foundation found even longer wait times. Forty percent of IBD patients they interviewed had experienced step therapy, which delayed care for the majority of them by three to seven months. Even if their insurance company eventually approved the drug, they still went through months of flare-ups without the treatment they needed.
Why Do Insurers Have This Policy, Anyway?
When step therapy delays proper treatment, it can ultimately be more expensive for the insurer — and takes a greater health toll on the person with Crohn’s. So why does it exist? Part of the reason, Lewin explains, is that there are very few trials comparing one Crohn’s treatment with another, so there is no definitive evidence to suggest that a more expensive or newer medication is better than an older or less expensive one. There’s more to it than just trials, though. Lewin adds that there are many considerations for which medication might be a fit, including where you live and your ability to readily access a medical facility for an infusion; if you travel frequently; and previous health conditions, such as cancer, that inform treatment and appropriate medications. Insurance approval does not take into account the nuances of finding treatment that will be a success for you, she says.
Accessing Treatment You Need
If you are subjected to step therapy, your doctor’s office can appeal with a letter or additional medical information to try to get approval, says Lewin. (The staff is on your side.) She also recommends looking into whether you qualify for assistance programs from pharmaceutical companies that manufacture these medications, which may make the drug available at a reduced or no cost. If you’re getting nowhere, you can also file a complaint with your state insurance bureau to request an independent review, she says. In addition, the Crohn’s & Colitis Foundation is working to pass legislation called the Safe Step Act to decrease the use of step therapy and make the appeals process easier. Some of the initiatives, says Sandell, include requiring a shorter time line for insurance companies to respond to requests and creating transparent processes for how these medications are approved or denied and which patients are given a medical exemption that allows them to skip “fail first.” The Foundation also has an advocacy network that you can join to help make a difference in this and other initiatives that better IBD care.
