This transcript has been edited for clarity.
Peter Higgins, MD, PhD: I'm Dr Peter Higgins, professor of gastroenterology and director of the IBD (inflammatory bowel disease) program at the University of Michigan and chair-elect of the Crohn's & Colitis Foundation National Scientific Advisory Committee. Welcome to Medscape's InDiscussion series on Crohn's disease. Today we'll be discussing the escalating battle between physicians and insurers to prescribe and deny new therapies for Crohn's disease, how denials and delays harm patients, step therapy laws, and how physicians can help their patients with Crohn's disease. First, let me introduce my guest, Dr Frank Scott, IBD specialist at the University of Colorado Medical Center in Denver where he does research on the effects of insurance delays and denials on patient outcomes in IBD. Frank has spent a lot of time thinking about this issue and researching the effects on patients. Dr Scott, welcome to InDiscussion.
Frank Scott, MD: Thanks so much for having me, Peter.
Higgins: Frank, I ask all my guests, what is it about IBD that first drew you to this field?
Scott: Back in college, I was actually a bit of an immunology nerd and spent a lot of time doing laboratory assays, assessing NK (natural killer) cell function in pediatric HIV. I had pegged myself as becoming a future immunologist and not a physician. After some consultation with some of my mentors, they convinced me to eventually go to medical school. I continued my research interests throughout medical school and residency and found that IBD and its emerging new therapies were a really unique marriage of my prior immunology interests and growing clinical interest in gastroenterology.
Higgins: It all comes together in IBD.
Scott: It really does.
Higgins: Dr Scott, I frequently find myself prescribing FDA-approved medications for my IBD patients and getting what appears to be automated insurance denials without any justification. Despite strong evidence of the efficacy of these therapies and using them at the approved doses, we seem to need to jump through several hoops of denials and appeals before the patient can get a life-altering therapy. Even worse, I sometimes have patients who've objectively done well on a particular biologic for several years whose prior authorizations expire, leading us to repeat the entire denial and appeal dance. How did we get here, and how can we change this wasteful and harmful process?
Scott: I think that the primary goal of payers and insurers in instituting these policies is cost containment. They'll often provide some language with regard to how they want to ensure these medications are being used appropriately, safely, and effectively. But they also inject language with regard to value of care. Undoubtedly, this mostly relates to the expanding utilization of biologics in rheumatologic autoimmune-mediated diseases such as IBD and the undeniable fact that these medications are expensive. When each dose of any of these medications runs in the thousands of dollars per dose or infusion or injection, any potential delay that's related to receiving a dose of this medication will subsequently result in shifting down the dosing schedule, so that in the current fiscal year, the number of doses a patient will receive will be reduced. Then, over the short time horizon, the costs related to medications for that particular patient will be decreased as well.
Higgins: This is clearly a cost issue. And it seems like insurers have multiple strategies to avoid delay or deny coverage of IBD medications. What are the main strategies you see in your practice?
Scott: The three main strategies we currently see in my practice are prior authorization, wherein you have to seek approval from the payer before you can prescribe a given therapy. We also see step therapy requirements, wherein you have to move through a particular formulary before you are allowed to prescribe the medication of interest. And then lastly, even perhaps increasing in frequency, is site of care requirements. Where you would like to give the medication may not be under contract with the payer, and the patient has to go and receive the medication at a different site.
Higgins: We're certainly seeing a lot more home infusions and sometimes just down the street from the plasma center infusions.
Scott: That is correct. Fortunately, infusion centers are everywhere. Once you figure out the right infusion center, it's often not that much of a burden for the patient, but it certainly adds time to the process while you try to figure it out. And I'd argue that when patients are trying to get on these medications to modify their disease, every day counts.
Higgins: Step therapy is a major component but also a pretty contentious component for cost containment. What's the logic behind it? And does it actually save money in the long run?
Scott: Yes, that's a great point. Step therapy is also often referred to as a fail-first requirement. As I mentioned earlier, this is a unique type of prior authorization where individuals have to step through — that is, try the medication and fail to get benefit from it — a given therapy that's been predetermined by the pharmacy benefit manager of an insurer. These algorithms are quite common. In a study that was published in 2018, it was estimated that about three quarters of prescriptions for specialty drugs involve some form of step therapy. And it appears, based on a recent study by the AMA, that the frequency is still increasing with regard to the step therapy requirements. With regard to whether or not they save money, it does appear that over the short term, these policies do reduce pharmacy benefit-related costs specifically. That makes sense. As I mentioned earlier, if you're delaying a dose of one of these medications that's given every 8 weeks, and you shift the time horizon of the drugs down into the next fiscal year, then for the current year you're in, it will look less expensive.
Higgins: I know you've put a lot of study into this. How do these denials and delays hurt patients, and could they potentially add inpatient costs so the net cost for the insurer might not be positive?
Scott: Absolutely. Over the short term, just thinking about the emotional and quality-of-life costs — we're often prescribing these medications for our patients with IBD when they're acutely ill, when they're having severe diarrhea, hematochezia, anemia, and other laboratory abnormalities, and when they are losing weight. From a quality-of-life standpoint, there's definitely a short-term cost. These patients are often also using corticosteroids. And as some of your research has shown, Peter, even those short courses of corticosteroids can potentially increase the risk of infection or thromboembolic events and increase the risk of adverse bone-related events. These policies have also been demonstrated to adversely affect compliance in several disease states, such as epilepsy, asthma, and several rheumatologic diseases. It's been shown that step therapy requirements reduce the actual number of fills over time once the patient has started on a medication. And then lastly, our work recently in IBD has demonstrated that downstream, over the next 6 months, and after one of these step therapy requirements or other prior authorization–related delays, there's a significantly increased risk of hospitalization, urgent care use, or even surgery.
Higgins: The restriction that I find the most infuriating is when a patient is on a medication that's working, and then January 1st, their prior authorization expires, and sometimes they miss a dose or two because of this gap in therapy. Once in a while, they'll actually develop antibodies to an effective biologic. How common are these annual renewal requirements, and how often do they lead to gaps in care and possibly flares?
Scott: We're doing the best we can with the medications we currently have and the existing therapeutic ceiling with these agents by trying to optimize them. It's completely disheartening once you've gotten a patient to a point where they're stable, to then have the payer say, "You can no longer have this medication." In terms of actually quantifying this in the IBD space, I don't believe there's actually been research to date that has suggested how frequently these types of new denials are occurring, but it absolutely should be measured. Our research has focused on the initial induction process of these medications. But when you look at the global scope of providers who suggest that more than 90% of their patients experienced some sort of prior authorization–related event and 50% might be harmed; some significant component of that is going to be related to maintenance therapy denials.
Higgins: Another challenge I have with step therapy is trying to come to an agreement with the insurer on what's a reasonable trial of a medication therapy. When can you agree that it's clearly not working? I find it hard to get the insurers to give me a definition. Is a calprotectin level over 500 µg/mg after 8 weeks when it is time to move on? It seems like it's really hard to pin them down on what that definition is.
Scott: Yeah, I think one of the real challenges here is that these algorithms are vague as a feature, and there's significant heterogeneity even in a single payer with regard to what their expectations are. And that may differ for each agent. Some payers may say, “How do you have endoscopic evidence of improvement for us to continue this dose-escalated medication vs some sort of biochemical marker?” There are really great data by Kelly Lenahan and colleagues out of Tufts demonstrating that more than two thirds of the time, these guidelines or algorithms are not consistent with societal recommendations with regard to how we should be managing these medications. So, the payers are inducing on us some goalposts that can consistently be shifting or may not be the same from drug to drug or plan to plan. That's not consistent with what our national experts are telling us we should be doing.
Higgins: Step therapy is a very contentious area, and a lot of patients across not just IBD but many areas have led to pushing legislators to have step therapy laws. I know the Crohn's & Colitis Foundation supports this. Do you think step therapy will be defeated by step therapy laws? And if it is, what will insurers come up with next?
Scott: That's a great question. I don't, unfortunately, see a future where step therapy is truly defeated. What I hope is that the process itself is significantly modified and improved and temporarily shortened, and that the overhead burden that's induced by step therapy requirements is markedly reduced. Currently, about 29 states have some sort of local provision with regard to ways to circumvent step therapy. And then, as you mentioned, at the national level, the Safe Step Act, which is currently moving through the House and Senate, is the most recent piece of legislation that may potentially have an impact. The Safe Step Act provides key clinical scenarios where step therapy requests could be circumvented by a provider for their patient. These scenarios include when the required treatment has already been tried and failed, when delays related to a given therapy may result in clinical harm, and when the required treatment is contraindicated, which would make sense. Other scenarios are when the required treatment would prevent the performance of activities of daily living, or when the patient’s disease is clinically stable on an existing therapy. This would get back to your original point with regard to the denial claims when patients are doing well on maintenance therapy. There's really a great review that was published in the The New England Journal of Medicine in March 2022 by Rachel Sachs that goes through each of these five steps and demonstrates how they're an improvement from where we're at. But there are potential problems with each of them. And I suspect one of the first things we'll see is payers trying to augment their policies to take advantage of these unique issues. So for anyone who’s listening who wants to learn a little bit more about the potential loopholes, I point you toward this review article. In terms of other potential future avenues, I do unfortunately see the potential for forced de-escalation, particularly in the setting of dual biologic therapy, as we're just starting to embark on this as a medical option for our patients. I've seen a growing number of denials without an opportunity to appeal where the physicians input is not even accepted. Ultimately, I think what needs to happen — both from a payer standpoint and from a societal standpoint — is that we need to reduce the overall cost of these therapies, which is really what's driving them in the first place.
Higgins: Absolutely. And I'm already seeing forced de-escalations with tofacitinib, which doesn't always work out that well. I've had a number of patients who really need 10 mg twice a day, but the insurer just isn't having it.
Scott: What's interesting about that is when you look at the wholesale acquisition cost of tofacitinib, it's the same price per pill. It doesn't necessarily make a ton of sense.
Higgins: It really doesn't make any sense. And then when I tell the insurance company that they don't believe me, it's actually kind of funny. Another wild thing is the idea that rebates from pharma actually affect the order of step therapy and how insurers push people toward particular drugs. How do rebates affect these step therapies and insurer choices?
Scott: Yeah, rebates are really interesting phenomena. The way we usually think about them is that they reduce the co-pays or out-of-pocket expenses for the patient receiving the drug, but they're bidirectional. The rebates are not just for the providers and the patients but also a kickback toward the payers. And this is a huge business. In Colorado alone, it was estimated in 2018 that $1.1 billion in rebates were used in the state in that 1 year. This can definitely influence step therapy selection algorithm development. If we go back to the concept of the pharmacy benefit manager who develops these algorithms, they can position therapies within their algorithm that have to be stepped through based on the degree of the rebate they would get from the manufacturer of a specific drug and maximize their profits for that drug.
Higgins: Yeah, it's pretty amazing. And it's really behind a curtain, so most Americans do not have any idea what's going on and why the pharmacy benefit managers are insisting [on step therapy]. A lot of it is kickbacks, to be honest.
Higgins: Thinking about health insurance in general, we know Americans change health insurers on average about every 3 years or so. I wonder about the costs of denied care, which could result in the development of antibodies to therapy or hospitalization. If drugs are delayed, is part of the reason insurers act this way because they might not directly harm the current health insurer? It might harm the next insurer because the patient has burned through two biologics, but it doesn't hurt the insurer any longer because the patient has moved on.
Scott: Yeah, I think this highlights a really important concept. It's two issues here. One is that this highlights the concept of silos, where one part of an insurer doesn't know what the other part of an insurer does because there's no one globally looking at the overall costs of care for a given patient within a plan. The other issue is time horizons, wherein if you're looking at your expenses for this year only, if something is delayed, you reduce the costs for that medication dose. But when you're dealing with chronic disease processes, wherein the complication is related to that delay, like you had mentioned, having to transition to another therapy because of a gap in care or having worsening fibrostenosis doesn't actually result in an obstructing complication until 2, 3, or 4 years down the line. The insurer is not experiencing the fiscal costs of that adverse event that is directly attributable to the delay in care.
Even over the short term, as our work has shown, if a patient gets hospitalized, an average cost of a hospitalization is about $25,000 [based on our internal calculations used for cost-effectiveness modeling]. That cost occurs 4 or 5 months down the line after the patient has been on steroids for months. If that cost gets shifted into the next fiscal year or during the time the patient switches jobs, and they end up on a different insurance plan — the current insurer is not going to experience the acute cost of that event.
Higgins: Yeah. And it's so easy to switch insurance because we re-enroll every year in the United States. Is there an incentive for insurers to treat people with chronic disease a little bit badly to kind of convince them to leave?
Scott: You could definitely make that argument for sure. If everyone is going to be shifting plans, you shift the burden of both the pharmaceutical costs and the healthcare costs.
Higgins: These costs get shifted to somebody else. It makes you wonder if US health insurers' would change their approach if they were responsible for the health of somebody with a chronic disease like IBD for 5 years or even 10 years. So instead of buying new insurance every year, you could buy it for a decade. Do you think that might change their incentives and get them to act differently in terms of preventive care or just generally taking care of patients with chronic diseases?
Scott: Yeah, I think that's true across multiple chronic medical conditions in the United States when you're looking at outcomes that are a decade down the road. I alluded to surgery earlier. We see this cumulative risk of surgery that curves downward over time, but it still is not flat by any stretch. And a significant proportion of our patients with Crohn's disease are at risk for having a surgery. But that risk is a decade down the road. If you are committed to a payer for 10 years, they would very much be interested in preventing that $100,000 surgery 5 or 6 years from now.
Higgins: Right. There's an incentive to kick the can down the road — at least a year down the road at this point. In your practice, in the escalating battle with insurers, do you have any advice for physicians facing these denials, appeals, or required peer-to-peer contacts? What do you do to make this work better for your patients?
Scott: There are a few things we try to employ to improve this process. First off, we try to standardize our documentation, so we have templated letters with cited literature for every medication and the multiple different types of denials — site of care denials, step therapy denials, and so on. Second, we have this coordinated in conjunction with our pharmacy. We have a clinical pharmacist on our staff who is amazing and has really helped accelerate this entire process and keep it organized. She is able to remain in contact with the payers, the pharmacy, and the infusion centers and navigate all of it. She's been a huge help. Third, there are some national resources that are available with regard to templating and standardizing and processes that help assist and facilitate expediting these processes. But also, it's up to us as providers to start getting involved in the process as well. We should take advantage of opportunities to participate in Days on the Hill and advocate for legislation that's going to help modify the process. I know it's time consuming and we're all extremely busy, but I would encourage everyone to consider getting involved in these sorts of advocacy plans because it can really help move the needle over the long term.
Higgins: Yes. Back to the cost — I think it'll really help us when we start to see more biosimilars and generics for the really expensive medications. Hopefully we'll see some movement there. In terms of where you think this is going in the future, where do you think we'll be in 5 years?
Scott: As I mentioned earlier, I would envision that step therapy and prior authorizations are still a part of what we have to do from day to day in terms of getting our patients access to these medications. But hopefully because we have increased competition at the medication level, as you mentioned, through biosimilars and more aggressive contracting, the overall costs will be reduced and contained through this mechanism. This would reduce the need to reduce their utilization on our side and potentially reduce costs. I also hope that more of the process is expedited and standardized across payers, and that we transition to electronic mechanisms that will allow us to do it faster. If there was a central hub wherein we could do prior authorizations across payers, for example, it could potentially reduce the time dramatically.
Higgins: Do you think that might be a legislative goal in a future beyond the Safe Step Act?
Scott: I know that certain national organizations such as the AMA are pushing for this. I think it's up to us as the outcomes researchers to try to work with payers and help them demonstrate that they can reduce the overhead burden, reduce costs, and still make sure that medications are being prescribed appropriately and safely, which is their purported goal.
Higgins: Today we've had national expert Frank Scott discussing the challenges of delays in care for IBD patients caused by insurance denials, and how these denials and delays harm IBD patients. He also discussed approaches to help your patients using standardized templated letters and a standardized approach with a clinical pharmacist if you have those resources available. Frank, any final takeaways for our physician listeners on these issues?
Scott: This is a challenging time to use these medications, but keep fighting the good fight. Support legislation that's going to help modify the process. And hopefully, even if step therapy and prior authorizations don't go away completely, they'll become a little bit more facile in the near future.
Higgins: Thank you so much for joining us. This is Dr Peter Higgins for InDiscussion.
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Cite this: How Physicians Can Help Patients With Crohn's Disease Navigate Insurance Delays and Denials - Medscape - Jun 21, 2022.