Inflammatory bowel disease (IBD) is a chronic idiopathic IBD which includes two main diseases, ulcerative colitis (UC) and Crohn's disease (CD). Approximately 3 million (1.2% of US population) people in the United States have a diagnosis of IBD.1 Overall, IBD carries significant morbidity and is associated with high health care costs from medications, surgery, and disease complications.2,3 Historically, patients have been treated with the step-wise escalation of pharmacologic therapy, first failing 5-aminosalycilates, thiopurines, and steroids, and only then initiating biologic therapy.4 More recently, however, the focus has shifted towards treating patients based on disease severity.4 Recently the American Gastroenterological Association (AGA) published guidelines on drug therapy for CD and developed a clinical pathway for drug therapy in UC.5,6 These pathways shift from the classic step-wise drug failures and, instead, recommend treatments based on disease severity.
Current data in both UC and CD indicate that antitumor necrosis factor (anti-TNF) agents are the most effective at inducing and maintaining remission in IBD.2,3 More recently, both vedolizumab (2014) and ustekinumab (2016) were approved as well for IBD.7–10 All of these agents have been shown to be efficacious in patients with moderate to severe disease. However, the ability to use these drugs in clinical practice is dictated by insurance company policies and their preferred agents. As reimbursements shift towards quality of care provided, it is of increasing importance to control disease activity and reduce complications.11 Studies have shown that biologic therapy is associated with a reduction in complications, surgery, and hospitalizations.7–10,12–14 Delays in initiating appropriate therapy may lead to an increased risk of complications and overall poorer quality of care.
Currently, insurance companies have varying policies related to the use of anti-TNF agents, vedolizumab, and ustekinumab in UC and CD. While the clinical practice of disease management has shifted away from step-wise drug failure, insurance policies have not been evaluated to see if this paradigm shift has also been implemented in their policies. Using the insurance companies with the largest market share, we sought to assess the anti-TNF and vedolizumab policies in UC and CD, and ustekinumab for CD, and determine if the policies are consistent with the current guidelines and general practice of treating patients based on disease severity, or if they still require step-wise failure of drug classes regardless of disease severity.
MATERIALS AND METHODS
Using the National Association of Insurance Commissioners report of the top 125 insurance companies by market share in 2014, we reviewed the first 50 companies that published their policies online regarding anti-TNF, vedolizumab, and ustekinumab therapies.15 Policies were reviewed for criteria needed for approval of biologic therapy. Additionally, policies were reviewed for separate UC and CD criteria for drug therapy approval. Step therapy was defined as the requirement by an insurance policy that a patient first try and fail one or more less expensive drugs before a more expensive drug can be approved regardless of the patient's disease-specific severity.16
For UC, we reviewed if there was a policy specific to UC. All policies were then reviewed if the step-wise failure of drug classes were required, number of drugs required to fail, and if primary approval of anti-TNF therapy was allowed. Additionally, policies were also reviewed to determine if there was a preferred anti-TNF agent (e.g., adalimumab or infliximab) therapy. Policies were also evaluated for criteria for vedolizumab approval, if the initial failure of anti-TNF therapy was required, and if primary vedolizumab approval was allowed.
For CD, we reviewed if there was a policy specific to CD. Policies were reviewed for allowance for primary approval of infliximab for fistulizing CD. Also, all policies were then reviewed if the step-wise failure of drug classes were required, number of drugs required to fail, and if primary approval of anti-TNF therapy was allowed. Additionally, policies were also reviewed to determine if there was a preferred anti-TNF agent (e.g., adalimumab or infliximab) therapy. Policies were also evaluated for criteria for vedolizumab approval, if the initial failure of anti-TNF therapy was required, and if primary vedolizumab approval is allowed. Additionally, given the recent approval of ustekinumab, policies were also assessed for the presence of policies related to ustekinumab approval and if primary ustekinumab approval was permitted.
All policies were reviewed for compliance with the current AGA clinical pathway recommendations for UC and CD.
Out of the 125 largest insurance companies by market share, 79 policies were reviewed. Twenty-nine policies were not available online. These policies were mostly from brokerage firms and not stand-alone insurance companies. For a list of policies reviewed please see Table 1, Supplemental Digital Content 1, http://links.lww.com/IBD/B511. Of the 50 policies reviewed, 96% (n = 48) had separate anti-TNF policies for UC and CD. For UC, 98% required step-wise therapy failure before approval of an anti-TNF (Table 1). Thirty-four percent required the failure of two or more agents before starting anti-TNF (Fig. 1). The choice of which anti-TNF therapy could be initiated was limited to adalimumab in 20% of cases (Fig. 2). For vedolizumab, only 11% of the reviewed policies allowed starting vedolizumab without initial failure of an anti-TNF agent. Furthermore, 21% required the failure of two or more anti-TNF agents before starting vedolizumab (Fig. 2).
For CD, 74% of policies allowed for initiating infliximab specifically for fistulizing CD consistent with the specific FDA approved indication unique to infliximab. However, 90% of the policies required step-wise therapy failure prior to starting anti-TNF for non-fistulizing CD (Table 1). Moreover, 28% of policies required failing of at least two or more drugs before starting anti-TNF therapy (Fig. 1). When choosing anti-TNF therapy, 26% of policies required the use of adalimumab as the first anti-TNF agent (Fig. 2). For vedolizumab, only 8% of the reviewed policies allowed starting vedolizumab without initial failures of an anti-TNF agent, and 28% required the failure of two anti-TNF agents before using vedolizumab (Fig. 2). When evaluating the newest FDA-approved agent, ustekinumab, only 34% had a separate policy specific to ustekinumab use for CD (Table 1). Among these policies, 71% allowed ustekinumab use without previous anti-TNF failure.
When comparing the policies with the current AGA guideline recommendations, most policies failed to meet the current recommendations. In UC, comparing the policies with the AGA UC clinical pathway for high-risk outpatient inductive/maintenance therapy, 98% of policies are inconsistent with the guidelines. The guidelines allow for the primary use of anti-TNF or vedolizumab regardless of prior therapeutic failures and do not include any required step-wise failure requirement (Fig. 3). Similarly, when comparing the policies with the AGA CD clinical pathway for patients with moderate-high risk, not in remission, 90% of the policies are inconsistent with the guideline. The guideline recommends for anti-TNF therapy regardless of previous therapeutic failures which was rarely allowed in the policies reviewed (Fig. 3).
In this study, we show that the vast majority of the largest insurance companies as determined by overall market share in the United States require the step-wise failure of drug therapy for both UC and CD. The plans do not allow for treatment based on disease severity but rather dictate treatment based on the required failure of different drug classes. Additionally, 34% of the policies require the failure of two drugs before approval of biologic therapy. In contrast, only 2% of UC policies and 10% of CD policies allowed for early initiation of biologic therapy to reduce the risk of complications. Finally, even with the recent approval of ustekinumab, only 34% of policies reviewed had an available policy established for its use in CD.
Despite the potential risk of complications related to disease severity, insurance policies still focus on treatments with less expensive medications instead of the AGA guidelines for drug therapy in UC and CD. Both UC and CD carry the risk of significant morbidity both related to the disease itself as well as related to the use of corticosteroids. Current quality measures from the AGA dictate that all patients on corticosteroids should be assessed for a steroid-sparing agent.17 The goal of medical management is to minimize the use of corticosteroids and, ideally, avoid them if possible. However, the majority of the current policies reviewed in our study preclude this standard-of-care management. Not only did over 90% of the policies require step-wise drug failure, but also, 34% of the policies required the failure of two drugs before a biologic could be considered. This would require the failure of corticosteroids and a second medication before a biologic drug can be considered. Such algorithms risk longer courses of corticosteroids, and place the patient and increased risk of developing complications from ongoing inflammation.18
At this time, the cost differential of the different medications for IBD is quite significant with the anti-TNF therapy, vedolizumab, and ustekinumab being the most expensive agents.19,20 While the use of these agents can increase the cost, early therapy focused on disease severity is likely to be cost effective and prevent long-term complications.21 However, the current policies reviewed do not allow for selection of therapy based on disease severity in most situations. Only 2% of UC policies and 10% of CD policies allowed for immediate initiation of biologic therapy. In CD where complications are more frequent, and only infliximab carries a specific FDA approval for fistulizing CD, 74% of policies allowed for starting therapy with infliximab.13 However, 26% still required step-wise therapy despite the lack of any FDA approval for any other medication in fistulizing CD. This study did not assess the reasons for this lack of compliance, but cost is a likely factor. While biologics have been shown to be cost effective in the long-term management of IBD, the newer agents cost more with significant price increases when comparing oral nonbiologic agents (e.g., mesalamine, prednisone, thiopurines) compared with biologics.22,23 Importantly, however, not every study has supported a long-term benefit of early top-down treatment compared with a step-up approach based on symptoms.24 Nevertheless, to provide patients with high-quality care, policies must allow physicians to treat their patients based on disease phenotypes and disease severity, and not require specific drug failures before approving other drugs.
The reason for why policies require specific drugs to fail before considering anti-TNF, vedolizumab or ustekinumab is unclear. There are no clinical studies to indicate that mesalamine must be tried and proved unsuccessful before infliximab or vedolizumab can be considered. In contrast, delaying appropriate therapy results in ongoing disease activity and resultant complications.25 Typically, insurance policies require that for use of more recently approved FDA drugs, patients must first fail older therapy before policies allow for the newer drug to be approved. In our study, majority of the policies we reviewed had limited access to drug therapy without specific prior medication failures, and only 34% of the companies had a policy for the recently approved FDA medication. Since this strategy is not specifically supported by clinical evidence or patient outcomes, organizations have worked to pass legislations prohibiting the requirement for step-wise drug therapy dictated by the insurance companies.26,27 California passed a bill in 2015 that would authorize a request for an exception to a health care service plan's or health insurer's step therapy process for prescription drugs to be submitted in the same manner as a request for previous authorization for prescription drugs, and would require the plan or insurer to treat and respond to the request in the same manner as a request for previous authorization for prescription drugs.28 Similarly, New York passed a bill effective January 1, 2017, whereby it requires a usage review agent to use evidence-based and peer-reviewed clinical review criteria that are appropriate for a particular patient and the patient's disease severity when making a determination about whether to override a step therapy protocol.29 Along similar lines, Bill H.791 in Massachusetts is awaiting review by the committee on House Ways and Means that would dictate similar requirements to the New York bill.30 Such policies change the focus from step-wise failure to which drug is most appropriate to treat the patient's disease and to provide the patients with the highest quality of care.
Our study has a number of strengths and limitations. By using the insurance companies based on market share, we were able to capture the largest and most influential policies. Therefore, the findings of this study should likely be generalizable to most patients with IBD cared for throughout the United States. A notable limitation of our study is that we only reviewed publicly available policies. It is possible that companies did not provide updated policies online but our ability to locate policies for most of these companies makes this possibility less likely. Additionally, it is possible that the companies' websites do not reflect their most current policies but this is unlikely. Most importantly, however, is that we did not review all the insurance companies in the United States, and policies may differ.
Most insurance policies do not comply with the current standard of care for treating IBD based on the severity of disease and best available pharmacologic therapy. Further studies are needed to understand the reason for the inconsistencies between current insurance company policies and the recommended standard of care as dictated by the AGA guidelines on drug therapy in UC and CD. Ideally, patients should be treated with medications most effective in improving their disease management.
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