Access to therapy for ulcerative colitis (UC) and Crohn disease (CD) may not be consistent with treatment guidelines because of payer policies that do not concur with the American Gastroenterological Association clinical pathways for the treatment of inflammatory bowel disease.
Biologics and other advanced therapies have revolutionized the treatment of a number of inflammatory diseases, with ulcerative colitis (UC) and Crohn disease (CD) in particular becoming subject to a more individualized treatment approach. However, access to therapy may not be consistent with treatment guidelines because of payer policies that do not concur with the American Gastroenterological Association clinical pathways for the treatment of inflammatory bowel disease.
In a paper recently published in Digestive Diseases and Sciences, a research team sought to identify whether insurance coverage for such therapies for UC and CD is routinely approved in clinical practice. In the study, they evaluated patient access to biologics and advanced small-molecule therapies using commercial and government policy information derived from the Managed Markets Insight and Technology database, as well as publicly available medical policies, prior authorization information, and pharmacy drug list documents.
In total, 301,748,186 and 302,057,543 lives were captured in the database under the medical and pharmacy benefits, respectively. The investigators assessed coverage for adalimumab, infliximab, biosimilar infliximab, the orally administered small-molecule drug tofacitinib, ustekinumab, and vedolizumab.
They found that 89% of lives required no or 1 prior biologic use before accessing any of the drugs of interest for the treatment of UC or CD, with the exception of tofacitinib in UC and subcutaneous ustekinumab for CD; access for these 2 therapies was 68% and 71%, respectively.
Products that had wider coverage were originator infliximab, biosimilar infliximab, and adalimumab. Originator and biosimilar infliximab were covered under the medical benefit without prior biologic failure for 95% of lives, and with the failure of 1 prior biologic for 89.8% for UC. The infliximab products were covered for 95% and 90% of lives, respectively, for CD.
Adalimumab was covered under the pharmacy benefit for 99% of lives, without prior biologic failure or with 1 prior biologic, for UC and CD.
Among newer drugs, vedolizumab had the widest coverage; for UC and CD, 81% of lives had access to the therapy without a prior biologic exposure. Tofacitinib had lower access, with 43% of lives having access without prior biologic exposure. Rates of coverage without a prior biologic for subcutaneous ustekinumab were lower (49%) than for the intravenously administered version of the drug (86%).
The authors write that approximately half of all covered lives had access to all biologics—although not to the small-molecule tofacitinib—as first-line therapy for UC and CD, and two-thirds had access after 1 biologic exposure.
“With the emergence of new therapies, including biosimilars, there will be an increased pressure on payers to manage therapies and an increased responsibility on physicians to choose the most appropriate agent,” conclude the authors, adding that “it is important that modern physicians understand how to navigate coverage policies and advocate to create an individualized treatment pathway for each patient.”
Dulai PS, Osterman MT, Lasch K, Cao C, Riaz F, Sandborn WJ. Market access analytics of biologics and small-molecule inhibitors for inflammatory bowel disease among US health insurance policies [published online March 28, 2019]. Dig Dis Sci. doi: 10.1007/s10620-019-05594-7.