Ulcerative colitis is a high-cost category with an increasing number of therapies that treat the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for ulcerative colitis, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Biologics and Injectables Index combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading specialty brands.
Commercial payers with almost two-thirds of covered lives said that AbbVie Inc.’s Humira (adalimumab) is their ideal first-line ulcerative colitis therapy, with many citing its efficacy (see chart). Payers representing almost one-third of lives indicated that Stelara (ustekinumab) from Johnson & Johnson subsidiary Janssen Biotech, Inc. is the top second-line drug due to its clinical evidence and contracting support.
Almost half of gastroenterologists responded that Janssen’s Remicade (infliximab) is their most ideal first-line treatment, pointing to its long-term clinical data. About one-third said the efficacy of Humira and Takeda Pharmaceutical Company Limited’s Entyvio (vedolizumab) make them their preferred second-line agents. Almost all gastroenterologists had prescribed Humira in the 12 months prior to the survey, followed by Entyvio and Remicade.
On Jan. 27, 2021, Pfizer Inc. said that a post-marketing safety study of Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) in rheumatoid arthritis failed to meet both primary endpoints, which were to demonstrate noninferiority to a tumor necrosis factor (TNF) inhibitor in both cardiovascular risk and cancer risk. Payers covering almost half of lives said the study results were highly influential in their anticipated management of ulcerative colitis, while two-thirds of gastroenterologists noted that the outcomes would highly influence their prescribing in the condition. More than half of gastroenterologists said the results would influence their prescribing of JAK/STAT inhibitors, and payers representing more than one-third of lives stated that the study would impact their management of these therapies.
On May 27, 2021, the FDA approved Bristol Myers Squibb’s Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis. Payers with almost two-thirds of lives said they expect to manage the drug to label. Those with almost half of lives said they do not expect to make any changes to their current contracts for and management of ulcerative colitis (see chart). More than half of gastroenterologists said they anticipate prescribing Zeposia over some other ulcerative colitis agents, with TNF inhibitors being the most likely choices.
The FDA had approved six biosimilars of Humira as of fall 2021, but they are not able to launch in the U.S. until 2023 due to settlement agreements with AbbVie. Payers with more than half of lives said they had received a portfolio contracting offer from AbbVie. Those covering more than three-fifths of lives said that their organization would accept a portfolio contracting offer with AbbVie. And payers with almost all covered lives said they were not delaying contracting with AbbVie in anticipation of Humira biosimilar launches.
Mechanism of Action
Message: “Entyvio has a very unique mechanism of action that is different than most of the biologics currently on the market for ulcerative colitis. Entyvio is gut selective so less opportunistic infections would be expected as compared to a biologic such as Humira. Humira is not gut selective so it has more indications but may not be a good selection for someone that suffers from opportunistic infection.”
Payer Thoughts: “Entyvio does have a different unique mechanism of action from other agents in the biologic class. The gut selectivity does not allow it to be used for other disease states but would work well for a patient that only has ulcerative colitis. Entyvio would be a good second-line agent after DMARDs have been tried.”
Zeposia May Face Challenges in Ulcerative Colitis
A recently approved product — Bristol Myers Squibb’s Zeposia (ozanimod) — in the ulcerative colitis therapeutic class brings a new mechanism of action. However, according to payers responding to a 2020 survey by Zitter Insights, the treatment may have some challenges breaking into the space. Payers with 67% of covered lives said they are unlikely to prefer Zeposia over other therapies approved for ulcerative colitis or to incentivize physicians to prescribe it.
Indication-Based Formularies Are Growing in Use
The anti-inflammatory therapeutic class consistently ranks at the top of the costliest specialty classes in the pharmacy benefit, prompting payers to try new management strategies. A few years ago, some payers began offering indication-specific formularies within the class, and the strategy continues to gain traction.