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: Ulcerative Colitis combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading specialty brands.
Payers covering almost two-thirds of commercial lives said that managing branded treatments for ulcerative colitis was a high priority for them. Medicare payers with almost half of beneficiaries considered management of the condition a very high priority. More than half of all payers said they have an aggressive management approach.
Plans with more than half of all lives expressed average satisfaction with current ulcerative colitis treatments. Almost four-fifths of gastroenterologists rated their satisfaction as average or high. Medicare payers with more than two-thirds of lives said there is moderate unmet need in treating the condition. Around three-fifths of gastroenterologists said that patients with ulcerative colitis have a high or very high disease burden.
The No. 1 treatment for ulcerative colitis was Takeda Pharmaceutical Company Limited’s Entyvio (vedolizumab), which gastroenterologists used to treat more than two-fifths of their unique patients in the year prior to the survey. That was followed closely by Remicade (infliximab) and Stelara (ustekinumab), both from the Janssen Pharmaceutical Companies of Johnson & Johnson. Entyvio also had the highest number of high prescribing gastroenterologists, meaning those who prescribe a product to at least 80% of patients. Janssen’s Simponi (golimumab) had the highest amount of low prescribing gastroenterologists, which are those who prescribe a product to 5% or less patients.
2025 will be a big year for the U.S. biosimilar market, when no less than three versions of Janssen’s Stelara (ustekinumab) are set to become available following the settlement of patent lawsuits. Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for multiple conditions, including the treatment of adults with moderately to severely active ulcerative colitis. Commercial payers with more than half of lives said that within the next two years, they expect to have two IL-12/IL-13 antagonists on their formulary, while those with more than one-third of beneficiaries said they anticipated three. Among the payers covering slightly more than half of commercial lives that anticipate having Stelara on formulary in 2025, those with almost half of beneficiaries said it would be a preferred brand.
Janssen’s Tremfya (guselkumab) is in Phase III trials for the treatment of adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional and/or advanced therapies. In May 2023, the company revealed that data from the QUASAR Induction Study showed statistically significant and clinically meaningful improvements among people with the disease. Payers with more than four-fifths of commercial lives were either moderately or extremely aware of Tremfya for the treatment of ulcerative colitis, while those with more than half of Medicare beneficiaries gave a similar response.
Message: “Finally, we discussed Avsola and any opportunity to add to formulary as currently is not covered, with Renflexis and generic Remicade being the only covered infliximab products. We discussed what it would take for us to move in that direction, being very aggressive, contracting potentially including a portfolio contract that may provide added value with Amjevita, Enbrel and Otezla. We discussed our current utilization of infliximab in order to evaluate if made sense to contract.”
Payer Thoughts: “Would have to be very aggressive to switch patients to Avsola. There may not be enough incentive to where contracting would make sense.”
Now That Humira Biosimilars Have Launched, What Are Lessons Learned for Stelara Biosimilars?
Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.
FDA Approved New Formulation of Takeda’s Entyvio
On Sept. 27, 2023, the FDA approved a subcutaneous formulation of Takeda Pharmaceuticals U.S.A., Inc.’s Entyvio (vedolizumab) for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC). The agency initially approved the drug on May 20, 2014, as an intravenous infusion, which remains available. The company says the integrin receptor antagonist is the only FDA-approved biologic for UC that offers the choice of intravenous or subcutaneous dosing.