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Report: Vedolizumab (Entyvio) Has Potential for Treatment of Ulcerative Colitis

Gastroenterologists cite drug’s novel mechanism of action and promising efficacy

Decision Resources Group, a health-care research firm located in Burlington, Mass., finds that, according to surveyed U.S. and E.U. gastroenterologists, the effect on mucosal healing and improvement in the maintenance of remission are two of the attributes that most strongly influence their prescribing decisions in moderate-to-severe ulcerative colitis.

Emerging therapies that offer an improved effect in these attributes over current therapies would be well received and poised for strong uptake, the report says. Based on thought leaders’ opinions and clinical trial data, vedolizumab (Entyvio, Takeda) appears to have major potential because of its improved efficacy in the maintenance of remission and long-term mucosal healing.

Surveyed gastroenterologists placed great importance in their prescribing decisions on therapies that improve efficacy, followed by therapies that offer improvement in safety and/or delivery. And yet, surveyed gastroenterologists also noted a high unmet need for therapies that offer a lower risk of serious or opportunistic infections and a more convenient dosage formulation.

Surveyed pharmacy directors at U.S. managed care organizations agreed that improvements in efficacy are the driving force behind their decisions on granting favorable formulary status to a new drug. Delivery improvements may strengthen a therapy’s reimbursement prospects, although such advances will likely need to be accompanied by other clinically meaningful therapeutic gains.

“Price is a determining factor in decision making for both gastroenterologists and payers,” said analyst Adi Reske, PhD. “However, therapies for moderate-to-severe ulcerative colitis that offer improvement on induction and maintenance of remission over current therapies would be eligible for substantial price premiums.”

The emerging therapy vedolizumab has the potential to fulfill gastroenterologists’ and payers’ unmet needs based on its strong maintenance of remission, according to the report. In addition, oral tofacitinib citrate (Xeljanz, Pfizer) has the advantage of being a safe therapy for ulcerative colitis, with a low burden of delivery.

“Gastroenterologists consistently express the need for new therapies with improved efficacy, lower risk of adverse events, and better delivery,” Reske said. “Emerging therapies for ulcerative colitis offer to fulfill some of these unmet needs; however, given physicians’ established long-term experience with the anti-TNF-alpha inhibitors, new therapies in the moderate-to-severe ulcerative colitis market will likely be reserved for the TNF-refractory subpopulation.”

Source: Decision Resources; April 21, 2014.

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