BURLINGTON, Mass., March 31, 2014 /PRNewswire/ -- Decision Resources Group finds that surveyed U.S. psychiatrists would prescribe EnVivo Pharmaceuticals/Bayer HealthCare/Mitsubishi Tanabe Pharma's encenicline to 25 percent of their patients with cognitive impairment associated with schizophrenia (CIAS). Assuming its promising—albeit preliminary—clinical profile is confirmed in ongoing Phase III studies, encenicline could become the first-ever therapy approved to treat this condition, fulfilling a major unmet need in the clinical management of schizophrenia. Surveyed psychiatrists also project patient shares of up to 20 percent for other emerging CIAS drugs, including AbbVie's ABT-126, Omeros's OMS-824, and Avineuro Pharmaceuticals' AVN-211.
Other key findings from the Decision Base report entitled Cognitive Impairment Associated with Schizophrenia: What Clinical Attributes Will Be Most Persuasive for Psychiatrists and Payers Regarding the First Novel Drugs in this Highly Underserved Arena?:
- Unmet need: Surveyed U.S. and European psychiatrists ascribed the highest level of unmet need for a therapy offering an improved effect on patient function, among queried efficacy attributes. Furthermore, 55 percent of surveyed U.S. payers expressed a high degree of willingness to grant favorable formulary coverage to such a therapy. These data align with an FDA mandate that novel therapies must demonstrate efficacy on a co-primary functional end point, such as the University of California San Diego Performance-Based Skills Assessment, in order to obtain approval for CIAS.
- Payers receptive, but demanding: Surveyed U.S. managed care organization pharmacy directors are receptive to novel drugs offering greater improvement from baseline on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MATRICS MCCB) than current off-label therapies (e.g., Eisai/Pfizer's Aricept, other brands, generics) occasionally prescribed for the treatment of CIAS, but hold high expectations for the effect-size gains that would motivate formulary coverage.
- Psychiatrists' willingness for trade-offs: Based on the results of a conjoint analysis, surveyed U.S. psychiatrists appear unwilling to make significant concessions in dosing frequency or price per day for a therapy that achieves even the maximum tested performance in improving CIAS patients' cognitive and functional outcomes.
Comments from Decision Resources Group Analyst John Crowley, Ph.D.:
- "A clear opportunity exists for drug development in CIAS, owing to the current lack of approved or meaningfully effective off-label therapies coupled with psychiatrists' recognition of and desire to treat CIAS in their patients. However, interviewed experts cite several hurdles to be overcome in this arena, including the need for well-validated, druggable targets, and defining the optimal enrollment criteria for CIAS patients in clinical trials."
- "Of interest, our findings show that a novel CIAS therapy that also offers an improved effect on positive and negative psychiatric symptoms presents the greatest opportunity for drug developers, based on the relatively high level of unmet need and high importance to prescribing choice that surveyed U.S. and European psychiatrists assigned to this attribute."
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