What Clinical Attributes Will Be Most Persuasive for Psychiatrists and Payers Regarding the First Novel Drugs in this Highly Underserved Arena?
Decision Resources Group forecasts the number of diagnosed prevalent cases of schizophrenia with comorbid cognitive impairment to exceed 4 million in the seven major pharmaceutical markets in 2022. Cognitive impairment associated with schizophrenia (CIAS)—which may include deficits in attention, working memory, and executive function—has a negative impact on patients’ quality of life and ability to function. Although cognitive symptoms in schizophrenia are well characterized, no formal diagnostic criteria exist. Furthermore, no pharmacological agents are approved to treat the condition, and no marketed therapy tested to date has established clear, meaningful efficacy, which underscores the difficulty of drug development in this arena and accentuates the unmet need for proven treatment options. Significant commercial opportunity awaits future innovative therapies that can improve cognition and functional capacity in schizophrenia patients as adjunctive therapy to antipsychotic medication.
Attributes included in conjoint analysis based assessment of target product profiles for CIAS:
- Overall cognition–standard-deviation improvement (effect size) from baseline over placebo on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB).
- Patient function–standard-deviation improvement (effect size) from baseline over placebo on the UCSD Performance-Based Skills Assessment (UPSA).
- Positive and negative symptoms–standard-deviation change (effect size) from baseline over placebo on the Positive and Negative Symptom Scale (PANSS).
- Incidence of serious or life-threatening side effects.
- Incidence of nausea.
- Dosing frequency.
- Price per day.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for CIAS:
- Improvement in overall cognition provided by a new CIAS drug prescribed as adjunctive therapy to an antipsychotic regimen.
- Improvement in patient function provided by a new CIAS drug prescribed as adjunctive therapy to an antipsychotic regimen.
- Improvement in positive and negative symptoms provided by a new CIAS drug prescribed as adjunctive therapy to an antipsychotic regimen.
- Incidence of nausea associated with use of a new, effective CIAS drug prescribed as adjunctive therapy to an antipsychotic regimen.
Physicians surveyed: 60 U.S. and 31 European psychiatrists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Donepezil (Pfizer/Eisai’s Aricept, other brands, generics)
- Modafinil (Teva’s Provigil, generics)
- Armodafinil (Teva’s Nuvigil)
- Memantine (Merz Pharmaceuticals/Grünenthal’s Axura; Lundbeck’s Ebixa, generics; Forest Laboratories’ Namenda/Namenda XR; Daiichi Sankyo’s Memary)
Rivastigmine (Novartis’s Exelon/Exelon Patch, other brands, generics)
- EnVivo Pharmaceuticals/Bayer HealthCare/Mitsubishi Tanabe Pharma’s encenicline
- AbbVie’s ABT-126
- Omeros’s OMS-824
- Avineuro’s AVN-211
- Teva’s irdabisant