Beyond Positive Symptoms: How Receptive Are U.S. Psychiatrists and Payers to Therapies Targeting Negative or Cognitive Symptoms of Schizophrenia? | Physician & Payer Forum | US | 2014

Schizophrenia is an often disabling psychiatric disease whose core treatment consists of up to a lifetime of treatment with antipsychotics (older typical antipsychotics or newer atypical antipsychotics). Antipsychotics have demonstrated efficacy on the positive symptoms of schizophrenia (such as delusions and hallucinations), but no currently available therapy has been shown to be substantially efficacious and reliable in treating negative symptoms (such as diminished emotional expression) or cognitive impairment associated with schizophrenia (CIAS). Some atypical antipsychotics—e.g., clozapine (Novartis’s Clozaril/Leponex; Jazz Pharmaceuticals’ FazaClo, generics) and Abilify (Bristol-Myers Squibb/Otsuka Pharmaceutical’s aripiprazole)—are sometimes preferred when cognitive or negative symptoms predominate, but some physicians try to address cognitive and/or negative symptoms with off-label, adjunctive treatment from varying non-antipsychotic drug classes that ultimately may offer little clinical benefit to patients. As a result, physicians identify drugs with greater efficacy against CIAS and against negative symptoms as the most critical unmet needs in the treatment of schizophrenia. Despite the large unmet need, emerging therapies for schizophrenia—whether they will predominantly treat positive symptoms, negative symptoms, and/or cognitive symptoms—will be entering a crowded and increasingly generic antipsychotics market, and developers of these emerging products will need to demonstrate their agent’s clear safety and/or efficacy advantages compared with (or when added to) current antipsychotics if new products are to gain regulatory approval, attain price premiums, and secure formulary coverage.