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.

Questions Answered in This Report:

  • Understand U.S. psychiatrists’ perceptions of attitudes toward currently marketed antipsychotics and uncover prescribing preferences. Which antipsychotics are perceived by physicians as being the most efficacious for the treatment of positive, negative, and cognitive symptoms of schizophrenia? What factors prevent physicians from prescribing their preferred antipsychotic?

  • Gain insight into current prescribing and reimbursement practices for the treatment of CIAS and negative symptoms. To what extent is adjunctive treatment currently prescribed for either CIAS or negative symptoms? What factors most influence reimbursement for adjunctive therapies, and what market access challenges exist for these agents? How will the expanding availability of generic atypical antipsychotics influence managed care organization pharmacy directors/medical directors’ (MCO PDs/MDs’) attitudes toward reimbursement of novel therapies used as adjuncts?

  • Ascertain psychiatrists’ receptivity to emerging therapies for CIAS or negative symptoms. How do physicians expect to incorporate emerging agents (Forum Pharmaceuticals/Bayer HealthCare/Mitsubishi Tanabe Pharma’s encenicline, AbbVie’s ABT-126, and Omeros’s OMS-824) into clinical practice, should the drugs launch in the United States? What does physician receptivity to these emerging therapies imply for developers of therapies for CIAS or negative symptoms of schizophrenia?

  • Learn about MCO PDs/MDs’ anticipated incorporation of emerging therapies for CIAS or negative symptoms into their formularies. What market access hurdles do surveyed MCO PDs/MDs expect to impose on novel agents for CIAS or negative symptoms, and how will these constraints, including tiering and formulary restrictions, impact the potential uptake of emerging drugs specifically treating CIAS or negative symptoms of schizophrenia?

Scope:

In this report, we explore the use, reception, and formulary status of key antipsychotics used for the treatment of schizophrenia, as well as the reception and use of adjuncts to antipsychotic therapy for the treatment of CIAS and negative symptoms, in a survey of 100 psychiatrists, 25 MCO PDs, and five MCO MDs. We also gauge physician and payer outlook on three emerging therapies: EnVivo Pharmaceuticals/Mitsubishi Tanabe Pharma/Bayer HealthCare’s encenicline (EVP-6124), AbbVie’s ABT-126, and Omeros’s OMS-824. By understanding the attitudes and expectations of prescribers and MCOs about current, recently approved, and emerging therapies used for the treatment of schizophrenia, and specifically, the treatment of CIAS or negative symptoms, stakeholders can gain an understanding of the treatment paradigm and changing reimbursement climate for this patient population.

Markets covered: United States.

Primary research: 100 psychiatrists, 30 MCOs (25 MCO PDs, 5 MCO MDs).

Population segments: Where appropriate, our data and analyses are segmented by the following patient populations: schizophrenia, positive symptoms, negative symptoms, CIAS.

Author(s): Alana K. Simorellis, Ph.D.

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