According to the National Institutes of Health, schizophrenia is a chronic, severe, and disabling brain disorder affecting 2.4 million Americans, often with onset in early adulthood. The course of schizophrenia is varied, frequently involving periodic relapses of the disease with sometimes incomplete response to treatment. As a result, each relapse can reduce treatment response, making it difficult for patients to achieve continued symptom control.
The costs associated with schizophrenia treatment are significant for stakeholders, even with strategies designed to reduce the health care costs for this complex psychiatric disorder. According to a recent study published in The Journal of Clinical Psychiatry that examined the economic burden of the illness in the United States using data from 2013, Cloutier and colleagues estimated the cost at $155.7 billion and included excess direct health care costs of $37.7 billion, direct non-health care costs of $9.3 billion, and indirect costs of $117.3 billion. The largest contributors were excess costs associated with unemployment (38%), productivity loss due to caregiving (34%), and direct health care costs (24%). Age, gender, insurance status, and comorbid conditions are also associated with schizophrenia-related costs.
Burden of Medication Nonadherence
Atypical antipsychotics are considered standard pharmacotherapy for schizophrenia. Four new antipsychotic agents were approved by the US Food and Drug Administration in 2015: Invega Trinza (paliperiodone palmitate; Janssen Pharmaceuticals Inc), Rexulti (brexpiprazole; Otsuka Pharmaceutical), Vraylar (cariprazine; Forest Laboratories LLC), and Aristada (aripiprazole lauroxil; Alkermes Inc).
Despite new treatments, medication nonadherence remains a persistent issue in schizophrenia, putting patients at greater risk of relapse and hospitalization, which in turn, leads to higher health care costs. Adherence to antipsychotic therapy is a key component of preventing relapses in patients with schizophrenia. In essentially the only study of costs of relapses for individuals treated for schizophrenia, Weiden and Olfson found that monthly relapse occurs in 3.5% of patients who are maintained on neuroleptics vs 11.0% for patients who have discontinued their antipsychotic medications. Treatment nonadherence is estimated to occur in 7.6% of patients per month in the community setting. Furthermore, 40% of hospital readmissions for patients with schizophrenia were attributed to nonadherence, with 60% accounting for the loss neuroleptic efficacy (Scizophr Bull. 1995;21(3):419-429).
A study on the cost and predictors of relapse in the BMC Psychiatry, by Ascher-Svanum and colleagues, found that costs for patients with prior relapse were about 3 times the costs for patients without prior relapse. Inpatient costs for patients with relapse during both the prior 6 months and the follow-up year were 5 times the costs for patients with relapse during the follow-up year only.
Recent research in the Journal of Managed Care and Specialty Pharmacy showed how accurate patient drug adherence information can generate value for payers by improving physician decision making among patients with schizophrenia. Researchers for this study found that new technologies which accurately monitor patient’s adherence rate could significantly reduce health care costs for patients who are non-adherent or adherent but poorly controlled.
Restricting Access to Antipsychotics: Good or Bad?
Cost-containment strategies for treating and managing schizophrenia are important to clinicians, payers, and other health care decision makers. These policies, such as prior authorizations, preferred drug lists, dispensing limits, and cost sharing, have increasingly been used by formulary decision makers to manage drug spending of the atypical antipsychotic drug class. Are these strategies beneficial to patients and do they result in reduced costs to the health care system?
Data has shown that these strategies may result in cost shifting instead translating to cost savings. Several studies have looked at the outcomes associated with restricted access to atypical antipsychotics.
For example, a review and synthesis of 15 studies in the literature by Rajagopalan and colleagues found that formulary restrictions aiming to reduce pharmacy costs for atypical antipsychotics may result in higher medical care utilization and shift the burden to other parts of the health care system. Additionally, evidence from 5 of 8 studies evaluating the changes in pharmacy costs and clinical outcomes showed pharmacy cost savings and increases in health care utilization or treatment discontinuation associated with formulary restrictions (Am J Manag Care. 2016;22(6):e208-e214).
While formulary management interventions are important in controlling costs for most medications, heterogeneity in individual neurobiology and differences among drugs requires individualized treatment, according to Basu and Melter. They reviewed the evidence on the impact of access restrictions for antipsychotic drugs in Medicaid programs generated from comparative effectiveness research (CER; J Comp Eff Res. 2012;1(2):171-180).
“Those who prescribe medications for patients with schizophrenia have the challenge to develop an efficacious and tolerable treatment plan for each of their patients. The management system that determines and controls access to these treatments should therefore aim to aid prescribers in making individualized, informed decisions rather than mandating solutions based on averages,” they wrote. “The available body of evidence does not support the notion that implementing prior authorization requirements for atypical antipsychotic drugs results in consistent and meaningful cost savings without adversely impacting patient well-being.”
Going forward, they noted that the emerging role of pharmacogenomics and other biomarkers in understanding treatment effect moderation should be the main focus of CER and help to translate such information into better decision-making.