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The American Journal of Managed Care June 2016
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Review of Outcomes Associated With Restricted Access to Atypical Antipsychotics
Krithika Rajagopalan, PhD; Mariam Hassan, PhD; Kimberly Boswell, MD; Evelyn Sarnes, PharmD, MPH; Kellie Meyer, PharmD, MPH; and Fred Grossman, MD, PhD
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Review of Outcomes Associated With Restricted Access to Atypical Antipsychotics

Krithika Rajagopalan, PhD; Mariam Hassan, PhD; Kimberly Boswell, MD; Evelyn Sarnes, PharmD, MPH; Kellie Meyer, PharmD, MPH; and Fred Grossman, MD, PhD
This literature review evaluates the impact of restricted access to atypical antipsychotic drugs in individuals with schizophrenia or bipolar disorder.
This literature review is bound by the limitations of each respective study. Many of the studies are based on administrative and pharmacy claims data, which may be limited by potential inaccuracies and the inability to establish causality for treatment discontinuation. Also, estimates of drug expenditures likely did not account for manufacturer rebates offered to state Medicaid programs. Further, although we did seek to be more inclusionary given the limited evaluations in the literature, there was much heterogeneity among the studies reviewed (eg, study period, evaluation period, geographic area, inclusion of control, outcomes measured, and type of cost containment policy evaluated). Seven of the 15 studies evaluated did not include a control comparison from another state. In most studies, the follow-up period after policy implementation was relatively short (≤1 year). Although the studies represented multiple states and geographic regions, the policies may not be representative of all states and may not be generalizable. In addition to the policy restrictions imposed, outcomes can be affected by a number of other factors, including the underlying patient population (eg, disease state, gender, age, socioeconomic status), provider prescribing behavior, and patient response.


CONCLUSIONS
Formulary restrictions are often used as a cost-containment strategy in an environment of rising prescription drug costs. Although most studies that evaluated a pharmacy cost change demonstrated a reduction in costs, the overall cost change in most cases was not measured. A reduction in pharmacy costs after the implementation of formulary restriction policies is often accompanied by increases in healthcare utilization, such as hospitalizations and treatment discontinuation. There exists a gap in the literature as to whether restricted access to AAPs results in overall cost savings or, rather, shifts the cost burden from pharmacy spending to other parts of the healthcare system. Further investigation is warranted to fully understand the clinical and economic impacts of formulary restriction of AAPs for individuals with schizophrenia or bipolar disorder.

Author Affiliations: Sunovion Pharmaceuticals Inc (KR, MH, FG), Marlborough, MA; Xcenda (KB, ES, KM), Palm Harbor, FL.

Source of Funding: This manuscript was supported by Sunovion Pharmaceuticals Inc.

Author Disclosures: Drs Boswell, Meyer, and Sarnes are employees of Xcenda, which is a consulting company that provides services to several pharmaceutical companies, including Sunovian. Drs Rajagopalan and Grossman are employees, and at the time of this research Dr Hassan was an employee, of Sunovion Pharmaceuticals Inc.

Authorship Information: Concept and design (MH, KM); acquisition of data (KB, MH); analysis and interpretation of data (KB, MH); drafting of the manuscript (KB, FG, MH, KM, KR, ES); critical revision of the manuscript for important intellectual content (FG, MH, KM, KR, ES); obtaining funding (MH); and supervision (FG, MH, KR, ES).

Address correspondence to: Kimberly Boswell, MD, 4114 Woodlands Pkwy, Ste 500, Palm Harbor, FL 34685. E-mail: kim.boswell@xcenda.com.
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