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The American Journal of Managed Care June 2016
Development of a Tethered Personal Health Record Framework for Early End-of-Life Discussions
Seuli Bose-Brill, MD; Matthew Kretovics, MPH; Taylor Ballenger, BS; Gabriella Modan, PhD; Albert Lai, PhD; Lindsay Belanger, MPH; Stephen Koesters, MD; Taylor Pressler-Vydra, MS; and Celia Wills, PhD, RN
The Value of Decreasing Health Cost Volatility
Marc Herant, PhD, MD, and Alex J. Brown, MEng, MBA
Variations in Patient Response to Tiered Physician Networks
Anna D. Sinaiko, PhD
Primary Care Appointment Availability and Nonphysician Providers One Year After Medicaid Expansion
Renuka Tipirneni, MD, MSc; Karin V. Rhodes, MD, MS; Rodney A. Hayward, MD; Richard L. Lichtenstein, PhD; HwaJung Choi, PhD; Elyse N. Reamer, BS; and Matthew M. Davis, MD, MAPP
Impact of Type 2 Diabetes Medication Cost Sharing on Patient Outcomes and Health Plan Costs
Julia Thornton Snider, PhD; Seth Seabury, PhD; Janice Lopez, PharmD, MPH; Scott McKenzie, MD; Yanyu Wu, PhD; and Dana P. Goldman, PhD
Risk Contracting and Operational Capabilities in Large Medical Groups During National Healthcare Reform
Robert. E. Mechanic, MBA, and Darren Zinner, PhD
The Evolving Role of Subspecialties in Population Health Management and New Healthcare Delivery Models
Dhruv Khullar, MD, MPP; Sandhya K. Rao, MD; Sreekanth K. Chaguturu, MD; and Rahul Rajkumar, MD, JD
When Doctors Go to Business School: Career Choices of Physician-MBAs
Damir Ljuboja, BS, BA; Brian W. Powers, AB; Benjamin Robbins, MD, MBA; Robert Huckman, PhD; Krishna Yeshwant, MD, MBA; and Sachin H. Jain, MD, MBA
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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
Effects of Physician Payment Reform on Provision of Home Dialysis
Kevin F. Erickson, MD, MS; Wolfgang C. Winkelmayer, MD, ScD; Glenn M. Chertow, MD, MPH; and Jay Bhattacharya, MD, PhD
Adoption of New Agents and Changes in Treatment Patterns for Hepatitis C: 2010-2014
Xiaoxi Yao, PhD; Lindsey R. Sangaralingham, MPH; Joseph S. Ross, MD; Nilay D. Shah, PhD; and Jayant A. Talwalkar, MD

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.
Disruption of treatment is an unintended and potentially serious consequence of restricted access to AAPs among patients with schizophrenia or bipolar disorder, especially considering that nonadherence and poor persistence to therapy is an ongoing challenge for patients with mental illness5—with or without formulary restrictions. Zhang et al evaluated the association of PAs for psychiatric drugs with medication discontinuation among patients with bipolar disorder in the Maine Medicaid program from 2001 to 2004.13 The PA policy was associated with an 8% reduction in utilization of nonpreferred AAPs and anticonvulsants without a corresponding increase in utilization of preferred agents, indicating that patients were discontinuing treatment rather than switching to the program-preferred agents. Rates of medication discontinuation were over twice as high with implementation of the PA policy (hazard ratio, 2.28). Researchers concluded that a modest reduction in pharmacy spending ($27 per patient during the 8-month policy period) may have largely been driven by higher rates of medication discontinuation. Using the same data for patients with schizophrenia, Soumerai et al (2008) found that initiation of AAPs during the implementation of the Maine Medicaid PA policy resulted in a 29% greater risk of treatment discontinuation versus before the policy, while providing only minimal pharmacy savings.14

Similarly, Lu et al evaluated the association of PAs (affecting new prescriptions for nonpreferred AAPs [including olanzapine, olanzapine/fluoxetine, and aripiprazole] and anticonvulsants) with medication discontinuation among patients with bipolar disorder in the Maine Medicaid program (2001-2004).15 Compared with pre-policy, implementation of the PA policy was associated with increased medication discontinuation for patients who visited CMHCs and patients who did not: CMHC attenders (ie, ≥2 visits) (38% vs 31%, respectively) and non-attenders (ie, <2 visits) (41% vs 33%, respectively). The frequency of psychiatric visits was reduced among CMHC attenders (−64 per 100 patients per month); however, emergency visits were increased among non-attenders (+16 per 100 patients per month). Researchers suggested that the administrative barriers associated with PA policies could affect continuity of care, leading to relapse while off treatment. Also, for CMHC non-attenders, attempts were being made to manage medication access issues in outpatient emergency departments (EDs).

The impact of formulary restrictions on AAP drug utilization was evaluated among 30 state Medicaid programs.16 Among 11 states that instituted PAs between 1999 and 2008, AAP utilization per enrollee increased by 14%—a smaller increase than that observed in the 19 states without PA requirements (19%). However, overall antipsychotic utilization decreased by 3.1% in states with PA policies, which suggests that the reduction in targeted AAPs was not offset by the substitution of other antipsychotics. A similar finding was reported in a 2001 to 2004 study by Lu et al of patients with bipolar disorder in the Maine Medicaid program.17 The PA policy was associated with an immediate decrease in the rate of initiation of bipolar treatments (1.8%). By 4 months after policy implementation, the relative rate of bipolar treatment initiation decreased by 32.3% without a corresponding increase in the initiation of preferred agents, indicating a potential failure to treat.

Busch et al conducted a study to evaluate the effect of a managed behavioral health carve-out on the quality of outpatient care for Medicaid patients with schizophrenia from 1994 to 2000.18 Quality of care was measured by treatment recommendations established by the schizophrenia Patient Outcomes Research Team. Results showed that the carve-out was negatively associated with achieving quality care, with reduced odds of receiving any individual therapy (odds ratio [OR], 0.27; 95% CI, 0.22-0.33), group therapy (OR, 0.19; 95% CI, 0.14-0.25), and psychosocial rehabilitation (OR, 0.31; 95% CI, 0.26-0.38). However, the likelihood of receiving AAPs was the same whether or not a patient was in the carve-out program, and prescribing these medications had no direct economic consequence for the carve-out vendor. In another study from 2005 to 2007, a mental health carve-out in the Florida Medicaid program was assessed to determine if the implementation was associated with changes in drug utilization.19 The introduction of the carve-out plan was associated with both positive (increased penetration and reduced polypharmacy) and negative changes (reduced adherence). Since overall Medicaid expenditures for antipsychotics declined, researchers cautioned whether the cost savings may have contributed to reduced quality of care.

Fung et al evaluated Medicare Advantage Part D cost sharing on antipsychotic drug spending, adherence, and clinical outcomes from 2006 to 2007 for beneficiaries with schizophrenia, bipolar disorder, or no mental health diagnosis.20 Among beneficiaries with a coverage gap, greater patient cost sharing during the gap decreased Medicare antipsychotic drug expenditures while increasing patient out-of-pocket costs. However, hospitalizations and ED visits increased during the gap, and adherence rates (as measured by proportion of days covered) decreased during the gap (schizophrenia: −20.6%; bipolar disorder: −18.1%).

Walthour et al demonstrated an improvement in patient outcomes after implementation of the PA policy for AAPs among patients with schizophrenia in the Georgia Medicaid program from 2003 to 2006.21 Olanzapine, aripiprazole, and olanzapine/fluoxetine were nonpreferred AAPs under the PA policy. New prescriptions were required to obtain a PA; patients already taking any of these medications at the time of implementation were eligible for grandfathering. Criteria for PA approval included trial of a generic typical antipsychotic agent; however, new and continuing prescriptions for other AAPs (ziprasidone, risperidone, clozapine, and olanzapine injection) did not require a PA. During the PA policy period, decreases in the mean number of all-cause ED visits (absolute difference = −0.042 PMPM; relative difference = −20.92%) and all-cause hospital admissions (absolute difference = −0.010 PMPM; relative difference = −22.27%) were observed. The analysis of utilization was not restricted to schizophrenia-related ED visits and hospitalizations. Of note, this Georgia Medicaid PA policy was far less restrictive than many other PA policies, providing both grandfathering of existing medications and multiple AAPs not requiring a PA.

Our review of the literature revealed that, when evaluated, formulary restrictions more often than not were associated with pharmacy cost savings. Eight of the 15 studies included an assessment of the impact of AAP formulary restrictions on both changes in pharmacy costs and clinical outcomes. Among these, 5 studies suggested that pharmacy cost savings were accompanied by increases in healthcare utilization (eg, hospitalizations, ED visits, and nursing home visits) or treatment discontinuation.7,9,13,14,20 Two studies suggested that pharmacy cost savings were accompanied by decreases in healthcare utilization (eg, hospitalizations, ED visits, and outpatient visits).8,21 An additional study, which evaluated a rescission of a PA exemption in a mental health subgroup, suggested that pharmacy cost increases were associated with a reduction in hospitalizations.12 Assessment of overall cost burden of formulary restrictions was limited in the literature: 2 studies reported increases in overall costs after the implementation of formulary restrictions,7,8 another study reported reduced overall costs after a shift from closed formulary access to open access,9 and a decision analytical model estimated potential modest cost savings associated with the PA policy in another study.10

The intent of a PA is to encourage appropriate use of medications and to contain costs without negatively affecting clinical outcomes. Overall, although PA programs are common, there is a lack of adequately evaluated outcomes of these programs, including the long-term impact.22 Based on an underlying concern that formulary restrictions may result in a similar or higher overall cost burden after implementation, states, such as California, have reversed their restriction policies. In these situations, pharmacy spending may be reduced following implementation of formulary restrictions, but the healthcare system’s overall cost burden may have simply shifted to other parts of the system (eg, medical resource utilization).7,8,20 In addition, increases in medication discontinuation rates have been reported after implementation of PA policies, suggesting that for some healthcare systems, a component of the pharmacy cost savings may be a result of patient nonadherence and a decline in medication utilization rather than a migration to lower-cost therapies.13-15 The potential impact on adherence is critical when considering cost-containment approaches, as medication nonadherence is already a concern for patients with mental illness. It is estimated that half of patients with schizophrenia are nonadherent to therapy, with poor adherence linked to worse functional outcomes and increased risk of hospitalization.23-26

Restricted access may have an untoward effect on patients with mental illness by creating an administrative barrier to refilling medications.13 Further, restrictions can be burdensome to administer and expensive to implement. A survey of Medicaid providers in Texas assessed the effects of a PA for psychiatric medications.27 Administrative issues associated with PA policies included costs, time away from patients, uncompensated administrative time, and an extra step in providing care. In the Texas preferred drug list program evaluated in this review, the administrative costs were $4.4 million for all drug classes in 2005.11 Moreover, restricting access for a drug class with a high treatment response variability could negatively affect patient care.28,29 A patient who fails to respond to initial treatment with one drug may have a positive response to treatment with another drug; therefore, open access is essential for a drug class that requires such individualized patient care.


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