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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.
ABSTRACT

Objectives:
Cost containment policies, such as prior authorization (PA), have increasingly been used by formulary decision makers to manage drug spending of the atypical antipsychotic (AAP) drug class. However, these drug cost containment policies may result in cost shifting rather than cost savings. Given the interest in coordination of care, the objective of this study was to evaluate the impact of restricted access to AAPs on healthcare costs and health outcomes in individuals with schizophrenia or bipolar disorder.

Study Design: Narrative literature review.

Methods: A literature search was conducted using MEDLINE (via PubMed) for studies published between January 1993 and December 2013.

Results: A total of 15 published studies were identified that evaluated restricted access to AAPs in regard to healthcare costs or health outcomes: 11 studies assessed PAs, 2 studies assessed carve-outs, 1 study assessed a payment limit (cap), and 1 study assessed Medicare Part D cost sharing. Among 8 studies evaluating changes in pharmacy costs and clinical outcomes, 5 studies reported that formulary restrictions were associated with pharmacy cost savings and increases in healthcare utilization or treatment discontinuation. Of the 4 studies that measured overall cost changes, 3 studies reported increases in overall cost burden and 1 study showed modest cost savings associated with formulary restrictions.

Conclusions: Study findings revealed 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, such as service utilization.

Am J Manag Care. 2016;22(6):e208-e214
Take-Away Points
  • Formulary restrictions aiming to curb pharmacy costs for atypical antipsychotics may result in higher medical care utilization and shift the overall cost burden to other parts of the healthcare system. A thorough review and synthesis of the literature was conducted to evaluate the impact of restricted access to atypical antipsychotics in individuals with either schizophrenia or bipolar disorder.
  • Evidence from 5 of 8 studies evaluating changes in pharmacy costs and clinical outcomes demonstrated pharmacy cost savings and increases in healthcare utilization or treatment discontinuation associated with formulary restrictions. 
  • Of the studies that measured overall cost changes, 3 reported increases in overall cost burden and 1 study showed modest cost savings associated with formulary restrictions.
Approximately 1 in 4 (26.2%) adults in the United States suffers from a diagnosable mental disorder in a given year,1 and owing to the high prevalence, mental disorders are associated with substantial financial burden on the healthcare system. The Substance Abuse and Mental Health Services Administration (SAMHSA) estimated that total direct costs for mental healthcare were $100 billion in 2003, representing 6.2% of all medical expenditures in the United States.2 In 2003, public payers provided more than half (58%) of the funding for mental health, with Medicaid representing the largest source of public funding (45%).2 Due to rising spend on pharmaceutical treatments in the last 2 decades, state Medicaid programs have increasingly been implementing pharmaceutical cost-containment strategies, such as prior authorizations (PAs), preferred drug lists, dispensing limits, mandatory use of generics, supplemental rebates, cost sharing, and step therapy.3 Although the goal is to encourage appropriate use of medications and to contain costs, these strategies may have unintended consequences; for example, PA requirements have been shown to increase the probability of drug access problems by 20%.4

Treatment decisions for patients with mental illness are driven by a complex interplay that includes efficacy, tolerability, prior drug history, patient preference, access, and drug interactions; successful pharmacological treatment is often only achieved after multiple therapeutic trials.5,6 Atypical antipsychotics (AAPs), which were introduced in the early 1990s, are considered standard pharmacotherapy for schizophrenia and bipolar disorder. Although AAPs are considered to belong to the same class, these drugs are quite heterogeneous as they exhibit different pharmacological profiles and may not be interchangeable. Patient responses to these agents can be variable—a lack of response to one agent does not necessarily predict a lack of response to another, even within the same drug class or vice versa.5 Compounding the variable nature of the clinical response, treatment resistance is a challenge to successful long-term management of the mentally ill. Given the absence of genetic biomarkers that can predict response with one agent compared with another, treatment optimization requires adequate trials of multiple antipsychotics.5 As such, the potential disruption of stable pharmacological management due to medication access challenges or restrictions may have serious clinical consequences, including treatment discontinuation, relapse, and deterioration of symptoms and/or function.5

Our objective was to conduct a thorough review and synthesis of the literature to evaluate the impact of restricted access to AAPs on healthcare costs and health outcomes in individuals with either schizophrenia or bipolar disorder.

METHODS
A narrative review of all English-language studies published in peer-reviewed journals between January 1993 and December 2013 was conducted using MEDLINE (via PubMed). Inclusion criteria were as follows: studies conducted in the United States involving an evaluation of healthcare costs or health outcomes with regard to restrictions on access to antipsychotic medications in health plan populations, and encompassing schizophrenia or bipolar disorder. The search was limited to original research articles; therefore, commentaries, editorials, and reviews were excluded.

Search terms included the following: (schizophrenia OR bipolar OR serious mental illness OR psychiatric illness) AND (atypical antipsychotic OR antipsychotic OR aripiprazole OR asenapine OR clozapine OR olanzapine OR lurasidone OR paliperidone OR quetiapine OR risperidone OR ziprasidone OR iloperidone OR haloperidol OR psychotherapeutic) AND (step edit OR step therapy OR formulary restriction [tier, control, cost] OR drug coverage restriction OR prior authorization OR drug utilization OR managed care OR Medicare OR Medicaid OR Veterans Affairs OR tiered therapy OR prescription limit OR open access). The following filters were applied: publication date (from 01/01/1993), humans, and English.

The search resulted in 230 hits, of which 208 were excluded based on review of title and/or abstract (Figure). The remaining 22 were further assessed for eligibility by review of full-text article. Studies were excluded based on the following: non-schizophrenia or bipolar patient population, no abstract available, non-US study, nonprimary research article, or no evaluation of restricted access on antipsychotics with regard to healthcare costs or health outcomes.

RESULTS
A total of 15 studies met the strict inclusion and exclusion criteria and were thus included in the review (eAppendix, available at www.ajmc.com). Among the 15 included studies, 11 assessed PAs, 2 assessed mental health benefit carve-outs, 1 assessed a payment limit (cap), and 1 assessed Medicare Part D cost sharing; of these, 1 study evaluated costs only. The remaining studies considered both costs and other outcomes, such as healthcare and drug utilization, treatment discontinuation, and quality of care. Studies were assessed based on their impact on pharmacy costs, nonpharmacy costs, overall costs, and clinical event rates (Table).

Impact on Expenditures

Findings from studies reporting the impact of cost-containment policies on healthcare expenditures are summarized below. Soumerai et al (1994) evaluated the effects of a New Hampshire Medicaid-imposed 3-prescription limit (cap) on the use of psychotropic drugs for schizophrenia during a study period from 1980 to 1983.7 The cap was associated with an immediate drop in the utilization of these drugs. However, it was also associated with a corresponding increase in visits to community mental health centers (CMHCs) of 1 to 2 visits per member per month (PMPM) and an increase in utilization of emergency mental health services and partial hospitalization from 1.2 to 1.4 episodes PMPM. It was estimated that during the 11-month period the cap was in effect, the increase in the statewide cost of mental health services was $390,000. The estimated increase in mental health services exceeded the savings in drug costs by a factor of 17.

Farley et al conducted a retrospective assessment of a step-therapy PA for AAPs implemented in the Georgia Medicaid program (1996-1997),8 where patients were required to fail 2 typical antipsychotics before receiving an AAP. In the subset of patients with schizophrenia, the PA policy demonstrated a $19.62 PMPM decrease in AAP expenditures; however, the savings were outweighed by a $31.59 PMPM increase in expenditures for outpatient services. The authors further explored the effect of the PA policy on the frequency of outpatient visits and found that the number of outpatient visits declined, albeit outpatient payments increased. This finding suggested the unintended consequence of greater payments per outpatient visit following the PA policy implementation.

McCombs et al evaluated the impact of a change in policy to allow open access (ie, remove formulary restrictions) to AAPs in the California Medicaid program during the period of 1994 to 2000.9 In the year following the initiation of open access, there was an increase in drug utilization and expenditures—this was especially noted in institutionalized patients; however, the increases in drug expenditures may have been offset by decreases in nursing home utilization. Additionally, total monthly costs increased in both the restricted and open-access periods, although the increase was greater in the restricted period compared with the open-access period (19.5% vs 15.2%, respectively).

Abouzaid et al developed a decision-analytic model to compare the economic impact of a PA for AAPs in the treatment of schizophrenia versus no PA over a 1-year time horizon.10 Researchers concluded that only modest potential cost savings would be recognized, without considering the potential increase in hospitalizations (ie, best-case scenario). Cost savings equated to $29 per patient per year when including increased costs of outpatient care and administrative costs associated with the PA program (2008 US dollars). The model was sensitive to the rate of hospitalizations; an increase in the subsequent hospitalization rate of only 0.5% would make the PA arm the more costly option. 

Although most studies demonstrated that cost-containment policies reduce pharmacy expenditures, some demonstrated minimal savings in drug cost. Law et al conducted an evaluation of PA policies for AAPs in West Virginia and Texas Medicaid programs from 1991 to 2005. The West Virginia PA required a 14-day trial of a preferred agent, with the following drugs subject to PA: aripiprazole, brand name clozapine, olanzapine/fluoxetine, and olanzapine. The Texas policy required treatment failure, contraindication, or allergic reaction to a preferred agent, with the following drugs subject to PA: brand name clozapine, olanzapine/fluoxetine, and olanzapine. Results demonstrated a reduction in market share for nonpreferred AAPs, but no appreciable decrease in pharmacy expenditures.11 Notably, there were extensive grandfathering provisions for patients already receiving AAPs. However, researchers hypothesized that the lack of change in pharmacy expenditures could be a result of alternative medications also being costly. Furthermore, providers may respond to PA policies by increasing the dose of less-optimal medications or combining medications (polypharmacy); both of these scenarios would reduce any savings.

In another study, from 2005 to 2007 in the Vermont Medicaid program, Simeone et al evaluated the effects of a rescission of a PA exemption on cost and utilization of behavioral health medications.12 In this phase-out of the PA exemption for patients with severe and persistent mental illness, beneficiaries were exempt from PA requirements for medications not on the Medicaid preferred drug list. The phase-out demonstrated modest increases in formerly exempt behavioral health medications (2.1% PMPM) and was associated with a reduction in the rate of mental health–related inpatient hospitalizations (from 0.6% to 0.4%).

Impact on Medication Adherence and Clinical Outcomes

 
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