Feature

Q&A: Second-generation antipsychotics for patients with schizophrenia, bipolar disorder

Leona Bessonova

Research presented at the annual meeting of the Academy of Managed Care Pharmacy — AMCP Nexus 2019 — highlighted real-world treatment patterns and costs for patients with schizophrenia and bipolar disorder in the United States.

According to researchers, second-generation antipsychotics (SGAs) have become common treatment options for both schizophrenia and bipolar disorders, but associated costs and actual treatment patterns in the U.S. for both disorders have not been comprehensively reviewed.

Leona Bessonova, PhD, director of health economics and outcomes research at Alkermes, and colleagues conducted two systematic literature reviews to address the clinical and economic research gaps for SGA use among these patient populations.

Healio Psychiatry spoke with Bessonova about the history of SGAs, the findings of these studies and potential future research. – by Joe Gramigna

Question: Can you provide background on second - generation antipsychotics and t heir use in bipolar disorder and schizophrenia.?

Answer: Antipsychotics have really been the pharmacologic standard of care for treating schizophrenia since around the 1950s, but these medications have evolved and changed over the years. Initially, there were first-generation antipsychotics, which were effective but were associated with a variety of side effects, such as extrapyramidal symptoms. Eventually, SGAs were developed. They are often preferred due to their improvements in safety-related issues and overall improved safety and tolerability profiles. SGAs are effective as a pharmacologic treatment for schizophrenia. Many medications that are effective in schizophrenia are also effective in bipolar disorder and have that indication per their labeling. Schizophrenia and bipolar disorder both are serious mental health conditions, and antipsychotic use has become common across both. Antipsychotics are certainly used for many individuals living with bipolar disorder, and many of them are labeled for and are effective in treating manic/mixed episodes and for maintenance therapy as well.

Q: What research needs were you seeking to address?

A: We were trying to understand the real-world literature and where unmet needs may exist in the treatment of schizophrenia and bipolar disorder. These were separate projects that were both presented at AMCP Nexus. A lot of the literature around antipsychotic treatment of these conditions comes from seminal studies that looked at clinical trial data and other large data sets. Our intent here was to conduct a systematic literature review of real-world data over the last 10 years regarding the use of antipsychotic medications in schizophrenia and bipolar disorder. We sought to understand what the treatment patterns were around adherence and discontinuation. We also wanted to understand the real-world evidence around health care resource utilization and associated medical costs. We thought that it was important to systematically understand the state of the science around these real-world data.

Q: What methods did you use to conduct these studies ?

A: We searched standard scientific databases like PubMed and the Cochrane Library to identify publications between 2008 and 2018 with a focus on data from adults living in the United States. In the schizophrenia study, we identified 81 articles for inclusion which totaled about 1.17 million patients captured across the real-world literature. For the bipolar disorder study, we identified 39 articles for inclusion that reflected studies with data for approximately 567,000 patients.

Q: What were the main findings of the studies?

A: The literature review revealed that among individuals with schizophrenia, there is still a prevailing unmet need for pharmacologic treatment that can improve adherence and reduce relapse. We saw that adherence was quite prevalent in the population as summarized across the literature. We also observed an increased risk for relapse as described by inpatient types of medical costs, health care resource utilization with respect to inpatient admissions, as well as ED visits and their associated costs.

We concluded that the development of new antipsychotic medications might reduce side effects, and this is perhaps one type of pharmacologic approach that may help improve adherence. Therefore, it also may impact some of the downstream health care resource utilization impacts, such as relapse and hospitalization.

Although side effects are not the only cause of stopping medication, a different study we conducted earlier this year included data from online surveys of participants living with schizophrenia or with bipolar I disorder. In both patient populations, side effects were the most common reason for nonadherence cited, although there were other reasons for not adhering to their oral antipsychotic medication.

Q: What additional research needs to be done regarding anti-psychotics for these patients?

A: We need more research into the impacts of antipsychotic side effects on patient perceptions of their treatment and treatment adherence, as well as the impact of side effects on social functioning and what happens in the real world when patients are taking these medications. Learning some of these gaps, especially from the patient perspective, can inform development of new medications that are highly efficacious and address patient needs.

References:

Bessonova L, et al. 3 Real-world treatment patterns and costs for patients with bipolar disorder: Results from a systematic literature review. Presented at: AMCP Nexus 2019; Oct. 29 to Nov. 1.; Fort Washington, Maryland.

Bessonova L, et al. Real-world treatment patterns and costs of oral antipsychotics

for treatment of schizophrenia in the United States. Presented at: AMCP Nexus 2019; Oct. 29 to Nov. 1.; Fort Washington, Maryland.

Disclosures: Bessonova is an employee of Alkermes.

Leona Bessonova

Research presented at the annual meeting of the Academy of Managed Care Pharmacy — AMCP Nexus 2019 — highlighted real-world treatment patterns and costs for patients with schizophrenia and bipolar disorder in the United States.

According to researchers, second-generation antipsychotics (SGAs) have become common treatment options for both schizophrenia and bipolar disorders, but associated costs and actual treatment patterns in the U.S. for both disorders have not been comprehensively reviewed.

Leona Bessonova, PhD, director of health economics and outcomes research at Alkermes, and colleagues conducted two systematic literature reviews to address the clinical and economic research gaps for SGA use among these patient populations.

Healio Psychiatry spoke with Bessonova about the history of SGAs, the findings of these studies and potential future research. – by Joe Gramigna

Question: Can you provide background on second - generation antipsychotics and t heir use in bipolar disorder and schizophrenia.?

Answer: Antipsychotics have really been the pharmacologic standard of care for treating schizophrenia since around the 1950s, but these medications have evolved and changed over the years. Initially, there were first-generation antipsychotics, which were effective but were associated with a variety of side effects, such as extrapyramidal symptoms. Eventually, SGAs were developed. They are often preferred due to their improvements in safety-related issues and overall improved safety and tolerability profiles. SGAs are effective as a pharmacologic treatment for schizophrenia. Many medications that are effective in schizophrenia are also effective in bipolar disorder and have that indication per their labeling. Schizophrenia and bipolar disorder both are serious mental health conditions, and antipsychotic use has become common across both. Antipsychotics are certainly used for many individuals living with bipolar disorder, and many of them are labeled for and are effective in treating manic/mixed episodes and for maintenance therapy as well.

Q: What research needs were you seeking to address?

A: We were trying to understand the real-world literature and where unmet needs may exist in the treatment of schizophrenia and bipolar disorder. These were separate projects that were both presented at AMCP Nexus. A lot of the literature around antipsychotic treatment of these conditions comes from seminal studies that looked at clinical trial data and other large data sets. Our intent here was to conduct a systematic literature review of real-world data over the last 10 years regarding the use of antipsychotic medications in schizophrenia and bipolar disorder. We sought to understand what the treatment patterns were around adherence and discontinuation. We also wanted to understand the real-world evidence around health care resource utilization and associated medical costs. We thought that it was important to systematically understand the state of the science around these real-world data.

Q: What methods did you use to conduct these studies ?

A: We searched standard scientific databases like PubMed and the Cochrane Library to identify publications between 2008 and 2018 with a focus on data from adults living in the United States. In the schizophrenia study, we identified 81 articles for inclusion which totaled about 1.17 million patients captured across the real-world literature. For the bipolar disorder study, we identified 39 articles for inclusion that reflected studies with data for approximately 567,000 patients.

Q: What were the main findings of the studies?

A: The literature review revealed that among individuals with schizophrenia, there is still a prevailing unmet need for pharmacologic treatment that can improve adherence and reduce relapse. We saw that adherence was quite prevalent in the population as summarized across the literature. We also observed an increased risk for relapse as described by inpatient types of medical costs, health care resource utilization with respect to inpatient admissions, as well as ED visits and their associated costs.

We concluded that the development of new antipsychotic medications might reduce side effects, and this is perhaps one type of pharmacologic approach that may help improve adherence. Therefore, it also may impact some of the downstream health care resource utilization impacts, such as relapse and hospitalization.

Although side effects are not the only cause of stopping medication, a different study we conducted earlier this year included data from online surveys of participants living with schizophrenia or with bipolar I disorder. In both patient populations, side effects were the most common reason for nonadherence cited, although there were other reasons for not adhering to their oral antipsychotic medication.

Q: What additional research needs to be done regarding anti-psychotics for these patients?

A: We need more research into the impacts of antipsychotic side effects on patient perceptions of their treatment and treatment adherence, as well as the impact of side effects on social functioning and what happens in the real world when patients are taking these medications. Learning some of these gaps, especially from the patient perspective, can inform development of new medications that are highly efficacious and address patient needs.

References:

Bessonova L, et al. 3 Real-world treatment patterns and costs for patients with bipolar disorder: Results from a systematic literature review. Presented at: AMCP Nexus 2019; Oct. 29 to Nov. 1.; Fort Washington, Maryland.

Bessonova L, et al. Real-world treatment patterns and costs of oral antipsychotics

for treatment of schizophrenia in the United States. Presented at: AMCP Nexus 2019; Oct. 29 to Nov. 1.; Fort Washington, Maryland.

Disclosures: Bessonova is an employee of Alkermes.