NAMI is proud to be part of the movement to assess value of health care treatments and interventions, and to build an infrastructure for patient engagement throughout the healthcare system, particularly in the shift to value-based payment and delivery models. However, we think it’s crucial that any efforts to measure and assess value, incorporate the patient perspective, and consistently and meaningfully engage patients along the way.
When organizations conducting value assessments initiate their work without engaging patients in the development of their fundamental research questions, we worry about its ultimate impact on affected patients. Without the perspective of patients at the table, the real-life benefits and risks of treatment that matter to patients cannot be identified and measured. Ultimately, if value is not measured from the patient’s perspective, patient access to important or necessary treatments could be impeded. We are concerned this may be the result of the upcoming assessment of treatments for tardive dyskinesia (TD) by the Institute for Clinical and Economic Review.
We have several outstanding concerns with the materials ICER has released thus far.
Lack of patient engagement. While we are hopeful that the background and scope proposal recently published by the Institute for Clinical and Economic Review (ICER) for its planned effectiveness and value review of available treatments for tardive dyskinesia (TD) will be the exception, it is not off to a great start in terms of patient engagement. It was not well-known that ICER was initiating this work, even for NAMI as the largest grassroots mental health organization. Therefore, organizations like ours that represent patients with this condition were forced to respond quickly. While PIPC and others have long advocated for ICER to engage patients early and often in their work to assess the value of treatments, we are discouraged by the initial process for patient engagement and the lack of transparency that ICER was initiating this work.
Failure to capture patient-centric outcomes. Though there is not a cure for TD, there are several promising treatments on the horizon. The possibility of an effective therapy to treat the disorder and manage symptoms would be of enormous value to patients, mitigating social isolation and the inability to interact with the public in settings. Any review of these new interventions must provide significant weight to the value of improving the quality of life for someone living with TD.
The study described by ICER fails to adequately take into account the personal burden that persons living with TD must bear every day. By limiting the focus to clinical effectiveness and economic impact, ICER review fails to consider the social impacts of TD, its impact on family caregivers and how TD contributes to other medical co-morbidities. We know limiting the scope of the review to schizophrenia is problematic and fails to capture the full breadth of the population impacted by TD, thereby limiting the utility of the review.
Failure to capture issues presented in real-world treatment scenarios. NAMI has experience to share about the challenges facing people living with TD seeking the right medication. Our NAMI 800 number Helpline takes hundreds of thousands of calls each year to assist people with mental illness in finding treatment. This has led us to take strong position against public policies that promote switching of medications. Yet, the proposed ICER scope document fails to consider the risk associated with such an approach and the lack of evidence supporting its effectiveness. In real-life clinical practice, reducing, replacing, or removing antipsychotic treatment can jeopardize recovery and stability for people living with a serious mental illness.
Inclusion of non-FDA approved indications. NAMI is very concerned that ICER’s proposed assessment specifically includes an off-label intervention for TD for which there is limited evidence in existing clinical treatment guidelines. Many in NAMI’s consumer and family membership continue to struggle everyday with TD. For too many of them, outdated off-label treatment has not offered them relief from this disabling and enormously stigmatizing condition. The promise of two near therapies that offer some hope of improvement and recovery is long overdue.
While we may worry that the design of ICER’s proposed review for TD treatments will result in limited access to potentially promising therapies, we also know that organizations like PIPC, National Health Council, FasterCures, National Patient Advocate Foundation and others are working diligently on patient-centered value frameworks that are aligned with what matters to patients. Moving forward, we hope that ICER will follow PIPC’s lead to make value to the patient the top priority.
We have several outstanding concerns with the materials ICER has released thus far.
Lack of patient engagement. While we are hopeful that the background and scope proposal recently published by the Institute for Clinical and Economic Review (ICER) for its planned effectiveness and value review of available treatments for tardive dyskinesia (TD) will be the exception, it is not off to a great start in terms of patient engagement. It was not well-known that ICER was initiating this work, even for NAMI as the largest grassroots mental health organization. Therefore, organizations like ours that represent patients with this condition were forced to respond quickly. While PIPC and others have long advocated for ICER to engage patients early and often in their work to assess the value of treatments, we are discouraged by the initial process for patient engagement and the lack of transparency that ICER was initiating this work.
Failure to capture patient-centric outcomes. Though there is not a cure for TD, there are several promising treatments on the horizon. The possibility of an effective therapy to treat the disorder and manage symptoms would be of enormous value to patients, mitigating social isolation and the inability to interact with the public in settings. Any review of these new interventions must provide significant weight to the value of improving the quality of life for someone living with TD.
The study described by ICER fails to adequately take into account the personal burden that persons living with TD must bear every day. By limiting the focus to clinical effectiveness and economic impact, ICER review fails to consider the social impacts of TD, its impact on family caregivers and how TD contributes to other medical co-morbidities. We know limiting the scope of the review to schizophrenia is problematic and fails to capture the full breadth of the population impacted by TD, thereby limiting the utility of the review.
Failure to capture issues presented in real-world treatment scenarios. NAMI has experience to share about the challenges facing people living with TD seeking the right medication. Our NAMI 800 number Helpline takes hundreds of thousands of calls each year to assist people with mental illness in finding treatment. This has led us to take strong position against public policies that promote switching of medications. Yet, the proposed ICER scope document fails to consider the risk associated with such an approach and the lack of evidence supporting its effectiveness. In real-life clinical practice, reducing, replacing, or removing antipsychotic treatment can jeopardize recovery and stability for people living with a serious mental illness.
Inclusion of non-FDA approved indications. NAMI is very concerned that ICER’s proposed assessment specifically includes an off-label intervention for TD for which there is limited evidence in existing clinical treatment guidelines. Many in NAMI’s consumer and family membership continue to struggle everyday with TD. For too many of them, outdated off-label treatment has not offered them relief from this disabling and enormously stigmatizing condition. The promise of two near therapies that offer some hope of improvement and recovery is long overdue.
While we may worry that the design of ICER’s proposed review for TD treatments will result in limited access to potentially promising therapies, we also know that organizations like PIPC, National Health Council, FasterCures, National Patient Advocate Foundation and others are working diligently on patient-centered value frameworks that are aligned with what matters to patients. Moving forward, we hope that ICER will follow PIPC’s lead to make value to the patient the top priority.
