ACMI Action Alert: Arizona’s 2021 Budget, Please Include These Items for SMI
SB1142 a modest (up to $1 million) tax incentive bill for employers who hire one of Arizona’s 40,000 individuals diagnosed as Seriously Mentally Ill. It serves 2 purposes: offset initial training costs and gives purpose and meaning to individuals ready to take the next step towards recovery and independence.
SB1786 a prisoner transition program designed specifically for individuals with the most serious mental diseases. Transition programs work for those with a serious mental illness and who are most at risk for harming themselves or others without effective transitioning (cost $1.3 million).
On their own, these bills do not solve every gap in Arizona’s continuum of care for individuals with chronic mental illness. However, they are vital parts of that continuum and important steps forward. People with serious mental illness can find support transitioning out of prison and others can find meaning and purpose through employment and inclusion in the community.
SB1030 — The PSRB Bill. With agreed upon floor amendments, this bill will not have a budget impact. It reforms the Psychiatric Security Review Board and will have a significant impact on Public Safety. You can read more about this important work in a recent Op-Ed published in the Arizona Capitol Times.
SB1716. The Arizona State Hospital (ASH) Bill. The Bill does not have an impact on the budget this year as well. We are confident that this is the beginning of reforming the bottleneck that leaves so many in Maricopa County languishing in inappropriate hospital settings or worse. This legislation also seeks to bring more accountability to ASH for the services it provides and improve patient safety.
But we need YOUR help NOW!
Please take a moment to email or call your State Representatives and Senator and ask them to support the two budget items! Every email or phone call matters and makes a huge difference!! Thank You!
Here is a link to find your AZ Representative’s and Senator’s email. You can also quickly email all House and Senate members through this site:
SCR1018 — The Concurrent Resolution. This expresses support for community-based efforts to provide clinically appropriate care to individuals with chronic serious mental illness; Passed unanimously in both the Senate and House! Please take some time to read this Resolution and thank our legislators on social media and through emails.
This Resolution acknowledges the needs of individuals and families living with chronic serious mental illness in Arizona and our legislators unanimously agreed that we must work toward providing a full continuum of care, including access to the Arizona State Hospital, for this group of people.
SENATOR BARTO— We continue to be grateful for Senator Nancy Barto’s tireless work on addressing these gaps in the continuum of care on behalf of the Chronically Mentally Ill in Arizona down at our State Capitol every week! Please express your appreciation when you have a moment as well to other legislators who support these important bills.
Please join us to learn about the “Mapping the Costs of Serious Mental Illness” which was a two-year study commissioned by ACMI to determine various costs associated with serious mental illness. There will be a presentation followed by a Q & A session.
Studies into the dangerous long-term effects of repeated psychosis should underscore the need for early and continued treatment for persons with psychotic disorders. We do understand that long-acting injectable anti-psychotic medications (LAIs) are expensive; however, one episode of psychosis necessitating an inpatient stay will far exceed the cost of LAI treatment. And, yet, despite this knowledge, insurers insist on step therapy. Let us share our experience with our insurer’s denial for our son’s long-acting injectable medication after he had failed at oral medication for a decade and subsequently been stable on an LAI.
Schizophrenia is a complicated chronic disease affecting approximately 3.5 million people in the United States, its annual healthcare costs exceed $155 billion. People living with schizophrenia often experience a reduced quality of life (QOL) and are likely to be homeless, unemployed, or living in poverty. Life expectancy for patients with schizophrenia is 25 years below the average lifespan. Furthermore, patients with schizophrenia experience numerous comorbidities; weight gain, increased cardiovascular risk, and mood and cognition deterioration. Treatment nonadherence can increase the risk of relapse, rehospitalization, and self-harm, leading to reduced Quality of Life (QOL) and increased economic burden.
Here is an Op-Ed from the Arizona Republic on April 23rd on our experience:
The following bills that seek to enhance the well-being of individuals and families with chronic mental illness in Arizona continue to move forward. Here’s where they stand and how you can help:
SB1059 – Clarifies current law requires that a person with mental illness and substance use diagnosis must be evaluated and not summarily dismissed due to the presence of drugs. The intention is to make treatment consistent.
Status: Passed in the Senate. Passed out of House Committees, currently waiting to go to House floor for a vote. Email all House members.
SB1142 – A tax incentive bill for employers who hire people with serious mental illness. Sets the credit amount at $2 for each hour worked by an SMI employee during the calendar year, not to exceed $20,000, tax-paying business owner. Government agencies excluded.
Status: Passed in the Senate. To be heard in the House Appropriations Committee this Tuesday, 3/30, for a vote.
SB1716 – Currently, only 55 patients from Maricopa County can be at the Arizona State Hospital (ASH) — even when there are empty beds. ASH will no longer limit the number of patients who can be admitted based on the county where the patient lives. Admission should be based on clinical needs.
Reforms the existing ASH Governing Body (Governing Body) to operate without conflicts of interest: Most members will NO LONGER be employees of the Department of Health Services, which oversees ASH. Requires that the Chair of the Independent Oversight Committee (IOC) be invited to Board meetings and provided quarterly reports about human rights violations with patients. Improves transparency — requires Governing Body file annual reports with the Legislature that describe the treatment provides and what is working.
Patient safety improvement: ASH has an outmoded video surveillance system that puts patient safety at risk. We need a better surveillance system. The bill requires ASH to maintain a surveillance system with video and audio and appropriates $500,000 to do so. ASH administration has requested a new system last year and is currently in a Request for Proposal.
Status: Passed in the Senate. To be heard in the House Appropriations Committee this Tuesday, 3/30, for a vote.
SB1029 & SB1030 – Psychiatric security review board (PSRB) bill, SB1029, requires more information and reports for the Board to ensure that it treats patients fairly and protects the public. The Board now operates without enough information on patients when it makes decisions. The bill has a retired judge become the Chair, so the Board operates by fair rules.
Because the PSRB Board opposes any changes and claims that it operates perfectly, SB1030 ends the PSRB and sends the functions that the PSRB performs to the Superior Court in each county. This saves the state money and will ensure that patients get a fair hearing in front of a judge who follows the law.
Status: Passed in the Senate. Passed in the House Committees, waiting to go to the House floor for a vote.
ACMI would like to thank Senator Nancy Barto, the sponsor of these bills, for her tireless and heroic work on behalf of individuals and families living with chronic mental illness in Arizona! When you have an opportunity, please thank her as well.
We realize that everyone’s life is full; if you are unable to call or email but still want to help the chronically mentally ill, you can partner with us financially. ACMI is a group of dedicated volunteers; no one receives a salary. Your gift will go directly toward improving the well-being of people living with chronic mental illness.
Please contact your legislators by this Monday morning.
Action Alert: Individuals living with chronic mental illness need your help!
Please take a few minutes to call and email members of the House Health and Human Services committee (contact information below) to urge them in supporting SB1716 that will be heard in an HHS Hearing this coming Monday, 3/22.
SB 1716 is a short, simple bill to help the AZ State Hospital (ASH) provide (a) better care for the sickest mentally ill individuals in Arizona, and (b) more transparency to the public and legislature for how care is provided at the hospital.
ASH will no longer be able to limit the number of patients who can be admitted based on the county where the patient lives. Currently, only 55 patients form Maricopa County can be at ASH. — even when there are empty beds:
ASH offers the highest level of psychiatric care. Admission should be based on clinical need, like dangerousness to self and others and beds used for the sickest psychiatric patients statewide.
Nobody should be excluded from treatment because of their zip code.
Reforms the existing ASH Governing Body (Governing Body) to operate like a private board and without conflicts of interest:
Majority of members will NO LONGER be employees of the Department of Health Services, which oversees ASH.
Requires that the Chair of the Independent Oversight Committee (IOC) be invited to Board meetings and provide quarterly reports about human rights violations with patients.
Improves transparency — requires Governing Body file annual reports with the Legislature that describe the treatment provides and what is working.
Patient safety improvement:
ASH has an outmoded video surveillance system that puts patient safety at risk. Need a better surveillance system. The bill requires ASH to maintain a surveillance system with video and audio and appropriates $500,000 to do so.
A better run State Hospital protects public safety and health by getting treatment to our most mentally ill patients ad holding the hospital accountable.
Sample of suggested email and/or talking points for phone call. Please tailor your own message using one or more of the following sentences:
Dear Representative _______,
I ask that you support SB 1716. We need to improve our State Hospital and protect the public.
All beds available there should be open to the sickest people in Arizona.
We need better accountability at the hospital because of the dangerousness of the people treated there.
House of Representatives,Health and Human Services Committee members contact information:
Every parent’s worst nightmare is the thought of possibly losing a child in an accident or to a serious illness. An even greater fear is the thought of losing a child to an abduction and never knowing where that child is or who the child is with. Moreover, no parent wants to see their child abused or to be an abuser.
I have lost a child……. to a serious mental illness and addictions.
I have lost a child to multiple “accidents” in the current mental health system in which I have tried to participate. I go to bed every night not knowing where my child is or who she is with. I face each new day with the fear that she did not survive the night. Every day I brainstorm and research what else I might do to find her and get her to a hospital where she can be helped. Occasionally, I get a call from a police officer who has had an encounter with her, usually for trespassing or loitering. The call is a result of recent missing persons’ report that I filed. I am told that she is “okay” by the officer, even if she is demonstrating psychotic behavior, dressed in appropriately for the weather, calling 911 because she believes that she has been run over by a truck, or staying in settings where assaults are frequent.
Because she has not been given proper care and limits are placed on those of us (family, primarily) who are trying to help her, the results are as follows: multiple arrests, jail time, cruel solitary confinement, car accidents, fines, court hearings, emergency calls to police and fire departments, hospitalizations for both physical and psychiatric treatment, rehabs, halfway houses, domestic violence calls, petitions, court ordered appointments at clinics, dental repairs from assaults, disease, property damage, job losses, and loss of all meaningful relationships of friends and family.
My “child” is an adult who is persistently and acutely disabled due to mental illness and addictions. I am told over and over by physicians, law enforcement officers, counselors and friends, “She is an adult. You can’t force her to get help.” “She has to hit bottom first.” “We can’t tell you if she has been admitted.” “She can be talking to a light pole, but unless she has threatened to harm herself or others, we cannot admit her.” “Since she is already under court ordered treatment, you cannot petition her for pick-up. She has been evaluated already. She just needs to show up for her meds at her assigned clinic.” These comments demonstrate the lack of understanding when it comes to mental health and addiction issues. People who are not thinking clearly cannot make decisions in their best interest. Their brain is lying to them and sending a false narrative. Hitting bottom often means death. What good is court ordered treatment, if once you get it you cannot be evaluated again should you have a setback in your mental stability! Most severely mentally ill people have a very difficult time managing their own medications and even getting to all of the appointments without assistance.
Based upon calls from the police, my daughter is most likely living in a box on the streets of Phoenix and has been there at least 10 months. Previous to her leaving my home, she had lived with me for a year. It was one of the nicest years we had spent with her. She had developed a few close friends, interacted with family again, paid off most of her fines, obtained a job, bought a car, traveled with us, and went to all of her appointments at the court appointed clinic.
There were two things that I think made the most difference in our daughter’s progress: parental involvement and a longer stay at the mental health hospital initially. Obtaining a lawyer and gaining temporary guardianship was the first step in being able to be more involved in her care. Additionally, the longer stay at the psychiatric hospital allowed her to be evaluated thoroughly, stabilized, and prescribed the correct medication. It was amazing to see the difference in how she interacted with us and life in general following her hospital stay. Previous stays in the hospital had been so short (3-7 days) resulting in her return to the streets.
What failed? Why are we back where we started over a year ago? I believe when a medication change took place through her clinic there was a set-back in her mental health at that time and her desire for meth increased. We (her legal guardians) once again admitted her to UPC due to psychotic behavior. She was then sent to a different hospital and there they changed her medication again rather than prescribe what she had previously taken successfully a year before. I believe if she had gone back to the same hospital and seen the same doctor, she would be in a different place now. Long term care offers a chance to stabilize and seeing the same doctor offers consistency in care. The out-patient clinics primarily serve as dispensaries of meds, not in-depth evaluation and continued care. When we sought to renew guardianship, this process was dead on arrival because our paperwork had to be completed by a psychiatrist. All of her appointments at her court ordered clinic had been with the equivalent of a PA.
We must increase the number of secure, mental health hospitals. Current numbers are grossly inadequate.The length of hospital stays must increase for the seriously mentally ill allowingtime for proper evaluation, stabilization, medication, and a proper post hospital plan. We needsupervised housing for the SMI once released from the hospital as a protection for the patient, family and the general public. Currently, many SMI patients find housing in drug rehab settings which are not set up for the SMI population. Others return to the street or with family who are not always equipped to provide adequate supervision and support.
For change to take place, we must not view mental illness/addictions any differently than we do someone with dementia, Alzheimer’s disease, autism, or delayed mental functions. We make sure that they are in a safe environment and decisions are made with their best interest at heart. The SMI are being neglected and not receiving the help they so desperately need. Just walk around downtown Phoenix to see how many of the SMI are living. We take care of stray dogs better than these precious human beings.
I hope our daughter can soon get the help she needs before it is too late. We have lived the nightmare and I have only shared a brief summary of this past year, not the previous twenty years.
Anonymous Parent (in order to protect my daughter’s privacy)
These are the families that ACMI advocate for. They are the most vulnerable.
Here are my thoughts about the IMS exclusion and appropriate treatment of people with serious mental illness. We need all the levels of care available in the continuum of care. Today in-patient care is significantly limited due to this archaic Medicaid rule.
In today’s blog from Pete Earley, he refers to a report by Steven Eida, a senior fellow at the Manhattan Institute and editor of City Journal, and Carolyn Gorman, a policy analyst on issues related to serious mental illness who has served as a board member of Mental Illness Policy Org., a nonprofit founded by the late DJ Jaffe.
The Association for the Chronically Mentally Ill (ACMI) has championed the rights of the chronically mentally ill for more than three years. Our focus has been on creating appropriate housing for people with chronic mental illness, in other words, those people with serious mental illness who are not adherent to the current treatments and policies available to them under our Arizona behavioral health system. This year, we made efforts to reform our state psychiatric hospital, the Arizona State Hospital (ASH). This article is directly on point and aligns perfectly with our goals in trying to make people realize that this group of non-adherent SMI, who we choose to call the chronically mentally ill, are not well served by relegating them to the usual treatments available in the community, but, instead, frequently need longer-term treatment in level 1 psychiatric hospitals.
Also, after stability, when released to the community, they need more intensive supervision in order to treat their chronic psychiatric illness and have meaningful lives.
In addition, an upcoming study by the Morrison Institute, sponsored by ACMI, found that there were significant savings to the behavioral health system because of the decreased costs that resulted when this notch group of seriously mentally ill, the chronically mentally ill, are treated appropriately, safely, and humanely.
Will Eliminating Old Rule Return “Snake pit” Hospitals Or Help Seriously Mentally Ill Americans Get Much Needed Long Term Care?
(2-26-21) A conservative think tank has joined a growing national chorus calling for an end of a federal rule that discourages states from building psychiatric hospitals and providing long-term, in-patient care for the seriously mentally ill.
What is the IMD Exclusion and why should you care?
It’s a rule that has been around since 1965 that discourages states from building and supporting large psychiatric hospitals and pushes them instead to provide community based treatment. The so-called “16 bed rule” accomplishes this by denying states Medicaid reimbursement for adults between the ages of 22-to-64 if they are treated in psychiatric hospitals and other facilities which have more than 16 beds. States must pay 100 percent of the cost of care for the seriously ill in most long-term psychiatric hospitals, compared to 50 percent for those treated in the community.
The new report’s authors, Stephen Eide and Carolyn D. Gorman, provide a thoughtful argument in favor of dumping the rule.
They document how difficult it is for parents and others to find hospital beds when someone is in the midst of a psychiatric crisis. It is not unusual for individuals to be turned away from emergency rooms or “boarded” in them for several days waiting for a hospital bed to become available. The lack of treatment beds also leads to individuals, who can’t get help, being arrested. The authors argue that Americans with serious mental illnesses simply can’t always get the long term help that they need in a community setting.
The 16 bed rule was enacted, in part, to put an end to warehousing patients in huge state hospitals, and those who support keeping it fear that state hospitals, once again, will become giant “snake pits” if the rule is repealed.
The authors of the Manhattan Institute report disagree.
They claim safeguards are in place now that weren’t years ago. Patients must be considered a danger to themselves or others before being held against their will in a state hospital. Many more treatment programs are available now than when state hospitals were the only choice. Federal laws, especially the Supreme Court’s Olmstead ruling, which requires individuals with mental illnesses be held in the least restrictive settings, will insure patients aren’t abused and forgotten in state hospitals. Plus, every state has a Protection and Advocacy Agency, specifically designed to investigate complaints about abuse in state hospitals and other long term facilities.
Modern psychiatric hospitals “are not designed as isolation wards” and “policies on seclusion and restraint are drastically changed” from the old days, the author’s wrote.
Opponents to dropping the rule warn that having Medicaid reimburse states for long term care in larger hospitals will blow up the Medicaid budget, costing as much as $1 trillion. They argue that states would reduce their spending on community care funding if given a choice between community programs and state hospitals.
The authors of the Manhattan Institute report argue the costs would be $5.4 billion spread over a ten year period and there would be no incentive for states to reduce spending on community programs.
Republicans attempted to eliminate the IMD Exclusion when former Rep. Tim Murphy (R-Pa) drafted the Helping Families In Mental Health Crisis Act. (Murphy was credited as an adviser to the Manhattan Institute Report.) But consumer groups, such as Mental Health America, and Disability Rights advocates strongly opposed ending the rule and Democrats successfully blocked Murphy’s language when his bill was incorporated into the 21st Century Cures Act in 2016.
Channeling the late D. J. Jaffe, who was a contributor at the Manhattan Institute, the authors argue that community based mental health services simply fail to help the seriously mentally ill who need long-term care to recover. Community services are failing this group, they argue, partly because of where they are directing their resources and efforts.
“As the number of diagnoses has expanded – and the number of Americans diagnosed at some point in their lifetimes with a mental disorder has increased – the number of claimants on public mental health resources has increased.”
We prefer to spend limited tax dollars and devote time to helping the “worried well” rather than those who need treatment the most.
You can read the full Manhattan Institute report here.
(Do you believe the IMD Exclusion should be dropped? Have you had trouble securing a hospital bed for someone in crisis? Would ending it hurt community services and turn back the clock to “snake pit” hospitals? Let me know your thoughts on my Facebook page.)
About the report’s authors:
Stephen Eide is a senior fellow at the Manhattan Institute and contributing editor of City Journal. He researches state and local finance and social policy questions such as homelessness and mental illness. He has written for many publications, including National Review, New York Daily News, New York Post, New York Times, Politico, and Wall Street Journal. He was previously a senior research associate at the Worcester Regional Research Bureau. Eide holds a B.A. from St. John’s College in Santa Fe, New Mexico, and a Ph.D. in political philosophy from Boston College.
Carolyn D. Gorman is a policy analyst on issues related to serious mental illness and has served as a board member of Mental Illness Policy Org., a nonprofit founded by the late DJ Jaffe. She was a senior project manager at the Manhattan Institute for mental illness policy and education policy. Gorman served on the U.S. Senate Committee on Health, Education, Labor and Pensions. Her writing has appeared in the Wall Street Journal, New York Daily News, New York Post, City Journal, National Review, and The Hill. Gorman holds a B.A. in psychology from Binghamton University and will graduate with an M.S. in public policy from the Robert F. Wagner Graduate School of Public Service at New York University in 2021. Twitter: @CarolynGorm
From the report:
Medicaid’s IMD Exclusion was crafted for an entirely different era. During the last half-century, America built a system of community-based mental health services that did not exist in 1965. Income-support programs for the disabled, assertive community treatment, clubhouse programs, supportive housing, assisted outpatient treatment, supported employment, peer support services—these either did not exist in the 1950s, or they operated on a much smaller scale than now. Nevertheless, a small subset of severely mentally ill individuals still needs inpatient treatment on a short-term, intermediate-term, and long-term basis. The IMD Exclusion inhibits those individuals’ access to medically appropriate care. ..
The Association of the Chronically Mentally Ill is focused on the sickest group within the SMI population. This group is non-compliant with treatment and often afflicted with anosognosia or the lack of ability to perceive the realities of one’s own condition. There are a number of systemic issues within our public systems that impact this target group. One such issue is the 55 bed limit at the Arizona State Hospital, which was created to incentivize the state to create community-based programs. Long past the usefulness of that policy, Josh Mozell’s November 30th, 2020 article in the Capitol Times help to explain some of the fallout of this policy, and the reasons the 55-bed limit should be eliminated.
Solving the problems of our broken mental health system often seems so overwhelming that work does not begin. However, there are narrow solutions with broad implications that can be implemented. One such solution is ending Arizona’s long-standing bed limitation placed upon our state hospital.
It may surprise many to learn that Arizona still has an operational mental asylum. Opened in 1887, it is now known as the Arizona State Hospital. The purpose of the State Hospital is and has always been to provide care for the most mentally ill in our community. For many in that group, months, if not years, of long-term programming is necessary for real recovery. That being the case, the State Hospital becomes the only place in Arizona where they have a chance for meaningful improvement.
However, the hospital is nearly inaccessible for Maricopa County’s residents due to an arbitrary 55-bed limitation. To provide perspective, health policy experts estimate that a community needs between 40 and 60 beds per 100,000 to meet the demand for state hospital beds. In Maricopa County, however, for those who are civilly committed, we have one bed per 100,000.
Why? In 1981, a path-breaking class-action lawsuit, Arnold v Sarn, was filed on behalf of Maricopa County’s mentally ill. The litigation lasted over 30 years, finally settling in 2014. During that time, the case revolutionized Arizona’s mental health system. But in 1995, the parties entered into a plan to resolve the litigation. In that stipulation, the parties agreed there would be a cap of 55-beds at the Arizona State Hospital for civilly committed patients from Maricopa County. Due to this limitation, the only pathway to gaining admission is to fail repeatedly, in spectacular fashion, and do it for years.
The failure looks like this: Because this group of chronically mentally ill does not receive the long-term treatment needed, they transition from one crisis to the next, experiencing more serious decompensation. This results in a constant recycling through the various public systems at an enormous cost to the taxpayers. Year by year the person is increasingly overcome by the disease. There are persistent police and fire interactions, multiple visits to emergency rooms, long medical hospital stays, arrests for petty crimes, and, unfortunately too often for serious crimes. Then there is the involvement of the judicial system, homeless shelters, and the penal system. Rinse and repeat – the cycle continues for years. For this group of people, the system is not just broken, but inhumane.
The bed limitation also has many downstream effects. For instance, those who need access to Arizona State Hospital do not disappear simply because there is not an available bed. Instead, they consume scarce mental health resources, which otherwise could be provided to others in need. The most serious manifestation is in our civil commitment system. To be hospitalized through civil commitment, a patient receives a bed at Valleywise Health, the one hospital system licensed to carry out the process in Maricopa County. The average length of stay during the process is 22 days, and, during those 22 days, the patient receives very good psychiatric care. But, we have just 343 beds in Maricopa County, which is far less than what is needed to serve the population. Due to that bed shortage, our system is already limited in its ability to treat those who need help.
The Arizona State Hospital 55-bed limit pours gasoline on a fire. To keep the patient and the public safe, Valleywise is often forced to keep the patient for months until the patient stabilizes, without the infrastructure for true long-term treatment. Therefore, despite maximizing the stabilization possible at a short-term hospital, it is not enough. The patient is often back at Valleywise within weeks after release. This routine can continue for years until the patient finally fails enough for State Hospital consideration.
Commonly, the amount of failing will total 1,000 days or more at Valleywise – in addition to visits to the ER, jail, crisis centers, etc. Therefore, on just one patient who would be most appropriately treated at Arizona State Hospital, 45 patients could receive a 22-day hospital stay at Valleywise. Consequently, the bed shortage is made worse, individuals do not receive care, and scarce state resources are exhausted. This extends the system to the point of breaking, which cannot be sustained.
Our system is broken in many ways. But again, there are many narrow fixes with broad positive implications which start the process of improvement. This is one of those narrow fixes. The 55-bed cap is a monumental failure – it should be eliminated.
Josh Mozell is a lawyer with Frazer, Ryan, Goldberg & Arnold, L.L.P.
I was pleasantly surprised to read this article stating the FDA approval for a new drug trial for schizophrenia. Research into the treatment of schizophrenia is long overdue, as it can be a devastating disease process.
Schizophrenia is a complicated chronic disease affecting approximately 3.5 million people in the United States, and its annual healthcare costs exceed $155 billion. People living with schizophrenia often experience a reduced quality of life (QOL) and are more likely to be homeless, unemployed, or living in poverty than the general population. Life expectancy for patients with schizophrenia is 15 to 20 years below the average. It is complicated by numerous comorbidities, such as weight gain, increased cardiovascular risk, and mood and cognition changes. Treatment nonadherence can increase the risk of relapse, rehospitalization, and self-harm, leading to a reduced QOL and increased economic burden.
Schizophrenia is a complex chronic illness with multiple comorbidities and high mortality rates. The development of Long-Acting Injectables and generic medication options has significantly improved patient adherence and reduced care costs in patients with schizophrenia. Despite these advances, schizophrenia has a high economic burden for patients and society. Providers caring for patients with schizophrenia are charged with a complicated task of ensuring individualized care while managing numerous adverse effects that may occur with recommended therapy (Wander, 2020).
The schizophrenia drug currently has a PDUFA date set for November 15.
A US Food and Drug Administration’s (FDA) advisory committee has given a recommendation for the ultimate approval of a combination of olanzapine and samidorphan (ALKS 3831) in schizophrenia patients.
During the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, the group voted 16-1 to approve the treatment, developed by Alkermes.
ALKS 3831 is an investigational, novel atypical antipsychotic earmarked for once-daily oral application for the 2 psychiatric disorders composed of samidorphan, a novel, new molecular entity, co-formulated with olanzapine, an established antipsychotic agent in a single bilayer tablet.
Recently, researchers presented data from the ENLIGHTEN-2 trial, a six-month study evaluating the weight gain profile of ALKS 3831 compared to olanzapine in 561 patients with stable schizophrenia.
“The favorable outcome of today’s joint advisory committee meeting represents an important milestone for the patients, clinicians and families who may benefit from new medicines for the treatment of schizophrenia and bipolar I disorder,” Craig Hopkinson, MD, chief medical officer and executive vice president of R&D at Alkermes, said in a statement. The personal testimonies shared during today’s open public hearing reinforced the need for treatment approaches that consider patients’ overall mental and physical health. The ALKS 3831 development program is part of our ongoing commitment to develop new therapeutic options for adults living with serious mental illness.”
There is currently a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15.