lais and the challenge of medication non-adherence...outcomes for patients, but also has important...
TRANSCRIPT
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LAIs and the Challenge of Medication Non-Adherence
The Care Transitions Network
National Council for Behavioral Health
Montefiore Medical Center
Northwell Health
New York State Office of Mental Health
Netsmart Technologies
Lauren Hanna, M.D. The Zucker Hillside Hospital
Northwell Health
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Welcome to the LAI Innovation Community Thank you for joining!• We will have a series of webinars and affinity group meetings
• The goals are:• To help practices understand LAIs as an important intervention for medication
non-adherence and
• To help practices increase their utilization of LAIs• Supports are available for clinical staff
• Supports are available for administrative staff
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What we will need from you
• Your enthusiasm for the Innovation Community
• Your active participation in the Innovation Community
• Your work within your agency to insure that your agency staff are aware of the LAI Innovation Community and that appropriate staff attend the Innovation Community events that support their agency role
• Developing and implementing plans specific to your agency for increasing LAI use
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Any questions before we get started?
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Care Transitions Network
Clinical Goal:Reduce all-cause re-hospitalization rates by 50% for people with serious mental illness
Transformation Goal: Support enrolled organizations in their preparation for transition to value-based payments
Reducing hospitalizations not only demonstrates improved clinical outcomes for patients, but also has important financial implications.
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Value-Based Payments
Incentive for Volume Incentive for Results
Fee For Service
Service Payment
Service
Service
Payment
Payment
Metrics to track:
• Unit of care
• Volume
Quality
CostPopulation
Metrics to track:
• Clinical outcomes/best practices
• Population
• Total cost
$$
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$33,187Estimated annual costs for care of a patient who has a relapse
Cost of Care for a Relapse of Schizophrenia
Avg. cost of a 10 day inpatient stay can range from approx. $10,000 - $17,000 or more
(depending on payer)
Estimated annual costs for care of a patient who does not have a relapse
$11,771
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What strategies can we use to reduce hospitalizations?
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We tend to focus on
what we don’t yet have
in treatments
Maybe we should also
focus on using better
what we already have
White House Medicine Cabinet during the Madison
administration
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One available treatment we could use better:
Long Acting Injectable Antipsychotics (LAIs)
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Long Acting Injectable (LAI) Antipsychotics
• They contain the same active medication as the oral form of the medication
• Each injection provides between 2 weeks to 3 months worth of continuous antipsychotic medication
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The Adherence ChallengeMaking the case for LAIs
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The Clinical Challenge
This leads to poor outcomes
At least half of people do notfollow prescribed treatments
It is difficult and time consuming to assess adherence with oral medications
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Medication Adherence: Basic Facts• Difficulty with adhering to chronic medical treatments is a human
characteristic
• It isn’t just people with psychosis, it is most people
• Help should be the norm, not just given to select people
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Non-adherence in the treatment of chronic disorders
• In developed countries, about 50% of patients with chronic diseases adhere to long-term therapy1
• 33–69% of all medication-related hospital admissions in the US are due to poor medication adherence2
• One-third of all prescriptions are never filled3
• >50% of filled prescriptions are associated with incorrect administration (not taken as prescribed)3
1. WHO Report 2003; Adherence to long-term therapies: evidence for action; 2. Osterberg, L and Blaschke, T. N Engl J Med 2005;353:487–97; 3. Peterson AM, et al. Am J Health Syst Pharm 2003;60:657–65.
15
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Stopping medication is the most powerful predictor of relapse among people with schizophrenia
0
1
2
3
4
5
6
Robinson D, et al. Arch Gen Psychiatry 1999;56:241–7
• Survival analysis: risk of a first or second relapse when not taking medication ~5 times greater than when taking it
4.894.57
First relapse Second relapse
Haz
ard
rat
io
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Poor antipsychotic adherence over time in schizophrenia
MPR = medication possession ratio; VA = Veterans Affairs.
Valenstein M, et al. J Clin Psychiatry. 2006;67(10):1542-1550.
0
10
20
30
40
50
60
70
Year 1 Year 2 Year 3 Year 4 Any Year
Analysis of 34,128 VA patients with schizophrenia receiving regular outpatient mental healthcare.
Poor antipsychotic adherence defined as annual MPR < .80. 18% had poor antipsychotic adherence
in all 4 years.
Ad
he
ren
ce (
%)
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Percentage of non-adherent patients identified by different methods
Non-adherence defined on the basis of electronic monitoring. Non-adherent patients took <80% of
prescribed medication over a 12-week period.
0
10
20
30
40
50
60
70
80
90
100
No
nad
her
ent
Pati
ents
, %
SelfReport
16
56
PhysicianReport
In-homePill Count
Velligan DI, et al. Psychiatr Serv. 2007;54:1187-1192.
42
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Clinical implications of LAIs
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LAIs eliminate covert non-adherence
Oral Medications
• Not always clear when a patient isn’t adhering to medication
• Detailed adherence assessments are needed at ALL visits
LAIs
• Treatment team knows whether a patient is taking a medication and dosage
• Simplifies adherence assessment
Knowing 100% whether a patient is or is not taking a medication greatly improves making treatment decisions
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Implications for Treatment
Oral Medication
• Often unclear if the lack of response it is because of non-adherence or actual non-response to the antipsychotic
• Mistaking non-adherence for non-response can lead to frequent medication switches, adding unnecessary additional medications or escalating the prescribed dose
LAIs
• Non-response to an adequate trial of a LAI, is a clear indication that a change to another antipsychotic is needed
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Implications for Relapse
Oral Medication
• There is often a time lag between the start of medication non-adherence and symptom relapse
• If a patient relapses, it is often unclear whether it was due to lack of adherence
LAIs
• If a patient relapses while taking a LAI it is clear that it was due to a failure of the medication and not a failure of the patient to take the medication
• Eliminates the need to “grill” the patient about adherence
• Maintenance medication decreases the risk of relapse but does not eliminate the occurrence of relapse
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Evaluating the need for clozapine
• Clozapine should be offered to all patients who need it but
• Clozapine should not be given to patients who would do well with other antipsychotics
• LAIs facilitate determining which patients do not respond to antipsychotics other than clozapine and for whom the benefit/risk ratio for clozapine is favorable
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Data supporting that these clinical advantages translate into better patient outcomes
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Strengths and weaknesses of different study types: impact on outcomes
Kishimoto T, et al. Schizophr Bull 2013; Jan 2 [Epub ahead of print]; Tiihonen J, et al. Am J Psychiatry 2011;168:603–609
Strengths Weaknesses
Randomizedcontrolled trials
• Design reduces expectancy and rater biases
• Not the best way to study interventions with potential adherence benefits
• Patients not representative of clinical practice – more adherent, less severe disease
• Double-blind studies may increase selection bias
Mirror-image studies • More reflective of clinical practice • Expectation bias is inherent in mirror-image studies and may impact the main outcome
• Patients switch from oral antipsychotics to LAIs but not vice versa
Cohort studies • Patient selection bias is reduced compared with other study types
• Selection of medication in open studies may introduce bias by improving adherence
• LAI patients are categorically different and more seriously ill than oral antipsychotic patients
• Confounding factors must be adjusted
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Real-world studies favor use of LAI antipsychotics
LAI=long-acting injectable antipsychotic; RCT=randomized controlled trial; RR=risk ratio.Kirson N et alPoster presented at: 52nd Annual Meeting of New Research Approaches for Mental Health Interventions; May 29-June 1, 2012; Phoenix, AZ.
2.0
1.8
1.6
1.4
1.2
1.0
0
0.8
0.6
0.4
0.2
Randomized Clinical Studies
2.2
Ad
just
ed
Ris
k R
atio
ProspectiveStudies
RetrospectiveStudies
RR=0.622
RR=0.877
RR=0.558
Favo
rs
ora
l
RelapseHospitalizationAll-cause discontinuationOverall
RCT Real-world
As study design shifts toward real-world populations, LAI formulations display significant advantages
Favo
rsLA
I
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A recent “real world” study
• Tihonen and colleagues studied 29,823 patients with schizophrenia obtained from comprehensive national databases in Sweden
• Mean duration of follow-up was 5.7 years
• 43.7% had a psychiatric hospitalization during the follow-up
• The risk of rehospitalization was 20% to 30% lower during LAI treatment compared with oral antipsychotic treatment
JAMA Psychiatry 2017;74:686-693
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Taking these data an applying them at your facility• A first step is to help staff at your agency understand how pervasive
non-adherence is at your facility• Its easy for staff to believe that patients are often non-adherent but hard to
acknowledge how frequently their own patients are non-adherent
• There are different methods to assess adherence. e.g. • Surveys
• Pill counts
• Electronic monitoring
• If your agency already monitors adherence, what are the results?
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An adherence measure available to everyone
• PSYCKES has an adherence measure “Adherence-Antipsychotic (Schiz)”
• It is “the percentage of adults 18-64 years with a diagnosis of schizophrenia who had an antipsychotic medication available to them less than 80 percent of the time (based upon prescriptions filled in the past 12 months, from the first antipsychotic prescription filled to the report date). NOTE: The % reported is the % WITHOUT medication.
• An important limitation: Just because a prescription is filled does not mean that a medication is taken. However, having a medication available to be taken is one requirement that needs to be fulfilled if a medication is going to be taken
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Statewide, the non-adherence rate is 38.1%
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Steps to find the rate at your facility
• First, log into PSYCKES
• Next, go to the Indicator Set
• Click on the BH QARR-Improvement Measure
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Finding the BH QARR Improvement Measure
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Once you click on BH QARR Improvement, you will see the adherence measure
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The non-adherence rate for this facility is 56.76% compared with 50.35% in their region and 38.1% statewide
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As the next de-identified example shows, clicking on the Adherence-Antipsychotic link brings up a list of all the patients at your facility who are non-adherent
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Summary
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Who Might Benefit by Adherence Enhancing Interventions such as LAIs?
• Data suggest at least half of all patients would benefit
• For patients who would benefit from an antipsychotic, LAIs are an important adherence enhancement tool
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Next steps
• Examine the adherence data from your site
• Start planning about how these data can be used at your site globally and in particular about LAI use
• Spread the word about the LAI Innovation Community to your fellow staff members
• Webinar #2• Helping patients and their families make informed decisions about LAIs• Target audience: prescribers and therapists
• A team member from Northwell will reach out to participants before the next webinar on 8/17
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Northwell Expert Support Team
John Kane, M.D.Chairman of the Department of PsychiatryHofstra Northwell School of Medicine
Lauren Hanna, M.D.Staff PsychiatristThe Zucker Hillside Hospital
Delbert Robinson, M.D.Professor of PsychiatryHofstra Northwell School of Medicine
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Event Date/Time Audience
Webinar #2: Helping Patients Make Decisions about LAI Treatment
Thursday 8/17 from 12-1pm Prescribers, other clinicians
Affinity Group #1: Current Reimbursement for LAIs
Thursday 8/31 from 12-1pm Administrators
Affinity Group #2: Setting up a LAI Program Thursday 9/14 from 12-1pm Administrators
Affinity Group #3: Switching Strategies, Dosing and Other Prescribing Issues
Thursday 9/28 from 12-1pm Prescribers
Affinity Group #4: Sustaining a LAI Program Thursday 10/12 from 12-1pm Administrators and Clinicians
Showcase Webinar Tuesday, 10/31, 12:00–1:00 pm E.T.Clinical Directors and Clinical
Supervisors
Upcoming Events
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Lauren Hanna, [email protected] Zucker Hillside HospitalNorthwell Health
The project described was supported by Funding Opportunity Number CMS-1L1-15-003 from the U.S. Department of Health & Human Services, Centers for Medicare & Medicaid Services.
Disclaimer: The contents provided are solely the responsibility of the authors and do not necessarily represent the official views of HHS or any of its agencies.