Transcript AAN MS Quality Measurement Set

CasePerspectives:
Illuminating Dark Pathways in Complex MS Cases
Program Highlights
Stephen Krieger, MD
Associate Professor of Neurology
Corinne Goldsmith Dickinson Center for MS
Director, Neurology Residency Program
Icahn School of Medicine at Mount Sinai
New York, New York
AAN MS Quality Measurement Set
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A multidisciplinary AAN working group identified areas for
improvement in the diagnosis and management of patients with MS
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The need for improvement is related to the high cost of treatment and
broad range of symptoms that affect patients with MS
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The AAN working group has recommended 13 areas for the quality
measurement set
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This program focuses on the guidelines that support the quality
measures related to MS diagnosis and treatment, but the full set
also addresses MS symptom management
American Academy of Neurology Multiple Sclerosis Quality Measurement Set Draft 2014.
Available at http://tools.aan.com/practice/measures/measures/MS-All.pdf.
Draft AAN MS Quality Measurement Set Emphasizes Using
2010 McDonald Diagnostic Criteria
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Diagnostic errors are common in MS—reducing misdiagnosis
would ensure that DMT is provided only to patients who need it
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2010 criteria rely primarily on validated MRI features to confirm the
MS diagnosis
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DIS and DIT, in the absence of an alternative diagnosis, remain the
foundation for establishing an MS diagnosis
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2010 revisions simplify and streamline diagnosis, and in cases
where the clinical picture is consistent with MS, are sensitive and
specific for MS
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Using the 2010 criteria can lead to an earlier diagnosis, with fewer
diagnostic tests, than previous versions of the diagnostic criteria
Polman CH, et al. Ann Neurol. 2011:69:292-302. American Academy of Neurology Multiple Sclerosis Quality Measurement Set Draft 2014.
Available at http://tools.aan.com/practice/measures/measures/MS-All.pdf.
Summary of the 2010 McDonald Diagnostic Criteria
for Relapsing-Remitting MS
Clinical
Attacks
Clinical Presentation
Additional Data
for MS Diagnosis
Objective clinical evidence
of ≥2 lesions
or
≥2 attacks
None
Clinical evidence of 1 lesion with
historical evidence of a prior attack
Objective clinical evidence
of 1 lesion
Dissemination in
time
Objective clinical evidence
of ≥2 lesions
Dissemination in
space
Objective clinical evidence
of 1 lesion
Both dissemination in
time and space
1 attack
Polman CH, et al. Ann Neurol. 2011:69:292-302.
Summary of 2010 McDonald Diagnostic Criteria
Requirements for DIS and DIT
Dissemination in Space (DIS)
≥1 T2 lesion in 2 of the following 4 regions
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•
•
•
Periventricular
Juxtacortical
Infratentorial
Spinal cord*
Another clinical attack at a distinct CNS site
*For patients with brainstem or spinal lesion, symptomatic lesions are excluded
Dissemination in Time (DIT)
A new T2 lesion and/or gadolinium-enhancing
lesion on follow-up MRI*
Simultaneous presence of asymptomatic
gadolinium-enhancing and non-enhancing lesions
A second clinical attack
*Compared to a baseline MRI, irrespective of its timing
Polman CH, et al. Ann Neurol. 2011:69:292-302.
Summary of 2010 McDonald Diagnostic Criteria for PPMS
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DIT and DIS, with other possible diagnoses excluded, remain the principle
for diagnosing PPMS
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Abnormal MRI features in the brain, combined with lesions in the spinal
cord, are sufficient to diagnose PPMS even in the absence of abnormal
cerebrospinal fluid (CSF)
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MRI of the cervical spine is recommended for all patients during the initial
workup for MS
2010 McDonald Diagnostic Criteria for PPMS
One year of disease progression
At least 2 of the following 3 criteria
• Dissemination in space based on ≥1 T2 lesion in the periventricular, juxtacortical, or infratentorial regions
• Dissemination in space in the spinal cord based on ≥2 T2 lesions in the cord
• Positive CSF (oligoclonal bands and/or elevated immunoglobulin G index)
Symptomatic lesions are excluded if the patient has a brainstem or spinal cord syndrome; gadolinium-enhancing lesions are not required.
Polman CH, et al. Ann Neurol. 2011:69:292-302. Giovannoni G. ANCR. 2012;12:8-11.
Rice CM, et al. J Neurol Neurosurg Psychiatry. 2013;84:1100-1106. Consortium of Multiple Sclerosis Centers. 2015 Revised MRI Protocol
and Guidelines. Available at http://www.mscare.org/?page=MRI_protocol.
Draft AAN MS Quality Measurement Set Aligns with
CMSC MRI Protocol for Monitoring Patients
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Monitoring schedule recommended in the draft AAN MS Quality
Measurement Set is based on the 2015 Consortium of Multiple
Sclerosis Centers (CMSC) MRI Protocol
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Patients should have an MRI every 1-2 years to evaluate
subclinical disease activity
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More frequent MRI would be appropriate to investigate clinical
deterioration or other clinical signs of disease activity
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Patient-related factors such as claustrophobia or inability to lie still
for the MRI could affect the frequency
American Academy of Neurology Multiple Sclerosis Quality Measurement Set Draft 2014. Available at
http://tools.aan.com/practice/measures/measures/MS-All.pdf. Consortium of Multiple Sclerosis Centers. 2015 Revised MRI Protocol and
Guidelines. Available at http://www.mscare.org/?page=MRI_protocol.
Summary of CMSC Guidelines for
MRI Monitoring of Patients with an Established Diagnosis of MS
Timing of core brain MRI protocol with gadolinium
for patients with an established diagnosis of MS1
No recent prior imaging available
Postpartum to establish a new baseline
Prior to starting or switching DMT
Approximately 6 months after switching DMT to establish a new baseline
on the new therapy
Every 1-2 years while on DMT to assess for subclinical disease activity
Unexpected clinical deterioration or reassessment of original diagnosis
Progressive multifocal leukoencephalopathy (PML) surveillance2:
1
2
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Every 12 months for serum JC virus (JCV) antibody-negative patients
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Every 3-6 months for serum JCV antibody-positive patients and ≥18 months on natalizumab
Routine spinal cord follow-up is not required unless syndrome is predominately recurrent transverse myelitis.
The core brain MRI protocol for monitoring patients on DMT includes the PML surveillance protocol sequences.
Consortium of Multiple Sclerosis Centers. 2015 Revised MRI Protocol and Guidelines. Available at http://www.mscare.org/?page=MRI_protocol.
Draft AAN MS Quality Measurement Set
Recommends an Annual Disability Assessment
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An annual assessment of disability using a validated MS disability
scale is recommended to provide a quantitative measure of
patient’s disease progression
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The Kurtzke EDSS is the most commonly used scale
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When administration of the formal EDSS is impractical, consider
estimating EDSS, using a focused neurologic exam, or utilizing an
alternative, such as the timed 25-foot walk
Polman CH, et al. Ann Neurol. 2011:69:292-302. American Academy of Neurology Multiple Sclerosis Quality Measurement Set Draft 2014.
Available at http://tools.aan.com/practice/measures/measures/MS-All.pdf.
Frequent Quantitative Monitoring Allows Timely Intervention
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Regular monitoring using MRI and formal neurologic assessments,
in addition to monitoring clinical signs of disease activity, allow
early identification of a suboptimal response to treatment
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The CMSC Consensus Conference for Therapeutic Decision
Making in MS has proposed algorithms for treating RRMS, CIS,
aggressive-onset MS, and for identifying suboptimal responses
Ford CF, et al. Int J MS Care. 2014;16(suppl 6): 23-28. Available at http://ijmsc.org/doi/pdf/10.7224/1537-2073-16.S6.1.
CMSC Consensus Conference on Therapeutic Decision Making
in MS: Proposed Criteria for Switching DMT
Criteria Proposed by the CMSC for Switching DMT
>1 relapses within 12 months while on treatment
≥1 significant relapse and poor recovery with permanent disability
Disease activity on MRI
• ≥1 gadolinium-enhancing lesion
• ≥2 new T2 lesions in 1 year
• MRI activity on consecutive MRIs 3-12 months apart
Sustained, objective disability worsening on the Kurtzke EDSS, 25-foot
timed walk, or cognitive testing
Ford CF, et al. Int J MS Care. 2014;16(suppl 6): 23-28. Available at http://ijmsc.org/doi/pdf/10.7224/1537-2073-16.S6.1.
New and Select Emerging Treatments for MS*
Compound
Mechanism
Status
Indication
Alemtuzumab
CD52 inhibitor
Approved
RRMS
Dimethyl fumarate
Anti-inflammatory
Approved
RRMS
Pegylated IFNβ-1a
Immunomodulator
Approved
RRMS
Teriflunomide
Dihydroorotate dehydrogenase
inhibitor
Approved
RRMS
Daclizumab
Humanized anti-CD25
Phase 3
RRMS
Laquinimod
Immunomodulator
Phase 3
RRMS, progressive MS
Masitinib
Tyrosine kinase inhibitor
Phase 3
Progressive MS
Phase 3
RRMS
Minocycline
Ocrelizumab
Humanized anti-CD20
Phase 3
RRMS, PPMS
Siponimod
Sphingosine-1-phosphate receptor
Phase 3
PPMS
RPC1063
Sphingosine-1-phosphate receptor
Phase 3
RRMS
*Therapies approved since 2012, or compounds with completed phase 3 trials for MS.
Select Pipeline Treatments*
Compound
Target
Compound
Target
Amiloride
Acid-sensing ion
channel 1
MT-1303
S1P1
Obinutuzumab
CD-20
Ocaratuzumab
CD-20
Ofatumumab
CD-20
ONO-4641
Sphingosine-1phosphate receptor
Oxcarbazepine
Sodium channels
Sphingosine-1phosphate receptor
Anti-LINGO1
Myelin
ATX-MS-1467
Immune system
Epigallocatechingallate
Oxidative damage
Firategrast
VLA-4
Ibudilast
Phosphodiesterases
Idebenone
Coenzyme Q10
Pones imod
Imilecleucel-T
T cells
rHIgM22
Myelin
Laquinimod
Quinoline-3
carboxamide
Riluzole
Glutamate receptors
Lipoic acid
cAMP signaling
SBI-087
CD-20
MIS416
Immune system
Secukinumab
IL17
Vatelizumab
VLA-2
Veltuzumab
CD-20
*Compounds with active phase1 or phase 2 trials, or no active phase 3 trials.