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Toxicity and side-effects of licensed MS disease-
modifying therapies: how to improve concordance
Gavin Giovannoni
Institute of Neurology, UCL and
the National Hospital for Neurology and Neurosurgery, UCLH,
Queen Square, London WC1N 3BG.
Lisbon 17-19th ‘05
Compliance: 96/101 (95%) were still on treatment
median of 26 months (range = 12-85) after starting treatment
Lisbon 17-19th ‘05
Redefining our relationship with our patients – “pink is the new black”
Lisbon 17-19th ‘05
What is concordance?
Lisbon 17-19th ‘05
What is concordance?
Two valid terms measuring different things
Compliance The extent to which patients take medicines
according to the prescribed instructions
Measures patient behaviour
Concordance Shared decision making about medicines
between a healthcare professional and a
patient, based on partnership, where the
patient’s expertise and beliefs are fully valued
Measures a consultation process
Source: Weiss M and Britten N, Pharmaceutical Journal vol 271 (493)
Lisbon 17-19th ‘05
Patients are supported
in taking medicines
Prescribing consultations
involve patients as partners
What is concordance?
CONCORDANCE
A process of prescribing and medicine
taking based on partnership
• Patients are as involved as they want to
be in treatment decisions
• Patients are invited to talk about their
views on the diagnosis and the
treatment options, and to voice any
concerns
• In light of this, prescribing decisions are
made jointly between professionals and
patients
• Professionals explain the agreed
treatment fully
• Patients are invited to talk about their
understanding of, and ability to follow,
treatments
• Knowledge empowers
patients to manage their own
health
• Patients are helped to access
information about their
conditions, and the
recommended medicines,
which is:
– based on their needs
– clear
– accurate
– sufficiently detailed
• All opportunities are used to
discuss medicines and
medicine taking
• Patients are asked for their
views on how their treatment
is progressing
• Information is effectively
shared between
professionals
• Medications are reviewed
regularly with patients
• Practical difficulties in taking
medicines are addressed
Patients have enough
knowledge to
participate as partners
Lisbon 17-19th ‘05
Non-compliance affects virtually all disease areas
35
40 40
55
80
Arthritis Epilepsy Hypertension Diabetes Asthma
Patients not complying per disease area %
Source: Whitney HAK, Jr. et al. (Editors). Medication compliance: a healthcare problem.
Annals of Pharmacotherapy 1993; 27 (9. Suppl).
Lisbon 17-19th ‘05
Concordance
… non-compliance with prescribed medicines is a major problem
An estimated
50%* of
medicines for
chronic
conditions are
not taken as
prescribed
Consequences
Ill-health and reduced quality of life
Reduced life expectancy
Avoidable healthcare cost
Economic loss to society
Reduced therapeutic efficacy
*30-95% for IFNb
Lisbon 17-19th ‘05
Past approaches to improving compliance have focused
on professional and practical issues
Barriers to optimal use of medicine
Professional
Practical
Information
Lifestyle choices
Beliefs about
medicine
Examples
Inappropriate prescribing
Mistakes in dispensing or administration
Forgetfulness
Inability to open containers
Lisbon 17-19th ‘05
24%
22%
4%
4%
37%Benefits far outweigh risks
Benefits slightly outweigh risks
Risks & benefits about the
same
Risks slightly outweigh
benefits
Risks far outweigh benefits
Positive
Negative
Source: MORI/Medicines Partnership survey of 2019 adults, 2003
Many people start with the belief that benefits of
medicines are outweighed by harms
Lisbon 17-19th ‘05
Under 40 40 to 59 Over 60
The large majority of patients want to be more involved
in decisions about treatment
Source: Cassileth BR, Zupkis RV, Sutton-Smith k, March V Annals of Internal Medicine 1980
87%
62%
51%
Share of patients wanting to be ‘more involved in decisions about treatment’
%, by age group
Lisbon 17-19th ‘05
But analyses of doctor-patient communications suggest that these beliefs and
views are often not explored in prescribing consultations
Perceived and actual frequency %
•Provide instructions
for taking the
medication
62%
87%
40%
31%
Communication
49%
34%
•Discuss side-effects
of the medication
•Discuss patient’s
ability to follow
treatment plan
•Find out what patient
thinks about treatment
plan
49%
8%
Doctor Estimate
Observed
•Doctors
underestimate the
degree to which
they ‘instruct’
•Doctors
overestimate the
degree to which
they consult and
elicit their patient’s
views
Source: Makoul G, Arntson P, Schofield T. (1995) Health promotion in primary care: physician-patient communication and
decision making about prescription medications. Soc Sci Med ; 41 (9): 1241-1254.
Lisbon 17-19th ‘05
Observational studies point to significant opportunity to better inform
patients during the average prescribing consultation
Discussion initiated by doctor %
•Instructions for use 87%
54%
Communication
•Intended benefits
•Patient’s opinion about
medication
•Possible side-effects
•Almost half of consultations fail to
explain benefits of medication
22%
15%
5% •Patient’s ability to
follow treatment plan
•Side-effects explained in every
5th consultation only
•Small minority of consultations
elicit patient’s view or surface
obstacles to compliance
Source: Makoul G, Arntson P, Schofield T. (1995) Health promotion in primary care: physician-patient communication and
decision making about prescription medications. Soc Sci Med ; 41 (9): 1241-1254.
Lisbon 17-19th ‘05
Moving from compliance to concordance requires a culture change
Concordance model Compliance model
Prescriber decides
diagnosis and treatment
Prescriber’s task is to
explain and instruct
Patient’s task is to
comprehend
Successful outcome is
compliance
Prescriber and patient
negotiate diagnosis and
treatment
Prescriber elicits, explains,
persuades and
accommodates
Patient explains, considers
and accommodates
Successful outcome is a
negotiated agreement
Source: From Compliance to Concordance, 1997
Lisbon 17-19th ‘05
A change in attitude
“The consumer is not a moron, she happens to be your wife.”
David Ogilvy – cofounder of Ogilvy & Mather Advertising
“The patient is not a moron, she could easily be your daughter
or quite possibly you.”
Gavin Giovannoni – member of non-patronising_doctors.org
Lisbon 17-19th ‘05
Expert Patient Program
‘When acute disease was the primary cause of illness, patients were
generally inexperienced and passive recipients of medical care. Now
that chronic illness has become the principle medical problem, the
patient must become a co-partner in the process’
(Holman & Lorig 2000)
Lisbon 17-19th ‘05
Expert patient program
Common experiences of patients:
Not enough involvement in decisions
No-one to talk to about anxieties/concerns
Tests/treatment not clearly explained
Insufficient information for family/friends
Insufficient information about recovery
Lisbon 17-19th ‘05
Expert patient programme
• Stage of MS
Diagnostic phase
Experiencing minimal impairment
Moderate disability
Severe disability
• One-to-one counselling
• Expert patient course
• NHNN MS hotline
• Information using standard protocols
• Integrative care pathways (ICPs)
• Decision making tools
• Etc.
Lisbon 17-19th ‘05
Decision Aids
• Tools to facilitate patient involvement and improve concordance
• Highly effective.
Increasing complexity and cost
Less costly
More accessible to
patients without
access to technology
More costly
More flexibility to
include interactivity
and visual images
Lisbon 17-19th ‘05
Partner organisations in creating the decision aid
And with patients recruited through:
York Hospital NHS Trust
Royal Preston Hospital
Queens University Hospital, Belfast
National Hospital for Neurology and Neurosurgery (UCLH)
Lisbon 17-19th ‘05
Lisbon 17-19th ‘05
Lisbon 17-19th ‘05
The best thing is that you
can go over specific
topics repeatedly
This site includes information
that patients have
no means of finding
The ratings tables are
very informative when
working out what the
important things in your life are
It helps other members of
the family take an interest…
they wouldn’t pick up a
book and read about MS
. All I could find at the time of
my decision was research papers
which were not in layman’s terms
and therefore not much help...
I would definitely have used
this site if it had been available
A young woman with MS tries out the site at the launch
It’s easy to navigate
Lisbon 17-19th ‘05
2. Examples were concordance is or will be critical.
Lisbon 17-19th ‘05
Treatment – disease modifying: CIS & IFNβ-1b
Risk reduction of
50% over 2 years (adjusted)
Cli
nic
ally D
efi
nit
e M
S
adjusted for key disease
prediction factors:
- steroid use
- mono/multifocal
- T2 lesion number at screening
Risk ratio: 0.50
Placebo (n=176)
Betaferon (n=292)
45%
28%
Primary endpoint -time to CDMS (Poser)
p=0.000075
Betaferon reduced the risk of progression to CDMS by 50%
within two years
Lisbon 17-19th ‘05
Risks: MITOXANTRONE
Mistry et al. Engl J Med. 2005 Apr 14;352(15):1529-38.
Lisbon 17-19th ‘05
Risks: MITOXANTRONE
Mistry et al. Engl J Med. 2005 Apr 14;352(15):1529-38.
Lisbon 17-19th ‘05
Treatment – disease modifying: MITOXANTRONE
Risks: MITOXANTRONE
Lisbon 17-19th ‘05
Natalizumab
NATALIZUMAB
Lisbon 17-19th ‘05
Benefits: NATALIZUMAB
Number of Patients at Risk
Placebo
Natalizumab
315 296 283 264 248 240 229 216 208 200
627 601 582 567 546 525 517 503 490 478
Pro
po
rtio
n W
ith
Su
sta
ine
d
Pro
gre
ss
ion
Hazard Ratio (HR)=0.58 (95% CI: 0.43, 0.77)
P=0.0002 Placebo 29%
Natalizumab 17%
0.0
0.1
0.2
0.3
0.4
Weeks
0 12 24 36 48 60 72 84 96 108 120
199
473
Sustained Disability Progression (Pre-specified Primary Endpoint)
Lisbon 17-19th ‘05
Benefits: NATALIZUMAB
FDA per-subject mean relapse rate at 2 years = 0.67 for placebo and 0.22 for natalizumab (67% reduction)
Placebo n=315
Natalizumab n=627
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
An
nu
ali
zed
Re
lap
se R
ate
(95%
CI)
P<0.0001
0.73
0.23
Years 0-2
68% 70%
P<0.0001
P<0.0001
0.78
0.67
0.27
0.20
Year 0-1 Year 1-2
66%
Annualized Relapse Rate
Lisbon 17-19th ‘05
Risks: NATALIZUMAB
PML
Kleinschmidt-DeMasters,et al. N Engl J Med. 2005 Jul 28;353(4):369-74.
Lisbon 17-19th ‘05
CAMPATH-1H
Lisbon 17-19th ‘05
Benefits: CAMPATH-1H
• Phase 2 trial randomized study in 49 centres in Europe and the US of 334 patients with active RR-
MS.
• Alemtuzumab (Campath-1h) (one of two doses) 1x/yr vs. Interferon-beta-1a 44mg s.c. TIW (Rebif-
44).
• Alemtuzumab (Campath-1h) treated patients had a 75% reduction in the risk for relapse after at
least 1-yr of follow up compared to Rebif-44 treated patients (p=0.00267).
• Alemtuzumab (Campath-1h) treated patients experienced >60% reduction in the risk for
progression of disability compared to Rebif-44 treated patients (p<0.05).
Genzyme and Schering AG, announce interim results
from trial of Campath for multiple sclerosis
Lisbon 17-19th ‘05
Benefits: CAMPATH-1H
100.0%
70.0%
17.5%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
Placebo Rebif-44 Campath-1h
Re
lati
ve
re
lap
se
ra
te
75%
>80%
Lisbon 17-19th ‘05
Benefits vs. expectations: CAMPATH-1H
Coles et al. J Neurol. 2005 Jul 27; [Epub ahead of print]
Lisbon 17-19th ‘05
Conclusions
• Acute disease vs. chronic illness
• Compliance vs. concordance
• Empowered or expert patient
Active process
• non-patronising_doctors.org
• Benefits vs. risks
Licensed vs. unlicensed therapies
Trials
Lisbon 17-19th ‘05
Acknowledgements – www.msdecisions.org
• Department of Health
• Medicines Partnership
• MS Specialist Nurses Association
• MS Trust
• MS Society
• Keele University
• UCL
• NHS
NHNN, UCLH NHS Trust
York Hospital NHS Trust
Royal Preston Hospital
Queens University Hospital, Belfast
• Motivation Multimedia
Geraldine Mynors
Bernadette Porter
Liz Keenan
Emily Harrison
Alan Thompson
David Miller
Teddy Graham
Norman Goodman
Duncan Short
Nicola Russell
Cathy Garner
Caron Caldwell
Andrew Russell
Jacqueline Tate
Lisbon 17-19th ‘05
Education!
Education!
Education!
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