Non patronising doctors.org

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


Redefining our relationship with our patients – “pink is the new black”


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)


Patients are supported

in taking medicines

Prescribing consultations

involve patients as partners


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


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).


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


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


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


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


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.


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.


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


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


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)


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


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.


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


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)


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


2. Examples were concordance is or will be critical.


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


Risks: MITOXANTRONE

Mistry et al. Engl J Med. 2005 Apr 14;352(15):1529-38.


Treatment – disease modifying: MITOXANTRONE

Risks: MITOXANTRONE


Natalizumab

NATALIZUMAB


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)


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


Risks: NATALIZUMAB

PML

Kleinschmidt-DeMasters,et al. N Engl J Med. 2005 Jul 28;353(4):369-74.


CAMPATH-1H


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


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%


Benefits vs. expectations: CAMPATH-1H

Coles et al. J Neurol. 2005 Jul 27; [Epub ahead of print]


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


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


Education!

Education!

Education!

Non patronising doctors.org

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