Multiple Technology Appraisal Beta interferon and glatiramer acetate for treating multiple sclerosis

959 Pages·2017·11.33 MB·English

Multiple Technology Appraisal

Beta interferon and glatiramer acetate for
treating multiple sclerosis (review of TA32)
[ID809]

Committee papers
© National Institute for Health and Care Excellence 2017. All rights reserved. See Notice of Rights. The content
in this publication is owned by multiple parties and may not be re-used without the permission of the relevant
copyright owner.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

MULTIPLE TECHNOLOGY APPRAISAL

Beta interferon and glatiramer acetate for treating multiple sclerosis (review of
TA32) [ID809]

Contents:

1. Pre-meeting briefing

2. Final Scope and Final Matrix

3. Full preceding guidance: beta interferon and glatiramer acetate for the
treatment of multiple sclerosis

4. Assessment Report prepared by Warwick Evidence in August 2016
 Assessment Report
 Addendum
 Erratum

5. Consultee and commentator comments on the August 2016 Assessment
Report
 Biogen
 Merck
 Novartis
 Teva
 Multiple Sclerosis Trust
 Association of British Neurologists
 Department of Health
 NHS Healthcare Improvement Scotland

6. Response to consultee and commentator comments on the August 2016
Assessment Report from Warwick Evidence

7. Company executive summaries from:
 Biogen
 Merck
 Teva

8. Professional group, patient group and NHS organisation submissions
from:
 Multiple Sclerosis Society
 Multiple Sclerosis Trust
 United Kingdom Multiple Sclerosis Specialist Nurse Association

9. Expert Personal perspectives from:
© National Institute for Health and Care Excellence 2017. All rights reserved. See Notice of Rights. The content
in this publication is owned by multiple parties and may not be re-used without the permission of the relevant
copyright owner.
 Dr Martin Duddy – clinical expert, nominated by the Association of
British Neurologists
 Ms Sarah Bittlestone – patient expert, nominated by the MS Trust
 Mrs Denise Murray – patient expert, nominated by the MS Trust

10. Assessment Group specification for the March 2017 Addendum

11. Addendum prepared by the Assessment Group in March 2017 as issued
to consultees and commentators
 Addendum
 Appendix

12. Consultee and commentator comments on the March 2017 Addendum
from:
 Bayer
 Biogen
 Merck
 Novartis
 Teva
 Multiple Sclerosis Trust
 Association of British Neurologists
 Department of Health
 Sanofi

13. AG response to the comments on the March 2017 Addendum

14. Additional information submitted by the companies in September 2017
from:
 Biogen
 Merck
 Teva

15. Assessment Group Addendum prepared by Warwick Evidence in
November 2017

Any information supplied to NICE which has been marked as confidential has been
redacted. All personal information has also been redacted.

© National Institute for Health and Care Excellence 2017. All rights reserved. See Notice of Rights. The content
in this publication is owned by multiple parties and may not be re-used without the permission of the relevant
copyright owner.
Committee slides – part 1 (ACIC information)
Lead team presentation
Beta interferon and glatiramer acetate
for treating multiple sclerosis (review
of TA32)
1st Appraisal Committee meeting
Committee B, 2nd November 2016
Lead team: Miriam McCarthy, Stephen Palmer and Dani
Preedy
Companies: Bayer, Biogen, Merck Serono, Novartis, Teva
Chair: Amanda Adler
Assessment group: Warwick Evidence
NICE technical team: Thomas Palmer, Jasdeep Hayre
ID809 beta interferon and glatiramer acetate pre-meeting briefing
Summary of evidence and key issues
Clinically isolated syndrome:
Key ICERs:
• Change in diagnostic criteria
• Pooled RSS Outcomes:
• Small number of trials
£27,200
• Is there sufficient evidence
• Pooled AG Sensitivity
to make a recommendation?
Analysis (NMA) Outcomes:
£8,100
Beta interferon
Pooled or individual
and glatiramer
estimates:
• RSS Pooled acetate for MS
RSS showed beta-
estimates
interferon and
• Individual AG NMA
glatiramer acetate:
results
• Reduced
Committee preferred
• Would committee
frequency of
base case:
ever recommend
relapse
• Treatment waning?
some but not all of
• Slowed
• Carer disutilities?
the drugs under
progression of
appraisal?
disease
2
ID809 beta interferon and glatiramer acetate pre-meeting briefing
Key issues
• Are beta interferon and glatiramer acetate clinically effective
for RRMS? Are all the technologies equally as effective?
• Which analyses reflect clinical practice (NMA or RSS?)
• Are the trial results for clinically isolated syndrome
generalisable?
• Does the committee prefer results including treatment waning
effects and carer disutilities?
• Does the committee prefer the treatment effectiveness
estimates from the risk sharing scheme or from the
assessment group meta-analysis?
• Innovation
• Equalities
• PPRS
ID809 beta interferon and glatiramer acetate pre-meeting briefing
Multiple sclerosis and clinically isolated
syndrome
• Multiple sclerosis (MS) is a chronic, neurodegenerative
disorder which affects the brain, optic nerves, and spinal cord
• It often results in progressive neurological impairment and
severe disability
• Associated with symptoms such as pain, disturbance to
muscle tone, chronic fatigue, unsteady gait, speech problems,
incontinence, visual disturbance and cognitive impairment
• Approximately 100,000 people in the UK have MS, and about
2500 people are newly diagnosed each year
• Onset typically between 20 and 50 years
• A single demyelinating event before MS is known as clinically
isolated syndrome (CIS)
– definition of clinically isolated syndrome (CIS) was revised in
2010 update of the diagnostic criteria
ID809 beta interferon and glatiramer acetate pre-meeting briefing
Patient and professional feedback
• These treatments have been shown to be effective in
reducing relapses and slowing the progression of MS
• They have formed an integral part of current practice
since the establishment of the risk sharing scheme
• There is a lot of experience of using these drugs and the
safety profiles are therefore more certain than for newer
treatments which can be an important consideration for
patients
• Choice of administration, both in terms of frequency and
method, is important. The greater the range of disease
modifying therapies available the more people that are
likely to find the treatment that suits them
• There are currently no other treatment options licensed
for clinically isolated syndrome
5
ID809 beta interferon and glatiramer acetate pre-meeting briefing
Multiple sclerosis
Clinically isolated syndrome
• first clinical episode with
Disease-modifying therapy
features suggestive of MS
(DMT) not recommended for
• may or may not develop into primary or secondary
clinically definite MS progressive MS, but some
drugs indicated for secondary
progressive disease with
relapses
~50%
within 10
years
Relapsing-remitting MS
Secondary
• 85-90% of people at
progressive
diagnosis
MS
ID809 beta interferon and glatiramer acetate pre-meeting briefing
Current management of MS
Rapidly-evolving
RRMS CIS severe
• Interferon beta? • Interferon beta? • Natalizumab
e (TA127)
• Glatiramer acetate? • Glatiramer acetate?
n
i • Alemtuzumab
l • Disease modifying
• Teriflunomide (TA303)
t
s
1 (TA312)
therapies
• Dimethyl fumarate (TA320)
• Alemtuzumab (TA312)
Change therapy – inadequate
response/ adverse events
Highly active disease
e • Teriflunomide
n
li • Dimethyl fumarate • Fingolimod (TA 254)
d
n • Alemtuzumab
2 • Alemtuzumab (TA312)
ID809 beta interferon and glatiramer acetate pre-meeting briefing