The public diary of AWMSG

aged 13 and ¼ years

Professor Phil Routledge

All Wales Therapeutics and Toxicology Centre

Academic Building, University Hospital Llandough

Penlan Road, Penarth CF64 2XX

AWMSG Masterclass, Cardiff City Stadium, November 25th 2015

2002 The birth is registered

1999: Responsibility for NHS Wales goes to Welsh Government under devolution

• Provide strategic advice for the Minister for Health and Social Services and NHS organisations

• Make recommendations to the Assembly to assist in the resolution of problems relating to prescribing at the interface between primary, secondary, tertiary and social care

• Appraise selected new (particularly high cost) medicines

2002 AWMSG is directed to

UK Benchmark for decisions:

incremental cost per QALY gained

Rawlins and Culyer, BMJ 2004;329:224-227

Increasing cost/QALY (log scale)

Pro

babilit

y o

f re

jecti

on o

n

gro

unds

of

cost

infe

cti

veness

£20,000 £30,000

0%

100%

2002 Social Value Judgements

Recognised values/criteria

• Reducing health inequalities

• Special consideration of the needs of disabled people

• Special consideration of the relief of stigma

• Innovation not adequately captured in measurement of health gain

• Special consideration of life-extending treatment at the end of life

Excluded values/criteria

• Treating rare disease or conditions as special

Rid A et al. The importance of being NICE. JRSM 2015; 108: 385-389

• “NICE does not take affordability into account when making judgments about cost effectiveness. It is NICE’s job to judge whether something ought to be purchased from within the resources made available to the NHS”

• “The government could therefore judge a particular intervention unaffordable for the NHS (because of the large numbers who would be eligible for treatment) even though NICE had judged it cost effective”

• “In such circumstances the government could respond in one of two ways:

• the Department of Health and the Welsh Government might formally advise the NHS to ignore NICE’s advice;

• alternatively, ministers might invoke one of the clauses in its directions to NICE stating that (in this particular case) it is required to take account of “advice from ministers on available resources”

• “So far, neither of these potential government responses have been proposed or threatened”

AFFORDABILITY IN HEALTH TECHNOLOGY

ASSESSMENT

Rawlins MD and Culyer AJ. National Institute for Clinical Excellence and its value judgments, BMJ 2004;329:224–7

All Wales Medicines Strategy Group

Prescribing Group NHS-Industry Forum

Welsh Assembly Government

New Medicines Group

2002 Original AMSG structure

2008 A Medicines Strategy

• Strategy for 2008-13

• 48 recommendations

• Increased HTA capacity

• Better communication of HTA decisions within NHS Wales

• Identify efficiencies in prescribing

2008 Learning to work together

• December: Last meeting of NHS Industry Forum

• 2009: Director Wales ABPI joins AWMSG Steering Group

• 2011 Applicant company contributes directly to HTA discussion at AWMSG

2009 A “Growth Spurt”

• Rec. 1: Timely HTA of medicines not on NICE programme

• Rec. 2: Adoption of end-of-life criteria for life-extending medicines

• Rec. 9: Improved communication and collaboration between UK HTA bodies (e.g. on horizon scanning)

http://www.wales.nhs.uk/documents/Routledge-Report-January-2009.pdf

2010 AWMSG takes on more HTAs

• “Towards improving the availability of medicines for patients in Wales”, January 2009

• Comprehensive HTA programme implemented, October 2010

• AWMSG HTA process accredited by NICE, 2011

0

20

40

60

80

100

120

140

160

180

200

220

240

Recommended (infull/optimised)

Not recommended

Nu

mb

er o

f ap

pra

isal

s

AWMSG appraisal outcome

NICE guidancewithrawn

NICE appraisalsuspended

NICE appraisal notscheduled

NICE appraisal inprogress

Not recommended byNICE

Recommended byNICE (infull/optimised)

AWMSG appraisals 2009-10 to 2013-15

with a Wales Patient Access Scheme (WPAS)

0

5

10

15

20

25

30

35

40

45

2009-2010 2010-2011 2011-2012 2012-2013 2013-2014 2014-2015

Nu

mb

er

of

Ap

pra

isal

s

Year

Appraisals (with PAS)

Appraisals (with WPAS)

Appraisals (no WPAS)

2012 Ten years old

• Ten-year Conference and report

• AWMSG signs memorandum of understanding with NICE

• Review of the work of the Scottish Medicines Consortium “The availability of new medicines for patients in Scotland”

2013 Third 5-year Strategy

• Improving Health – Medicines Appraisals

• Improving Health – Prescribing guidance

• One System for Health

• Fully Integrated Network of Care

• Aiming at Excellence

• Transparency of Performance

• Partnership with the Public

• Making Every Penny Count

2014 “Orphans” & “ultra-orphans”

Form B submitted for an orphan /ultra-orphan medicine

AWTTC prepares a critique of the evidence (the ASAR) and provides a view on the applicability of the orphan or ultra-orphan criteria

Draft ASAR sent to market authorisation (MA) holder for commentASAR may be subsequently updated in light of comments received

Preliminary appraisal by the New Medicines Group (NMG)Preliminary recommendation and final ASAR sent to MA holder

for comment within 5 working days from NMG meeting

MA holder accepts the NMG preliminary appraisal recommendation

The appraisal process continues and appraisal by AWMSG is undertaken within

normal timelines

Appraisal by AWMSG

MA holder disputes NMG recommendation &/or factors affecting the decision & requests meeting of Clinical & Patient Involvement Group (CAPIG).

Appraisal process suspended & meeting of CAPIG convened (additional 8-12 weeks may be

added to timeline)

CAPIG meeting held. Template completed for consideration by AWMSG

2014- AWMSG & PRUDENT

2015 HEALTHCARE

• achieve health and wellbeing with the public, patients and professionals as equal partners through co-production

• care for those with the greatest health need first, making the most effective use of all skills and resources

• do only what is needed, no more, no less; and do no harm• reduce inappropriate variation using evidence based

practices consistently and transparently

• Signed new MOU with NICE• Highest ever annual number of appraisals (42

in 2014-15)• Pilot of AWMSG’s appraisal process for orphan

and ultra-orphan medicines Dr Stuart Linton

0

5

10

15

20

25

30

35

40

45

2009-2010 2010-2011 2011-2012 2012-2013 2013-2014 2014-2015

Total appraised

Recommended

Recommended with restrictions

Not recommended

AWMSG appraisals 2009-2010

to 2014-2015

90% recommended/ optimised

ACKNOWLEDGEMENTS

• Professor David Lawson

• Professor Ceri Phillips

• Professor David Cohen

• Professor Dyfrig Hughes

• Sir Mike Rawlins

• Sir Andrew Dillon

• Professor Carol Longson

• Meindert Boysen

• Professor Roger Walker

• Dr Paul Buss

• Patients/ Carers & Patient Support Groups

• Scottish Medicines Consortium (SMC)

• NICE

• Association of British Pharmaceutical Industries (ABPI) & TDA Users’ Group

• Ethical Medicines Industry Group (EMIG)

• AWTTC Team

• Members of AWMSG, AWPAG and NMG

• Chief Pharmacists in Wales

• Health professionals/ HP Groups in NHS Wales

Lo! the Flat Hills of my homeland

By

A A Mole

Pandora!I adore ya.

I implore ye,Don’t ignore me.

The Growing Pains of Adrian Mole (1985)The True Confessions of Adrian Albert Mole (1989)Adrian Mole: The Wilderness Years (1993)Adrian Mole: The Cappuccino Years(1999)Adrian Mole & the Weapons of Mass Destruction (2004)The Lost Diaries of Adrian Mole, 1999-2001 (2008)Adrian Mole: The Prostrate Years (2009)

Diolch yn fawr

routledgepa@cardiff.ac.uk 20

Getting the best outcomes

From medicines for (the people

of) Wales

The Future of AWMSG?