technology appraisal in action
DESCRIPTION
TECHNOLOGY APPRAISAL IN ACTION. Mrs Karen Samuels Programme Manager. WHO WHAT WHERE RELATED ORGANISATIONS CHALLENGES FUTURE. WMP MULTIDISCIPLINARY PARTNERSHIP. 1. WMIC 2. WeMeReC 3. WCM Therapeutics and Toxicology Centre 4. YCC Wales (Core WMP). ESTABLISHED 2002. - PowerPoint PPT PresentationTRANSCRIPT
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TECHNOLOGY APPRAISAL IN ACTION
Mrs Karen Samuels
Programme Manager
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• WHO
• WHAT
• WHERE
• RELATED ORGANISATIONS
• CHALLENGES
• FUTURE
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WMP MULTIDISCIPLINARYPARTNERSHIP
• 1. WMIC
• 2. WeMeReC
• 3. WCM Therapeutics and Toxicology Centre
• 4. YCC Wales
• (Core WMP)
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ESTABLISHED 2002
• Appraised up to 8 High cost drugs per year
• Strategic advice
• Met 4 times per year
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ORGANISATIONAL STRUCTURE
AWMSG
NHSIF AWPAG
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INITIAL PERIOD (2002-2006)
• One step process
• Public meeting
• WMP appraisal team
• One medical expert
• Patient perspective
• Two pharmaceutical company representatives
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CHALLENGES
• One step
• Public nature
• Medical expert
• PIG submission
• Health Economic issues
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CHALLENGES (continued)• Small number of specialist medicines
• Dependent on pharmaceutical Industry submission
• Service links
• Need
• Commissioners (HCW)
• Public demand e.g. trastusumab
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APRIL 2007
• Second phase, 32 appraisals per year
• 1. High cost
• 2. Cancer drugs
• 3. Cardiovascular drugs
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MODIFIED PROCESS
• Met with SMC
• New sub group NMG
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PROCESS• In the pipeline
• MHRA licence (MA)
• Company launch in the UK
• Preliminary application (Form A)
• Detailed application (Form B)
• Patient Interest Groups
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NMG ROLE AND MEMBERSHIP
• Expert clinical & cost effectiveness advice to AWMSG
• Broad spectrum membership
• Lay representative
• ABPI representative
• Not in public
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DATA CONSIDERED
• WMP assessment report (AS AR)
• Company response
• Company’s detailed application (Form B)
• Advice from Medical Expert (s)
• Patient interest group submission
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Appraisal Process from 1st April 2007
Receipt of submission of Form B(inc electronic copy of references and confirmation of
receipt of EMEA positive opinion) within 2 months fromW MP's letter confirming receipt of Form A
Medic al Expertsidentif ied
AW MSG Sec retar iat AssessmentReport
(AS AR) prepared
New Medicines Group meetingLead assessors from NMG
provide overview
AS AR sent to Company for fac tualinac c urac ies and written response(returned within 10 working day s)
Company response c onsidered(AS AR may be amended)
If no response submitted, proc ess proc eeds
Patient Interest Groupsidentif ied
14 w e e ks
AW MSG Sec retar iat AssessmentReport (AS AR) teams identif ied
11 w e e ks
8 w e e ks
Doc uments sent to New Medic ines Group ( NMG) members(AS AR, written medic al expert opinion, written Company
response to AS AR and Form B)
12 w e e ks
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New Medicines Group meeting
AW MSG meetingPAR, c ompany response and patient perspec tive c onsidered.
AW MSG rec ommendation agreed.
Lead assessors from NMGprovide overview
AS AR amended / signed off by NMG Chairsaved as Preliminary Appraisal Report (PAR)
within 5 working day s of NMG meeting
PAR sent to c ompany with initial NMGrec ommendation / c omments invited in writing
(returned within 5 working day s)
14 w e e ks
18 w e e ks
Ap
pra
isa
l pro
cess
in a
ccu
mu
late
d w
ee
ks
Appraisal doc uments (PAR and c ompanyresponse) posted on AW MSG website
approximately 10 day s pr ior to public meeting
15 w e e ks
NMG Chair /V ic e Chair or NMGlead present assessment
summary to AW MSG
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AWMSG ROLE AND MEMBERSHIP
• Consider strategic, societal, affordability aspects
• Broader strategic
• Senior NHS managers
• Senior Finance directors
• Lay representative
• ABPI representative
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DATA CONSIDERED
• NMG preliminary appraisal report (PAR)
• Company response to the PAR
• Patient Interest Group submissions
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AW MSG rec ommendation to Minister
Final Appraisal Report (FAR) approved byAW MSG Chairman
AW MSG meetingPAR, c ompany response and patient perspec tive c onsidered.
AW MSG rec ommendation agreed.
NMG Chair/V ic e Chair or NMGlead present assessment
summary to AW MSG
Manufac turers allowed 5/10 working day s frommeeting to ac c ept / rejec t AW MSG rec ommendation
18 we e ks
Upon c onfirmation of Minister ial ratif ic ation notic edisseminated to servic e and posted on AW MSG website
and c ommunic ated to manufac turers
19/20 w e e ks
20/21 w e e ks
W AG informed of AW MSG rec ommendationwhen c onfirmation rec eived by manufac turers
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HOW?
• In public
• Announced at the meeting
• Minister for Health and Social Services
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RELATED ORGANISATIONS• NICE/AWMSG/SMC
• ABPI
• CDG
• All-Wales Cardiac and Cancer networks
• Health Commission Wales
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REQUEST FOR APPRAISAL OF CANCER DRUGS
Is drug/indication licensed?
Is drug beingAppraised by NICE?
Await NICEguidance
Refer to AWMSGfor appraisal
Refer to Cancer New DrugsGroup for appraisal
Yes
Yes
No
No
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ALL WALES CANCERDRUGS GROUP
• No backlog
• AWCDG to help prioritise
• Engaging network– Oncologists– Oncology pharmacists
• Horizon scanning
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• England and Wales - NICE
takes precedence
• Wales - AWMSG
Local MTC’s
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SCOTLAND SMC
• Streamlined process
• Similar paperwork
• Simultaneous submissions
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ABPI
• Users Group
• Regular
• Input process
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FUTURE
• Extend to all new medicines?
• Increased links with patient groups
• Further collaboration with NICE/SMC
• Review process after 2 cycles