TECHNOLOGY APPRAISAL IN ACTION
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Transcript of TECHNOLOGY APPRAISAL IN ACTION
TECHNOLOGY APPRAISAL IN ACTION
Mrs Karen Samuels
Programme Manager
• WHO
• WHAT
• WHERE
• RELATED ORGANISATIONS
• CHALLENGES
• FUTURE
WMP MULTIDISCIPLINARYPARTNERSHIP
• 1. WMIC
• 2. WeMeReC
• 3. WCM Therapeutics and Toxicology Centre
• 4. YCC Wales
• (Core WMP)
ESTABLISHED 2002
• Appraised up to 8 High cost drugs per year
• Strategic advice
• Met 4 times per year
ORGANISATIONAL STRUCTURE
AWMSG
NHSIF AWPAG
INITIAL PERIOD (2002-2006)
• One step process
• Public meeting
• WMP appraisal team
• One medical expert
• Patient perspective
• Two pharmaceutical company representatives
CHALLENGES
• One step
• Public nature
• Medical expert
• PIG submission
• Health Economic issues
CHALLENGES (continued)• Small number of specialist medicines
• Dependent on pharmaceutical Industry submission
• Service links
• Need
• Commissioners (HCW)
• Public demand e.g. trastusumab
APRIL 2007
• Second phase, 32 appraisals per year
• 1. High cost
• 2. Cancer drugs
• 3. Cardiovascular drugs
MODIFIED PROCESS
• Met with SMC
• New sub group NMG
PROCESS• In the pipeline
• MHRA licence (MA)
• Company launch in the UK
• Preliminary application (Form A)
• Detailed application (Form B)
• Patient Interest Groups
NMG ROLE AND MEMBERSHIP
• Expert clinical & cost effectiveness advice to AWMSG
• Broad spectrum membership
• Lay representative
• ABPI representative
• Not in public
DATA CONSIDERED
• WMP assessment report (AS AR)
• Company response
• Company’s detailed application (Form B)
• Advice from Medical Expert (s)
• Patient interest group submission
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
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
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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
AWMSG ROLE AND MEMBERSHIP
• Consider strategic, societal, affordability aspects
• Broader strategic
• Senior NHS managers
• Senior Finance directors
• Lay representative
• ABPI representative
DATA CONSIDERED
• NMG preliminary appraisal report (PAR)
• Company response to the PAR
• Patient Interest Group submissions
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
HOW?
• In public
• Announced at the meeting
• Minister for Health and Social Services
RELATED ORGANISATIONS• NICE/AWMSG/SMC
• ABPI
• CDG
• All-Wales Cardiac and Cancer networks
• Health Commission Wales
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
ALL WALES CANCERDRUGS GROUP
• No backlog
• AWCDG to help prioritise
• Engaging network– Oncologists– Oncology pharmacists
• Horizon scanning
• England and Wales - NICE
takes precedence
• Wales - AWMSG
Local MTC’s
SCOTLAND SMC
• Streamlined process
• Similar paperwork
• Simultaneous submissions
ABPI
• Users Group
• Regular
• Input process
FUTURE
• Extend to all new medicines?
• Increased links with patient groups
• Further collaboration with NICE/SMC
• Review process after 2 cycles