technology appraisal in action mrs karen samuels programme manager

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TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

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Page 1: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

TECHNOLOGY APPRAISAL IN ACTION

Mrs Karen Samuels

Programme Manager

Page 2: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

• WHO

• WHAT

• WHERE

• RELATED ORGANISATIONS

• CHALLENGES

• FUTURE

Page 3: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

WMP MULTIDISCIPLINARYPARTNERSHIP

• 1. WMIC

• 2. WeMeReC

• 3. WCM Therapeutics and Toxicology Centre

• 4. YCC Wales

• (Core WMP)

Page 4: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

ESTABLISHED 2002

• Appraised up to 8 High cost drugs per year

• Strategic advice

• Met 4 times per year

Page 5: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

ORGANISATIONAL STRUCTURE

AWMSG

NHSIF AWPAG

Page 6: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

INITIAL PERIOD (2002-2006)

• One step process

• Public meeting

• WMP appraisal team

• One medical expert

• Patient perspective

• Two pharmaceutical company representatives

Page 7: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

CHALLENGES

• One step

• Public nature

• Medical expert

• PIG submission

• Health Economic issues

Page 8: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

CHALLENGES (continued)• Small number of specialist medicines

• Dependent on pharmaceutical Industry submission

• Service links

• Need

• Commissioners (HCW)

• Public demand e.g. trastusumab

Page 9: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

APRIL 2007

• Second phase, 32 appraisals per year

• 1. High cost

• 2. Cancer drugs

• 3. Cardiovascular drugs

Page 10: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

MODIFIED PROCESS

• Met with SMC

• New sub group NMG

Page 11: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

PROCESS• In the pipeline

• MHRA licence (MA)

• Company launch in the UK

• Preliminary application (Form A)

• Detailed application (Form B)

• Patient Interest Groups

Page 12: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

NMG ROLE AND MEMBERSHIP

• Expert clinical & cost effectiveness advice to AWMSG

• Broad spectrum membership

• Lay representative

• ABPI representative

• Not in public

Page 13: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

DATA CONSIDERED

• WMP assessment report (AS AR)

• Company response

• Company’s detailed application (Form B)

• Advice from Medical Expert (s)

• Patient interest group submission

Page 14: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

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

Page 15: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

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

Page 16: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

AWMSG ROLE AND MEMBERSHIP

• Consider strategic, societal, affordability aspects

• Broader strategic

• Senior NHS managers

• Senior Finance directors

• Lay representative

• ABPI representative

Page 17: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

DATA CONSIDERED

• NMG preliminary appraisal report (PAR)

• Company response to the PAR

• Patient Interest Group submissions

Page 18: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

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

Page 19: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

HOW?

• In public

• Announced at the meeting

• Minister for Health and Social Services

Page 20: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

RELATED ORGANISATIONS• NICE/AWMSG/SMC

• ABPI

• CDG

• All-Wales Cardiac and Cancer networks

• Health Commission Wales

Page 21: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

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

Page 22: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

ALL WALES CANCERDRUGS GROUP

• No backlog

• AWCDG to help prioritise

• Engaging network– Oncologists– Oncology pharmacists

• Horizon scanning

Page 23: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

• England and Wales - NICE

takes precedence

• Wales - AWMSG

Local MTC’s

Page 24: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

SCOTLAND SMC

• Streamlined process

• Similar paperwork

• Simultaneous submissions

Page 25: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

ABPI

• Users Group

• Regular

• Input process

Page 26: TECHNOLOGY APPRAISAL IN ACTION Mrs Karen Samuels Programme Manager

FUTURE

• Extend to all new medicines?

• Increased links with patient groups

• Further collaboration with NICE/SMC

• Review process after 2 cycles