technology appraisal in action mrs karen samuels programme manager

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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cess

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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