hta core model for rapid assessment simone warren anna ... · european network for health...

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Apply(ing) theHTA Core Model for Rapid

Assessmentfor national adaptation and

reportingSime Warren, National Health Care Institute of the Netherlands, Diemen, the NetherlandsAnna Nachtnebel, Ludwig Boltzmann Institute for HTA, Vienna, AustriaWP5 - Applying the HTA Core Model for Rapid Assessment for national adaptation andreporting

Third WP2 Face to Face Training Course for EUnetHTA stakeholders, Brussels, 23rd of April2015


WP5 Partners Overview

May 8, 2015 2

27 Associated Partners:Austria, Belgium, Croatia,Cyprus, Czech Republic,Denmark, Finland, France,Germany, Hungary, Ireland, Italy,Latvia, Lithuania, Malta,Netherlands, Norway, Poland,Portugal, Slovakia, Slovenia,Spain

Lead Partner: ZIN, the NetherlandsCo-Lead Partner: LBI for HTA, Austria

24 Collaborating Partners:Austria, Belgium, Bulgaria,Denmark, Germany, Italy,Ireland, LuxembourgRussia, Romania, Scotland,Spain, Switzerland, Turkey

2

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 33


No recommendations!

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 5

Work Package 5 Strand A

Rapid relative effectiveness assessment ofpharmaceuticals

5


Topic Selection

Technology under evaluation by Committee for Medicinal Productsfor Human Use (CHMP)

Expression of interest by WP5 SA members based on the CHMP list

Expression of interest to participate by the Market AuthorizationHolder (by letter)

6


Tools for Strand A

Proceduremanual thatdescribesStrand Aprocess

Assessmenttemplate thatprovidesguidance forreporting

Guidelinesthat providemethodo-logicalguidance

Model thatprovidesworkingframeworkthrough a setof researchquestions

*+ checklist for ethical, organisational, social and legal issues

Submissionfile templatethat issubmitted bymanufacturer

7


agency X

Agency A Agency B

author co-author

agency C agency D agency E agency Gagency F

pool of dedicated reviewers

agency Xagency X

agency X

agency Xagency X

agency Xagency X

agency Xagency X

agency X

MAH (Strand A)/ WP5 members review

Strand A - Processes for Rapid Assessments

1st version of REA

Editorial versionof REA

Final of REA

8


Scoping Phase


1. Expression of interestregarding topic by:

Pharmaceuticalscompany

HTA organisation(WP5 members)

2. Selection ofAuthor/Co-Author/Reviewers(WP5 internal process)

3. Receive draftsubmission file fromMAH

4. Pre-Scoping E-

Meeting

WP5 Strand A - Scoping Phase

10

1.

1.

2.

4.

3.


5. Scoping meetingwith MAH (f-t-f)

6. Feedback fromAuthors on draftsubmission file

7. Receive finalsubmission file

8. Finalisation ofproject planincluding timelines

WP5 Strand A - Scoping Phase

11

6.

5.

7.

8.


WP5 Strand A - Assessment Phase

12



1. Preparing the firstdraft of the assessmentby the Author and Co-Author (35 days)

2. Review by dedicatedreviewers (10 days)

3. Preparation ofsecond draft of theassessment by authors(15 days)

13

2.

1. 3.



4. Editorial review andlayouting (15 days)

5. Consultation phase of allWP5 members and marketauthorization holder (10days)

6. Final version of theassessment (15 days)

7. Publication of final reportand implementation into thenational context

14

4. 6.

5.

7.

5.


First Pilot: Zostavax

Zostavax for the prevention of herpes zosterand post herpetic neuralgia

Pilot team:

o Author: CVZ (NL)

o Co-Author: “A. Gemelli” Teaching Hospital (IT)

o Dedicated reviewers: HAS (FR), GOG (A),MoH Czech Republic, DPA/MFH (M), RIZIV(B), MSSSI (S), Regio Veneto (IT)

Duration: 04/2013- published on the EUnetHTAwebsite on 08/2013

Uptake or use in local/national reports: Austria(twice, 2013), Spain (2013), the Netherlands (2014),possible France (2014)

http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Zostavax_main%20report%20including%20appendices_20130922.pdf

15


Second Pilot: Canagliflozin

Canagliflozin for the treatment of type IIdiabetes mellitus

Pilot team:

o Authors: AAZ (Croatia), FIMEA (Finland),Regione Veneto (Italy)

o Dedicated reviewers: HAS, HVB; CAHIAQ;Medical University of Sofia; MoH CzechRep.

Duration: 05/2013 -02/2014

o Delay mostly due to external factors (i.e.delayed decision of CHMP)

Local reports Finland, Croatia, theNetherlands

(Data still being updated)

http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/WP5_SA-2_canagliflozin_for_the_treatment_of_diabetes_mellitus.pdf

16


Third Pilot: Sorafenib

Sorafenib for the treatment of progressive,locally advanced or metastatic, differentiated(papillary/follicular/Hürthle cell) thyroidcarcinoma refractory to radioactive iodine

Pilot team:

o Authors: AIFA (Italy), INFARMED (Portugal)

˗ Dedicated reviewers: RIZIV (Belgium), FIMEA (Finland), GYEMSZI (Hungary),NCPE (Ireland), Slovakian MoH

Duration: 07/2014 -03/2015

Local reports Awaiting more information

http://www.eunethta.eu/news/joint-assessment-sorafenib-nexavar-and-its-use-treatment-thyroid-carcinoma-0

17


Fourth Pilot: Ramucirumab

Ramucirumab in combination with Paclitaxelas second-line treatment for adult patients withadvanced gastric or gastro-oesophagealjunction adenocarcinoma

Pilot team:

o Authors: NOKC (Norway), AAZ (Croatia),

o Dedicated reviewers: Slovak Ministry ofHealth, FIMEA (Finland), GYMSZI(Hungary), A.Gemelli Teaching Hospital(Italy)

Duration: 11/2014 -03/2015

o Pilot met the agreed upon timelines

Local reports Awaiting more information

http://www.eunethta.eu/news/joint-assessment-ramucirumab-cyramza-combination-paclitaxel-second-line-treatment-adult-patient

18


Future Pilot Planning

19

WorkPackage 5

Strand A

WP5- SA5

AssessmentPhase

WP5-SA6

ScopingPhase

WP5-SA7

Topicselection

19

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

WP5 Strand B –Joint Assessment on ‘other technologies’


Tools for Strand B

Proceduremanual

thatdescribesStrand Bprocess

Assessmenttemplateprovides

guidance forreporting

Guidelinesprovide

methodo-logical

guidance

providesworking

frameworkthrough a

set ofresearch

questions*

*+ checklist for ethical, organisational, social and legal issues

SubmissionFile template

that issubmitted bymanufacturer

(s)

+ consideration ofother Core Model

applications

22


Relevance of topic assessed will determine participation by other membersAND uptake of assessment in local/national context,

No technology specific assessments – class assessments

2 options:

1. Call for collaboration: Authoring agency selects 2 topics out of their ownwork programme – WP5 members are asked to indicate their preference –choice of final topic

Also members are asked if they want to contribute: co-authors, dedicatedreviewers

1. POP- Database: overlap in topics indicate potential partners forcollaboration and also relevance for other countries. Authors can approachagencies directly and ask if collaboration would be feasible

Team Building and Topic selection

23


1 authoring agency: responsible for the overall quality of theassments, usually for Effectiveness and Safety Domain and for theSummary

1 – 3 co-authors: assist authoring agency in selection of relevantassessment elements of HTA Core Model for Rapid REA; quality ofassurance of work of author; usually responsible for authoring 1 – 2other domains

Dedicated reviewers: 3 – 6; read first draft of assessment – qualityassurance

Coordination Team: LBI-HTA for managing contact withmanufacturers/Stakeholder Forum(Stakeoholder Advisory Group),overseeing communication/work-flow within pilot team

Team

24


Modes of collaboration

agency X

Agency A: authorof all domains

Agency B: co-authorchecks work of author

agency 4

agency 1

agency 3

agency X

agency X

agency Xagency X

agency 5

agency 2

agency X

agency Xagency X

agency Xagency X

Agency C:1-? domains

Agency B:1- ? domains

Agency A:1 - ? domains

Agency D:1 - ? domains

agency 3

agency 1 agency 2

agency 5agency 4

Authors and co-authors

Dedicated reviewers

WP5

25


Pilot team:

1 – 3 (co)authors

3 – 6 dedicated reviewing agencies

Coordination Team

EUnetHTA members

Stakeholders:

Manufacturers: evidence, reimbursement status, project plan, assessment,submission file

Patient/Consumer representatives: project plan, assessment

Medical experts: project plan, assessment

Stakeholder Advisory Group/Stakeholder Forum: project plan

Public: project plan

Production of assessments

26


Scoping Phase

27


Assessment Phase

28


Published Joint Assessments

29

Duodenal-jejunalbypass sleeve for thetreatment of obesitywith or without type IIDiabetes mellitus

Renal denervation fortreatment resistanthypertension

Balloon EustachianTuboplasty for thetreatment ofEustachian tubedsyfunction

Duration January 2013 – August2013

April 2013 – December2013

April 2014 – February2015

Pilot team agencies, n 8 8 5

(Co-)Authoring HTAbodies

LBI-HTA (Austria)AAZ (Croatia)

NOKC (Norway) Avalia-t(Spain)CFK (Denmark)

FinOHTA/THLHIQA (Ireland)

Dedicated reviewing HTAbodies

GYMEZSI (Hungary)HIQA (Ireland)HVB (Austria)ISCIII (Spain)NOKC (Norway)Charles UniversityPrague (Czech Republic)

HIS (UK)FinOHTA/THL (Finland)AHTAPol (Poland)GYMEZSI (Hungary)IQWiG (Germany)

GYMEZSI (Hungary)HVB (Austria)AHTAPol (Poland)


Ongoing Joint Assessment

30

Biodegradable stentsfor benign refractoryesophageal stenosis

Implantable devices for

the treatment of mitral

valve regurgitation

Mechanical thrombectomy

in acute ischaemic stroke

Duration April 2014 – August2015

October 2014 – September

2015

April 2015 – December 2015

(TBC)

Pilot team agencies, n 5 9 7

(Co-)Authoring HTAbodies

ISCIII (Spain)SAGEM (Turkey)

Agenas (Italy)

AAZ (Croatia)

MoH (Slovakia)

HIQA (Ireland)

Interdisciplinary Centre for

HTA and Public Health

University of Erlangen-

Nürnberg (Germany)

Dedicated reviewing HTAbodies

VASPVT (Lithuania)Slovak Ministry ofHealth (Slovakia)LBI-HTA (Austria)

HAS (France)

BIQG/GÖG (Austria)

AETSA (Spain)

AAZ (Croatia)

HIQA (Ireland)

HIS (Scottland)

CFK (Denmark)

LBI-HTA (Austria)

HAS (France)

HIS (Scotland)

A. Gemelli Hospital (Italy)

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

National adaptation…?

May 8, 2015 31


WP3 Survey results – Has your organisationused HTA information?

32


WP3 Survey results – Purpose of use

33


WP3 Survey results – Have you planned touse HTA information

34


LBI produced local report based onEUnetHTA Zostavax (November2013)

Assessment

• Translation to German

• Adapation to LBI format

• Tables directly copied fromEnglish EUnetHTA assessment

• Shorter Version

• Adaptation with context specificAustrian data on e.g.epidemiology, costs

Examples for national adaptation ofAssessments

35


ISCIII produced local reportbased on EUnetHTAEndobarrier assessment(September 2014)

• Translation to Spanish

• Adaptation to ISCIII format

• English summary

• Update of literature search

Examples of national adaptation

36


Could you/would you use the assessment

directly for deriving a decision? If so, why? If not,

why not, which further information would you still

need?

Which decision would YOU derive based on the

information provided in the assessment?

Group work

37


Thank you!

This presentation arises from the EUnetHTA

Joint Action 2 which has received fundingfrom the European Union, in the framework ofthe Health Programme

hta core model for rapid assessment simone warren anna ... · european network for health...

Documents