P t i t d ti b ti f h lthPost-introduction observation of healthcare technologies after coverage

The Galician experience with percutaneous aortic valve replacement (TAVIs)

Leonor Varela LemaLeonor Varela LemaTeresa Queiro VerdesMarisa López GarcíaJeanette Puñal Riobóo

Bilbao. 26th June 2012

Conditional coverage framework

APPROVAL/ REIMBURSEMENT

ORDER 7 JULY 2003 (Galicia)/Royal Decree 1030/2006 (NHS)

NON APPROVAL HTA rapid assessment

PETITION FOR er

COMMERCIALIZATION OF A NEWNON PHARMACEUTICAL

TECHNOLOGY ADDITIONAL ASSESSMENT

(Full HTA report,

PETITION FOR INTRODUCTION IN REGIONAL HEALTH

SERVICES PORTFOLIO (Health care centres,

regional healthauthority) P

olic

ym

ake

ADVISORY COMMISSION FOR THE INTRODUCTIONOF NEW TECHNOLOGIES

cost-effectiveness analysis)

CONDITIONAL COVERAGE SPECIAL FOLLOW UP

CONDITIONS

Advisory Commission is composed of chief executives of various health care departments:-Health Insurance-Public Health and Innovation-Health Care Provision-Budget allocation CONDITIONSBudget allocation-Human resources-Pharmacy and medical devices-HTA agency

SPECIAL FOLLOW UP/MONITORED USEIf there is insufficient evidence on effectiveness and/or safety technologiesmight be reimbursed BUT only under special follow up conditions, subjectto specific indications, application and evaluation protocols, authorized onlyin designated centers and for a limited period of time.

Context

It can hamper the early introduction of technologies that are deemed to have an important

Concerns regarding the applicability of “special follow up” schemesIt can hamper the early introduction of technologies that are deemed to have an important impact on health.

In some cases the new technology has already diffused within the health system and patients who are candidates for the procedure can be discriminated from receiving it if they do not attendwho are candidates for the procedure can be discriminated from receiving it if they do not attend the authorized centers.

Research studies are frequently very demanding (too many variables, follow up visits, long follow up times) and clinicians allege that they have great difficulty in collaborating (lack of timefollow up times) and clinicians allege that they have great difficulty in collaborating (lack of time, important workload that difficults data collection, patient losses).

The process is very lengthy and medical procedures frequently evolve during the research process, to the point that indications might be obsolete or the trials findings might be of little relevanceto the point that indications might be obsolete or the trials findings might be of little relevance when results are available.

Does not provide useful information to resolve uncertainties regarding appropiate use in daily practice and best clinical managementpractice and best clinical management.

ReferenceVarela‐Lema Leonor, Atienza Merino Gerardo, López García Marisa, Vidal Martínez María, Gervas Triana Elena, Cerdá Mota Teresa. Demands and expectationsfor health technology assessment: qualitative analysis from the perspective of decision makers and clinicians. Gaceta Sanitaria 2011; 25(6):454‐460

Post-introduction observation conditional coverage scheme

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Reimbursement

Res

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Brief report

Int

Advi

sory

Intr

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Real life data

Post-introduction observation

There is sufficient evidence to establish that thetechnology is effective and safe but there are importantdoubts as to the applicability of the results when thetechnology is used in wider populations or importantuncertainty regarding the diffusion or application of thetechnology in real life practice (off label use, costdeviations).

Improving health caremanagementmanagement

Methodological guideline developed within the National Health Quality Plan

What Prioritisationtool

technologies and how?

tool(Pritec.tools)

Identification of prioritisation criteriaSelection and weighting of prioritisation criteriaprioritisation criteria

Data collection

DELPHI PROCEDURE

Systematic reviewand expert

opinion

Identification of common data collection methodsBasic considerations regarding each

Basic requirements for protocol

opinion Basic considerations regarding eachof these methods

Implementation

Basic requirements for protocoldevelopmentMethodology for development of outcome indicators and assessmentof results

Working group: 15 HTA expertsfrom Spanish

HTA

References1. Varela‐Lema L, Ruano‐Ravina A, Cerdá Mota T, Blasco‐Amaro JA, Gutiérrez‐Ibarluzea, ,  Ibargoyen‐Roteta N, et al.  Post‐introduction observation of Health Technologies. A methodological guideline. Quality Plan for the National Health System. Galician Health T h l A t A 2007

organizations

Technology Assessment Agency; 2007.2. Varela Lema L, Ruano‐Ravina A, Cerdá Mota T. Observation of Health Technologies after their introduction into clinical practice: a systematic review on data‐collection instruments. J Eval Clin Practice 2011; Aug 23. doi: 10.1111/j.1365‐2753.2011.01751.x. 3. Varela‐Lema L, Ruano‐Ravina A, Cerdá Mota T, Ibargoyen‐Roteta N, Imaz I, Gutiérrez‐Ibarluzea, Blasco‐Amaro JA, Soto‐Pedre E, Sampietro‐Colom L. Post‐introduction observation of healthcare technologies after coverage: the Spanish proposal. Int J Health Technol Assess Health Care; 2012 (in press) 

Main considerations derived from the guideline

Only key data should be collected (MINIMUM DATA SET)

The different stakeholders should be implicated from the beginning and should be involved in theestablishement of data requirements, data collection methods, follow up schedule and outcomeindicators that are considered feasible, clinically meaningfull and relevant to the health caresystemy

Data recorded should be as far as possible, final result variables and be part of data recordedroutinelly in medical records or considered relevant for decision making

The study should not increase the number of procedures or tests performed to the patient

Whenever possible, follow up contacts should be in agreement with routine check ups

The follow up should be as short as possible, even though sufficient for obtaining an adequatenumber of patients in each study subgroup

Data collection instruments should be context specific. The incorporation of outcome variables into theelectronic clinical records is the recommended option but not always feasible.

Post-introduction observation of transcatheter aortic valve implantation

Patient recruiment

D t ll ti

IMPLEMENTATIONPLANNINGPRIORITISATION

Data collection

Information exchange

HTA based follow up protocolSystematic review

Representatives from health authority

Opinion of clinicians from authorized centres

All 3 authorized centres

Approval of TAVI (transapical and transfemoral) for treatment of

1st meeting: consensus on outcome variables, subgroups, follow up schedule, data collection instruments , information exchange, information rights,

Proposal for post-introductionObservation of TAVI from health authority

for treatment of non operable or high risk patients with severe aortic stenosis (> 75 years old)

Creation data base

Protocol development

o a o g ,confidentiality

2º meeting: Discussion of results and recommendations

Data analysis

Technical report

avalia tavalia-t

Data collectionData collection: pre-intervention, post-intervention, 1, 6 and 12 monthsExcel questionnaire form to be completed on the computer or manuallyE-mail or ordinary mail

INTERVENTION

FOLLOW UP

Patient´s selection criteria

Adverse events

Description of procedure

Valve hemodynamics and NYHA functional class

Success of the intervention

Hospital complications

Hospital readmissions

F ll l d d hFollow up losses and death causes

Vía de accesoResults of post-introduction observation of TAVIs

Type of accessType of access

45

50

n= 48

94 TAVI implantations6 follow up lossesAll symptomatic patients with

25

30

35

40

45

transaxilar

transapical

n= 33

All symptomatic patients withhigh surgical risk orinoperable

0

5

10

15

20 transfemoraln= 14

0Hospital 1 Hospital 2 Hospital 3

Results of post-introduction observation of TAVIs

Mean age: 82 years (64-93)8,5% < 75 yrsNo significant differences among hospitals

Age distribution

50%

60% 51,1%48,5%

43,5%42 2% 42,5% 43,8%

g

20%

30%

40%

,42,2% 42,5%

< 75 yrs

75-84 yrs

≥ 85 yrs

0%

10%

20%

Hospital 1 Hospital 2 Hospital 3

6,7% 9,1%12,5%

Hospital 1 Hospital 2 Hospital 3

Results of post-introduction observation of TAVIs

Logistic EuroScore: 15,1% (2,9-73,2)

EuroScore distribution

50%

60%

70%60,0%

36 4%

45,5%50,0%

EuroScore< 10%

20%

30%

40%

18% 18%

25%

36,4%

25,0%22,2%

EuroScore< 10%

EuroScore 10-20%

EuroScore > 20%

0%

10%

Hospital 1 Hospital 2 Hospital 3

Results of post-introduction observation of TAVIs

Distribution of adverse events

Correct implantation: 96,8% 35%

40%

45% 42,4%43,9%

37,7%

p ,Hospital mortality: 7,4%Acumulated 1 year survival: 81,7%Complications: 40,4 %

20%

25%

30%

22%18,8%

25,1%

Hospital 1

Hospital 2

All patients improved NYHA functional class

5%

10%

15%

20% 16%

4%2%

9%

3%

Hospital 3

0%

5%

Vascular complications

Cardiac Complications

Renal failure Others complications

2%3%0%

Proposal derived from the stakeholder meeting

Update of systematic review and creation of a multidisciplinar group for therevision of selection criteria for TAVI authorization

Policy makers

Representatives from authorized centres

Creation of a multidisciplinary Hospital Commission within each authorizedhospital to consensuate TAVI implantation

Cardiologists and cardiac surgeonsCardiologists and cardiac surgeons

Analise implantation variability not attributed to geographical differences(accessibility problems, overuse, underuse?)

Main limitations

Delay in the forwarding of data (various contacts and active collection in 1 centre)

Different follow up visits and data recording times

Not all patients underwent transthoracic echocardiography before or after the intervention and so it was impossible to assess valve hemodynamics, paravalvular leaks or severity of aortic stenosis

The majority of centres only took into account disnea to establish symptomatology

Insufficient number of patients to determine if there are deviations in adverse events (n s) or if there are differences between different subgroups (type of access type of(n.s) or if there are differences between different subgroups (type of access, type of valve, hospital, etc)

Insufficient patients to detect cost deviations

Reticence of clinicians to be evaluated by external organizations

Ongoing strategies to improve applicabilityOngoing strategies to improve applicability

Definition and standardization of result variables to homogeneizeDefinition and standardization of result variables to homogeneizedata recording

Development of a web application to promote visibility and use ofDevelopment of a web application to promote visibility and use of the tool in collaborative projects in order to increase power todetect deviations in effectiveness/safety and allow for subgroupanalysisy

NEAR FUTURE!!! Incorporate result variables in electronic clinicalrecords and develop linkage mechanism to import data

Contact person:

Leonor Varela: avalia-t1@sergas.es