Post-introduction observation of health care technologies after

coverageThe Galician experience with percutaneous aortic valve replacement

(TAVIs)

Leonor Varela LemaTeresa Queiro VerdesMarisa López GarcíaJeanette Puñal Riobóo

Bilbao. 26th June 2012

NON APPROVAL

COMMERCIALIZATION OF A NEWNON PHARMACEUTICAL

TECHNOLOGY

APPROVAL/ REIMBURSEMENT

ADDITIONAL ASSESSMENT

(Full HTA report, cost-effectiveness analysis)

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

HTA rapid assessment

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-Human resources-Pharmacy and medical devices-HTA agency

PETITION FOR INTRODUCTION IN REGIONAL HEALTH

SERVICES PORTFOLIO (Health care centres,

regional health authority)

Conditional coverage framework

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

Policy m

aker

ADVISORY COMMISSION FOR THE INTRODUCTIONOF NEW TECHNOLOGIES

It 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 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 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 relevance when results are available.

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

Concerns regarding the applicability of “special follow up” schemes

Context

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

Intr

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Advis

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Reimbursement

Real life data

Post-introduction observation

Resolu

tion

Brief report

Post-introduction observation conditional coverage scheme

There is sufficient evidence to establish that the technology is effective and safe but there are important doubts as to the applicability of the results when the technology is used in wider populations or important uncertainty regarding the diffusion or application of the technology in real life practice (off label use, cost deviations).

Improving health care management

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 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)

Methodological guideline developed within the National Health Quality Plan

What technologies and how?

Prioritisation tool

(Pritec.tools)

Identification of prioritisation criteria

Selection and weighting of prioritisation criteria

Data collection

Implementation

Basic requirements for protocol development

Methodology for development of outcome indicators and assessment of results

DELPHI PROCEDURE

Systematic review and

expert opinion

Identification of common data collection methods

Basic considerations regarding each of these methods

Working group: 15 HTA experts from Spanish

HTA organizations

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 the establishement of data requirements, data collection methods, follow up schedule and outcome indicators that are considered feasible, clinically meaningfull and relevant to the health care system

Data recorded should be as far as possible, final result variables and be part of data recorded routinelly 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 adequate number of patients in each study subgroup

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

Post-introduction observation of transcatheter aortic valve implantation

Patient recruiment

Data collection

Information exchange

All 3 authorized centres

HTA based follow up protocolSystematic review

Representatives from health authority

Opinion of clinicians from authorized centres

IMPLEMENTATIONPLANNINGPRIORITISATION

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

2º meeting: Discussion of results and recommendations

Proposal for post-introductionObservation of TAVI from health authority

Approval of TAVI (transapical and transfemoral) for treatment of non operable or high risk patients with severe aortic stenosis (> 75 years old)

Data analysis

Technical report

avalia-t

Creation data base

Protocol development

Data collection: pre-intervention, post-intervention, 1, 6 and 12 months

Excel questionnaire form to be completed on the computer or manually E-mail or ordinary mail

Data collection

INTERVENTION

FOLLOW UP

Patient´s selection criteria

Description of procedure

Success of the intervention

Hospital complications

Adverse events

Valve hemodynamics and NYHA functional class

Hospital readmissions

Follow up losses and death causes

Vía de acceso

94 TAVI implantations 6 follow up losses All symptomatic patients

with high surgical risk or inoperable

Type of access

Results of post-introduction observation of TAVIs

n= 48

n= 33

n= 14

Results of post-introduction observation of TAVIs

Mean age: 82 years (64-93) 8,5% < 75 yrs No significant differences among hospitals

Results of post-introduction observation of TAVIs

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

Results of post-introduction observation of TAVIs

Correct implantation: 96,8% Hospital mortality: 7,4% Acumulated 1 year survival:

81,7% Complications: 40,4 % All patients improved NYHA

functional class

Proposal derived from the stakeholder meeting

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

Policy makers

Representatives from authorized centres

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

Cardiologists 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 valve, hospital, etc)

Insufficient patients to detect cost deviations

Reticence of clinicians to be evaluated by external organizations

Ongoing strategies to improve applicability

Definition and standardization of result variables to homogeneize data recording

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

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

Contact person:

Leonor Varela: avalia-t1@sergas.es