Post-introduction observation of health care technologies after coverage.

1. Post-introduction observation of health
care technologies after coverage
The Galician experience with percutaneous aortic valve replacement
(TAVIs)
Leonor Varela Lema
Teresa Queiro Verdes
Marisa López García
Jeanette Puñal Riobóo
Bilbao. 26th June 2012

2. Conditional coverage framework
ORDER 7 JULY 2003 (Galicia)/Royal Decree 1030/2006
AP PROVA L/
(NHS) REIMBURSEM ENT
HTA rapid assessment NON APPROV AL
Policy maker
PETITION FOR
COMM ERCIA LIZ ATION OF A NEW INTRODUCTION IN
ADVISORY COMMISSION
NON PHA RMACEUTICAL REGIONAL HEALTH
FOR THE INTRODUCTION
T ECHNOLOGY SERVICES PORTFOLIO
OF NEW TECHNOLOGIES
(Health care centres, ADDIT IONA L
regional health authority) ASSE SSME NT
(F ull HT A report,
cost-effectivenes s anal ysi s)
Advi sory Com mission is
com posed of chi ef executives of
various health care departments:
-Health Insurance
-Public Health and Innovation CONDITIONAL COVERAGE
-Health Care Provision SPECIAL FOLLOW UP
-Budget allocation CONDITIONS
-Human resources
-Pharmacy and medical devices
-HTA agency
SPECIAL FOLLOW UP/M ONIT ORED USE
If 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 only
in designated centers and for a limited period of time.

3. Context
Concerns regarding the applicability of “special follow up”
 schemes the early introduction of technologies that are deemed to have an important
It can hamper
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.
Reference
Varela-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

4. Post-introduction observation conditional coverage
scheme
Advisory Comission for the
Introduction
Introduction of NT
Resolution
Reimbursement
Brief
report
There is sufficient evidence to establish that the
technology is effective and safe but there are important
Real life Post-introduction doubts as to the applicability of the results when the
technology is used in wider populations or important
data observation
uncertainty regarding the diffusion or application of the
technology in real life practice (off label use, cost
deviations).
Improving health care
management

5. Methodological guideline developed within the National Health Quality Plan
What Prioritisation
tool
technologies (Pritec.tools)
and how? Identification of prioritisation criteria
Selection and weighting of prioritisation
DELPHI PROCEDURE
Systematic review Data collection
 Identification of common data
and expert collection methods
 Basic considerations regarding each
opinion
of these methods
 Basic requirements for protocol
development
 Methodology for development of
Im plem entation
Working group: outcome indicators and assessment
15 HTA experts
of results
from Spanish
HTA
organizations
References
1. 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)

6. 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.

7. Post-introduction observation of transcatheter aortic valve
implantation
PRIORITISAT ION P LANNING IM PLE MENTA TION
Patient recruiment
Data collection
HTA based follow Opinion of clinicians Representatives from
up protocol from authorized centres health authority
Systematic review Information exchange
All 3 authorized centres
Approval of
TAV I
(transapic al and
trans femoral )
for treatment of Proposal for post- 1 s t meeting: consensus Protocol development
non operable or introduction on outcome variables,
hi gh ris k Observation of subgroups, follow up
patients with TAVI from health schedule, data collection Creation data base
severe aortic authority instruments , information
stenos is (> 75 exchange, information
years old) rights, confidentiality
Data analysis
2º meeting: Discussion
of results and
recommendations Technical report
avalia-t

8. Data collection
 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
INTERVENTION
FOLLOW UP
Adverse events
Patient´s selection criteria
Valve hemodynamics and NYHA
functional class
Description of procedure
Success of the intervention
Hospital readmissions
Hospital complications
Follow up losses and death
causes

9. Results of post-introduction observation of TAVIs
Vía de acceso
Type of access
n= 48
n= 33
 94 TAVI implantations
 6 follow up losses
 All symptomatic patients with n= 14
high surgical risk or inoperable

10. Results of post-introduction observation of TAVIs
 Mean age: 82 years (64-93)
 8,5% < 75 yrs
 No significant differences among hospitals

11. Results of post-introduction observation of TAVIs
 Logistic EuroScore: 15,1% (2,9-73,2)

12. R esults 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

13. 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?)

14. 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

15. 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

16. Contact person:
Leonor Varela: avalia-t1@sergas.es