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Conditional Coverage. Access with evidence development. Leonor Varela.
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Conditional Coverage. Access with evidence development. Leonor Varela.


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Post-introduction observation of health care technologies after coverage.

Post-introduction observation of health care technologies after coverage.

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  • 3 centres authorized and corresponding centralized circuits established to derive patients to these hospitals.
  • I would just like to outline the main resultsar
  • Problems in getting the data forwarded to us,
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    • 1. Post-introduction observation of health care technologies after coverageThe 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 FORCOMM 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. ContextConcerns 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 coveragescheme 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 PlanWhat Prioritisation tooltechnologies ( 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 organizationsReferences1. 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 HealthTechnology 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 TechnolAssess 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 theestablishement of data requirements, data collection methods, follow up schedule and outcomeindicators that are considered feasible, clinically meaningfull and relevant to the health caresystem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.
    • 7. Post-introduction observation of transcatheter aortic valveimplantation 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 centresApproval ofTAV I(transapic al andtrans femoral )for treatment of Proposal for post- 1 s t meeting: consensus Protocol developmentnon operable or introduction on outcome variables,hi gh ris k Observation of subgroups, follow uppatients with TAVI from health schedule, data collection Creation data basesevere aortic authority instruments , informationstenos is (> 75 exchange, informationyears 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 TAVIsVía 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 ofTAVIs 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: