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The role of the economic
evaluation in the RENEWING
      HEALTH Project
                                           Silvia Mancin
                                                Arsenàl.IT
             Veneto’s Research Centre for eHealth innovation




 Bilbao, 27th June 2012
Background


 The overall background of the project is a number of
         EU conferences and reports describing
   telemonitoring and the potential benefits of a wider
       use of telemedicine applications in Europe.



    Why telemonitoring is not widely diffused in health
                         systems?



11/10/12                                                  2
Possible reasons

 Evidences of contribution to quality of care
 Technology

 Organizative models

 Physician/patients perspective

 Legal aspects

 Cost/effectiveness
                                        X
 Monies


  11/10/12                                       3
RENEWING HEALTH:
                    REgioNs of Europe WorkINg toGether for HEALTH

• Programme: RENEWING HEALTH is the second Pilot Type
  A eHealth project funded under the Competitiveness
  and Innovation Framework Programme CIP ICT PSP
  (Information and Communications Technologies –
  Policy Support Programme)
• Project start date: 1st February 2010
• Total budget: 14.000.000 Euros
• EU contribution: 7.000.000 Euros
• European Regions involved: 9
• Patients involved: about 8000
AIM of RENEWING HEALTH


Validating, in real life settings and with a common
rigorous assessment methodology (MAST), the use
of existing Personal Health Systems for innovative
types of Telemedicine services used to monitor
chronic patients with
Cardiovascular Disease (CVD),

Chronic Obstructive Pulmonary Disease (COPD)

Diabetes

       and prepare for their wider deployment.
Assessment Methodology:
                         MAST

 MAST – Model for ASsessment of Telemedicine

 New model for assessing the effectiveness and
  contribution to quality of care of telemedicine
                   applications

A multi-disciplinary process that summarizes and
 evaluates information about the medical, social,
 economic and ethical issues related to the use of
telemedicine in a systematic, unbiased and robust
                       manner
Telemonitoring services
Cluster 1 Diabetes                            Cluster 6 CVD
Medium-term health                            Medium-term health
coaching and life-long                        coaching and life-long
monitoring                                    monitoring


Cluster 2 Diabetes                            Cluster 7 CVD
Life-long monitoring                          Remote monitoring of
                                              Congestive Heart
                                              Failure
Cluster 3 Diabetes
Ulcer monitoring                              Cluster 8 CVD
                                              Remote monitoring of
                                              implantable cardiac
Cluster 4 COPD                                devices
Short-term follow-up after
hospital discharge
                                              Cluster 10 Multi
                                              pathology
Cluster 5 COPD                                Monitoring of frail
Life-long                                     patients with chronic
monitoring                                    deseases
Elegibility Criteria and Sample
                       Size – Cluster 5 COPD
 Diagnosis of COPD, GOLD Class III-IV
 Life expectance > 12 months
 Patient able to use the equipment provided (alone or
  assisted).




11/10/12                                                 8
Elegibility Criteria and
                            Sample Size – HF Cluster 7
 Age ≥ 65 years
 Discharge from hospital after acute HF in the previous 3 months and EF < 40%
  or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalisation
 No comorbidities prevalent on CHF with life expectation < 12 months
 No myocardial infarction or percutaneous coronary intervention in last 3
  months, or scheduled
 No coronary artery bypass, valve substitution or correction in last 6 months
 Patient able to use the equipment provided (alone or assisted)
 Being on waiting list for heart transplantation
 Being enrolled in other trial




11/10/12                                                                         9
Veneto Region service
                                                                                             Specialist
                     Patient’s home                       Regional eHealth
                                                               Centre
              Telemonitoring
                 devices
                                            Gateway
                                     2
                                                      3                         7       General Practitioner
    1




                                                               4
Patient                                                                                 Intervention service

                                                                                    6

                                                      5


               Alarm device                                 Regional Centre’s
                                                                Operator                   Social worker




                                                                                        Family/Caregiver
          Data transmission
          Data access through Home Care portal
                                                                                             10
   10     Alarm management
          Contact with the patient
Assessment Methodology: MAST- Model for
                           ASsessment of Telemedicine
HEALTH TECHNOLOGY




                                                        HEALTH TECHNOLOGY
   ASSESSMENT




                                                           ASSESSMENT
                      Rigorous assessment
                               of
                        TELEMONITORING
                            SERVICES




                                                                 11
Outcomes




CLUSTER 5 - COPD
Outcomes




CLUSTER 7 – Heart Failure
Project timeline


 Enrollment start: October 2011

 Enrollment period: 6 months  12 months

 Follow up period: 12 months

 Final Results: December 2013



11/10/12                                    14
Veneto Region COPD
                                                  Consort
                                  Assessed for elegibility (n=369)

                                                                        Excluded (n=92)
                                                                        Not meeting inclusion criteria (n=67)
                                                                        Decline to participate (n=19)
                                                                        Other reasons (n=6)

                                       Randomised (n=277)



Allocated to intervention (n=198)                       Allocated to usual care (n=79)
Received allocated intervention (n=152)
Did not received intervention (n=8)
Waiting to receive intervention (n=37)


Lost to follow-up (n=3)                                 Lost to follow-up (n=5)
Discontinued intervention (n=0)                         Discontinued intervention (n=0)


Analysed (n=0)                                          Analysed (n=0)
Excluded from analysis (n=0)                            Excluded from analysis (n=0)
                                                                                                       15
* 93% of Sample Size updated to 21 May 2012
Veneto Region HF
                                                  Consort
                                  Assessed for elegibility (n=163)

                                                                        Excluded (n=29)
                                                                        Not meeting inclusion criteria (n=24)
                                                                        Decline to participate (n=5)
                                                                        Other reasons (n=0)

                                       Randomised (n=134*)



Allocated to intervention (n=89)                        Allocated to usual care (n=45)
Received allocated intervention (n=61)
Did not received intervention (n=8)
Waiting for receiving intervention (n=20)


Lost to follow-up (n=2)                                 Lost to follow-up (n=8)
Discontinued intervention (n=0)                         Discontinued intervention (n=0)


Analysed (n=0)                                          Analysed (n=0)
Excluded from analysis (n=0)                            Excluded from analysis (n=0)
                                                                                                       16
*43% of Sample Size update to 21 May 2012
Preliminary Results at
            baseline



Who is the patient?

Socio-Demographics level
Veneto Preliminary Outcomes:
           Socio-demographic at baseline
Cluster 5 COPD Life-long monitoring
Veneto Preliminary Outcomes:
           Socio-demographic at baseline
Cluster 7 Remote monitoring of CHF
Skills with technology
Are you familiar with using a personal   Are you familiar with using a mobile
computer (PC)?                           phone?




    11/10/12                                                              20
Who is the patient?

 Geographical spread
Patients – Cluster 5




Patients’ distance from healthcare structure
Average distance (one way): 9,5 km
Average travelling time (one way): 15,4 minutes
Patients – Cluster 7




Patients’ distance from healthcare structure
Average distance (one way): 10,1 km
Average travelling time (one way): 17,5 minutes
Transport used to go to the
              healthcare structure




11/10/12                             24
Assessment Methodology: MAST- Model for
                           ASsessment of Telemedicine
HEALTH TECHNOLOGY




                                                        HEALTH TECHNOLOGY
   ASSESSMENT




                                                           ASSESSMENT
                      Rigorous assessment
                               of
                        TELEMONITORING
                            SERVICES




                                                                 25
Economic analysis
         Societal                       Business Case
                          Perspective

• Broad: takes into account      •   Narrower: adopts the LHA’s
  all kinds of resources and         point of view
  benefits
• Aim: assessing the service’s   •   Aim: assessing the
  overall cost-effectiveness         company’s financial return
                                     when providing the service

                            Outcomes

• ICER (Incremental Cost-        •   Return on Investments (ROI)
  effectveness ratio)– based     •   Total cost of intervention
  on SF-6D’s QALYs               •   Break even analysis
• Cost per clinical event        •   DRG-rate
  avoided (CEA)
Cost analysis and reporting

     Describe resources, data collection and level of estimation




27
Veneto Preliminary Outcomes:
       Costs at baseline
   Cluster 5 COPD
Life-long monitoring
Veneto Preliminary Outcomes:
          Costs at baseline
     Cluster 7 CVD
Remote monitoring of CHF
Veneto:
                          demographics
In the Veneto Region*:

• 20% of population is over 65
• 16.5% of the elderly population is at risk of poverty
• 68% of people over 75 years is suffering from at least
  two chronic degenarative diseases
• 46% prelevance of multiple chronic diseases in the
  population aged between 65 and 74
• Patients affected by COPD 238.000
• Patients affected by CHF 70.000
                                      Rapporto Statistico 2011, Veneto Region
                                      *
Expected Results

 Carring out a detailed and rigorous
report to be used as a basis for decision

 Validating a New model for the
assessment of telemedicine services
(Health Technology Assessment)

 Guidelines for the European Countries
on how the european prototypes of
telemonitoring services can become
Large Scale Pilots.

   FROM PILOT TO MARKET
Thank you for your attention
       Silvia Mancin
 smancin@consorzioarsenal.it




www.renewinghealth.eu

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The role of the economic evaluation in the RENEWING HEALTH Project. Silvia Mancin

  • 1. The role of the economic evaluation in the RENEWING HEALTH Project Silvia Mancin Arsenàl.IT Veneto’s Research Centre for eHealth innovation Bilbao, 27th June 2012
  • 2. Background The overall background of the project is a number of EU conferences and reports describing telemonitoring and the potential benefits of a wider use of telemedicine applications in Europe. Why telemonitoring is not widely diffused in health systems? 11/10/12 2
  • 3. Possible reasons  Evidences of contribution to quality of care  Technology  Organizative models  Physician/patients perspective  Legal aspects  Cost/effectiveness X  Monies 11/10/12 3
  • 4. RENEWING HEALTH: REgioNs of Europe WorkINg toGether for HEALTH • Programme: RENEWING HEALTH is the second Pilot Type A eHealth project funded under the Competitiveness and Innovation Framework Programme CIP ICT PSP (Information and Communications Technologies – Policy Support Programme) • Project start date: 1st February 2010 • Total budget: 14.000.000 Euros • EU contribution: 7.000.000 Euros • European Regions involved: 9 • Patients involved: about 8000
  • 5. AIM of RENEWING HEALTH Validating, in real life settings and with a common rigorous assessment methodology (MAST), the use of existing Personal Health Systems for innovative types of Telemedicine services used to monitor chronic patients with Cardiovascular Disease (CVD), Chronic Obstructive Pulmonary Disease (COPD) Diabetes and prepare for their wider deployment.
  • 6. Assessment Methodology: MAST MAST – Model for ASsessment of Telemedicine New model for assessing the effectiveness and contribution to quality of care of telemedicine applications A multi-disciplinary process that summarizes and evaluates information about the medical, social, economic and ethical issues related to the use of telemedicine in a systematic, unbiased and robust manner
  • 7. Telemonitoring services Cluster 1 Diabetes Cluster 6 CVD Medium-term health Medium-term health coaching and life-long coaching and life-long monitoring monitoring Cluster 2 Diabetes Cluster 7 CVD Life-long monitoring Remote monitoring of Congestive Heart Failure Cluster 3 Diabetes Ulcer monitoring Cluster 8 CVD Remote monitoring of implantable cardiac Cluster 4 COPD devices Short-term follow-up after hospital discharge Cluster 10 Multi pathology Cluster 5 COPD Monitoring of frail Life-long patients with chronic monitoring deseases
  • 8. Elegibility Criteria and Sample Size – Cluster 5 COPD  Diagnosis of COPD, GOLD Class III-IV  Life expectance > 12 months  Patient able to use the equipment provided (alone or assisted). 11/10/12 8
  • 9. Elegibility Criteria and Sample Size – HF Cluster 7  Age ≥ 65 years  Discharge from hospital after acute HF in the previous 3 months and EF < 40% or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalisation  No comorbidities prevalent on CHF with life expectation < 12 months  No myocardial infarction or percutaneous coronary intervention in last 3 months, or scheduled  No coronary artery bypass, valve substitution or correction in last 6 months  Patient able to use the equipment provided (alone or assisted)  Being on waiting list for heart transplantation  Being enrolled in other trial 11/10/12 9
  • 10. Veneto Region service Specialist Patient’s home Regional eHealth Centre Telemonitoring devices Gateway 2 3 7 General Practitioner 1 4 Patient Intervention service 6 5 Alarm device Regional Centre’s Operator Social worker Family/Caregiver Data transmission Data access through Home Care portal 10 10 Alarm management Contact with the patient
  • 11. Assessment Methodology: MAST- Model for ASsessment of Telemedicine HEALTH TECHNOLOGY HEALTH TECHNOLOGY ASSESSMENT ASSESSMENT Rigorous assessment of TELEMONITORING SERVICES 11
  • 13. Outcomes CLUSTER 7 – Heart Failure
  • 14. Project timeline  Enrollment start: October 2011  Enrollment period: 6 months  12 months  Follow up period: 12 months  Final Results: December 2013 11/10/12 14
  • 15. Veneto Region COPD Consort Assessed for elegibility (n=369) Excluded (n=92) Not meeting inclusion criteria (n=67) Decline to participate (n=19) Other reasons (n=6) Randomised (n=277) Allocated to intervention (n=198) Allocated to usual care (n=79) Received allocated intervention (n=152) Did not received intervention (n=8) Waiting to receive intervention (n=37) Lost to follow-up (n=3) Lost to follow-up (n=5) Discontinued intervention (n=0) Discontinued intervention (n=0) Analysed (n=0) Analysed (n=0) Excluded from analysis (n=0) Excluded from analysis (n=0) 15 * 93% of Sample Size updated to 21 May 2012
  • 16. Veneto Region HF Consort Assessed for elegibility (n=163) Excluded (n=29) Not meeting inclusion criteria (n=24) Decline to participate (n=5) Other reasons (n=0) Randomised (n=134*) Allocated to intervention (n=89) Allocated to usual care (n=45) Received allocated intervention (n=61) Did not received intervention (n=8) Waiting for receiving intervention (n=20) Lost to follow-up (n=2) Lost to follow-up (n=8) Discontinued intervention (n=0) Discontinued intervention (n=0) Analysed (n=0) Analysed (n=0) Excluded from analysis (n=0) Excluded from analysis (n=0) 16 *43% of Sample Size update to 21 May 2012
  • 17. Preliminary Results at baseline Who is the patient? Socio-Demographics level
  • 18. Veneto Preliminary Outcomes: Socio-demographic at baseline Cluster 5 COPD Life-long monitoring
  • 19. Veneto Preliminary Outcomes: Socio-demographic at baseline Cluster 7 Remote monitoring of CHF
  • 20. Skills with technology Are you familiar with using a personal Are you familiar with using a mobile computer (PC)? phone? 11/10/12 20
  • 21. Who is the patient? Geographical spread
  • 22. Patients – Cluster 5 Patients’ distance from healthcare structure Average distance (one way): 9,5 km Average travelling time (one way): 15,4 minutes
  • 23. Patients – Cluster 7 Patients’ distance from healthcare structure Average distance (one way): 10,1 km Average travelling time (one way): 17,5 minutes
  • 24. Transport used to go to the healthcare structure 11/10/12 24
  • 25. Assessment Methodology: MAST- Model for ASsessment of Telemedicine HEALTH TECHNOLOGY HEALTH TECHNOLOGY ASSESSMENT ASSESSMENT Rigorous assessment of TELEMONITORING SERVICES 25
  • 26. Economic analysis Societal Business Case Perspective • Broad: takes into account • Narrower: adopts the LHA’s all kinds of resources and point of view benefits • Aim: assessing the service’s • Aim: assessing the overall cost-effectiveness company’s financial return when providing the service Outcomes • ICER (Incremental Cost- • Return on Investments (ROI) effectveness ratio)– based • Total cost of intervention on SF-6D’s QALYs • Break even analysis • Cost per clinical event • DRG-rate avoided (CEA)
  • 27. Cost analysis and reporting Describe resources, data collection and level of estimation 27
  • 28. Veneto Preliminary Outcomes: Costs at baseline Cluster 5 COPD Life-long monitoring
  • 29. Veneto Preliminary Outcomes: Costs at baseline Cluster 7 CVD Remote monitoring of CHF
  • 30. Veneto: demographics In the Veneto Region*: • 20% of population is over 65 • 16.5% of the elderly population is at risk of poverty • 68% of people over 75 years is suffering from at least two chronic degenarative diseases • 46% prelevance of multiple chronic diseases in the population aged between 65 and 74 • Patients affected by COPD 238.000 • Patients affected by CHF 70.000 Rapporto Statistico 2011, Veneto Region *
  • 31. Expected Results  Carring out a detailed and rigorous report to be used as a basis for decision  Validating a New model for the assessment of telemedicine services (Health Technology Assessment)  Guidelines for the European Countries on how the european prototypes of telemonitoring services can become Large Scale Pilots. FROM PILOT TO MARKET
  • 32. Thank you for your attention Silvia Mancin smancin@consorzioarsenal.it www.renewinghealth.eu

Editor's Notes

  1. The term PHS means both the wearable/portable devices used to monitoring some clinical parameters and the integrated telemedicine services for the remote data control.
  2. The model is a part of the results from the MethoTelemed project. The MethoTelemed project is a bid for the SMART 2008/0064: Assesing the effectiveness of telemedicine applications Il MAST è stato elaborato da Danesi e Norvegesi.
  3. Tele-health Service The patient at his home uses the provided devices for the measurement of of his clinical parameters (heart rate, blood pressue, 1-lead ECG, pulse-oxymetry and weight if he has heart failure, pulse-oxymetry and heart rate if he has COPD and blood glucose level if he has diabetes). T he telemonitoring devices, used by the patient, collects the data and send them to the gateway device wirelessly. The gateway device transmits data collected by the patient to the server of a Regional eHealth Centre, where a group of operators are in charge of data management. The Centre’s operator checks the data sent by the patient accessing them through the Home Care portal. In case of clinical parameters out of normal range, the telemonitoring software detects the alarm situation that the operator has to manage following the standard protocol. In case of alarm situation, the operator contacts the patient to verify the alarm. If the alarm is verified, according to its severity, the operator contacts the GP of that patient or the Emergency Department. For the proper management of the alarm situation, after the notification by the Centre’s operator, the GP accesses the Home Care Portal to check patient data and take the proper actions. Any time they need, not only in case of alarms, the GPs can access the Home Care portal to monitor the patients health conditions. Tele-care Service The patient, in case of emergency, uses the alarm device provided to trigger an alarm The alarm device sends the alarm signal to the gateway The gateway device transmits the alarm to the Regional eHealth Centre The Centre’s operator checks the alarms sent by the patient accessing them through the Home Care portal The operator manages the alarm situation first contacting the patient to verify the alarm. Second, if the alarm is verified and depending on its severity, the operator contacts the patient’ s family and the Emergency Departiment and/or the Social Service.   T he Centre’s operators calls periodically the patients to monitor their life conditions and quality of life.
  4. MAST – Model for ASsessment of Telemedicine New model for assessing the effectiveness and contribution to quality of care of telemedicine applications A multi-disciplinary process that summarizes and evaluates information about the medical, social, economic and ethica l issues related to the use of telemedicine in a systematic, unbiased and robust manner
  5. Tolto ADI  59 pazienti Motivazioni per la mancata attivazione: decesso (2), Volontà del paziente o dei familiari di uscire dallo studio (5), Problemi tecnici per l&apos;installazione delle apparecchiature (1), Ricorrenti cambi di domicilio (1) Motivazioni per il dropout: Intervento: Decesso (3), Controllo: Decesso(2) Volontà del paziente o dei familiari di uscire dallo studio*(2), Problemi tecnici per l’istallazione apparecchiature (1)
  6. Motivazioni per la mancata attivazione: decesso (2), Volontà del paziente o dei familiari di uscire dallo studio (5), Problemi tecnici per l&apos;installazione delle apparecchiature (1), Ricorrenti cambi di domicilio (1) Motivazioni per il dropout: Intervento: Decesso (2), Trasferimento del paziente in casa di riposo* (3) Controllo: Decesso(1) Volontà del paziente o dei familiari di uscire dallo studio*(3), Trasferimento del paziente in casa di riposo* (3) Problemi tecnici per l’istallazione apparecchiature (1)
  7. MAST – Model for ASsessment of Telemedicine New model for assessing the effectiveness and contribution to quality of care of telemedicine applications A multi-disciplinary process that summarizes and evaluates information about the medical, social, economic and ethica l issues related to the use of telemedicine in a systematic, unbiased and robust manner
  8. Il numero di ultra 65enni in Veneto, oggi più di 975 mila pari al 20% della popolazione, crescerà del 45% da qui a vent&apos;anni, e la variazione prevista sale addirittura al 67% per la fascia di età dei molto anziani, ossia dagli 80 anni in poi. Destano attenzione alcuni importanti conseguenze sociali ed economiche del fenomeno dell&apos;invecchiamento. I territori in calo demografico e in cui la popolazione è prevalentemente anziana dovranno rivedere l&apos;offerta di beni e servizi pubblici di base come la salute, il trasporto e la proposta residenziale; senza contare i cambiamenti negli equilibri familiari e l&apos;aumento di potenziali anziani soli. Dal punto di vista economico gli anziani rappresentano un segmento vulnerabile della popolazione. In Veneto il 16,5% degli anziani è a rischio di povertà, più della popolazione complessiva (9,7%); maggiormente esposte le donne anziane, che incontrano serie difficoltà economiche date le pensioni mediamente più basse: circa 1 su 5 è a rischio di povertà. Mediamente un anziano veneto vive con una pensione di 11.300 euro, neanche mille euro al mese, poco meno della situazione nazionale. Oltre alla questione previdenziale, l&apos;invecchiamento sta richiamando l&apos;attenzione sul tema della sostenibilità della spesa pubblica sanitaria, specie per l&apos;assistenza di lungo periodo: se è vero che la vita media si allunga, è vero anche che nell&apos;ultima parte della vita l&apos;anziano non sarà autosufficiente, anzi il periodo compreso tra l&apos;insorgere della non autosufficienza e il decesso è destinato nel tempo a dilatarsi. Ad esempio, in Veneto il 68% delle persone di oltre 75 anni è affetto da almeno due malattie croniche degenerative, mentre per le persone di età 65-74 anni la prevalenza della multi cronicità è del 46%. L&apos;evoluzione della spesa sanitaria dipenderà quindi non solo dall&apos;invecchiamento, ma anche dall&apos;incidenza della disabilità tra gli anziani, dal disequilibrio tra cure formali e informali, oltre che dalla tipologia di servizi che il sistema intende mettere a disposizione: residenziale, semiresidenziale o domiciliare, di natura economica o in forma di servizi. In Veneto la rete assistenziale rivolta agli anziani non autosufficienti è frutto di politiche che negli anni hanno prodotto una molteplicità di interventi in relazione alla complessità del bisogno sociale e sanitario. Inoltre, considerando l&apos;importanza di mantenere l&apos;anziano nel proprio ambiente familiare, abitativo e sociale, l&apos;orientamento delle politiche regionali sta assecondando la permanenza della persona anziana presso il proprio domicilio, riservando l&apos;accoglienza residenziale alle persone non altrimenti assistibili. Nel 2010 il Fondo regionale per la non autosufficienza ammonta a oltre 704 milioni di euro, in aumento rispetto all&apos;anno precedente del 3,5%. Anche se la maggior parte delle risorse è destinato alla residenzialità per gli anziani (65%), le politiche regionali hanno inteso potenziare negli anni più recenti il finanziamento della domiciliarità, che oggi copre il 13% delle risorse.