InnovaSEC
An initiative of the Spanish Society of Cardiology to study the best way to introduce innovation in cardiovascular diseases in Spain
Scientific Committee InnovaSEC:Dr Josep Brugada (President)Dra Laura Sampietro-ColomDr Mariano Larman TellecheaDr Alberto San Roman CalvarDr Fernando Worner Diz
InnovaSEC
Difficult balance between market access and value demonstration
Decrease in the percentage of GNP invested in health
Increasing sophistication in technological innovations
Spain2007 2008 2009 2010 2011 2012
InnovaSEC
Heterogeneity between different centers in the incorporation of innovation in cardiology
Adequate information is not always available to decide on innovation adoption
The perspective and experience of the professionals are key elements in the process of innovation assessment
InnovaSEC Objective
To elaborate a proposal on how to incorporate innovation in the field of cardiology (technology/equipment, medical devices, pharmacological compounds) in the Spanish Health System, and to define the role of Spanish Society of Cardiology in this process
Objective:
InnovaSEC Objective
Working plan:
I. Constitution of the Scientific Committee
II. Agreement on definitions
III. Establishing the criteria needed to inform the introduction of
technological innovation in the field of cardiology
IV. Define the role of the Spanish Society of Cardiology
• Dr. Josep Brugada Terradellas President
• Dr. Mariano Larman Tellechea Representing Large Equipments
• Dra. Laura Sampietro – Colom
Representing Health Technology Assessment
• Dr. Alberto San Roman Calvar
Representing Devices
• Dr. Fernando Worner Diz Representing Drugs
I. Scientific Committee
II: Agreement on definitions
• Implementation of new solutions to answer new requirements or non solved needs
• provides improvements in health outcomes, from the perspective of patients, professionals and the health system in general.
• Innovation
• “Value” of an innovation
Improves health outcomes (i.e. health status, quality of life, and decreases mortality) at a reasonable cost.
III: Establishing criteria: Process
• Review of Scientific and Grey literature andSelection
• Discussion and Consensus by the Scientific Committee
• Review and comments from the different sections of SSC
III: Establishing criteria for Assessment
1. Innovation related
Characteristics and size of the affected population Disease clinical burden Disease economical burden (cost-of-illness) Level of innovation Clinical efficacy and effectiveness Safety and tolerability Impact on direct health care costs (BIA) Cost-effectiveness Quality and degree of evidence Organizational requirements Risk of inappropriate use Capacity to stimulate research Legal requirements Equity (access) Feasibility to introduce the innovation (health care context)
III: Establishing criteria for Assessment
2. Health care system related (needed requirements for adoption)
Training requirements
Learning curve
Team skills
Activity volume and quality indicators
Transparency in results reporting
Patient information and informed consent
IV: Spanish Society of Cardiology role (SSC)
A. SSC Innovation Committee: InnovaSEC
• Reference Point within SSC for innovation related issues.
• Multidisciplinary team. Conflict of interest declaration in each process
• Objective: analyze proposals for innovation adoption in the health system on behalf of SSC.
• Functions:
1. To identify proactively valuable innovations in the cardiology arena (horizon scanning)
2. To commission and supervise the technology assessment of innovations (when requested)
3. To participate in the planning for the introduction of innovations in the spanish health care system
4. Any other issues that may arise related to innovation
B. Key principles in the innovation adoption process
Assessment:
Systematic, structured, evidence-based, robust and non-biased
Use of the most appropriate methodologies (quantitative and qualitative) according to the characteristic of the technology to be evaluated
Spanish health system context consideration (i.e. epidemiology and health care context)
Decision process (appraisal):
Transparent (explain sources and process)
Clear explanation on how and why the decision was made
Opportunity to appeal before the final decision
IV: Spanish Society of Cardiology role (SSC)
• Recommendations from appraisal
Positive recommendation
Positive recommendation with monitoring
Adoption only if clinical evidence is developed (i.e. CED)
Negative recommendation
IV: Spanish Society of Cardiology role (SSC)
• InnovaSEC: SSC initiative to contribute to introduce innovations in the Spanish Health Care System in a rational and sound way.
- Methodological document:
• Aimed to define a structured incorporation of technological innovations in the field of Cardiology in the Spanish healthcare system.
• Provides with a structured, systematic and professionalized way of assessing innovations in cardiology.
• Prioritize the introduction of those innovations of proven added-value to make a proper use of scarce resources.
- Reviewed and approved by the SSC, ESC, AHA and ACC
• InnovaSEC not intended to replace technology assessment agencies, but provide the vision of the professionals to the debate.
IV: Spanish Society of Cardiology role (SSC)
Cost-Effectiveness of Barostim in hypertensive patients
refractory to conventional treatment
Marcelo Soto, PhDLaura Sampietro-Colom, MD, MScPH, PhDJosep Brugada, MD, PhD
Valores Caso Base
Base-Case Scenario
ManDiabeticNo-smoking
Initial Age 55Initial systolic blood pressure 170 mmHG Total cholesterol 190 mg/dLHigh density lipoprotein 35 mg/dL
Used Model: Markov Model
Hypertension
Heart Failure
Coronary Heart Disease
Post-Infarction
ESRD (dialysis)
Death (from any state)
Post-Transplant
Post-Stroke
Stroke Myocardial Infarction
Stroke
ESRD (dialysis) & HF
Renal Transplant
Frequency of events per cohort
OMT Barostim DifferencePercentage
change
Acute Myocardial Infarction 0.217 0.184 -0.033 -15.2%
First AMI 0.196 0.167 -0.029 -14.7%
Recurrent AMI 0.021 0.017 -0.004 -19.7%
Stroke 0.305 0.200 -0.104 -34.2%
First Stroke 0.234 0.156 -0.078 -33.2%
Recurrent Stroke 0.071 0.044 -0.027 -37.6%
Heart failure 0.241 0.208 -0.032 -13.5%
End Stage Renal Disease 0.073 0.061 -0.011 -15.7%
Effectiveness Barostim (base case): decrease arterial pressure of 35 mmHg between 2 and 4 years after implantat (Bisognano et al 2011; Bakris et al 2012)
Results: base-caseOMT Barostim Difference
Life years gained 16.23 16.77 0.53QALYs 14.92 15.70 0.78Direct cost per patient (€) 17 480 71 180 53 700
Hospitalization and monitoring* 17 480 12 986 -4 494Cost of implant --- 1 672 1 672
Barostim System --- 21 000 21 000Battery --- 35 522 35 522
Indirect cost per patient ** (€) 23 223 20 301 -2 923
Direct cost per year of life (€) 100 519Direct cost per QALY (€) 69 153
Direct cost + Indirect cost per QALY (€) 65 389
* Direct costs of events (ischemic heart disease, MIA, stroke, etc.)** Lost productivity due to disability or death
• Suggested
Recommended with monitoring + look for the group of
patients with higher benefit (eg CED)
Negotiation of prices (battery)
Recommendation
V. InnovaSEC: Next Steps
• Publication of methodological document (i.e.criteria to inform decisions)
• Constitution and ratification by SSC of Innovation committee (done end October)
• Performing two additional assessments as pilots, one in the field of drugs and other in the field of large equipment
• Start structured evaluation process requests from: strategic partners, healthcare industry in general and the initiative of SSC or the administration
• InnovaSEC logistics: Explicit and transparent