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