denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
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Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Universidade do Estado do Rio de Janeiro
Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos
Introduction of participants and
objectives of the meeting objectives of the meeting
Denizar Vianna
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaAgenda
Who are we?
Meeting objectives
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaAgenda
Who are we?
Meeting objectives
PAHO’s ProVac InitiativePAHO’s ProVac Initiative
Agenda
Who are we?
Meeting objectives
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
To discuss how to create a regional team, involving
collaborations across multiple organizations: regulatory authorities, academic institutions, medical specialities associations;
Meeting objectives
associations;
To present tools for provide training to national multidisciplinary teams;
To discuss how to develop an Economic Model and Shared Decision Making for BioSimilar in Latin America.
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Universidade do Estado do Rio de Janeiro
Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos
Overview of projects to be
conducted by CLAPBio conducted by CLAPBio
Denizar Vianna
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Universidade do Estado do Rio de Janeiro
Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos
Infrastructure for regulatory
authorities in LA Countries authorities in LA Countries
Denizar Vianna
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaREQUIREMENTS WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA
The reference product must be licensed by the
national regulatory authority based on a full
development dossier (quality, safety, and efficacy
data)
no yes yes no yes no NA
A biosimilar/intended copy may be a reference
product in case the innovative product is not
available in the market
no no yes no no no no NA
available in the market
Full quality dossier (manufacturing process,
characterization, specifications, analytical
techniques and stability) plus head-to-head
comparison with the reference product
yes yes yes yes/no yes yes yes yes
Functional, physicochemical and biological head-to-
head characterization data in comparison with the
reference product
yes yes yes yes/no yes yes yes
Identical primary amino acid sequence yes yes no yes no No
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
REQUIREMENTS WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA
Non-clinical requirements: Abbreviated head-to-
head non-clinical pharmacology and toxicology
studies in comparison with the reference product
yes yes yes yes/no yes yes yes
Clinical requirements: But with no specific
requirements establishedNA NA yes NA NA NA yes
Clinical requirements: Abbreviated head-to-head
Pharmacokinetic (PK) and Pharmacodynamic (PD)
studies in comparison with the reference product
yes yes no yes/no yes yes NA
Clinical requirements: Abbreviated head-to-head
efficacy studies in comparison with the reference
product: equivalence or non-inferiority clinical trials
yes yes no NAIt is not
clear yetNA NA
Clinical requirements: Abbreviated head-to-head
efficacy studies in comparison with the reference
product: equivalence, non-inferiority or superiority
clinical trials
NA NA no yes/noIt is not
clear yetNA NA
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaREQUIREMENTS WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA
Clinical requirements: Abbreviated head-to-head
safety studies including immunogenicity in
comparison with the reference product
yes yes yes no yes no no
Product-class specific guidelines on non-
clinical/clinical datano yes no yes yes yes no
Extrapolation across indications (if justified and
specific criteria is satisfied)yes yes yes yes yes yes NA
Active pharmacovigilance plan and safety
specification (including submission of Periodic
Safety Update Reports [PSURs] and Adverse Drug
Reaction [ADR] Reporting)
yes yes yes yes yes yes yes yes
Risk Management Plan (RMP) yes yes no yes yes yes yes yes
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
REQUIREMENTS WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA
Prescription by non-proprietary name (INN), a
unique brand name and batch number for a
traceability system
yes yes no NAIt is not
clear yetyes no
Automatic substitution (interchangeability) NA NA yes NA no NA no
Prescribing information (package insert) clearly
specifying the clinical safety and efficacy data specifying the clinical safety and efficacy data
obtained by the biosimilar product itself from those
taken over from the reference product, particularly
in extrapolated indications where no studies have
been done at all
no no no no no no no
Special differentiated labelling (outer cartons and
labels) between biosimilars and reference productno no yes no no no no
Intellectual property (Patents and/or Data
Protection)NA yes yes yes no no no
Stand alone pathway accepted if intended copy is
not similar to the reference product (full licensing
application)
yes yes yes yes/no yes yes yes
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Universidade do Estado do Rio de Janeiro
Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos
Budget Impact Analysis Tool
Denizar Vianna
Health Care System
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaAgenda
1. Estimating Savings from Biosimilars in Latin America
2. Health Economics
3. CLAPBio’s objectives
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaAgenda
1. Estimating Savings from Biosimilars in Latin America
2. Health Economics
3. CLAPBio’s objectives
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
“Experience with biosimilars is very limited, as is
reliable information about their impact on
pharmaceutical markets.
As a result, behaviour and expectations by all
stakeholders currently is based more on stakeholders currently is based more on
assumption than on fact”.Professor Bengt Jönsson
Source: Mattison et al. Biosimilars: How much entry and price competition will
result? December 2010. Office of Health Economics
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaExamples of Impact Estimates
Source: Mattison et al. Biosimilars: How much entry and price competition will
result? December 2010. Office of Health Economics
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaAgenda
1. Estimating Savings from Biosimilars in Latin America
2. Health Economics
3. CLAPBio’s objectives
Eff
ect
ive
ne
ss
Co
sts
Cost versus Effectiveness
Eff
ect
ive
ne
ss
Co
sts
Treatment
Cost versus Effectiveness
Treatment
Eff
ect
ive
ne
ss
Co
sts
Cost versus Effectiveness
Treatment
What is Economic Evaluation?
� Definition: Economic Evaluation is ...
– the identification, measure, and comparison of
the costs (i.e. resources consumed) and the costs (i.e. resources consumed) and
outcomes (clinical, economic) of interventions
(pharmaceuticals, diagnostics, public health
programs)
Cost Effectiveness Analysis (CEA)
� Cost-effectiveness analysis (CEA) compares the cost of the intervention with the effect, resulting in a cost per effect (eg, cost per year of life gained) that can be compared across interventions.
� In CEA, the effectiveness is expressed in terms of non-� In CEA, the effectiveness is expressed in terms of non-monetary units that describes the desired objective.
– lives saved (life years gained)
- disability days avoided
- cases treated
“Outcome” examples :
- Events avoided (e.g. MI,
stroke, or vascular death)
Cost-Effectiveness Analysis
Relates Costs to Health Effects
“Costs” examples :
- hospitalizations,
treatment interventions, stroke, or vascular death)
- Life-years saved due to
events prevented (e.g. MI,
stroke, or vascular death)
“Incremental Cost-Effectiveness Ratio (ICER)”
= Difference in costs divided by difference in health
outcome between two treatment strategies
Costs Outcomes
1. Drummond et al. Ann Int Med 1987; 107(1): 88–92
2. Kobelt G. Health Economics: an introduction to economic evaluation. London: OHE, 2002
treatment interventions,
labs, side-effects, study
drug, transportation, lost
of productivity, etc.
Total Population
Sick Population
Incidence
Prevalence
% diagnosed
Total Population
Incidence (For
Preventive
interventions )
Diagnosis
NewNew
Sick Population
CURRENT ENVIRONMENT NEW ENVIRONMENT
KEY FACTOR IMPACT ON
NewNew
Framework of the Budget Impact Analysis
Target Population
Resources Utilization
Cost of Illness
% diagnosed
% treated
Current way of
treatment
Unit costs
Diagnosis
Treatment
Hospitalization,
Follow-up, etc.
New therapy/
procedure
Target Population
Resources Utilization
DIFERENCE
Budget Impact
Cost of Illness
NewNew
NewNew
NewNew
Definition of Model
• “A model is a logical mathematical framework that permits the integration of facts and values , and that links these of facts and values , and that links these data to outcomes that are of interest to health -care decision makers .”
Fonte: Weinstein MC, O'Brien B, Hornberger J, et al. Principles of good practice of decision analytic modeling in health care evaluation: Report of the ISPOR Task Force on Good Research Practices-Modeling Studies. Value Health 2003; 6:9-17
Economic Model
INPUTSOUTPUTS
MODEL
Agenda
1. Estimating Savings from Biosimilars in Latin America
2. Health Economics
3. CLAPBio’s objectives
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
The general guiding principle of CLAPBio is that
decisions regarding new BioSimilar introduction
should be country-led and grounded in an
Background
should be country-led and grounded in an
appropriate comparative, head to head quality,
non-clinical and clinical studies.
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Central to the CLAPBio approach is the formation
of a regional team, involving collaborations across
multiple organizations – regulatory authorities,
Background
multiple organizations – regulatory authorities,
healthcare organizations, international academic
institutions, medical specialities associations.
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
The CLAPBio’s goal is to strengthen the
national capacity to make informed, in
CLAPBio’s goal
national capacity to make informed, in
an appropriate comparative, head to
head quality, non-clinical and clinical
studies decisions regarding BioSimilar
introduction.
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Strengthen infrastructure for decision-makers
Develop tools for provide training to national multidisciplinary teams
CLAPBio’s objectives
multidisciplinary teams
Develop an Economic Model for BioSimilar in Latin America
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Conduct specific studies in the Latin American, considering each country’s specificity
Provide technical support to national multidisciplinary
CLAPBio collaboration
with LA Countries
Provide technical support to national multidisciplinary teams in regulatory and economic evaluations on BioSimilars in various countries in Latin America
Support LA Countries in providing training through workshops and long distance learning on regulatory and economic analysis
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Methodological guides & instruments for estimation of health services utilization and costs
Acceptable country-level data ranges for model
Collaboration
objectives
Acceptable country-level data ranges for model parameters
Model to evaluate impact of BioSimilar
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Launch an advisory board from opinion leaders
Strengthening infrastructure
for decision-making
leaders
Build a research center to examine price trajectories that might develop over time
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
How much price competition can we expectfrom Biosimilars in Latin America?
Develop an Economic Model
for Biosimilar in Latin America
Models of market entry and pricing in Latin America
Forecasts about the impact of Biosimilars in Latin America
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
The implementation of the CLAPBio Initiative’s plan of
work will result in several products, including but not limited to: development of models for BioSimilar studies, data collection tools; regional training workshops; direct
Strengthening infrastructure
for decision-making
data collection tools; regional training workshops; direct technical support to individual countries that make a request to CLAPBio; development of a regional network of academic CLAPBio Centers; development of the web-based CLAPBio e-Support Center; and technical support for National Regulatory Authorities .
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
This approach will be supported by a regional network of CLAPBio Centers based in academic institutions across Latin
Strengthening infrastructure
for decision-making
regional network of CLAPBio Centers based in academic institutions across Latin America
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e PesquisaDeveloping CLAPBio models and
tools, and provide training
The CLAPBio initiative will establish the
CLAPBio e-Support Center
(www.clapbio.com.br) to disseminate current (www.clapbio.com.br) to disseminate current
activities, online learning courses and links to
relevant literature
Universidade do Estado do Rio de JaneiroPoliclínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Universidade do Estado do Rio de Janeiro
Departamento de Clínica Médica
Centro Latino Americano de Pesquisa em Biológicos
Thank you
Denizar Vianna
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