Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]

Universidade do Estado do Rio de Janeiro
Universidade do Estado do Carneiro
Policlínica Piquet Rio de Janeiro
Departamento de Clínica Médica
Instituto de Ensino e Pesquisa
Centro Latino Americano de Pesquisa em Biológicos

Introduction of participants and
objectives of the meeting

Denizar Vianna

Policlínica Piquet Carneiro
Agenda

Who are we?

Meeting objectives

Agenda
Who are we?

Meeting objectives

Meeting objectives

To discuss how to create a regional team, involving
collaborations across multiple organizations: regulatory
authorities, academic institutions, medical specialities
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.


Overview of projects to be
conducted by CLAPBio

Denizar Vianna


Infrastructure for regulatory
authorities in LA Countries

Denizar Vianna

REQUIREMENTS Policlínica Piquet Carneiro
WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA
The reference product must be licensed by the
national regulatory authority based on a full
no yes yes no yes no NA
development dossier (quality, safety, and efficacy
data)

A biosimilar/intended copy may be a reference
product in case the innovative product is not no no yes no no no no NA
available in the market

Full quality dossier (manufacturing process,
characterization, specifications, analytical
yes yes yes yes/no yes yes yes yes
techniques and stability) plus head-to-head
comparison with the reference product

Functional, physicochemical and biological head-to-
head characterization data in comparison with the yes yes yes yes/no yes yes yes
reference product

Identical primary amino acid sequence yes yes no yes no No

REQUIREMENTS WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA
Non-clinical requirements: Abbreviated head-to- de Ensino e Pesquisa
Instituto
head non-clinical pharmacology and toxicology yes yes yes yes/no yes yes yes
studies in comparison with the reference product

Clinical requirements: But with no specific
NA NA yes NA NA NA yes
requirements established

Clinical requirements: Abbreviated head-to-head
Pharmacokinetic (PK) and Pharmacodynamic (PD) yes yes no yes/no yes yes NA
studies in comparison with the reference product

It is not
efficacy studies in comparison with the reference yes yes no NA NA NA
clear yet
product: equivalence or non-inferiority clinical trials

efficacy studies in comparison with the reference It is not
NA NA no yes/no NA NA
product: equivalence, non-inferiority or superiority clear yet
clinical trials

REQUIREMENTS
Instituto de Ensino e MEXICO BRAZIL CHILE
WHO EMA
Pesquisa PERU CUBA PANAMA

safety studies including immunogenicity in yes yes yes no yes no no
comparison with the reference product

Product-class specific guidelines on non-
no yes no yes yes yes no
clinical/clinical data

Extrapolation across indications (if justified and
yes yes yes yes yes yes NA
specific criteria is satisfied)

Active pharmacovigilance plan and safety
specification (including submission of Periodic
yes yes yes yes yes yes yes yes
Safety Update Reports [PSURs] and Adverse Drug
Reaction [ADR] Reporting)

Risk Management Plan (RMP) yes yes no yes yes yes yes yes

BRAZIL CHILE PERU CUBA PANAMA
REQUIREMENTS
PoliclínicaWHO EMACarneiro
Piquet MEXICO
Prescription by non-proprietary name (INN), a
It is not
unique brand name and batch number for a yes yes no NA yes no
clear yet
traceability system

Automatic substitution (interchangeability) NA NA yes NA no NA no

Prescribing information (package insert) clearly
specifying the clinical safety and efficacy data
obtained by the biosimilar product itself from those
no no no no no no no
taken over from the reference product, particularly
in extrapolated indications where no studies have
been done at all

Special differentiated labelling (outer cartons and
no no yes no no no no
labels) between biosimilars and reference product

Intellectual property (Patents and/or Data
NA yes yes yes no no no
Protection)

Stand alone pathway accepted if intended copy is
not similar to the reference product (full licensing yes yes yes yes/no yes yes yes
application)


Budget Impact Analysis Tool

Denizar Vianna

Agenda

1. Estimating Savings from Biosimilars in Latin America

2. Health Economics

3. CLAPBio’s objectives


“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
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

Examples of Impact Estimates

Source: Mattison et al. Biosimilars: How much entry and price competition will
result? December 2010. Office of Health Economics

Effectiveness
Cost versus Effectiveness

Costs

Effectiveness

Costs
Treatment

Treatment
Effectiveness

Costs

What is Economic Evaluation?
Definition: Economic Evaluation is ...
– the identification, measure, and comparison of
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-
monetary units that describes the desired objective.
– lives saved (life years gained)
- disability days avoided
- cases treated

Cost-Effectiveness Analysis
Relates Costs to Health Effects

“Costs” examples : “Outcome” examples :
- hospitalizations, - Events avoided (e.g. MI,
treatment interventions, stroke, or vascular death)
labs, side-effects, study - Life-years saved due to
drug, transportation, lost Costs Outcomes events prevented (e.g. MI,
of productivity, etc. stroke, or vascular death)

“Incremental Cost-Effectiveness Ratio (ICER)”
= Difference in costs divided by difference in health
outcome between two treatment strategies

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

Framework of the Budget Impact Analysis
CURRENT ENVIRONMENT NEW ENVIRONMENT
New
KEY FACTOR IMPACT ON
Total Population Total Population
Incidence (For
Incidence Preventive
Prevalence interventions ) New
Sick Population Sick Population
% diagnosed Diagnosis
% treated Treatment
New
Target Population Target Population
Current way of Hospitalization,
treatment Follow-up, etc.
New
Resources Utilization Resources Utilization
New therapy/
Unit costs
procedure
New
Cost of Illness DIFERENCE Cost of Illness

Budget Impact

Definition of Model

• “A model is a logical mathematical
framework that permits the integration
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

OUTPUTS
INPUTS MODEL

Agenda
1. Estimating Savings from Biosimilars in Latin America

2. Health Economics

3. CLAPBio’s objectives

Background

The general guiding principle of CLAPBio is that
decisions regarding new BioSimilar introduction
should be country-led and grounded in an
appropriate comparative, head to head quality,
non-clinical and clinical studies.

Background

Central to the CLAPBio approach is the formation
of a regional team, involving collaborations across
multiple organizations – regulatory authorities,
healthcare organizations, international academic
institutions, medical specialities associations.

CLAPBio’s goal

The CLAPBio’s goal is to strengthen the
national capacity to make informed, in
an appropriate comparative, head to
head quality, non-clinical and clinical
studies decisions regarding BioSimilar
introduction.

CLAPBio’s objectives

Strengthen infrastructure for decision-makers

Develop tools for provide training to national
multidisciplinary teams

Develop an Economic Model for BioSimilar in
Latin America

CLAPBio collaboration
with LA Countries
Conduct specific studies in the Latin American,
considering each country’s specificity

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

Collaboration
objectives
Methodological guides & instruments for
estimation of health services utilization and costs

Acceptable country-level data ranges for model
parameters

Model to evaluate impact of BioSimilar

Strengthening infrastructure
for decision-making

Launch an advisory board from opinion
leaders

Build a research center to examine price
trajectories that might develop over time

Develop an Economic Model
for Biosimilar in Latin America

How much price competition can we expect
from Biosimilars in Latin America?

Models of market entry and pricing in Latin
America

Forecasts about the impact of Biosimilars in
Latin America

for decision-making
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
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 .

for decision-making

This approach will be supported by a
regional network of CLAPBio Centers based
in academic institutions across Latin
America

Developing de Ensino e Pesquisa and
Instituto CLAPBio models
tools, and provide training

The CLAPBio initiative will establish the
CLAPBio e-Support Center
(www.clapbio.com.br) to disseminate current
activities, online learning courses and links to
relevant literature


Thank you

Denizar Vianna

Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]

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