Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]

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