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Universidade do Estado do Rio de Janeiro      Universidade do Estado do Carneiro           Policlínica Piquet Rio de Janei...
Universidade do Estado do Rio de Janeiro               Policlínica Piquet Carneiro                      Agenda            ...
Universidade do Estado do Rio de Janeiro               Policlínica Piquet Carneiro                      Agenda            ...
PAHO’s ProVac Initiative
AgendaWho are we?Meeting objectives
Universidade do Estado do Rio de Janeiro               Policlínica Piquet Carneiro             Meeting objectives         ...
Universidade do Estado do Rio de Janeiro    Universidade do Estado do Carneiro         Policlínica Piquet Rio de Janeiro  ...
Universidade do Estado do Rio de Janeiro     Universidade do Estado do Carneiro          Policlínica Piquet Rio de Janeiro...
Universidade do Estado do Rio de Janeiro                  REQUIREMENTS   Policlínica Piquet Carneiro                      ...
Universidade do Estado do Rio de Janeiro                   REQUIREMENTS                   WHO  EMA MEXICO BRAZIL CHILE    ...
Universidade do Estado do Rio de Janeiro                                  Policlínica Piquet Carneiro                   RE...
Universidade do Estado do Rio de Janeiro                                                          BRAZIL CHILE            ...
Universidade do Estado do Rio de Janeiro     Universidade do Estado do Carneiro          Policlínica Piquet Rio de Janeiro...
Health Care System
Universidade do Estado do Rio de Janeiro                 Policlínica Piquet Carneiro                        Agenda        ...
Universidade do Estado do Rio de Janeiro                 Policlínica Piquet Carneiro                        Agenda        ...
Universidade do Estado do Rio de Janeiro                      Policlínica Piquet Carneiro                    Instituto de ...
Universidade do Estado do Rio de Janeiro         Examples of Impact Estimates                      Policlínica Piquet Carn...
Universidade do Estado do Rio de Janeiro                 Policlínica Piquet Carneiro                        Agenda        ...
Effectiveness                Cost versus Effectiveness                                            Costs
Cost versus EffectivenessEffectiveness                                             Costs                Treatment
Cost versus Effectiveness                                   TreatmentEffectiveness                                        ...
What is Economic Evaluation?   Definition: Economic Evaluation is ...   – the identification, measure, and comparison of  ...
Cost Effectiveness Analysis (CEA)  Cost-effectiveness analysis (CEA) compares the cost of  the intervention with the effec...
Cost-Effectiveness Analysis                          Relates Costs to Health Effects       “Costs” examples :             ...
Framework of the Budget Impact Analysis CURRENT ENVIRONMENT                                              NEW ENVIRONMENT  ...
Definition of Model• “A model is a logical mathematical  framework that permits the integration  of facts and values, and ...
Economic Model                          OUTPUTSINPUTS        MODEL
Agenda1. Estimating Savings from Biosimilars in Latin America2. Health Economics3. CLAPBio’s objectives
Universidade do Estado do Rio de Janeiro              Policlínica Piquet Carneiro                 Background            In...
Universidade do Estado do Rio de Janeiro              Policlínica Piquet Carneiro                 Background            In...
Universidade do Estado do Rio de Janeiro            Policlínica Piquet Carneiro             CLAPBio’s goal          Instit...
Universidade do Estado do Rio de Janeiro              Policlínica Piquet Carneiro          CLAPBio’s objectives           ...
Universidade do Estado do Rio de Janeiro             CLAPBio collaboration                 Policlínica Piquet Carneiro    ...
Universidade do Estado do Rio de Janeiro                 Collaboration                Policlínica Piquet Carneiro         ...
Universidade do Estado do Rio de Janeiro              Policlínica Piquet Carneiro      Strengthening infrastructure       ...
Universidade do Estado do Rio de Janeiro        Develop an Economic Model              Policlínica Piquet Carneiro        ...
Universidade do Estado do Rio de Janeiro                 Policlínica Piquet Carneiro         Strengthening infrastructure ...
Universidade do Estado do Rio de Janeiro              Policlínica Piquet Carneiro      Strengthening infrastructure       ...
Universidade do Estado do Rio de Janeiro                 Policlínica Piquet Carneiro         Developing de Ensino e Pesqui...
Universidade do Estado do Rio de Janeiro   Universidade do Estado do Carneiro        Policlínica Piquet Rio de Janeiro    ...
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
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Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]

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Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]

  1. 1. 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 BiológicosIntroduction of participants and objectives of the meeting Denizar Vianna
  2. 2. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Agenda Instituto de Ensino e PesquisaWho are we?Meeting objectives
  3. 3. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Agenda Instituto de Ensino e PesquisaWho are we?Meeting objectives
  4. 4. PAHO’s ProVac Initiative
  5. 5. AgendaWho are we?Meeting objectives
  6. 6. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Meeting objectives Instituto de Ensino e Pesquisa To discuss how to create a regional team, involvingcollaborations across multiple organizations: regulatoryauthorities, academic institutions, medical specialitiesassociations;To present tools for provide training to nationalmultidisciplinary teams;To discuss how to develop an Economic Model andShared Decision Making for BioSimilar in Latin America.
  7. 7. 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 BiológicosOverview of projects to be conducted by CLAPBio Denizar Vianna
  8. 8. 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 BiológicosInfrastructure for regulatory authorities in LA Countries Denizar Vianna
  9. 9. Universidade do Estado do Rio de Janeiro REQUIREMENTS Policlínica Piquet Carneiro WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA Instituto de Ensino e PesquisaThe reference product must be licensed by thenational regulatory authority based on a full no yes yes no yes no NAdevelopment dossier (quality, safety, and efficacydata)A biosimilar/intended copy may be a referenceproduct in case the innovative product is not no no yes no no no no NAavailable in the marketFull quality dossier (manufacturing process,characterization, specifications, analytical yes yes yes yes/no yes yes yes yestechniques and stability) plus head-to-headcomparison with the reference productFunctional, physicochemical and biological head-to-head characterization data in comparison with the yes yes yes yes/no yes yes yesreference productIdentical primary amino acid sequence yes yes no yes no No
  10. 10. Universidade do Estado do Rio de Janeiro REQUIREMENTS WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA Policlínica Piquet CarneiroNon-clinical requirements: Abbreviated head-to- de Ensino e Pesquisa Institutohead non-clinical pharmacology and toxicology yes yes yes yes/no yes yes yesstudies in comparison with the reference productClinical requirements: But with no specific NA NA yes NA NA NA yesrequirements establishedClinical requirements: Abbreviated head-to-headPharmacokinetic (PK) and Pharmacodynamic (PD) yes yes no yes/no yes yes NAstudies in comparison with the reference productClinical requirements: Abbreviated head-to-head It is notefficacy studies in comparison with the reference yes yes no NA NA NA clear yetproduct: equivalence or non-inferiority clinical trialsClinical requirements: Abbreviated head-to-headefficacy studies in comparison with the reference It is not NA NA no yes/no NA NAproduct: equivalence, non-inferiority or superiority clear yetclinical trials
  11. 11. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro REQUIREMENTS Instituto de Ensino e MEXICO BRAZIL CHILE WHO EMA Pesquisa PERU CUBA PANAMAClinical requirements: Abbreviated head-to-headsafety studies including immunogenicity in yes yes yes no yes no nocomparison with the reference productProduct-class specific guidelines on non- no yes no yes yes yes noclinical/clinical dataExtrapolation across indications (if justified and yes yes yes yes yes yes NAspecific criteria is satisfied)Active pharmacovigilance plan and safetyspecification (including submission of Periodic yes yes yes yes yes yes yes yesSafety Update Reports [PSURs] and Adverse DrugReaction [ADR] Reporting)Risk Management Plan (RMP) yes yes no yes yes yes yes yes
  12. 12. Universidade do Estado do Rio de Janeiro BRAZIL CHILE PERU CUBA PANAMA REQUIREMENTS PoliclínicaWHO EMACarneiro Piquet MEXICO Instituto de Ensino e PesquisaPrescription by non-proprietary name (INN), a It is notunique brand name and batch number for a yes yes no NA yes no clear yettraceability systemAutomatic substitution (interchangeability) NA NA yes NA no NA noPrescribing information (package insert) clearlyspecifying the clinical safety and efficacy dataobtained by the biosimilar product itself from those no no no no no no notaken over from the reference product, particularlyin extrapolated indications where no studies havebeen done at allSpecial differentiated labelling (outer cartons and no no yes no no no nolabels) between biosimilars and reference productIntellectual property (Patents and/or Data NA yes yes yes no no noProtection)Stand alone pathway accepted if intended copy isnot similar to the reference product (full licensing yes yes yes yes/no yes yes yesapplication)
  13. 13. 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 BiológicosBudget Impact Analysis Tool Denizar Vianna
  14. 14. Health Care System
  15. 15. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Agenda Instituto de Ensino e Pesquisa1. Estimating Savings from Biosimilars in Latin America2. Health Economics3. CLAPBio’s objectives
  16. 16. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Agenda Instituto de Ensino e Pesquisa1. Estimating Savings from Biosimilars in Latin America2. Health Economics3. CLAPBio’s objectives
  17. 17. Universidade do Estado do Rio de Janeiro Policlínica 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 assumption than on fact”. Professor Bengt JönssonSource: Mattison et al. Biosimilars: How much entry and price competition willresult? December 2010. Office of Health Economics
  18. 18. Universidade do Estado do Rio de Janeiro Examples of Impact Estimates Policlínica Piquet Carneiro Instituto de Ensino e PesquisaSource: Mattison et al. Biosimilars: How much entry and price competition willresult? December 2010. Office of Health Economics
  19. 19. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Agenda Instituto de Ensino e Pesquisa1. Estimating Savings from Biosimilars in Latin America2. Health Economics3. CLAPBio’s objectives
  20. 20. Effectiveness Cost versus Effectiveness Costs
  21. 21. Cost versus EffectivenessEffectiveness Costs Treatment
  22. 22. Cost versus Effectiveness TreatmentEffectiveness Costs
  23. 23. 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)
  24. 24. 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
  25. 25. 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 strategies1. Drummond et al. Ann Int Med 1987; 107(1): 88–922. Kobelt G. Health Economics: an introduction to economic evaluation. London: OHE, 2002
  26. 26. 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. NewResources Utilization Resources Utilization New therapy/ Unit costs procedure New Cost of Illness DIFERENCE Cost of Illness Budget Impact
  27. 27. 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, OBrien 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
  28. 28. Economic Model OUTPUTSINPUTS MODEL
  29. 29. Agenda1. Estimating Savings from Biosimilars in Latin America2. Health Economics3. CLAPBio’s objectives
  30. 30. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Background Instituto de Ensino e Pesquisa The general guiding principle of CLAPBio is thatdecisions regarding new BioSimilar introductionshould be country-led and grounded in anappropriate comparative, head to head quality,non-clinical and clinical studies.
  31. 31. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Background Instituto de Ensino e PesquisaCentral to the CLAPBio approach is the formationof a regional team, involving collaborations acrossmultiple organizations – regulatory authorities,healthcare organizations, international academicinstitutions, medical specialities associations.
  32. 32. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro CLAPBio’s goal Instituto de Ensino e Pesquisa The CLAPBio’s goal is to strengthen thenational capacity to make informed, inan appropriate comparative, head tohead quality, non-clinical and clinicalstudies decisions regarding BioSimilarintroduction.
  33. 33. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro CLAPBio’s objectives Instituto de Ensino e PesquisaStrengthen infrastructure for decision-makersDevelop tools for provide training to nationalmultidisciplinary teamsDevelop an Economic Model for BioSimilar inLatin America
  34. 34. Universidade do Estado do Rio de Janeiro CLAPBio collaboration Policlínica Piquet Carneiro Instituto de Ensino e Pesquisa with LA Countries Conduct specific studies in the Latin American,considering each country’s specificityProvide technical support to national multidisciplinaryteams in regulatory and economic evaluations onBioSimilars in various countries in Latin AmericaSupport LA Countries in providing training throughworkshops and long distance learning on regulatory andeconomic analysis
  35. 35. Universidade do Estado do Rio de Janeiro Collaboration Policlínica Piquet Carneiro Instituto de Ensino e Pesquisa objectivesMethodological guides & instruments forestimation of health services utilization and costsAcceptable country-level data ranges for modelparametersModel to evaluate impact of BioSimilar
  36. 36. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Strengthening infrastructure Instituto de Ensino e Pesquisa for decision-making Launch an advisory board from opinionleadersBuild a research center to examine pricetrajectories that might develop over time
  37. 37. Universidade do Estado do Rio de Janeiro Develop an Economic Model Policlínica Piquet Carneiro Instituto de Ensino e Pesquisa for Biosimilar in Latin AmericaHow much price competition can we expectfrom Biosimilars in Latin America?Models of market entry and pricing in LatinAmerica Forecasts about the impact of Biosimilars inLatin America
  38. 38. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Strengthening infrastructure Instituto de Ensino e Pesquisa for decision-making The implementation of the CLAPBio Initiative’s plan ofwork will result in several products, including but notlimited to: development of models for BioSimilar studies,data collection tools; regional training workshops; directtechnical support to individual countries that make arequest to CLAPBio; development of a regional networkof academic CLAPBio Centers; development of the web-based CLAPBio e-Support Center; and technical supportfor National Regulatory Authorities .
  39. 39. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Strengthening infrastructure Instituto de Ensino e Pesquisa for decision-making This approach will be supported by aregional network of CLAPBio Centers basedin academic institutions across LatinAmerica
  40. 40. Universidade do Estado do Rio de Janeiro Policlínica Piquet Carneiro Developing de Ensino e Pesquisa and Instituto CLAPBio models tools, and provide trainingThe CLAPBio initiative will establish theCLAPBio e-Support Center(www.clapbio.com.br) to disseminate currentactivities, online learning courses and links torelevant literature
  41. 41. 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 PesquisaCentro Latino Americano de Pesquisa em Biológicos Thank you Denizar Vianna

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