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The Problem :

The role of regulatory policies in relation to the local biosimilars production. The Problem :.

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The Problem :

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  1. The role of regulatory policies in relation to the local biosimilarsproduction

  2. The Problem: The increased coverage and access to high-cost drugs, will end up by defunding the health systems of developing and poorer countries. New policies are needed to decide who should be cover, which drugs should be provide and which will be the costs associated to whose decisions.

  3. Pobulationneeds Unlimited needs Limited resources Demand New needs are created Offer New products Science , Innovation and Technology MARKET Gustavo H. Marin – gmarin2009@gmail.com

  4. Populationdemands StateRegulates Gustavo H. Marin – gmarin2009@gmail.com

  5. UniversityResearch Center of Pharmacology –PAHO/WHO CUFAR wasenchargedby PAHO todevelop a strategy in severalcountries in ordertoselect a list of medicines thatshouldbecoveredbythegoverments and torecommendthebestpoliciesthatallowthecoverage of thosedrugs. • Barbados 2010 • Brazil 2005 • Ecuador 2007 • Guyana 2009 • Uruguay 2003 • Costa Rica 2016 • Guatemala 2016 • Jamaica 2017 • T & Tobago 2014 • Honduras 2017 • Haiti 2010 • Panamá 2009 • Paraguay 2012 • Perú 2006 • Venezuela 2007

  6. TheMethod • It begins with an order from the Pharmaceutical Industry, an association of patients or medical prescriber who request a high cost drug for a certain disease. • Study the local context (prevalence of the disease, epidemiology, etc). • Objective of the treatment of that disease (Hard Variables: Cure? Reduce complications? NOT Soft Variables like reduce a level of a laboratory parameter. • Which are results obtained by the present treatments in order to modify hard Variables? • Comparative analysis between the new high cost drug and the classical treatment

  7. Hurdles in evaluation of medicines for National List of Medicines Other Impacts Budget Impact Cost-Effectiveness Quality Safety Efficacy Local Context Epidemiology Alternative medicines Multi-disciplinary and independent team PICO questions Evidence search Systematic Reviews Other article types Synthesis of Evidence Local costs, economic evaluation Recomendation GRADE Diffusion Implementation Update Application form Priorization process Proccess of Evaluation

  8. BreastCancer ShouldweincorporatetotheNationalList (and provide) ? Pertuzumab Trastuzumab

  9. PertuzumabforBreastCancerObjective : OS or DFS 1 year 5 years (10 years ideal) Systematic Review, RCT, cohort study -Cost-effectiveness -Budget Impact Analysis Pertuzumab + Breast cancer HER2+ Doxorrubicin CFM Pacitaxel Doxorrubicin CFM Pacitaxel

  10. TrastuzumabforBreastCancerObjective : OS or DFS 1 year 5 years (10 years ideal) Systematic Review, RCT, cohort study -Cost-effectiveness -Budget Impact Analysis Trastuzumab + Breast cancer HER2+ Doxorrubicin CFM Pacitaxel Doxorrubicin CFM Pacitaxel

  11. Sequency of Research + • Cochrane Collaboration • Pubmed • Guías de Practica Clinica • NICE • SIGN • Independent Bulletins INTERNAL VALIDITY -

  12. Results of theresearch • Pertuzumab gives an overal survival of 45 day in average in early breast and metastasic cancer HER2 +

  13. El trastuzumab improved OS and DFS in women with HER2+ breast either recently diagnosed or in metastasic cases

  14. Economical analysis

  15. ClassicalTreatments New Tratments

  16. Conclusion of theresearch • Alone, Pertuzumab was unable to improve survival in breast cancer disease. • Pertuzumab+Doxorrubicin+CFM+Pacitaxel+Trastuzumab improves the overall survival in 45 day in average to women with HER2 + Breast cancer . • If we provide Pertuzumab in order to extend patient’s life in 45 days, all the Health’s budget must be used in this decision. • Trastuzumabimprovedoverallsurvival up to 40% at 5 years in womenwith HER2 + Breastcancer and toprovidethisdrugitisneedthe 30% of thebudget.

  17. HealthBudget • 604.105.851 Dollars Doxorrubicina (60 mg/m2) 67.32 CFM (900mg/m2) 60.2 Pacitaxel (175mg/m2) 132.8 Trastuzumab (6mg/Kg) 27005.28 Doxorrubicina (60 mg/m2) 67.32 CFM (900mg/m2) 60.2 Pacitaxel (175mg/m2) 132.8 US$ US$ Por 12 ciclos x paciente Por 12 ciclos x paciente

  18. Final Decision: Inclusion of Trastuzumab and exclusion of Pertuzumab in BreastcancerTreatment. OtherDecision: WhichTrastuzumabwillbeprovidebytheGoverment? -Original molecule? - Generic? -Biosimilar? Bauchner H, Fontanarosa PB, Golub RM. Scientific Evidence and Financial Obligations to Ensure Access to Biosimilars for Cancer Treatment.  JAMA. 2017 Jan 3;317(1):33-34. doi: 10.1001/jama.2016.18743.

  19. Economical analysis

  20. Economical and EthicalJudgements ScientificJudgement Value Judgement Evidence Analysis Political Decision Evidence Outcomesinformation

  21. Prices of Innovation Industry Pressure Respect for Patents Pressure of the Community Judicial pressure Access Guarantee (Without melting the Health System) Select Rationally Biosimilar

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