title: IMPLICATIONS OF GLOBAL PRICING POLICIES ON ACCESS TO INNOVATIVE DRUGS: THE CASE OF TRASTUZUMAB IN SEVEN LATIN AMERICAN COUNTRIES.
abstract: OBJECTIVE
  Differential pricing, based on countries' purchasing power, is recommended by the World Health Organization to secure affordable medicines. However, in developing countries innovative drugs often have similar or even higher prices than in high-income countries. We evaluated the potential implications of trastuzumab global pricing policies in terms of cost-effectiveness (CE), coverage, and accessibility for patients with breast cancer in Latin America (LA).
  
  
  METHODS
  A Markov model was designed to estimate life-years (LYs), quality-adjusted life-years (QALYs), and costs from a healthcare perspective. To better fit local cancer prognosis, a base case scenario using transition probabilities from clinical trials was complemented with two alternative scenarios with transition probabilities adjusted to reflect breast cancer epidemiology in each country.
  
  
  RESULTS
  Incremental discounted benefits ranged from 0.87 to 1.00 LY and 0.51 to 0.60 QALY and incremental CE ratios from USD 42,104 to USD 110,283 per QALY (2012 U.S. dollars), equivalent to 3.6 gross domestic product per capita (GDPPC) per QALY in Uruguay and to 35.5 GDPPC in Bolivia. Probabilistic sensitivity analysis showed 0 percent probability that trastuzumab is CE if the willingness-to-pay threshold is one GDPPC per QALY, and remained so at three GDPPC threshold except for Chile and Uruguay (4.3 percent and 26.6 percent, respectively). Trastuzumab price would need to decrease between 69.6 percent to 94.9 percent to became CE in LA.
  
  
  CONCLUSIONS
  Although CE in other settings, trastuzumab was not CE in LA. The use of health technology assessment to prioritize resource allocation and support price negotiations is critical to making innovative drugs available and affordable in developing countries.
authors.affiliation: IECS - Institute for Clinical Effectiveness and Health Policy;School of Public Health,University of Buenos Airesapichon@iecs.org.ar.
authors.forename: Andres
authors.initials: A
authors.lastname: Pichon-Riviere
authors.affiliation: IECS - Institute for Clinical Effectiveness and Health Policy.
authors.forename: Osvaldo Ulises
authors.initials: OU
authors.lastname: Garay
authors.affiliation: IECS - Institute for Clinical Effectiveness and Health Policy;School of Public Health,University of Buenos Aires.
authors.forename: Federico
authors.initials: F
authors.lastname: Augustovski
authors.affiliation: Universidad de La Frontera.
authors.forename: Carlos
authors.initials: C
authors.lastname: Vallejos
authors.affiliation: Universidad Peruana Cayetano Heredia.
authors.forename: Leandro
authors.initials: L
authors.lastname: Huayanay
authors.affiliation: Universidad de San Andrés.
authors.forename: Maria del Pilar Navia
authors.initials: Mdel P
authors.lastname: Bueno
authors.affiliation: Fondo Nacional de Recursos (FNR).
authors.forename: Alarico
authors.initials: A
authors.lastname: Rodriguez
authors.affiliation: Brazilian National Cancer Institute-INCA.
authors.forename: Carlos José Coelho
authors.initials: CJ
authors.lastname: de Andrade
authors.affiliation: Department of Pharmacology,School of Medicine,University of Antioquia.
authors.forename: Jefferson Antonio
authors.initials: JA
authors.lastname: Buendía
authors.affiliation: Centre for Health Economics,University of York.
authors.forename: Michael
authors.initials: M
authors.lastname: Drummond
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D003906:Developing Countries; D006801:Humans; D007843:Latin America; D008390:Markov Chains; D017059:Models, Econometric; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D000068878:Trastuzumab / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D000068878:Trastuzumab
keywords: Cost utility; Cost-effectiveness; Latin America; drug pricing; trastuzumab