IMPLICATIONS OF GLOBAL PRICING POLICIES ON ACCESS TO INNOVATIVE DRUGS: THE CASE OF TRASTUZUMAB IN SEVEN LATIN AMERICAN COUNTRIES.

OBJECTIVES: 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.

Validation of the Portuguese version of functional assessment of cancer therapy-fatigue (FACT-F) in Brazilian cancer patients.

GOALS OF WORK: The purpose of this study was to validate the Portuguese version of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) in order to establish its assessment properties, including validity and reliability in a sample of Brazilian cancer patients. MATERIALS AND METHODS: Two hundred seventy patients with different types of cancer were included for this study; the mean age was 50.5 years. The reliability was assessed by internal consistency and reproducibility. Construct validity was assessed through convergent validity and discriminant validity. Convergent validity was examined by comparing the FACT-F to the SF-36. Discriminant validity of the FACT-F evaluated the ability of the scale to differentiate defined groups, discriminating patients according to Eastern Cooperative Oncology Group Performance Status and different stages of disease. MAIN RESULTS: FACT-F had high internal consistency (Cronbach alpha coefficient was 0.78 for physical well-being, 0.68 for social/family well-being, 0.75 for emotional well-being, 0.74 for functional well-being, 0.91 for fatigue, and 0.92 for total FACT-F). The range of test-retest intraclass correlation was from 0.72 to 0.91 (p < 0.0001). The Pearson product correlation revealed good correlations between the total FACT-F and subscales of the SF-36 in most dimensions, ranging from r = 0.51 to r = 0.76, except for SF-36 physical (r = 0.31). The positive correlations between the SF-36 vitality scale and FACT-F total (r = 0.76) and the fatigue subscale (r = 0.77) support the convergent validity. CONCLUSIONS: The Portuguese version of FACT-F is a reliable and valid instrument to assess quality of life and fatigue, representing a valid tool to screen cancer-related fatigue in Brazilian cancer patients.