Agenda. Cost-effectiveness analysis of vemurafenib compared to dacarbazine for the metastatic melanoma treatment in Brazilian Public Health System

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1 Cost-effectiveness analysis of vemurafenib compared to dacarbazine for the metastatic melanoma treatment in Brazilian Public Health System Telma Rodrigues Caldeira Priscila Louly Gabrielle Troncoso Misani Ronchini André Luis da Silva Rodrigo Ribeiro Issue Panel 5: International cooperation between Argentina, Brazil and Uruguay: How does the development of cost-effectiveness studies and of health knowledge in MERCOSUR support the process of decision making? Funded by: Agenda Background; Objective; Methods; Results; Limitations; Conclusion; Acknowledgments. 1

Background Melanoma: malignancy of melanocytes (skin cancer); 4% of skin cancers;* 90% of all skin cancer-related deaths worldwide;* Metastatic melanoma: median survival (stage IV): from 8 to 18

2 Background Melanoma: malignancy of melanocytes (skin cancer); 4% of skin cancers;* 90% of all skin cancer-related deaths worldwide;* Metastatic melanoma: median survival (stage IV): from 8 to 18 months after diagnosis, depending on the substage and health system support.** BRAZILIAN MINISTRY OF HEALTH. Clinical Guidelines - Melanoma. April **CHAPMAN et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med Jun 30;364(26): Background New drugs for metastatic melanoma cutaneous treatment were licensed in Brazil ( ): Vemurafenib and Ipilimumab How effective are X these new drugs? Promising drugs Expensive Are they cost-effective? costs 2

3 Objective To estimate the incremental costeffectiveness ratio (ICER) of vemurafenib compared to dacarbazine, the standard treatment for metastatic melanoma in the Brazilian government perspective. Is vemurafenib (intervention) more cost-effective on overall survival (outcome) than dacarbazine (comparator) in metastatic melanoma patients (population)? Methods The Excel-based model was developed to compare two sets of strategies over 10 years 1 2 st nd 3

4 Progression-free survival Methods Disease- -progression Transition probabilities: from one Phase III Clinical Trial, BRIM III. Death Progression-free survival: patients with melanoma metastatic without the tumor or metastasis progression (extract from survival curve); Disease-progression: patients with progression of the tumor or metastasis (extract from survival curve); Death: patients deaths for any causes. 4

5 Methods Element of health technology assessment Perspective benefits Perspective costs Type of economic evaluation Time horizon Cycle length Reference-case Direct effects on health states SUS (Brazilian Public Health System, specifically on the federal government) Cost-effectiveness analysis 10 years 1 week Methods Element of health technology assessment Costs and resources source Reference-case Frequency of hospital admissions: SUS s oncologists; Health care costs and resources were obtained from government databases in 2013; Price of mutation test: extracted from Emergency Care Research Institute (ECRI); Vemurafenib price: calculated based on the Maximum Public Sector Price. 5

6 Methods Element of health technology assessment Measure of health effects Discount rate Reference-case QALYs (assumption from utilities which were based on international data) 5% year (0, % weekly) on benefits and costs Results 10 years To test BRAF V600E (new strategy) Not to test BRAF V600E (standard strategy) Costs USD USD 5.700,00 QALY 1,06 0,92 ICER USD ,46 / 1 QALY 6

7 Results 10 years To treat BRAF+ with vemurafenib To treat BRAF- with dacarbazine Costs USD ,00 USD 5.800,00 QALY 1,20 0,92 ICER USD ,10 / 1 QALY Results To test BRAF V600E x Not to test BRAF V600E ICER 10 anos USD ,46 / 1 QALY To test BRAF V600E and treat BRAF+ with vemurafenib x To treat BRAF- with dacarbazine ICER 10 anos USD ,10 / 1 QALY 7

8 Results Deterministic sensitivity analysis: Proportion of patients BRAF+/BRAF- Which did not affect the final ICER; Vemurafenib prices: USD ~ 2,050.00; Considering the WHO threshold for Brazilian system (~ USD 34,890.00, three times GDP per capita) the costeffective price to vemurafenib is USD ; Nowadays, there is not an official Brazilian government threshold. Maximum Public Sector Price for vemurafenib (USD 1,968.00) Cost-effective price to vemurafenib (USD ) 8

9 Limitations Synthesis of evidence outcomes: from only one RCT III; Absence of transitions probabilities - in order to estimate the number of patients on each state (after ~60 week), it was used the HR, and when there was not the HR available, the probabilities were extracted from survival curves (GetData Graph Digitizer version ); Source of preference data: not available in Brazilian reality; Absence of probabilistic sensitivity analysis. Conclusion In Brazil, vemurafenib is not cost-effective for metastatic melanoma, and its threshold price (USD ) is 22% of the Maximum Public Sector Price (USD 1,968.00); The Maximum Public Sector Price is a result of the use of mandatory minimum discount applied on the prices of drugs that are purchased by the public health system. 9

10 Acknowledgments Health Technology Assessment Institute (IATS); Maria Inez Gadelha, Brazilian Ministry of Health; Sandro José Martins, University of Brasília; Subcommitte of HTA on Health Subgroup on MERCOSUR; Brazilian Ministry of Health. Thank you! Superintendence of Health Regulatation and Market Supervision (SUREG) Brazilian Health Surveillance Agency (ANVISA) 10

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