- Cost-effectiveness of Imatinib versus Interferon- in the Treatment of Patients Newly Diagnosed With Chronic Myeloid Leukemia, Under the Brazilian Public Healthcare System Perspective. Blood. 2006; 108:3314

1. Cost-effectiveness of Imatinib versus Interferon-α in the Treatment of Patients Newly Diagnosed
With Chronic Myeloid Leukemia, Under the Brazilian Public Healthcare System Perspective
Fábio Mataveli, MD,MBA1*, Alessandra Calabró, MBA2*, Wellington Mendes, MD2*, Denizar Vianna, MD,PhD3*, Pedro Dorlhiac-Llacer, MD,PhD4*, Ricardo Bigni, MD,PhD5,
and Vania Hungria, MD,PhD6.
1
Internal Medicine, Federal University of São Paulo, São Paulo, SP, Brazil; 2Novartis Biociências S.A., São Paulo, SP, Brazil; 3Internal Medicine, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil; 4Fundação Pró-Sangue, State University of São Paulo, São Paulo, SP, Brazil;
5
Hematology, National Institute of Cancer, Rio de Janeiro, RJ, Brazil and 6Hematology, Santa Casa de São Paulo, São Paulo, SP, Brazil.
BACKGROUND Table 1. Outcomes per patient Figure 1. Adverse Events Management Average Annual Cost
(100 patients cohort)
CONCLUSIONS
Outcome Per Patient Gleevec INF-α
The 60-month follow-up data for patients randomized to imatinib in the International • Assuming a conservative cost-effectiveness threshold of less than US$ 25,500, which
Randomized Interferon vs STI571 Study (IRIS) demonstrated significant clinical Life Years Saved* 17.09 9.1 7.99 DRUG is three times the GDP per capita in Brazil (US$ 8,500 in 2005), the ICER for imatinib
improvements in survival rates and QALYs gained (17,09 years; 13,58 QALYs) in compared with INF-α falls within the range considered by the World Heath Organization
patients newly diagnosed with chronic myeloid leukemia (CML) and treated with Discounted Life Years saved 14.52 8.22 6.3 Gleevec US$ 76,684 as a cost-effective fist line treatment for patients newly diagnosed with CML6.
imatinib in comparison to patients under interferon-alpha (INF-α) (9,10 years; 6,31
QALYS) as first line therapy (Table 1)1. Although reimbursed as second line QALYs saved 13.58 6.31 7.27 • Adoption of Gleevec as first line therapy in the treatment of chronic phase CML would
INF-a US$ 140,604 immediately benefit patients that are still under INF-α therapy.
therapy for chronic phase CML patients who did not respond to INF-α, imatinib was
Discounted QALY’s saved 11.57 5.7 5.87
not considered for public reimbursement as first line treatment in Brazil based
solely on drug costs. An economic evaluation of imatinib as first line treatment *discount rate: 1.5% per year
0 50 100 150 US$
versus INF-α was performed under the Brazilian Public Healthcare System References
perspective, according to the long-term follow-up data from IRIS, literature 1. B. J. Druker, F. Guilhot, S. O’Brien, R. A. Larson, N. Journal of Clinical Oncology,
recommendations and prior health technology assessment from the National Table 2. Base-case model results
2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20
Institute for Clinical Excellence (NICE) to consider long term follow-up survival and • The resulting incremental cost-effectiveness ratio (ICER) of imatinib, compared Supplement), 2006: 6506
Costs(US$)* Drug Therapy Gleevec INF-α
adverse events costs2,3. to IFN-α, considering adverse events was US$ 18,637 per QALY gained (Table 3 and
Average patient cost/year 21,405 13,345 8,060 Table 4). 2. Health Technology Assessment 2004; Vol. 8: No. 28.
Lifetime cost ** 193,023 81,813 111,210 3. Agency for Healthcare Research and Quality (AHRQ). Report on the relative efficacy of
Table 3. Incremental Cost-Effectiveness Ratio (ICER)
oral cancer therapy for medicare beneficiares versus currently covered therapy.
Adverse Events per 100 patients/yr
OBJECTIVE Drug Gleeve INF-α Imatinib for Chronic Myeloid Leukemia. November, 2005.
Depression 1,634 6,301 (4,667) Total Lifetime Cost per patient (US$) 199,938 90,538 109,400 4. O’Brien SG, Guilhot F, Larson RA, et al. Imatinib compared with interferon and
Evaluate the cost-effectiveness of imatinib compared with IFN-α for first-line treatment of
chronic myeloid leukemia under the Brazilian public healthcare system perspective. low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukaemia.
Neutropenia 72,724 127,140 (54,416) Discounted QALYs 11.57 5.7 5.87 N Engl J Med. 2003;348:994-1004.
Abnormal Liver Function tests 2,274 3,914 (1,640) Incremental Cost Effectiveness Ratio US$ 18,637 5. Bonifazi F, de Vivo A, Rosti G, et al. Chronic myeloid leukemia and interferon-alpha: a
METHODS Nausea 50 3,249 (3,199) *1 US$=R$ 2.28
study of complete cytogenetic responders. Blood. 2001;98:3074-3081.
For the economic model, a base case of 100 patients for each treatment option was **discount rate: 6% per year 6. WHO Commission. Macroeconomics and health: investing in health for economic
Total AE Cohort Cost per year 76,684 140,604 (63,920)
constructed focused on drug costs, adverse events and utilities values from the IRIS development. Geneva: World Health Organization; 2002
study for both groups (Table 1 and 2). Drug costs were estimated based on the Total Lifetime Cost per patient 199,938 90,538 109,400 Table 4. Values used to calculate the Incremental Cost-effectiveness Ratio
Brazilian public healthcare reimbursement payment (APAC-SUS) for chronic phase CML (ICER). Discount rates; 1.5% per year on QALYs and Life Years; 6% per
treatment. Febrile neutropenia (grade III and IV), depression, nausea and abnormal *1 US$=R$ 2.28
year on costs.
liver-function results were considered as adverse events. Clinical guidelines and **discount rate: 6% per year
protocols from two public hematology Brazilian centers, Fundação Pró-Sangue FM-USP Drug Survival Annual Lifetime QALY Cost per Incremental
and Instituto Nacional do Cancer, were used to estimate adverse events treatment (years) Average Costs saved QALY cost-
costs. Adverse events frequency for all grades was based on data published by NICE RESULTS Costs
(US$)
(US$) effectiveness
ratio (US$)
and the Agency for Health Care Research and Quality2,3. Due to the high crossover rate
from INF-α to Imatinib group observed in the IRIS study (64.9% from INF-α to imatinib • The annual average costs for the treatment of adverse effects in the INF-α were almost
after a median follow-up of 60 months) the estimated life time survival for INF-α twice (1.83) as that for the imatinib group. Adverse events lifetime costs for INF-α were INF-a 8,22 14,751 90,538 5,70 15,884
treatment group was based on the European Study Group on Interferon in Chronic 24% higher than imatinib, even though imatinib granted a projected 6.3 years survival
Gleevec 14,52 24,365 199,938 11,57 17,281 18,637
Myeloid Leukemia4,5. Annual discount rates were of 6% for costs and 1.5% for QALYs. advantage over INF-α (Figure 1).
per QALY