Cost effectiveness of treatment-free remission in chronic myeloid leukemia patients: A report from a developing country.

131 Background: Current recommendations for first line therapy in chronic phase chronic myeloid leukemia (CP-CML) is life-time use of tyrosine kinase inhibitors (TKI's). Unfortunately, the financial burden of continuous TKI therapy is unsustainable especially in developing countries. In Pakistan, an access-program for Imatinib (IM) and Nilotinib is available; the cost of therapy is subsidized with the Government paying for 3 months and Novartis for 9 months. Updated results from several trials support continued long term durability of treatment free remission (TFR). We attempted TFR in our patients in an attempt to reduce financial burden and improve quality of life for the patients. We aimed to evaluate the economic impact of discontinuing imatinib versus continuous use of imatinib in patients taking IM 400mg. Methods: 57 patients of CP-CML taking Imatinib 400 mg for the last 10 years who were negative by FISH for at least 3 years or in MR 4.5 at least once in 12 months were evaluated. Of these 30 were screening failures, 4 patients refused consent prior to screening and 25 were eligible for the trial. Two consecutive RQ-PCR were performed 3 months apart prior to enrollment. Patients were eligible if they achieved MR 4.5 for at least 3 months prior to entering the study. Molecular response was assessed by Quantitative BCR-ABL RQ-PCR every 4 weeks after discontinuation for year 1 and 8 weeks at year 2. Cost of Imatinib 400 mg per month was calculated as well as the cost of BCR-ABL RQ-PCR by gene expert for the trial. Results: Of the enrolled 25 patients, 10 lost their deep molecular response and were restarted on therapy, 5 withdrew consent after screening.10 patients are currently on trial at varying time intervals (10-14 months) of cessation of imatinib. The cost of one month of imatinib is US $ 800 and the cost of RT PCR is $ 67. TFR translated into approximately US 1.2 million saved. Conclusions: The discontinuation of TKI in this small subset of patients has resulted in remarkably large savings with significant impact on the meager health budget in our resource limited setting.