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Medicine expenditures consume a large share of the health budget, so knowledge on the use of these funds is essential for decision-making in public health and improvement of pharmaceutical care. This study analyzed the indebtedness of a high-complexity university hospital due to increased spending on imatinib mesylate. The descriptive study was based on analysis of documents and records in the Hospital Information System (SIH) from 2002 to 2010. Starting with inclusion of the medicine in the budget, the study mapped strategies by the pharmaceutical industry and government, as well as government responses to reduce the product's price. The systematization and publication of information stored in files and electronic databases can help monitor the results of programs funded by the Brazilian Ministry of Health.

Background: Chronic myeloid leukemia (CML) treatment guidelines recommend first-line therapy with either first- or second-generation tyrosine kinase inhibitors (1GTKI, 2GTKI), but do not specify which generation should be used first., Objective: To examine the association between initiation of 2GTKI versus 1GTKI and medication adherence, health services utilization, and healthcare costs., Method: This was a retrospective cohort study utilizing administrative claims data from a single health plan within the US of commercial and Medicare patients newly initiating 1GTKI or 2GTKI therapy for CML between June 2010 and December 2011. Multivariate logistic regression was used to investigate the association between TKI therapy and adherence, defined as proportion of days covered ≥0.85. Multivariate logistic regression and generalized linear models examined the association between TKI and health services utilization and direct healthcare costs (plan and patient paid) during the 12 month follow-up period., Results: Among the 368 patients included, there was no difference in adherence between patients initiating a 2GTKI compared to a 1GTKI (odds ratio = 0.88, 95% confidence interval [CI] 0.55-1.40). Initiating a 2GTKI was associated with increased outpatient visits (incidence rate ratio [IRR] = 1.12, 95% CI 1.06-1.20); however, there were no statistically significant differences in emergency room visits or inpatient visits between the treatment groups. Total costs were 1.3 times higher for 2GTKI initiators versus 1GTKI initiators ($86,509 versus $66,443; p = 0.001), with a significant difference in TKI pharmacy costs., Conclusions: Although there were no differences in adherence, hospitalizations, or emergency room visits among patients initiating a second- versus first-generation TKI, total all-cause costs and outpatient visits were higher for 2GTKI initiators. With the impending release of generic imatinib, these comparative data will become germane in the selection of a first-line TKI therapy. Because this study used claims from a single health plan, it may not be generalizable to the general population.

Purpose: The introduction of imatinib, a tyrosine kinase inhibitor (TKI), has greatly increased survival for patients with chronic myeloid leukemia (CML). Conversely, nonadherence to imatinib and other TKIs undoubtedly results in disease progression and treatment resistance. We examined trends in imatinib expenditures from 2002 to 2011 and assessed the association between copayment requirements for imatinib and TKI adherence., Patients and Methods: We used MarketScan health plan claims from 2002 to 2011 to identify adults (age 18 to 64 years) with CML who initiated imatinib therapy between January 1, 2002, and June 30, 2011, and had insurance coverage for at least 3 months before through 6 months after initiation (N = 1,541). Primary outcomes were TKI discontinuation and nonadherence. The primary independent variable was out-of-pocket cost for a 30-day supply of imatinib. By using a propensity-score weighted sample, we estimated the risk of discontinuation and nonadherence for patients with higher (top quartile) versus lower copayments., Results: Monthly copayments for imatinib averaged $108; median copayments were $30 (range, $0 to $4,792). Mean total monthly expenditures for imatinib nearly doubled between 2002 and 2011, from $2,798 to $4,892. Approximately 17% of patients with higher copayments and 10% with lower copayments discontinued TKIs during the first 180 days following initiation (adjusted risk ratio [aRR], 1.70; 95% CI, 1.30 to 2.22). Similarly, patients with higher copayments were 42% more likely to be nonadherent (aRR, 1.42; 95% CI, 1.19 to 1.69)., Conclusion: Patients with higher copayments are more likely to discontinue or be nonadherent to TKIs. Given the importance of these therapies for patients with CML, our data suggest a critical need to reduce patient costs for these therapies.

Introduction: New tyrosine kinase inhibitor treatments for chronic myeloid leukemia based on nilotinib, dasatinib and imatinib have improved patient quality of life and have turned chronic myeloid leukemia from a fatal disease into a chronic disease., Objective: To evaluate the cost-effectiveness of nilotinib, 600 mg, and dasatinib, 100 mg, each compared to imatinib, 400 mg, as first-line therapy in chronic myeloid leukemia in Colombia from a third-party payer's perspective., Materials and Methods: A cost-effectiveness analysis was performed using a Markov model to evaluate a hypothetical cohort of one hundred 55 year-old patients with newly diagnosed chronic myeloid leukemia in the chronic phase, and the time horizon for the baseline case was established as being until the end of life. Progression-free life-years saved were considered the primary outcome. Transition probabilities for major molecular response, disease progression to accelerated phase or blast crisis, and chronic myeloid leukemia related deaths were analyzed in the model for each arm. A 3% discount rate was applied to all costs and patient outcomes. Model robustness was evaluated using both univariate and multivariate Montecarlo sensitivity analysis., Results: Nilotinib was higher in expected progression-free life-years saved (15.21 vs. 12.64 for imatinib), followed by dasatinib (14.91 vs. 14.54 for imatinib). Imatinib had lower total lifetime costs. The incremental cost-effectiveness ratio was US$ 33,120.36 in the nilotinib arm and US$ 514,939.08 in the dasatinib arm per progression-free life-years (PF-LYs) saved, each compared to imatinib. When analyzing nilotinib versus dasatinib indirectly, nilotinib was found to be dominant due to higher efficacy (2.25 PF-LYs) and lower costs (US$ 44,674) in the baseline case. The average estimated cost to manage disease progression per year was US$ 101,978.78, considered to be the threshold., Conclusion: In Colombia, using PF-LYs as the efficacy outcome, nilotinib is highly cost-effective when compared to imatinib and dominant vs. dasatinib in first-line therapy for CML in chronic phase.

Background: The Glivec International Patient Assistance Program (GIPAP) is designed to provide access to the cancer therapy Imatinib (Glivec⊠), which is indicated for the treatment of chronic myelogenous leukemia (CML) and gastrointestinal stromal tumors (GIST)., Objectives: To identify factors those influence the quality of care and structural improvements. Design . Physicians (n=50), hospital administrators (n=10) and Ministry of Health officials (n=7) in 39 developing countries participated in qualitative interviews. The interviews focused on the impact of GIPAP on service delivery, patient tracking systems and cancer registries, health financing, and workforce., Results: Service delivery, patient management, access to care, diagnostic capacity, and health workers' skills improved at participants' institutions following implementation of GIPAP., Conclusions: Positive institutional changes that improve care of CML/GIST patients arose from GIPAP. Some of these changes may strengthen institutions' capacity to treat other diseases as well. The GIPAP model could be deployed to improve access to care for patients with other chronic diseases.

The improper adherence to therapy is an emerging medical and economic issue in oncology which raised with the increasing use of oral anti-cancer treatment. Currently, the average rate of non-adherence to oral anti-cancer therapy is estimated at around 21%. In this study, we use the examples of the imatinib treatment against chronic lymphocytic leukemia and the tamoxifene treatment against breast cancer to assess the negative consequences of the non-adherence to therapy in terms of medical outcome and health care cost. One of the main causes of non-adherence to these oral cancer treatments is depression. Surprisingly, this aspect is still relatively unknown to oncologists, while depression has been taken into account for the treatment of other chronic diseases (e.g. diabetes…). We therefore propose that cancer patients should be screened for depression throughout their treatment to improve the adherence to therapy. Cancer patients should have the opportunity to explain their own perception of their disease and their treatment that are key parameters in the onset of depression. The recent use of oral therapy in cancer treatment should thus be accompanied by the establishment of a global management of cancer patient on a case-by-case basis.

Objective: To investigate the desirability and feasibility of a cyclic reimbursement process to address uncertainty accompanying initial decision making., Methods: We performed desk research for three expensive outpatient drugs: imatinib, pegfilgrastim, and adalimumab. We analysed the evidence base at the time of decision making (T=0) and May 2011 (T=1). For T=0, public reports of the Dutch reimbursement agency were investigated regarding available clinical and economic evidence, and a systematic review was performed to retrieve additional economic evidence. For T=1, the systematic review was extended till May 2011., Results: The evidence base at T=0 lacked information on clinically relevant outcomes such as mortality, morbidity, and quality of life (5/8 reports), (long-term) adverse events (2/8 reports) and experience in use (1/8 reports). One budget impact analysis and one economic evaluation were available but no pharmacoeconomic dossiers. The systematic review identified 39 cost-utility studies (of 52 economic evaluations) for T=1, characterised by methodological heterogeneity., Conclusions: Given the considerable uncertainty accompanying initial decision-making, a more cyclic reimbursement process seems feasible to reduce uncertainty regarding the therapeutical and economical value of expensive drugs. A mandatory evidence development requirement seems desirable to sufficiently meet decision makers' needs., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: Surgical resection of gastrointestinal stromal tumour (GIST) is rarely curative in patients at high risk of tumour recurrence and therefore 1 year of post-surgery adjuvant imatinib therapy has been recommended in this sub-group. Recently, adjuvant imatinib therapy administered for 3 years has been demonstrated to further increase recurrence-free survival and overall survival. The goal of this study was to assess the economic value of extending the duration of adjuvant imatinib therapy in high-risk patients in the Netherlands., Methods: A multistate Markov model was developed to simulate how patients' clinical status after GIST excision evolves over time until death. The model structure encompassed four primary health states: free of recurrence, first GIST recurrence, second GIST recurrence, and death. Transition probabilities between the health states, data on medical care costs, and quality-of-life were obtained from published sources and from expert opinion., Results: The expected number of life years (or quality-adjusted life years, QALYs) was higher in the 3-year group than in the 1-year group, 8.91 (6.55) and 7.04 (5.18) years, respectively. In the 3-year and 1-year group, the expected total costs amounted to €120,195 and €79,361, of which, €74,631 (62%) and €27,619 (35%) were adjuvant therapy drug costs, respectively. The difference in health benefits, that is 1.87 life years or 1.37 QALYs, and costs, €40,835, resulted in incremental cost-effectiveness ratios (ICER) of €21,865 per life year gained, and €29,872 per QALY gained., Limitations: A limitation of the study was inherently related to the uncertainty around the predictions of RFS. Scenario analyses were conducted to test the sensitivity of different RFS predictions on the results., Conclusions: Delayed recurrence due to treatment with longer-term adjuvant imatinib therapy represents a cost-effective treatment option with an ICER below the generally accepted threshold in the Netherlands.

Background: Recent clinical trial data have demonstrated that 3 years vs 1 year of adjuvant imatinib therapy for patients with surgically resected Kit+ Gastrointestinal Stromal Tumors (GIST) leads to a significant improvement in recurrence-free survival and overall survival. This study assesses the cost-effectiveness of treating patients with 3 years vs 1 year of imatinib from a US payer's perspective., Methods: A Markov model was developed to predict GIST recurrence and treatment costs. Patients enter the model after surgery and transition among three health states: free of recurrence, recurrence, and death. Recurrence, mortality, costs, and utilities were derived from clinical trial and published literature. Expected costs and quality-adjusted life years (QALYs) were estimated and discounted at 3%/year. Deterministic and probabilistic sensitivity analyses were conducted., Results: Patients receiving 3 years of imatinib had higher QALYs (8.53 vs 7.18) than those receiving 1 year of imatinib. Total lifetime per-patient cost was $302,100 for 3 years vs $217,800 for 1 year of imatinib. Incremental cost effectiveness ratio of 3 years vs 1 year of imatinib was $62,600/QALY. Model results were sensitive to long-term rate of GIST recurrence (beyond 5 years) and cost of imatinib. At a threshold of $100,000/QALY, 3 years vs 1 year of imatinib was cost-effective in 100% of simulations., Limitations: The model is a simplified representation of disease natural history and may not account for all possible health states and complications associated with disease. Resource utilization on treatment was estimated using the resource use data from previous trials, therefore calculated medical costs might be over-estimated compared to the real-world setting., Conclusions: Model results suggest that treatment with 3 years vs 1 year of imatinib is cost-effective at a $100,000/QALY threshold. Clinical and economic results suggest treating surgically resected Kit+ GIST patients with 3 years of imatinib would result in improved quality-adjusted survival.