Health economic changes as a result of implementation of targeted therapy for metastatic renal cell carcinoma: national results from DARENCA study 2.

BACKGROUND: Limited data exist on the economic consequences of implementing targeted therapy (TT) for metastatic renal cell carcinoma (RCC) in a real-world setting. OBJECTIVE: To analyze health care and productivity costs for TT implementation in a national cohort of patients. DESIGN, SETTING, AND PARTICIPANTS: Costs were measured per patient per year during a 2-yr follow-up during 2002-2005 (immunotherapy only) and 2006-2009 (TT implementation). All Danish patients with a diagnosis code for RCC and a procedure code for TT or immunotherapy were linked to the Danish National Patient Registry (contains information on all contacts with primary and secondary health sector). Health care and productivity costs were retrieved from the Danish case-mix system and Coherent Social Statistics, respectively. Drug costs were calculated separately from procedure codes and retail prices. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Generalized linear models were used to analyze costs adjusted for age, gender, and civil status. RESULTS AND LIMITATIONS: A total of 439 patients were included for 2006-2009 and 192 for 2002-2005. Comparison of the health care cost per patient per year between 2006-2009 and 2002-2005 revealed lower inpatient costs (€11 899 vs €19 944, adjusted relative risk [RR] 0.64), higher outpatient costs (€14 308 vs €6209, RR 2.39), lower radiotherapy costs (€194 vs €633, RR 0.31), higher radiology costs (€676 vs €191, RR 3.73), and higher separately calculated drug costs (€12 040 vs €3103, RR 3.82, all p<0.001) for the former. Total health care costs per patient per year did not significantly differ (€27 676 vs €27 856, RR 1.05, p=0.5) between the two periods. Income from employment did not significantly differ between 2006-2009 and 2002-2005 (RR 1.11, p=0.11) and costs associated with loss of productivity were €7852 and €8265, respectively. CONCLUSIONS: A different pattern of health care costs were observed but total health care costs per patient per year did not significantly differ after implementation of TT for patients with mRCC. PATIENT SUMMARY: In this nationwide study, we found changes in the pattern of health care costs for patients with metastatic kidney cancer after implementation of targeted therapy compared to an immunotherapy control period; however, total health care costs and income from employment were without significant changes.

Current and predicted cost of metastatic renal cell carcinoma in Finland.

UNLABELLED: Information on detailed treatment costs and the economic burden of renal cell carcinoma (RCC) is rare. The current study provides treatment costs and outcomes of patients with metastatic RCC (mRCC), as well as estimates of the future burden from the perspective of Finnish health care. These results offer a baseline against which the impact of emerging treatments may be evaluated. MATERIALS AND METHODS: Information on treatment modalities, survival, and the cost of treatment was retrospectively gathered from mRCC patients (n = 83) receiving first-line interferon-alpha (IFN). Predictions of the number of new cases, premature deaths, and productivity losses were made using local epidemiological data, which were projected to the future using population growth forecasts. The future costs of mRCC treatment and the budget impact of sunitinib were estimated through modeling. RESULTS: Patients survived 11.9 months (median; 95% CI 9.2-14.7) after initiation of active IFN treatment, accruing an average total treatment cost of 951 euros. Most of the treatment costs were due to hospitalization and active IFN treatment. The aging of the population leads to nearly a 2% increase in the absolute number of new diagnoses annually, while at the same time it results in declining productivity losses. The estimated five-year population cost of IFN-based treatment was 16M euros-26M euros. Adding sunitinib to the first-line treatment protocol increased this cost by 13M eruos-41M euros. CONCLUSIONS: Despite the limited number of patients, metastatic renal cell carcinoma places a considerable economic burden on Finnish society. Treatment costs are likely to increase substantially due to the adoption of new and more expensive medications, the aging population, and enhanced survival times.

Economic evaluation of sunitinib malate for the first-line treatment of metastatic renal cell carcinoma.

PURPOSE: To assess the cost effectiveness and cost utility of sunitinib malate as a first-line treatment in metastatic renal cell carcinoma (mRCC) compared with interferon-alfa (IFN-alpha) and interleukin-2 (IL-2) from a US societal perspective. METHODS: A Markov model was developed to simulate disease progression and to determine progression-free survival, total life-years (LYs), and quality-adjusted life-years (QALYs) gained. Model parameters were derived from the pivotal trial of sunitinib, published literature, government sources, and clinical experts' opinions. The model included trial-based adverse events (AEs). Costs of drug treatment, routine follow-up, AEs, disease progression, and best supportive care (BSC) of terminally ill patients were included. Results were tested using probabilistic and deterministic sensitivity analyses. RESULTS: Treatment with sunitinib is associated with a gain in progression-free years of 0.41 and 0.35 over IFN-alpha and IL-2. The estimated gains over IFN-alpha were 0.11 LYs and 0.14 QALYs, and over IL-2 were 0.24 LYs and 0.20 QALYs. Both IFN-alpha and sunitinib treatments dominate IL-2 treatment; the incremental cost-effectiveness ratio of sunitinib versus IFN-alpha was $18,611 per progression-free year gained and $67,215 per LY gained, and the cost-utility ratio is $52,593 per QALY gained (at a 5% discount rate). Sensitivity analyses found the results to be most sensitive to utility values during treatment, the cost of sunitinib, and the cost of BSC. Model results were robust to changes in other model variables. CONCLUSION: These results suggest that sunitinib is a cost-effective alternative to IFN-alpha as a first-line treatment for mRCC.

The use of interleukin-2 in human immunodeficiency virus infection.

Advances in antiretroviral therapy for human immunodeficiency virus (HIV) have led to reductions in HIV-related morbidity and mortality. Although antiretroviral therapy has shown success in suppressing viral loads, it does not adequately restore the immune system in all individuals infected with HIV. In light of this incomplete success, interleukin (IL)-2 is being evaluated as adjunctive therapy to antiretroviral therapy. The agent has demonstrated mixed yet promising results in restoring immune function in patients who are HIV positive.

The clinical experience with interleukin-2 in cancer therapy.

In May 1992, interleukin-2 (IL-2) was formally approved by the U.S. Food and Drug Administration for use in cancer treatment based on its activity in metastatic renal cell carcinoma. IL-2 alone or in combination with activated lymphocytes or other cytokines has significant anti-tumor activity against renal cell carcinoma and melanoma with response rates of 15-20%, some of which are quite durable. Limited anti-tumor effects have been noted in some patients with colorectal cancer and lymphoma. Too few patients have been studied to establish the level of activity in most other specific tumor types. The mechanism of this anti-tumor effect appears to be entirely mediated by the immunostimulatory effects of IL-2. Toxicities are dose related, but are substantial and similar regardless of the schedule of administration. Randomized trials have failed to establish (1) the superiority of high-dose bolus over continuous infusion IL-2, (2) the superiority of IL-2 plus interferon over IL-2 alone, or (3) the superiority of IL-2 plus LAK cells versus IL-2 alone. Further investigation is needed to determine the optimum dose and schedule from the standpoint of cost:benefit and risk:benefit, and to determine the role of IL-2 in the therapy of other malignant diseases.