Impact of ibrutinib and idelalisib on the pharmaceutical cost of treating chronic lymphocytic leukemia at the individual and societal levels.

PURPOSE: To evaluate the impact of approval of ibrutinib and idelalisib on pharmaceutical costs in the treatment of chronic lymphocytic leukemia (CLL) at the societal level and assess individual out-of-pocket costs under Medicare Part D. METHODS: Average wholesale price of commonly used CLL treatment regimens was ascertained from national registries. Using the population of Olmsted County, Minnesota, we identified the proportion of patients with newly diagnosed CLL who experience progression to the point of requiring treatment. Using these data, total pharmaceutical cost over a 10-year period after diagnosis was estimated for a hypothetic cohort of 100 newly diagnosed patients under three scenarios: before approval of ibrutinib and idelalisib (historical scenario), after approval of ibrutinib and idelalisib as salvage therapy (current scenarios A and B), and assuming use of ibrutinib as first-line treatment (potential future scenario). RESULTS: Estimated 10-year pharmaceutical costs for 100 newly diagnosed patients were as follows: $4,565,929 (approximately $45,659 per newly diagnosed patient and $157,446 per treated patient) for the historical scenario, $7,794,843 (approximately $77,948 per newly diagnosed patient and $268,788 per treated patient) for current scenario A, $6,309,162 (approximately $63,092 per newly diagnosed patient and $217,557 per treated patient) for current scenario B, and $16,414,055 (approximately $164,141 per newly diagnosed patient and $566,002 per treated patient) for the potential future scenario. Total out-of-pocket cost for 100 patients with newly diagnosed CLL under Medicare Part D increased from $9,426 under the historical scenario (approximately $325 per treated patient) to $363,830 and $255,051 under current scenarios A and B (approximately $8,800 to $12,500 per treated patient) and to $1,031,367 (approximately $35,564 per treated patient) under the future scenario. CONCLUSION: Although ibrutinib and idelalisib are profound treatment advances, they will dramatically increase individual out-of-pocket and societal costs of caring for patients with CLL. These cost considerations may undermine the potential promise of these agents by limiting access and reducing adherence.

The Functional Assessment of Cancer Therapy - General (FACT-G) is valid for monitoring quality of life in patients with non-Hodgkin lymphoma.

Quality of life (QoL) is an important outcome in patients with non-Hodgkin lymphoma (NHL). We assessed the validity of administering the Functional Assessment of Cancer Therapy - General (FACT-G) at 12-month intervals over 3 years in a longitudinal study of 611 prospectively enrolled, newly diagnosed patients with NHL. We evaluated corrected item-total correlation and percent missing to identify items that may be less useful in certain NHL patient subgroups. The FACT-G subscales and total score demonstrated good internal consistency reliability, convergent validity and known-groups validity. Most scores also demonstrated good responsiveness to change. Questions that could be problematic included GE3 (losing hope) and GP2 (nausea) for patients in remission, and GP5 (bothered by side effects) for patients being observed. Overall, the FACT-G was a valid measure for monitoring QoL over time in patients with NHL. However, sensitivity analyses based on subscale scoring that excludes potentially problematic items may be warranted.

Quality of life in chronic lymphocytic leukemia: an international survey of 1482 patients.

Although a diagnosis of chronic lymphocytic leukemia (CLL) can have a profound effect on the quality of life (QOL), few studies have objectively measured the QOL of CLL patients or compared it to the general population. We conducted an international, web-based survey of patients with CLL using standardized instruments with published population norms to evaluate fatigue and QOL. Co-morbid health conditions were assessed using the Charlson Co-Morbidity Index. Between June and October 2006, 1482 patients with CLL responded to the survey. The physical, social/family, functional, and overall QOL scores of CLL patients were similar to or better than published population norms. In contrast, the emotional well-being scores of CLL patients were dramatically lower than that of both the general population (P < 0.001) and patients with other types of cancer (P < 0.001). QOL scores were lower among individuals with advanced stage disease (all P < 0.05). Factors associated with lower overall QOL on multivariate analysis included older age, greater fatigue, severity of co-morbid health conditions, and current treatment. CLL has a profound impact on QOL at all disease stages. The effects of CLL on QOL appear to differ from that of other malignancies with a more marked impact on emotional QOL. Research identifying efficacious psycho-oncologic support interventions for patients with CLL is needed.