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Hemoglobin Decline in Chemotherapy Patients Prior to and after Policy Changes Affecting Use of Erythropoiesis-Stimulating Agents: 2006 – 2009

OBJECTIVE: Since 2007, the use of erythropoiesis-stimulating agents (ESAs) to treat anemia in cancer patients receiving chemotherapy has been increasingly restricted in the USA. This study assessed hemoglobin (Hb) decline over time among chemotherapy patients. METHODS: Episodes of chemotherapy care were identified in a large US-oncology electronic medical record database; weekly Hb levels were computed in the first 8 weeks. Unadjusted and adjusted proportions of patient-weeks with Hb decline > 1 g/dl (i.e. representing clinically significant decline) within 1 or 2 weeks were analyzed. RESULTS: Between 2006 and 2009, unadjusted proportions of patient-weeks with Hb decline > 1 g/dl increased (1-week, from 12.7% to 14.9%; 2-week, from 19.3% to 26.3%). Adjusted 1-week proportions in 2007 were similar to 2006, but increased in 2008 (odds ratio [OR] 1.135; 95% confidence intervals [CI] 1.067, 1.208) and in 2009 (OR 1.235; 95% CI 1.094, 1.395). Adjusted 2-week proportions had the same pattern. CONCLUSIONS: Since restrictions on ESA use were introduced in the USA, more patients have experienced a clinically significant Hb decline after chemotherapy initiation. Initiating anemia therapy at the earliest indicated opportunity may help reduce the risk of such declines.

Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data

IntroductionBlinatumomab is a bispecific T cell-engaging antibody construct indicated for adult patients with relapsed/refractory (R/R) Ph(−) B-precursor acute lymphoblastic leukemia (ALL), an aggressive disease with poor prognosis. A phase 2 single-arm clinical study showed that 43% of patients achieved CR/CRh within two cycles and approximately 20% of patients receiving blinatumomab were still alive after 2xa0years.MethodsThe objective of the current analysis was to estimate long-term survival of patients receiving blinatumomab beyond the observed time period in the clinical study using a large historical observational dataset. Conditional survival probabilities of blinatumomab-treated patients beyond month 60 were assumed to be the same as the US general population.ResultsAt month 60, the estimated proportion of blinatumomab-treated patients alive was more than double that of historical patients (12.6% vs 5.4%). The mean overall survival was 76.1xa0months for blinatumomab patients and 39.8xa0months for historical patients. Sensitivity analyses including additional follow-up data from the clinical study showed consistent results.ConclusionsThese findings suggest that blinatumomab provides substantial overall survival benefit to patients with (R/R) Ph(−) B-precursor ALL compared with salvage chemotherapy.FundingAmgen.Trial RegistrationClinicalTrials.gov identifier NCT01466179 and NCT02003612.

Cost-effectiveness of blinatumomab versus salvage chemotherapy in relapsed or refractory Philadelphia-chromosome-negative B-precursor acute lymphoblastic leukemia from a US payer perspective

Abstract Objective: To evaluate the cost-effectiveness of blinatumomab (Blincyto) vs standard of care (SOC) chemotherapy in adults with relapsed or refractory (R/R) Philadelphia-chromosome-negative (Ph−) B-precursor acute lymphoblastic leukemia (ALL) based on the results of the phase 3 TOWER study from a US healthcare payer perspective. Methods: The Blincyto Global Economic Model (B-GEM), a partitioned survival model, was used to estimate the incremental cost-effectiveness ratio (ICER) of blinatumomab vs SOC. Response rates, event-free survival (EFS), overall survival (OS), numbers of cycles of blinatumomab and SOC, and transplant rates were estimated from TOWER. EFS and OS were estimated by fitting parametric survival distributions to failure-time data from TOWER. Utility values were based on EORTC-8D derived from EORTC QLQ-C30 assessments in TOWER. A 50-year lifetime horizon and US payer perspective were employed. Costs and outcomes were discounted at 3% per year. Results: The B-GEM projected blinatumomab to yield 1.92 additional life years and 1.64 additional quality-adjusted life years (QALYs) compared with SOC at an incremental cost of

Economic burden associated with adverse events of special interest in patients with relapsed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia in the United States

180,642. The ICER for blinatumomab vs SOC was estimated to be

Health-related quality of life in adults with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab

110,108/QALY gained in the base case. Cost-effectiveness was sensitive to the number and cost of inpatient days for administration of blinatumomab and SOC, and was more favorable in the sub-group of patients who had received no prior salvage therapy. At an ICER threshold of

Health-Related Quality of Life (HRQoL) of Blinatumomab Versus Standard of Care (SOC) Chemotherapy in Patients with Relaspsed or Refractory Philadelphia Negative B-Cell Precursor Acute Lymphoblastic Leukemia in a Randomized, Open-Label Phase 3 Study (TOWER)

150,000/QALY gained, the probability that blinatumomab is cost-effective was estimated to be 74%. Limitations: The study does not explicitly consider the impact of adverse events of the treatment; no adjustments for long-term transplant rates were made. Conclusions: Compared with SOC, blinatumomab is a cost-effective treatment option for adults with R/R Phu2009−u2009B-precursor ALL from the US healthcare perspective at an ICER threshold of

Cost effectiveness (CE) of blinatumomab (BLIN) vs inotuzumab ozogamicin (INO) in adult patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL) with no more than one prior salvage therapy (S0/S1) from a US payer perspective.

150,000 per QALY gained. The value of blinatumomab is derived from its incremental survival and health-related quality-of-life (HRQoL) benefit over SOC.

Indirect treatment comparison of blinatumomab versus inotuzumab ozogamicin for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia receiving zero or one prior salvage therapy.

ABSTRACT Background: Infections, cytopenia, and gastrointestinal (GI) toxicity are adverse events of special interest (AESI) affecting most relapsed Philadelphia chromosome–negative (Ph−) B-cell acute lymphocytic leukemia (ALL) patients. This study quantified real-world rates and economic burden of these events among relapsed Ph− B-cell ALL patients in the United States. Methods: Adults with relapsed Ph− B-cell ALL during 1 April 2009–31 October 2016 were selected from MarketScan® healthcare claims databases. Outcomes included proportions of patients with AESIs and AESI-related costs during 100 days after relapsed hospitalization. Results: Of 400 relapsed Ph− B-cell ALL patients, 92.5% experienced ≥1 AESI during the median 100-day follow-up, of which 64.6% had infections, 94.6% cytopenia, and 46.2% GI toxicities. Mean (SD; median) AESI-related total cost per patient during follow-up was

Treatment pattern and unmet need in adults with Philadelphia positive (Ph+) relapsed or refractory (R/R) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) in EU-5 countries.

197,213 (

Utilization of intravenous bisphosphonates (IVBs) in patients with bone metastases (BMets) secondary to breast, lung, or prostate cancer (BC, LC, PC).

308,551;