Budgetary Impact of Bendamustine Ready-to-Dilute Products in Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma to a United States Infusion Facility.

BACKGROUND: Bendamustine hydrochloride (BND HCl) is indicated for first-line treatment of chronic lymphocytic leukemia (CLL) and rituximab-refractory indolent non-Hodgkin lymphoma (iNHL). There are two ready-to-dilute (RTD) formulations of BND HCl on the US market: a large-volume, long-duration infusion (BND-L) and a small-volume, short-duration infusion (BND-S). It is estimated that the shorter duration infusion could result in cost savings to infusion facilities. OBJECTIVE: Estimate the one-year budget impact between BND-S and BND-L for use in the treatment of CLL and iNHL when all current BND-L utilization is replaced with BND-S, from the US infusion facility perspective. METHODS: An illustrative budget impact model estimated the change in costs associated with a projected increase from 50% to 100% market share for BND-S. The model included CLL and iNHL patient populations. Budgetary costs reflected facility expenditures on drug acquisition and administration based on recommended dosing for BND-S and BND-L. The base-case model assumptions and inputs were derived from scientific literature and publicly available resources. The total budget impact was calculated annually, along with the differences in per patient cost; one-way sensitivity analyses were conducted. RESULTS: Per-patient savings with BND-S use after the utilization shift were estimated at $2812.24 for CLL and $4769.01 for iNHL. Across both indications, the total annual incremental savings after the utilization shift were estimated at $452,209 for 250 CLL and iNHL patients in a 10,000-patient infusion facility, resulting in cost savings of $150.74 per BND HCI patient per month and $1808.84 per BND HCI patient per year. The model was sensitive to changes in proportion of patients receiving BND HCI infusions for CLL and iNHL, patient body surface area, and BND-S wholesale acquisition cost. CONCLUSION: This analysis estimated over $450,000 in annual savings for a 10,000-patient chemotherapy infusion facility following a utilization shift from 50% use of each RTD product to 100% use of BND-S in CLL and iNHL patients, driven by lower acquisition costs for BND-S and lower administration labor costs associated with rapid infusion.

Patient-Administered Biologic and Biosimilar Filgrastim May Offer More Affordable Options for Patients with Nonmyeloid Malignancies Receiving Chemotherapy in the United States: A Budget Impact Analysis from the Payer Perspective.

BACKGROUND: Granulocyte colony-stimulating factors (G-CSFs) are often administered to reduce the incidence, severity, and duration of febrile neutropenia (FN) in chemotherapy patients. Tbo-filgrastim and filgrastim-sndz represent a follow-on biologic and a biosimilar version, respectively, of the short-acting G-CSF filgrastim with comparable efficacy and safety. OBJECTIVE: To estimate the budget impact of increasing use of patient-(home-) administered tbo-filgrastim and filgrastim-sndz from a U.S. payer perspective. METHODS: An interactive budget impact model was developed to estimate the changes in drug cost associated with projected increases in the market share of tbo-filgrastim from 5% to 10% and of filgrastim-sndz from 10% to 12% (with a corresponding decrease in filgrastim market share from 85% to 78%) for a 1 million-member health plan among patients with nonmyeloid malignancies receiving chemotherapy with a high risk of FN. Patient self-administration at home was assumed for 20% of patients receiving short-acting G-CSF treatment; all products were purchased through the patient's pharmacy benefit and were assumed to have tier 3 formulary status with a patient copay of $54 per prescription. Base-case data were derived from publicly available resources. The total plan budget impact was calculated using a 1-year time horizon, along with the differences in per member per month and per member per year (PMPY) costs between the current and future scenarios. RESULTS: The effective annual per-patient drug cost to the plan totaled between $16,961 and $27,199, depending on dosage and packaging, for tbo-filgrastim; between $16,216 and $26,015 for filgrastim-sndz; and between $19,134 and $30,663 for filgrastim. The estimated total annual plan cost associated with patient-administered short-acting G-CSFs was $53,298,217 (PMPY = $53.30) in the current scenario and $52,828,832 (PMPY = $52.82) in the future scenario. Cost savings totaled $469,385 (PMPY = $0.48). The model was most sensitive to changes in the percentage of patients self-administering G-CSF at home and to the wholesale acquisition cost for filgrastim. CONCLUSIONS: The effective annual plan per-patient drug costs for tbo-filgrastim and filgrastim-sndz were 11% and 15% lower than filgrastim, respectively. The present analysis estimated an annual U.S. health plan cost savings approaching $0.5 million following increases in market shares of approximately 5% for tbo-filgrastim and 2% for filgrastim-sndz. DISCLOSURES: This study was sponsored by Teva Branded Pharmaceutical Products R & D, which participated in the study design, data interpretation and analysis, the writing of the report, and the decision to submit. Aventine Consulting received consulting fees from Teva Pharmaceuticals and developed the cost model and provided data analysis support. Trautman and James are employed by Aventine Consulting. Szabo and Tang are employed by Teva Pharmaceuticals.

Scales for assessing nonmotor symptom severity changes in Parkinson's disease patients with symptom fluctuations.

UNLABELLED: ABSTRACT Background: In Parkinson's disease (PD), the impact of nonmotor symptoms can outweigh the effect of worsening physical mobility on Health-Related Quality of Life (HRQoL). As PD progresses, patients may experience more severe changes in fluctuating nonmotor symptoms. OBJECTIVE: This review summarizes nonmotor symptom assessments in patients with fluctuating symptoms, focusing on scales utilizing a daily-diary format for a broad spectrum of nonmotor symptoms. METHODS: Medline on PubMed and EMBASE were searched for relevant articles published between January 2002 and October 2009. RESULTS: Several nonmotor symptom scales were found, but no single scale with all desirable characteristics was identified. The Scales for Outcomes in Parkinson's Disease (SCOPA) battery of assessments, the Nonmotor Symptoms Scale (NMSS), and the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I offered a majority of the desirable characteristics, while practical, valid, and reliable. CONCLUSION: A single daily-diary instrument for assessing a broad spectrum of fluctuating nonmotor symptoms was not identified; however, the battery of SCOPA scales, the NMSS, and the MDS-UPDRS Part I provide useful nonmotor symptom severity assessment. The development of a diary assessment would be helpful in evaluating treatment interventions to improve HRQoL in patients with fluctuating symptoms.