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.
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.
Background: MM treatment has changed substantially in the past 5 years as a result of the FDA approval of single agent bortezomib (VELCADE®, Vel), the combinations of thalidomide (Thalomid®, Thal) plus dexamethasone (Dex), lenalidomide (Revlimid®, Rev) plus Dex, and most recently Vel with pegylated liposomal doxorubicin (DOXIL®, Dox). The aim of this budget impact model was to evaluate the direct resource utilization of these 4 therapies, including drug cost, medical cost and cost of management of adverse events (AE). Methods: A managed care payer perspective was used. Drug costs were calculated based on AWP - 15% with 10% (Thal/Dex, Rev/Dex) or 20% (Vel, Vel/Dox) patient coinsurance. Cost of therapy and costs of treating each AE were obtained from standard sources such as the Red Book or from peer-reviewed publications and/or meeting presentations. Incidence of AE (all ≥5% grade 3/4 AE or AE that require significant resource utilization) and assumptions for supportive care/prophylaxis were obtained from the full Prescribing Information (PI) for each of the 4 approved MM therapies. For key AE with no information available in the PI, data were obtained from peer-reviewed publications. Specifically, the rates of febrile neutropenia and DVT/PE for Vel/Dox were obtained from the pivotal ph3 trial (Orlowski et al, JCO 2007), while the rates of grade 3/4 dyspnea, pneumonia/grade 3/4 infections were inferred from Orlowski et al, ASH 2006; the rate of febrile neutropenia for Rev/Dex was obtained from the pivotal ph3 study (Dimopoulos et al, EHA 2006). Duration of therapy (DOT) for each regimen was based on the published median DOT of the respective pivotal ph3 study: 6 cycles for Vel (Richardson, NEJM 2005) and Vel/Dox (Orlowski, JCO 2007), and 11 cycles for Rev/Dex (Stadtmauer, ASCO 2006). DOT for Thal/Dex (9 cycles) was based on the average DOT from 2 ph2 studies (Palumbo, Haematologica 2001; Terpos, Leukemia 2005) as it better reflects actual use. Medical costs included evaluation and management, chemotherapy administration, hydration, laboratory tests and prophylaxis. This analysis did not account for differences in patient population or in efficacy; efficacy could not be compared due to incomplete/inconsistent reporting of outcomes data in the PIs for the 4 regimens. Results: Total costs for these 4 regimens were substantially different, primarily driven by direct drug costs (Table). Based on emerging clinical data, prophylaxis for herpes zoster (Vel, Vel/Dox) and DVT/PE (Rev/Dex, Thal/Dex) are recommended. Thus we performed an additional analysis assuming appropriate prophylaxis based on published literature. The total costs +/− prophylaxis did not differ substantially as increased medical costs offset decreased AE management costs. Conclusions: This analysis showed a substantial difference in resource utilization for the 4 US approved MM regimens with Vel being the lowest and Rev/Dex the highest. A complete cost-effectiveness model is warranted as more outcomes data become available. Vel Vel/Dox Rev/Dex Thal/Dex *with prophylaxis;data not available w/o prophylaxis Drug Costs $22,734 $34,794 $64,806 $37,281 Medical Costs $5,886 $7,041* $1,623 $1,397 AE Costs $5,209 $6,094* $5,243 $7,910 TOTAL (per patient) $33,829 $47,929* $71,672 $46,588 TOTAL w/ prophylaxis (per patient) $33,966 $47,929 $72,822 $47,002 type of prophylaxis herpes zoster DVT/PE
e18821 Background: Rituximab-abbs is a CD20-directed monoclonal antibody and the first rituximab biosimilar approved in the US, expected to significantly reduce drug acquisition costs. This budget impact model (BIM) estimated budgetary impact of replacing a proportion of rituximab/hyaluronidase human subcutaneous injection (SC-R) utilization for NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) and CLL with rituximab-abbs (IV-R-BIOSIM). The objective was to project incremental cost differences between IV-R-BIOSIM and SC-R over one year for a hypothetical 5-million-member US healthcare insured (Medicare) population. Methods: An illustrative BIM was developed to estimate 1-year drug and administration costs for a one-quarter shift in SC-R market utilization to IV-R-BIOSIM, with equal efficacy and safety assumed. Values for epidemiology, market share, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Infused rituximab (IV-R) dosing assumed a mean body surface area (BSA) of 1.8m2. Annual dose counts of IV-R-BIOSIM or SC-R per patient were: 10 untreated FL with maintenance; 8 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 6 CLL. IV-R infusion duration was 3 hours. Drug acquisition and infusion/subcutaneous administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. SC-R costs included an initial IV-R originator dose. Patient cost share was based on 2020 Medicare Part B 20% cost-share for office visits and drugs. Univariate sensitivity analyses were conducted. A scenario analysis used 2-year dosing to estimate costs for further FL maintenance treatment. Results: For a 5-million-member insured population, an estimated 972 patients would receive rituximab for NHL or CLL; 49 would receive SC-R. Estimated total incremental savings for one year for a 13-patient shift from SC-R to IV-R-BIOSIM were $57,864, equating to $0.02 per enrolled member per year (PMPY). Per-patient incremental annual savings with IV-R-BIOSIM for one year ranged between $2,359–$8,186 (Table). The model was most sensitive to low or high BSA dosing and proportion of patients with CLL. Conclusions: This BIM estimated annual savings of over $57,000 ($0.02 PMPY) for a 5-million-member US payer following a 25% shift of current SC-R use to IV-R-BIOSIM. These findings demonstrate the potential economic benefits of IV-R-BIOSIM vs SC-R that may result in expanded access to rituximab therapy.[Table: see text]
Introduction: Granulocyte colony-stimulating factors (G-CSFs) are often administered to reduce the incidence, severity, and duration of febrile neutropenia in chemotherapy patients. Tbo-filgrastim and filgrastim-sndz are short-acting G-CSFs with comparable efficacy and safety to that of filgrastim. The present analysis estimated the budget impact of increasing utilization of health care provider (HCP)-administered tbo-filgrastim and filgrastim-sndz on patients with nonmyeloid malignancies treated with myelosuppressive chemotherapy from a US payer perspective. Methods: An interactive budget impact model was developed to estimate the changes in drug and administration costs for a 1 million member health plan. Administration by an HCP (within a clinic or other outpatient setting) was assumed for 80% of patients receiving short-acting G-CSF treatment, with the majority (85%) of products adjudicated through the patient's medical benefit/provided by the HCP and the remaining 15% purchased through the patient's pharmacy benefit. For medical benefit adjudication, the model projected increases in the market share of tbo-filgrastim from 37% to 42% and filgrastim-sndz from 2% to 4% (with a decrease in filgrastim market share from 61% to 54%). For pharmacy benefit adjudication, the model projected increases in the market share of tbo-filgrastim from <1% to 2% and filgrastim-sndz from 5% to 7% (with a decrease in filgrastim market share from 95% to 91%). Base case data were derived from publicly available resources. The overall plan budget impact was calculated using a 1-year time horizon, along with the difference in per-member per-year (PMPY) cost between the current and future scenarios; one-way sensitivity analyses were conducted. Results: The effective annual plan per-patient drug cost totaled between $11,904 and $27,199, depending on dose, presentation, and benefit adjudication, for tbo-filgrastim, between $15,418 and $26,015 for filgrastim-sndz, and between $15,573 and $30,663 for filgrastim. The estimated overall annual plan cost associated with HCP-administered short-acting G-CSFs was $177,151,918 (PMPY = $177.15) in the current scenario and $175,230,445 (PMPY = $175.23) in the future scenario. Cost savings totaled $1,921,473 (PMPY = $1.92). The model was most sensitive to changes in the overall proportion of patients with HCP-administered G-CSFs and to HCP filgrastim acquisition cost. Conclusions: Budget impact analyses examine the financial impact associated with the introduction of new treatments or shifting existing treatment patterns in order to help decision makers determine how best to allocate resources. The majority of HCP-administered G-CSF is adjudicated through the medical benefit, where the effective annual plan per-patient drug cost was lowest for tbo-filgrastim (24% lower cost than filgrastim). For the remainder of HCP-administered G-CSF adjudicated through the pharmacy benefit, the effective annual plan per-patient drug cost was lowest for filgrastim-sndz (15% lower cost than filgrastim). The present analysis estimated an annual US health plan cost savings approaching $2 million overall or almost $2.00 PMPY following an increase of market share by approximately 5% for tbo-filgrastim and 2% for filgrastim-sndz. Disclosures Trautman: Teva Pharmaceuticals, Inc.: Consultancy. Szabo:Patient Centered Outcomes Research (PCORI): Consultancy; Teva Pharmaceuticals, Inc.: Employment; Eli Lilly & Company; Zoetis: Equity Ownership. Lo-Coco:Teva, Novartis, Baxalta, Pfizer: Consultancy; Teva, Lundbeck: Honoraria, Speakers Bureau. James:Teva Pharmaceuticals, Inc.: Consultancy. Gabriel:Teva Pharmaceuticals, Inc.: Employment. Pathak:Teva Pharmaceuticals: Employment, Equity Ownership. Tang:Teva Pharmaceuticals, Inc.: Employment.
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