U.S. budget impact analysis of an intravenousrituximab biosimilar versus subcutaneous rituximab for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18821-e18821
Author(s):  
Elizabeth James ◽  
Holly Trautman ◽  
Ali McBride ◽  
Azhar Choudhry ◽  
Stephen Thompson

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]

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18820-e18820
Author(s):  
Elizabeth James ◽  
Holly Trautman ◽  
Ali McBride ◽  
Azhar Choudhry ◽  
Stephen Thompson

e18820 Background: Rituximab-abbs is an anti-CD20 monoclonal antibody and an important immuno-oncology agent for the treatment of B-cell malignancies NHL (diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL]) and CLL. It is also indicated for patients with RA, GPA, and MPA. Rituximab-abbs was the first rituximab biosimilar approved in the US and is expected to reduce drug acquisition costs. This budget impact model (BIM) estimated the impact of replacing a share of originator rituximab (IV-R-REF) use with rituximab-abbs (IV-R-BIOSIM) for NHL (DLBCL and FL), CLL, RA, GPA, and MPA. The objective was to project incremental annual cost differences between IV-R-BIOSIM and IV-R-REF for a hypothetical 1-million-member US healthcare insured (Medicare) population. Methods: An illustrative BIM estimated changes in 1-year drug and administration costs for an increased IV-R-BIOSIM uptake from 17.5% to 22.0%. Values for epidemiology, market share distribution, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Dosing was based on a mean patient body surface area of 1.8 m2. Annual dose counts per patient were: 10 untreated FL with maintenance; 8 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 6 CLL, and 4 for RA, GPA, or MPA. All treatments were assumed to infuse over 3 hours. Drug acquisition and administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. Patient cost share was based on 2020 Medicare Part B 20% cost-share for office visits and drug products. Univariate sensitivity analyses were conducted. A scenario analysis was performed to project 2-year costs for extended FL maintenance treatment. Results: Estimated total annual plan incremental savings for a 1-million-member payer after the utilization shift were $312,379, equating to $0.31 per enrolled member per year (PMPY). Per-patient incremental drug cost savings with IV-R-BIOSIM for 1-year were $5,474–$12,924 (Table). The model was most sensitive to IV-R-REF cost and proportion of patients with RA. Conclusions: This analysis estimated annual savings of over $310,000 ($0.31 PMPY) for a 1-million-member US payer following a 4.5% utilization shift from IV-R-REF to IV-R-BIOSIM, demonstrating that IV-R-BIOSIM may confer considerable economic benefits vs originator rituximab.[Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18822-e18822
Author(s):  
Stephen Thompson ◽  
Holly Trautman ◽  
Ali McBride ◽  
Azhar Choudhry ◽  
Elizabeth James

e18822 Background: The first rituximab biosimilar approved in the US, rituximab-abbs, is a CD20-directed monoclonal antibody that is expected to significantly reduce drug acquisition costs. This economic analysis evaluated budgetary impact of BSA-based rituximab-abbs (IV-R-BIOSIM) vs flat-fixed rituximab/hyaluronidase human subcutaneous injection (SC-R) dosing in NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) and CLL. The objective was to project incremental cost differences per patient between IV-R-BIOSIM and SC-R from a US healthcare insured (Medicare) population. Methods: An illustrative BIM estimated 1-year costs for IV-R-BIOSIM and SC-R. The model assumed equal efficacy and safety between products. Values for epidemiology, market share distribution, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Costs for the first infused rituximab (IV-R) dose were excluded for appropriate comparison. IV-R-BIOSIM doses used BSAs of 1.6 m2, 1.8 m2, infusion duration was 3 hours. Annual dose counts of IV-R-BIOSIM or SC-R were: 9 untreated FL with maintenance; 7 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 5 CLL. Drug acquisition and administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. Patient cost share was 2020 Medicare Part B 20% cost-share for office visits and drugs. A scenario analysis was also performed to estimate FL maintenance costs for 2-year dosing. Results: Estimated 1-year savings with IV-R-BIOSIM for 1.8 m2 BSA dosing were $1,067–$6,893 with variability between indications (Table). For 1.6 m2 BSA dosing, estimated 1-year savings with IV-R-BIOSIM were $3,819–$10,856. Estimated 2-year savings with IV-R-BIOSIM for FL maintenance dosing were $9,191 for 1.8 m2 BSA dosing and $14,475 for 1.6 m2 BSA dosing. Savings of up to $1,900 were seen for higher-than-average BSA dosing, regardless of regimen. Conclusions: These findings demonstrate the potential economic benefits of replacing a proportion of SC-R use with BSA-based IV-R-BIOSIM from a US payer perspective, especially when lower BSA dosing is used. Savings are driven by drug costs and may increase with IV-R-BIOSIM as patient BSA decreases due to static costs with SC-R doses. These data also suggest that drug wastage may occur with SC-R in lower BSA patients.[Table: see text]


2021 ◽  
Vol 14 (4) ◽  
pp. 348
Author(s):  
Manuel García-Goñi ◽  
Isabel Río-Álvarez ◽  
David Carcedo ◽  
Alba Villacampa

Since the first biosimilar medicine, Omnitrope® (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain. We estimate the budget impact of biosimilars in Spain from the perspective of the National Health System (NHS) over the period between 2009 and 2019. Drug acquisition costs considering commercial discounts at public procurement procedures (hospital tenders) and uptake data for both originator and biosimilar as actual units consumed by the NHS were the two variables considered. Two scenarios were compared: a scenario where no biosimilars are available and the biosimilar scenario where biosimilars are effectively marketed. All molecules exposed to biosimilar competition during this period were included in the analysis. The robustness of the model was tested by conducting multiple sensitivity analyses. From the payer perspective, it is estimated that the savings produced by the adoption of biosimilars would reach EUR 2306 million over 11 years corresponding to the cumulative savings from all biosimilars. Three molecules (infliximab, somatropin and epoetin) account for 60% of the savings. This study provides the first estimation of the financial impact of biosimilars in Spain, considering both the effect of discounts that manufacturers give to hospitals and the growing market share of biosimilars. We estimate that in our last year of data, 2019, the savings derived from the use of biosimilars relative total pharmaceutical spending in Spain is 3.92%. Although more research is needed, our evidence supports the case that biosimilars represent a great opportunity to the sustainability of the NHS through rationalizing pharmaceutical spending and that the full potential of biosimilar-savings has not been achieved yet, as there is a high variability in biosimilar uptake across autonomous regions.


2016 ◽  
Vol 56 (5) ◽  
pp. 613-624 ◽  
Author(s):  
Sally Driml ◽  
Roy Ballantyne ◽  
Jan Packer

A concerning issue with Economic Impact Analysis (EIA) is that many EIAs give results for one year, without being explicit about how long impacts are expected to last. New tourism attractions should not be assumed to provide continuing positive impacts into the future. For instance, the Giant Pandas at Adelaide Zoo generated a positive economic impact in their first year of residence (22% of a sample of tourists visited Adelaide “due to pandas,” additional tourism expenditure in the region was $27.7 million, with $2.3 to $4.6 million captured by the zoo); however, increased numbers visiting to see the pandas lasted only two years. Investment decision makers expected larger, longer-term economic benefits than eventuated, and the zoo experienced financial difficulties. This study provides advice for predictive EIA of new tourism attractions and prompts a call for tourism EIA studies to be explicit about the time period for which results are relevant.


2017 ◽  
Vol 24 (3) ◽  
pp. 214 ◽  
Author(s):  
M. Elmi ◽  
H. Hussain ◽  
S. Nofech-Mozes ◽  
B. Curpen ◽  
A. Leahey ◽  
...  

Background The Odette Cancer Centre’s recent implementation of a rapid diagnostic unit (rdu) for breast lesions has significantly decreased wait times to diagnosis. However, the economic impact of the unit remains unknown. This project defined the development and implementation costs and the operational costs of a breast rdu in a tertiary care facility.Methods From an institutional perspective, a budget impact analysis identified the direct costs associated with the breast rdu. A base-case model was also used to calculate the cost per patient to achieve a diagnosis. Sensitivity analyses computed costs based on variations in key components. Costs are adjusted to 2015 valuations using health care–specific consumer price indices and are reported in Canadian dollars.Results Initiation cost for the rdu was $366,243. The annual operational cost for support staff was $111,803. The average per-patient clinical cost for achieving a diagnosis was $770. Sensitivity analyses revealed that, if running at maximal institutional capacity, the total annual clinical cost for achieving a diagnosis could range between $136,080 and $702,675.Conclusions Establishment and maintenance of a breast rdu requires significant investment to achieve reductions in time to diagnosis. Expenditures ought to be interpreted in the context of institutional patient volumes and trade-offs in patient-centred outcomes, including lessened patient anxiety and possibly shorter times to definitive treatment. Our study can be used as a resource-planning tool for future rdus in health care systems wishing to improve diagnostic efficiency.


2017 ◽  
Vol 20 (9) ◽  
pp. A864
Author(s):  
AS Duva ◽  
RP Rosim ◽  
AF Ballalai Ferraz ◽  
C Cachoeira ◽  
IL Mojica

Author(s):  
Michaela Barbier ◽  
Nicholas Durno ◽  
Craig Bennison ◽  
Mathias Örtli ◽  
Christian Knapp ◽  
...  

Abstract Introduction Venetoclax in combination with rituximab (VEN + R) demonstrated prolonged overall survival (OS) and progression-free survival (PFS) for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) in comparison to standard chemoimmunotherapy [bendamustine + rituximab (BR)]. We conducted a cost-effectiveness and budget impact analysis comparing VEN + R versus six comparators from the Swiss healthcare payer perspective. Methods A three-state partitioned survival model, developed in accordance with NICE and ISPOR decision modelling guidelines, was adapted to Switzerland. Model inputs were informed by the MURANO trial (survival data, patient characteristics), publicly available Swiss sources (drug prices, inpatient and outpatient costs), Swiss National Institute of Cancer Epidemiology and Registration data (incidence and prevalence values), and Swiss medical expert feedback. We used published (dis-)utility values and adverse event probabilities. Results Over a lifetime, VEN + R resulted in an expected gain of 2.60 quality-adjusted life years (QALYs) per patient and incremental costs of Swiss Francs (CHF) 147,851 compared to BR, leading to an incremental cost-effectiveness ratio of CHF 56,881/QALY gained. Other treatment strategies (for example ibrutinib versus VEN + R) resulted in higher costs and lower QALYs. Results were not different for subgroups of patients with/without deletion of chromosome 17p/tumour protein 53 mutation. In scenario analysis, changes in post-progression treatment costs demonstrated a high impact on results. We estimated an expected value of perfect information of CHF 3,318/patient. A moderate VEN + R uptake was estimated to save CHF 12.3 million during 5 years. Conclusions Using a threshold of CHF 100,000 per QALY, VEN + R was projected to be cost-effective vs BR.


2021 ◽  
Author(s):  
Gihan Hamdy El-sisi ◽  
Ayman Afify ◽  
Ashraf Abgad ◽  
Ibtissam Zakaria ◽  
Nabil Nasif ◽  
...  

Abstract IntroductionType 2 diabetes mellitus (T2DM) causes a sizable burden globally both from health and economic points of view.This study aimed to assess the budget impact of substituting sitagliptin with liraglutide versus other glucose lowering drugs from the private health insurance perspective in Egypt over a 3-year time horizon. MethodsTwo budget impact models were comparedthe standard of care (metformin, pioglitazone, gliclazide, insulin glargine, repaglinide, and empagliflozin)administered in addition to liraglutide or sitagliptin versus the standard of care with placebo. A gradual market introduction of liraglutide or sitagliptin was assumed, and the existing market shares for the other glucose lowering drugs were provided and validated by Expert Panel. The event rates were extracted from the LEADER and TECOS trials. Direct and mortality costs were measured. Sensitivity analyses were performed. ResultsThe estimated target population of 120,574 T2DM adult patients were associated with CV risk. The budget impact per patient per month (PPPM) for liraglutide is EGP29 ($6.7), EGP39 ($9), and EGP49 ($11.3) in the first, second, and third year, respectively. The budget impact PPPM for sitagliptin is EGP11 ($2.5), EGP14 ($3.2), and EGP18 ($4.1) in the first, second, and third year, respectively. Furthermore, adoption of liraglutide resulted in 203 fewer deaths and 550 avoided hospitalizations, while sitagliptin resulted in 43 increased deaths and 14 avoided hospitalizations. The treatment costs of liraglutide use are mostly offset by substantial savings due to fewer CV-related events, avoided mortality and avoided hospitalizations over 3-years. Conclusion Adding liraglutide resulted in a modest budget impact, suggesting that the upfront drug costs were offset by budget savings due to fewer CV-related complications and deaths avoided compared to the standard of care. While sitagliptin resulted in a small budget impact but associated with deaths increased and less hospitalizations avoided.


MedPharmRes ◽  
2021 ◽  
Vol 5 (1) ◽  
pp. 8-14
Author(s):  
Nhac-Vu Hoang-Thy ◽  
Thi-Ngoc-Van Tran ◽  
Thi-Thu-Ha Do

Objectives: To analyze the budget impact of the HIV/AIDS treatment on a national scale, from the Vietnam Social Security (VSS) perspective. Methods: A model with a 5-year time horizon was developed. The total first year direct medical cost (DMC) and its cost components were estimated for HIV-infected populations each year. Budget impact was described through the proportion of the DMC over the social health insurance (SHI) budget. A scenario analysis was conducted with four settings of different proportions of members and coverage levels of the SHI. All costs were converted to 2020 US dollars. 1-way sensitivity analyses were conducted with variations of mean values in a range of ±25%. Results: The total DMC was estimated at $1.8M (10,000 cases) to treat all new infections and $27.7M (150,000 cases) to reach the treatment goal of the Ministry of Health (MOH) in 2020. The total DMC accounted for 0.6% of the SHI budget for the year 2020 to meet the treatment goal. The costs of CD4-count test and fully suppressive regimen containing Tenofovir Disoproxil Fumarate (TDF) were identified as key cost drivers. The proportion of the total DMC over the SHI budget among different scenarios did not vary significantly. Conclusion: This is the first-ever study analyzing the budget impact of the HIV/AIDS treatment on a national scale, from the VSS perspective. The results showed that the cost of HIV/AIDS care was economical and the impact on the SHI budget was reasonable. Findings could be used to notify the MOH to allocate domestic resources and to optimize the current programs.


Sign in / Sign up

Export Citation Format

Share Document