scholarly journals Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

2021 ◽  
Vol 14 (4) ◽  
pp. 348
Author(s):  
Manuel García-Goñi ◽  
Isabel Río-Álvarez ◽  
David Carcedo ◽  
Alba Villacampa
Keyword(s):  
Impact Analysis ◽  
Budget Impact ◽  
Public Procurement ◽  
National Health System ◽  
Drug Acquisition ◽  
Sensitivity Analyses ◽  
Full Potential ◽  
Great Opportunity ◽  
Pharmaceutical Spending ◽  
Uptake Data

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.

U.S. budget impact analysis of biosimilar versus originator intravenous rituximab for the treatment of non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18820-e18820
Author(s):  
Elizabeth James ◽  
Holly Trautman ◽  
Ali McBride ◽  
Azhar Choudhry ◽  
Stephen Thompson
Keyword(s):  
B Cell ◽  
Impact Analysis ◽  
Budget Impact ◽  
Drug Acquisition ◽  
B Cell Lymphoma ◽  
Economic Benefits ◽  
Lymphocytic Leukemia ◽  
Sensitivity Analyses ◽  
Cost Share ◽  
The Impact

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]

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
Keyword(s):  
Impact Analysis ◽  
Budget Impact ◽  
Drug Acquisition ◽  
Subcutaneous Administration ◽  
B Cell Lymphoma ◽  
Economic Benefits ◽  
Lymphocytic Leukemia ◽  
Sensitivity Analyses ◽  
Cost Share ◽  
One Year

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]

scholarly journals Budget Impact Analysis of Xydalba from the Perspective of Italian National Health System

2016 ◽  
Vol 19 (7) ◽  
pp. A564-A565
Author(s):  
A Marcellusi ◽  
C Bini ◽  
N Petrosillo ◽  
FS Mennini ◽  
P Sciattella
Keyword(s):  
Health System ◽  
National Health ◽  
Impact Analysis ◽  
Budget Impact ◽  
National Health System ◽  
Budget Impact Analysis ◽  
Italian National Health

scholarly journals Budget impact analysis of a breast rapid diagnostic unit

2017 ◽  
Vol 24 (3) ◽  
pp. 214 ◽  
Author(s):  
M. Elmi ◽  
H. Hussain ◽  
S. Nofech-Mozes ◽  
B. Curpen ◽  
A. Leahey ◽  
...  
Keyword(s):  
Health Care ◽  
Impact Analysis ◽  
Budget Impact ◽  
Tertiary Care ◽  
Resource Planning ◽  
Budget Impact Analysis ◽  
Sensitivity Analyses ◽  
Definitive Treatment ◽  
Base Case ◽  
Diagnostic Unit

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.

scholarly journals Budget impact analysis of Fractional Exhaled Nitric Oxide Monitoring for the Management of Childhood Asthma: The Colombian National Health System perspective

2021 ◽  
Vol 32 (2) ◽  
Author(s):  
JA Buendía ◽  
R Acuña-Cordero ◽  
CE Rodriguez-Martinez
Keyword(s):  
Nitric Oxide ◽  
National Health ◽  
Impact Analysis ◽  
Budget Impact ◽  
National Health System ◽  
Persistent Asthma ◽  
Exhaled Nitric Oxide ◽  
Fractional Exhaled Nitric Oxide ◽  
System Perspective ◽  
The Cost

Background: Fractional exhaled nitric oxide is a simple, non-invasive measurement of airway inflammation with minimal discomfort with results available within a few minutes. For policymakers, the main concerns is the economic impact implicated in adapting this technology, especially in developing countries. This study to evaluate the budget impact of asthma management using fractional exhaled nitric oxide monitoring in patients between 4 and 18 years of age in Colombia. Methods: A budget impact analysis was performed to evaluate the potential financial impact deriving from Fractional exhaled nitric oxide. The analysis considered a 5-year time horizon and Colombian National Health System perspective. The incremental budget impact was calculated by subtracting the cost of the new treatment, in which FeNO is reimbursed, from the cost of the conventional treatment without FeNO (management based on clinical symptoms (with or without spirometry/peak flow) or asthma guidelines (or both), for asthma-related). Univariate one-way sensitivity analyses were performed. Results: In the base-case analysis the 5-year costs associated to FeNO and no-FeNO were estimated to be € 469.904.130 and € 480.485.149 respectively, indicating savings for Colombian National Health equal to € 10.581.019, if FeNO is adopted for the routine management of patients with persistent asthma. This result was robust in univariate sensitivity one-way analysis. Conclusion: Fractional exhaled nitric oxide was cost-saving in emergency settings for infants with persistent asthma. This evidence can be used by decision-makers in our country to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.

scholarly journals A Budget Impact Analysis of Substituting Sitagliptin with Liraglutide in Type 2 Diabetes from A Private Health Insurance Perspective in Egypt

2021 ◽  
Author(s):  
Gihan Hamdy El-sisi ◽  
Ayman Afify ◽  
Ashraf Abgad ◽  
Ibtissam Zakaria ◽  
Nabil Nasif ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Health Insurance ◽  
Private Health Insurance ◽  
Impact Analysis ◽  
Budget Impact ◽  
Standard Of Care ◽  
Sensitivity Analyses ◽  
Glucose Lowering ◽  
Insurance Perspective

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.

Budget impact analysis of the HIV/AIDS treatment on a national scale: a study from the Vietnam Social Security perspective

MedPharmRes ◽  
2021 ◽  
Vol 5 (1) ◽  
pp. 8-14
Author(s):  
Nhac-Vu Hoang-Thy ◽  
Thi-Ngoc-Van Tran ◽  
Thi-Thu-Ha Do
Keyword(s):  
Social Security ◽  
Impact Analysis ◽  
Budget Impact ◽  
Social Health Insurance ◽  
Treatment Goal ◽  
Sensitivity Analyses ◽  
National Scale ◽  
Mean Values ◽  
The Impact ◽  
Hiv Aids

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.

Potential budget impact of capecitabine versus 5-FU/LV as adjuvant chemotherapy for stage III (SIII) colon cancer in Canada and its provinces

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6581-6581
Author(s):  
K. Virik ◽  
C. Skedgel ◽  
T. Younis
Keyword(s):  
Colon Cancer ◽  
Steady State ◽  
Adjuvant Chemotherapy ◽  
Impact Analysis ◽  
Budget Impact ◽  
Cost Effective ◽  
Standard Of Care ◽  
Sensitivity Analyses ◽  
Effectiveness Model ◽  
Start Up

6581 Background: Adjuvant chemotherapy for SIII colon cancer is an accepted standard of care. Oral Capecitabine (CAP) has been shown to be at least equivalent and possibly superior to 5FU/LV (Mayo regimen) with regards to a superior relapse free survival. This new option is associated with a higher drug cost but improved toxicity profile and appears to be cost-effective (CE). An economic analysis was undertaken to examine the potential budget impact for CAP in Canada and its provinces for 2007 onwards. Methods: A previously developed cost-effectiveness model was adapted to a prevalence perspective to project the net budgetary impact of CAP over a 5 year horizon. The projected population and incidence of colon cancer for each Canadian province from 2007–2016 was obtained and the proportion of patients with SIII colon cancer suitable for adjuvant chemotherapy was estimated from the literature. The average budget impact in the first 5 years (start up phase) and subsequent years (steady state) was assessed in Canadian $. Results: The projected average annual impact for Canada is 13.9 million (M) during the start up phase and $11.8 M during the steady state phase (NL $210K, PEI $63K, NS $424K, NB $282K, QC $2.92M, ON $4.66M, MB $464K, SK $336K, AB $993K and BC 1.45M). Budget impact is greater during the initial start-up phase (2007–11), as the steady state impact (2012–16) includes relapses avoided over a 5-year period. Sensitivity analyses for key parameters will be provided. Conclusions: The annual budget impact of CAP decreases over time and reaches a steady state after 5 years when the full impact of decreased recurrences is captured. As CAP appears to be CE, budget impact analysis has the potential to assist in the planning of healthcare funding resources regarding this treatment option. [Table: see text]

Budget impact analysis of sargramostim use in patients with chemotherapy-induced neutropenia

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20596-e20596
Author(s):  
M. Duh ◽  
E. L. Toy ◽  
C. L. Porter ◽  
P. L. Books ◽  
F. Vekeman ◽  
...  
Keyword(s):  
Health Plan ◽  
Impact Analysis ◽  
Budget Impact ◽  
Drug Acquisition ◽  
Cost Savings ◽  
Recent Analysis ◽  
Substantial Cost ◽  
Gm Csf ◽  
Spreadsheet Model ◽  
Chemotherapy Induced Neutropenia

e20596 Background: Myeloid growth factors are used to treat and prevent chemotherapy-induced neutropenia (CIN). Filgrastim and its long-acting version pegfilgrastim are granulocyte colony-stimulating factors (G-CSF), whereas sargramostim is a dual granulocyte- macrophage colony-stimulating factor (GM-CSF). This study analyzed the budget impact of substituting GM-CSF for G-CSF in the management of CIN from the perspective of a US health plan. Methods: A spreadsheet model was developed to compute annual and per-member-per-month (PMPM) costs associated with CSFs. Inputs included cancer prevalence, the proportion of patients receiving chemotherapy and G/GM-CSFs, incidence and cost of relevant adverse events (e.g., bone pain), and G/GM-CSF drug acquisition and administration costs. Incidence and cost of infection- and febrile neutropenia-related hospitalizations, based on recent analysis of medical insurance claims data, were also used. Cost savings (2006 USD) were assessed for utilization share switches from G-CSF to GM-CSF. Results: For a health plan with 1 million members, an estimated 976 patients received G/GM-CSF annually. Increasing baseline utilization shares for pegfilgrastim, filgrastim, and sargramostim of 70/30/0%, respectively, to alternative shares of 50/25/25% yielded substantial cost savings (see Table ), primarily related to G/GM-CSF acquisition and administration costs. Savings for patients switching from pegfilgrastim were greater than for patients switching from filgrastim. Results were sensitive to assumptions for drug cost and frequency of administration, but cost savings were observed for most scenarios. Conclusions: This study suggests that health plans can realize substantial cost savings by substituting sargramostim for filgrastim and pegfilgrastim in CIN patients. With 25% of sargramostim substitution, the cost saving could reach ≈$2 million for a health plan with 1 million members, or a saving of 16 cents per member per month. [Table: see text] [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document