Dataset Information

Budget Impact Analysis of the Introduction of Rituximab and Trastuzumab Intravenous Biosimilars to EU-5 Markets.

ABSTRACT:

Background

Biologic treatments impose a large financial burden on healthcare payers. Subcutaneous formulations of trastuzumab and rituximab offer administration cost savings relative to the intravenous products through reduced preparation and infusion times. However, intravenous biosimilars have the potential to offset administration costs through lower drug costs.

Objective

The objective was to develop a budget impact model (BIM) from a payer's perspective for the EU-5 countries (UK, France, Germany, Spain, Italy) to demonstrate the economic impact of using intravenous trastuzumab and rituximab biosimilars.

Methods

An incidence-based BIM was developed to estimate the net budget impact utilising epidemiology data from the literature, market research data on the use of relevant treatments in all approved indications, and corresponding costs. The budget impact was estimated for 5 years following introduction of the biosimilars.

Results

Analysis using the base-case results indicated that adoption of the biosimilars trastuzumab and rituximab would result in net cost savings. At year 5, the net budget saving ranged from €4.05 million to 303.86 million for rituximab and from €19 million to 172 million for trastuzumab. The cost saving could potentially extend treatment to 291-15,671 more patients with rituximab and 622-3688 more patients with trastuzumab.

Conclusion

This budget impact analysis emphasised that increased use of intravenous rituximab and trastuzumab biosimilars may result in cost savings from the payer's perspective across the EU-5 countries.

SUBMITTER: Jang M

PROVIDER: S-EPMC7803676 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Budget Impact Analysis of the Introduction of Rituximab and Trastuzumab Intravenous Biosimilars to EU-5 Markets.

Jang Minyoung M Simoens Steven S Kwon Taeksang T

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 20201224 1

<h4>Background</h4>Biologic treatments impose a large financial burden on healthcare payers. Subcutaneous formulations of trastuzumab and rituximab offer administration cost savings relative to the intravenous products through reduced preparation and infusion times. However, intravenous biosimilars have the potential to offset administration costs through lower drug costs.<h4>Objective</h4>The objective was to develop a budget impact model (BIM) from a payer's perspective for the EU-5 countries ...[more]

PMID: 33368051

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Project description:IntroductionNew biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment. The rituximab biosimilar CT-P10 has recently been approved in Europe in all indications held by reference rituximab (RTX), including rheumatoid arthritis, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. We analyzed the budgetary impact of the introduction of CT-P10 into the European Union (EU) for use in patients with rheumatoid arthritis and cancer diagnoses, using a budget impact analysis model.MethodsThe model used a base case scenario in which the 1-year uptake of CT-P10 was estimated at 30%, and the cost of CT-P10 was assumed to be 70% of the cost of RTX. A second 1-year scenario was also modeled, in which the market share of CT-P10 was assumed to be 50% (scenario 2). Finally, 3-year time horizon outcomes were calculated, in which the market share of CT-P10 was assumed to be 30%, 40%, and 50% in the first, second, and third years, respectively.ResultsIn the base case scenario, the introduction of CT-P10 was associated with projected savings of €90.04 million in the first year, which would allow 7531 additional patients to access rituximab treatment. This was equivalent to a 6.4% increase in the number of rituximab-treated patients. In scenario 2, budget savings were €150.10 million, with a total of 12,551 additional patients able to access rituximab, equivalent to a 10.7% increase. Over a 3-year time horizon, projected budget savings were approximately €570 million, equating to 47,695 additional patients able to access rituximab.ConclusionsThe model predicted that the introduction of CT-P10 in the EU will be associated with significant budget savings, the reallocation of which will enable many more patients to access rituximab treatment. This is likely to have a significant impact on health gains at patient and societal levels.FundingCELLTRION Healthcare Co., Ltd. sponsored the development and analysis of the budget impact analysis model.

Project description:BackgroundCopanlisib was recently granted accelerated approval by the FDA for the treatment of adult patients with relapsed follicular lymphoma (FL) after 2 previous systemic therapies. It is important to assess the effect that this and other changes in the treatment landscape of relapsed FL have on a payer's budget to inform formulary decisions.ObjectiveTo assess the budget impact associated with the addition of copanlisib to a formulary as third- or higher-line treatment for adult patients with relapsed FL who have received at least 2 previous systemic therapies, from the perspective of a U.S. third-party payer.MethodsA budget impact model was developed over a 1-year horizon. The model considered a hypothetical population of 1 million people enrolled in a commercial health plan; patients with relapsed FL were identified based on epidemiology data. Treatments included copanlisib and approved and off-label therapies used for management of relapsed FL. Treatment distributions within the target population were based on a market research survey. Drug acquisition, administration, prophylaxis, and monitoring costs were based on prescribing information, clinical trials, literature, and expert opinion. All costs were inflated to 2017 U.S. dollars. Total costs were compared between 2 scenarios, 1 without and 1 with copanlisib on a formulary. A deterministic sensitivity analysis (DSA) was conducted to evaluate the robustness of the model.ResultsWithin the 1 million-member health care plan, 18 patients had relapsed FL and had received at least 2 previous systemic therapies. Over 1 year, the addition of copanlisib and an increase in the use of obinutuzumab + bendamustine (from 9.0% without copanlisib to 13.1% with copanlisib) and lenalidomide + rituximab (from 0.3% to 12.0%) were estimated to increase drug acquisition costs by $238,536, drug administration and prophylaxis costs by $3,565, and monitoring costs by $539. The increase in total budget was $242,641, corresponding to $0.02 per member per month; 21.8% of this increase was attributable to copanlisib, 12.9% to obinutuzumab + bendamustine, and 65.3% to lenalidomide + rituximab. Results were generally robust in the DSA.ConclusionsOver a 1-year period, the model found that the addition of copanlisib to a formulary resulted in a small increase in total budget of $242,641, corresponding to $0.02 per patient per month and taking into account a concurrent increase in the use of obinutuzumab + bendamustine and lenalidomide + rituximab. Therefore, adding copanlisib to a formulary appears to be an affordable option for payers. Further studies should be conducted to more comprehensively assess the clinical and economic implications of adding copanlisib to the treatment armamentarium of relapsed FL.DisclosuresThis study was funded by Bayer HealthCare Pharmaceuticals. The study sponsor was involved in study design, data interpretation. and data review. All authors contributed to the development of the manuscript and maintained control over the final content. Appukkuttan, Yaldo, Gharibo, and Babajanyan report employment with Bayer HealthCare Pharmaceuticals at the time of this study. Duchesneau, Zichlin, Bhak, and Duh report employment with Analysis Group, which received research funds from Bayer HealthCare Pharmaceuticals for work on this study. A synopsis of the current research was presented in poster format at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Project description:Neuromyelitis optica spectrum disorder (NMOSD) is an inflammatory condition of the central nervous system. The extent of disability depends on the severity of the disease and the number of relapses. Although azathioprine is currently the main treatment for patients with NMOSD in Thailand, patients often relapse during its use. Hence, it is argued that there are other drugs that would be more effective. The purpose of this study is to evaluate, from a societal perspective and from the economic impact on Thailand's healthcare system, the cost utility of treatment with mycophenolate mofetil (MMF) and rituximab in patients resistant to azathioprine. The Markov model with a one-year cycle length was applied to predict the health and cost outcomes in patients with NMOSD over a lifetime. The results showed that rituximab exhibited the highest quality-adjusted life year (QALY) gains among all the options. Among the rituximab-based treatments, the administration of a rituximab biosimilar with CD27+ memory B cell monitoring proved to be the most cost-effective option. At the willingness-to-pay threshold of 160,000 Thai baht (THB), or 5,289 US dollar (USD), per QALY gained, the treatment exhibited the highest probability of being cost effective (48%). A sensitivity analysis based on the adjusted price of a generic MMF determined that the treatment was cost effective, exhibiting an incremental cost-effectiveness ratio of -164,653 THB (-5,443 USD) and a 32% probability of being cost effective. The calculated budget impact of treating patients resistant to conventional therapy was 1-6 million THB (33,000-198,000 USD) for the first three years, while after the third year, the budget impact stabilized at 3-4 million THB (99,000-132,000 USD). These data indicate that, in Thailand, treatment of drug resistant NMOSD with a rituximab biosimilar with CD27+ memory B cell monitoring or treatment with a generic MMF would be cost effective and would result in a low budget impact. Therefore, the inclusion of both the rituximab biosimilar and a generic MMF in the National Drug List of Essential Medicine for the treatment of NMOSD may be appropriate.

Dataset Information

Budget Impact Analysis of the Introduction of Rituximab and Trastuzumab Intravenous Biosimilars to EU-5 Markets.

Background

Objective

Methods

Results

Conclusion

Publications

Budget Impact Analysis of the Introduction of Rituximab and Trastuzumab Intravenous Biosimilars to EU-5 Markets.

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