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A systematic literature review undertaken by the ISPOR Biosimilar Special Interest Group highlighted that limited guidance exists on how to assess biosimilars value and on appropriate economic evaluation techniques. This study described current health technology assessment (HTA) agency approaches for biosimilar value assessment. Semi-structured interviews (n = 16) were carried out with HTA experts in Africa, America, Asia, Australia, and Europe to investigate current HTA practices for biosimilars. Data categorization was based on a thematic analysis approach. Findings from the qualitative data analysis were interpreted in view of relevant published literature. Our research suggests that in systems in which frameworks for biosimilar regulatory approval are well established, HTA agencies can accept the regulators' comparability exercise, and reimbursement decisions can generally be based on price comparisons. This approach is accepted in practice and allows streamlining of biosimilars value assessment. Nevertheless, conducting HTAs for biosimilars can be relevant when (1) the originator is not reimbursed, (2) the biosimilar marketing authorization holder seeks reimbursement for indications/populations, pharmaceutical forms, methods and routes of administration that differ with respect to the originator, and (3) a price premium is sought for a biosimilar based on an added-value claim. Further, HTA agencies' role conducting class-review updates following biosimilar availability can support greater patients' access to biologics. Internationally, there are differences in how national competent authorities on pricing and reimbursement of pharmaceuticals perceive HTA's role for biosimilars. Therefore, HTA agencies are encouraged to issue clear guidance on when and how to conduct HTAs for biosimilars, and on which economic techniques to apply. • National competent authorities on pricing and reimbursement of pharmaceuticals perceive health technology assessment (HTA)'s role for biosimilars differently. Limited guidance exists on assessing biosimilars value and addressing limitations of current value assessment frameworks. • This article addresses knowledge gaps on HTA agency approaches for biosimilar value assessment. • Our study indicates that biosimilar reimbursement decisions do not need to be systematically informed by HTAs. Nevertheless, conducting HTAs can be occasionally relevant. For example, when: (1) the originator is not reimbursed, (2) biosimilar manufacturers seek reimbursement for indications/populations, pharmaceutical forms, methods and routes of administration that differ with respect to the originator, and (3) price premiums are sought for biosimilars based on added-value claims. [ABSTRACT FROM AUTHOR]

Biosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics' large patent portfolios asserted during litigation against biosimilar developers, particularly that the manufacturing patents filed after the originator is approved is an important driver of these delays. Our objective was to investigate the accuracy of these claims. We reviewed US Court document submissions for litigation data, including the details of patents asserted against biosimilar owners, and collated biosimilar market launch dates from publicly available databases. We find that, although approximately half of all patents asserted in litigation were manufacturing patents, a greater proportion of composition, active pharmaceutical ingredient, and treatment patents are associated with longer market launch delays, whereas a greater proportion of manufacturing patents are associated with shorter market launch delays. Our results suggest that manufacturing patents were having less of an impact on market launch delays than other types of patents. Our findings have implications for both biosimilar and originator developers, as well as patent policy and its association with healthcare accessibility. • Although it has been claimed that manufacturing patents filed after the originator is approved are a key driver of biosimilar market launch delay, we lack a detailed empirical understanding of the association between the number and types of patents asserted in litigation by originator owners in the United States and how that affects litigation outcome and length of biosimilar commercial market entry delay. • It was found, unexpectedly, that manufacturing patents were having less of an impact on market launch delays than other types of patents, which is contrary to current thinking. • These findings support greater efforts at exploring and addressing biosimilar market launch delays caused not just by manufacturing patents, but also active pharmaceutical ingredient, composition, and treatment patents and the broader implications for patent policy. [ABSTRACT FROM AUTHOR]

This study aims to provide an overview of the gaps and challenges in the value assessment of biosimilars and to identify potential approaches to address them. A multidisciplinary, international team of biosimilar experts identified gaps and challenges. A systematic review was conducted of the peer-reviewed literature in PubMed, EMBASE, Web of Science Core Collection, EBSCOhost Business Source Complete; and of the gray literature. Preliminary results were presented at ISPOR conferences and this article benefited from 2 review rounds among ISPOR Biosimilar Special Interest Group members. Given that a biosimilar is highly similar to its reference biologic, health technology assessment agencies should accept the comparability exercise approved by regulatory authorities and, thus, conduct a price comparison when biosimilar reimbursement is requested for the same indication as the reference biologic. If the reference biologic is not reimbursed or is not the standard of care, a full economic evaluation of the biosimilar versus a relevant comparator needs to be conducted. To date, little consideration has been given to specific challenges, such as how biosimilar value assessment can account for the nocebo effect, potential differences between biologic-naive and biologic-experienced patients, the availability of intravenous and subcutaneous administration forms or different administration devices for the same active compound, value-added services, and the contribution of biosimilars for generating health gain at the population level. There is a need to gather further insights in the methodology of value assessment for biosimilars, and health technology assessment agencies need to develop more elaborate guidance on biosimilar value assessment in specific circumstances. • There is debate about the methodology of value assessment for biosimilars, and the practices of health technology assessment agencies can vary. • This article discusses and proposes approaches to address multiple challenges in biosimilar value assessment. • In light of the comparability exercise approved by regulatory authorities, a price comparison is appropriate when biosimilar reimbursement is requested for the same indication as the reference biologic. A full economic evaluation needs to be conducted in other specific circumstances. [ABSTRACT FROM AUTHOR]

Objectives: To estimate the effect of filgrastim-sndz market entry on patient out-of-pocket costs and claim payments for filgrastim products.Methods: This study used a single interrupted time series design with longitudinal, nationally representative, individual-level claims data from IBM MarketScan. Analyses included all outpatient and prescription claims for branded filgrastim (filgrastim and tbo-filgrastim) and biosimilar filgrastim (filgrastim-sndz) from January 1, 2014, to December 31, 2017. Outcomes of interest included changes in monthly claim payments and monthly patient out-of-pocket costs for filgrastim products.Results: In the baseline period (January 2014 to February 2016), insurers paid an average of $472.21 (95% confidence interval [CI]: 465.38-479.03) for 480 mcg of branded filgrastim, whereas patients paid an average of $49.26 (CI: 34.25-64.27). Filgrastim-sndz market entry was associated with a statistically significant and immediate 1-month decrease in insurer payment of $30.77 (95% CI: -40.59 to -20.94) and a significant decrease in monthly insurer payment trend of $3.10 per month (95% CI: -3.90 to -2.31) relative to baseline. Long-term changes in patient out-of-pocket costs were modest and restricted to beneficiaries enrolled in high cost sharing plans.Conclusions: Biosimilar filgrastim availability led to significant immediate and long-term decreases in claims payments for filgrastim products, supporting efforts to facilitate biosimilar adoption in the United States. Nevertheless, there were only slight changes in patient out-of-pocket costs, restricted to beneficiaries enrolled in high cost sharing plans, suggesting the importance of further work assessing the relationship between biosimilar availability and patient out-of-pocket costs. [ABSTRACT FROM AUTHOR]

Objectives: To examine the uptake of filgrastim-sndz (Zarxio), the first biosimilar to launch in the United States, in the Medicare Part B fee-for-service program from its launch in September 2015 to December 2017 and compare characteristics of patients and facilities that used filgrastim-sndz or originator filgrastim (Neupogen).Methods: The 20% sample of Medicare Part B fee-for-service administrative claims data was used to extract information on claims for any filgrastim product between January 1, 2015 and December 31, 2017.Results: The utilization of filgrastim-sndz in Medicare Part B increased sharply between January and August 2016, surpassing filgrastim by November 2017, contributing to a 30% decrease in overall spending on this drug since 2015. Uptake was faster and larger in physician practices compared with hospital outpatient departments. About 77% of patients receiving filgrastim-sndz were new users. Utilization patterns indicated that product selection occurred at the facility level, rather than being at the discretion of the prescribing physician or driven by patient characteristics.Conclusion: Uptake of biosimilar filgrastim in the Medicare Part B program occurred despite multiple challenges to the adoption of biosimilars in the US market, suggesting that substantial potential savings could be generated by improving biosimilar uptake. Our findings indicated that physician practices and hospital outpatient departments have distinctive biosimilar uptake patterns. Thus policy makers aiming to contain Medicare Part B spending might consider focusing on incentivizing biosimilar uptake among hospital outpatient departments. [ABSTRACT FROM AUTHOR]

Objectives: Biologic disease-modifying antirheumatic drugs (bDMARDs) are prescribed sequentially in the treatment of rheumatoid arthritis (RA). Healthcare decision makers continue to debate their use, mainly because of their high costs. Our aim was to perform an economic evaluation for France of bDMARD sequences for treatment of moderate-to-severe RA after inadequate response or intolerance to conventional DMARDs (eg, methotrexate).Methods: A discretely integrated condition event simulation was developed to track the course of patients from first bDMARD through switches to further lines in a sequence. The model included 11 events, 91 conditions, and 21 controlling equations. Inputs were obtained from a meta-analysis of clinical trials, a French registry, national drug lists, and databases. Survival, time with minimal activity, quality-adjusted life-years (QALYs), and total costs were output. Structural and probabilistic sensitivity analyses were conducted.Results: Sequences starting with etanercept biosimilars (ETB) cost less, with ETB-abatacept-infliximab the least expensive: the mean lifetime discounted total cost was €116 912 per patient, with a mean of 11.166 QALYs. Most other strategies were dominated or led to small QALY gains (0.0008-0.0329). Only ETB-tocilizumab-abatacept made it onto the efficiency frontier, but at €955 778 per QALY gained. These results were confirmed in several scenarios and uncertainty analyses.Conclusion: Given minor differences in QALYs gained between bDMARD sequences with large cost differences, starting with biosimilars was more efficient than starting with branded products. Our model and findings should provide French and other decision makers with useful tools to address the challenges of comparing sequences of treatments for RA. [ABSTRACT FROM AUTHOR]

The fully integrated biosimilars utilization management system (FIBS) at Centro Hospitalar e Universitário de Coimbra (CHUC) relies on prescription and dispensing of biologic therapies by international non-proprietary name and aims to promote the initiation of or switching to (for patients at least 12 months on the same biologic therapy brand) the biologic therapy brand with the best economic value. In its second year of implementation, The Fully Integrated Biosimilars utilization management System of CHUC keeps demonstrating high levels of efficiency, integration and control over the utilization of biosimilars at hospital level. [Extracted from the article]

For products with the main usage in hospital or the tender market the (net) price erosion is substantial for some products up to 90% of list price. Many products have both TLV reimbursement and participate in regional tender processes but only one category of biosimilars have a national net price agreement. Products with an exclusively outpatient profile are less likely to participate in tenders and price erosion is thus small. [Extracted from the article]

While the European Union (EU) is regarded as the most advanced market and the pioneer in the regulation of biosimilar medicines, the biosimilar market in the United States (US) remains relatively new. The aim of this research was to compare the policies status of the interchangeability, switching and substitution of biosimilars in 5 main EU countries (France, Germany, Italy, Spain and the UK) and the USA. [Extracted from the article]