Translating European regulatory approval into healthcare uptake for biosimilars: the second translational gap

Acha, Virginia; Mestre-Ferrandiz, J.

doi:10.1080/09537325.2017.1285396

Cited by 8 publications

(7 citation statements)

References 31 publications

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“…Our approach overcomes some of these difficulties by making explicit reference to, and characterising the uncertainty of ATI development as the driver for differences in treatment outcomes. This addresses potential areas of concern relating to the extrapolation exercise while allowing for the uncertainty to be quantified -both in terms of identifying whether the cost savings are sufficient for a health-care payer to accept a potentially inferior product, and the value of conducting further research [60]. This is especially relevant in the UK system where biosimilars are not subjected to health technology appraisal, but instead existing guidance for originator drugs is applied to the biosimilar once they have gained marketing approval [61].…”

Section: Discussionmentioning

confidence: 99%

Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn’s Disease

et al. 2019

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Aim: Regulatory approval of biosimilars often depends on extrapolating evidence from one clinical indication to all of those of the originator biologic. We aimed to develop a quantitative benefit-risk analysis to assess whether the resulting increase in the uncertainty in the clinical performance of biosimilars (i.e. risk) may be countered by their lower pricing (benefit). Methods: A one-year decision-analytic model was developed for the biosimilar infliximab (Inflectra®) for Crohn's disease. The perspective was that of the NHS in the UK and costs were valued to 2015/16. A hypothetical cohort of biologic-naïve patients with moderate-to-severe Crohn's disease were simulated through the model. Immunogenicity to infliximab was a key modifier, influencing rates of non-response and infusion reactions. Net health benefit was estimated based on quality-adjusted life years (QALYs). A range of sensitivity analyses tested the robustness of the results and explored how the biosimilar price must respond to varying immunogenicity to remain the preferred option. Results: The base-case analysis predicted a positive incremental net health benefit of 0.04 (95% Central Range 0.00-0.09) favouring the biosimilar, based on 0.803 QALYs, and costs of £18,087 and £19,176 for biosimilar and originator, respectively. Two-way sensitivity analyses suggested that if 50% of patients developed antibodies, the value-based price of £410 per vial must be lower than that of the originator (£420), but remain higher than the actual market price (£378). Conclusions: The model supports the use of Inflecta® for Crohn's disease in the UK, and provides a framework for the quantitative evaluation of biosimilars in the context of health technology assessment. Value-based pricing using this methodology could protect health systems from the potential risks of biosimilars where they are untested in the approved populations. Key points for decision makers  The base-case analysis predicts a positive incremental net health benefit of 0.04 (95% Central Range 0.00-0.09) favouring the biosimilar and suggests that if 50% of patients developed antibodies, the value-based price would need to be below the originator but higher than the current market price.  The study presents a novel framework for the quantitative benefit-risk assessment of biosimilars, illustrated with biosimilar infliximab for Crohn's disease  The methods provide an explicit framework for balancing risks (the uncertainty in the efficacy and harms of biosimilars) against their benefits (cost advantages)

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Section: Discussionmentioning

confidence: 99%

Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn’s Disease

et al. 2019

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“…However, as previously pointed out by Acha and Mestre-Ferrándiz (2017) [ 55 ] (p. 263) the biosimilar market faces “the second translational gap” once concerns about the guarantees of the regulatory framework have been dispelled. The authors recognise that “Despite many efforts by regulators to reach out to clinicians, there remains a translational gap for biosimilars which need to be incorporated in healthcare pathways and understood by clinicians and patients.…”

Section: Barriers According To Stakeholdersmentioning

confidence: 99%

“…Attitudes such as opposition to transparency or to performance assessment leading to differentiated remuneration must be corrected, as they have a very negative effect on the morale of the vast majority of those who are compliant. When it comes to biosimilars, the strong ties that originator companies have with physicians through supporting clinical research or training may influence prescription choices [ 55 ]. Additionally, guidelines with an economic rationale intended to deliver benefits at societal level may be badly received by some physicians, who may consider that their professional decisions are challenged [ 81 ].…”

Section: Barriers According To Stakeholdersmentioning

confidence: 99%

Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain

Lobo

Río-Álvarez²

2021

Pharmaceuticals

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Incentives contribute to the proper functioning of the broader contracts that regulate the relationships between health systems and professionals. Likewise, incentives are an important element of clinical governance understood as health services’ management at the micro-level, aimed at achieving better health outcomes for patients. In Spain, monetary and non-monetary incentives are sometimes used in the health services, but not as frequently as in other countries. There are already several examples in European countries of initiatives searching the promotion of biosimilars through different sorts of incentives, but not in Spain. Hence, this paper is aimed at identifying the barriers that incentives to prescribe biosimilars might encounter in Spain, with particular interest in incentives in the framework of clinical governance. Both questions are intertwined. Barriers are presented from two perspectives. Firstly, based on the nature of the barrier: (i) the payment system for health professionals, (ii) budget rigidity and excessive bureaucracy, (iii) little autonomy in the management of human resources (iv) lack of clinical integration, (v) absence of a legal framework for clinical governance, and (vi) other governance-related barriers. The second perspective is based on the stakeholders involved: (i) gaps in knowledge among physicians, (ii) misinformation and distrust among patients, (iii) trade unions opposition to productivity-related payments, (iv) lack of a clear position by professional associations, and (v) misalignment of the goals pursued by some healthcare professionals and the goals of the public system. Finally, the authors advance several recommendations to overcome these barriers at the national level.

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“…The introduction of biosimilar drugs to the European market in 2006 created new challenges for the pharmaceutical industry and its legal regulations. Biopharmaceuticals are an entirely distinct category of medicines (5). In contrast to small-molecule drugs, the active substance of a biopharmaceutical is a large molecule (typically a protein) created in a multi-step biotechnological process that involves genetically modified organisms such as bacteria or fungi.…”

Section: Knowledge and Attitude Of Community Pharmacy Employees Towards An Automatic Drug Substitution Of Generics And Biosimilarsmentioning

confidence: 99%

Knowledge and attitude of community pharmacy employees towards an automatic drug substitution of generics and biosimilars

Łukasik¹,

Nowicki²

2018

Acta Poloniae Pharmaceutica - Drug Research

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In recent years many patent protections of original biopharmaceuticals have expired and biosimilar medicines are being developed and are entering the pharmaceutical market. Polish legal framework does not narrow down automatic therapeutic substitution (ATS) of biopharmaceuticals at the pharmacy level. The aim was to assess the awareness of Polish community pharmacy employees and their attitude towards ATS of generics and biosimilar medicines. A self-designed online questionnaire consisting of 27 questions addressing ATS of generics and biopharmaceuticals was created. The survey respondents were approached personally at local pharmacies, via pharmacy managers, chain pharmacy owners and Chambers of Apothecaries. Data collected were entered into descriptive statistics tool provided by the survey hosting server. Simultaneously a printed survey dedicated to patients was created to asses patterns of behavior related to ATS. According to Polish community pharmacy employees the main reason for ATS was price competitiveness, unavailability of the reference drug and patientís wish. 7.3% of respondents have ever taken part in any drug safety monitoring program. 9.1% of pharmacy technicians and 46.8% masters of pharmacy claimed to have considerable knowledge about biosimilar drugs and evaluated biosimilars as carrying a higher risk of adverse events than generics. 17.2% would offer a substitution of a biopharmaceutical. 33.3% of patients did not tell their prescribing doctor about the ATS. The results of the study should be interpreted with caution since they might have been influenced by the selection of survey respondents. Nevertheless, the results suggest that there is a lack of knowledge and information, lack of national guidance on the conduct of ATS, and deficient communication between prescribers, pharmacies, and patients. Thus, there is a need for communication between the stakeholders to deliver information, guidance, and training for the ATS of all medicinal products, including biopharmaceuticals. Explicit legislation regulating ATS between reference biopharmaceuticals and biosimilars may be considered depending on the national policy.

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Translating European regulatory approval into healthcare uptake for biosimilars: the second translational gap

Cited by 8 publications

References 31 publications

Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn’s Disease

Value Assessment and Quantitative Benefit-Risk Modelling of Biosimilar Infliximab for Crohn’s Disease

Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain

Knowledge and attitude of community pharmacy employees towards an automatic drug substitution of generics and biosimilars

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