Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!

Dutta, Binita; Huys, Isabelle; Vulto, Arnold G.; Simoens, Steven

doi:10.1007/s40259-019-00395-w

Cited by 91 publications

(102 citation statements)

References 33 publications

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“…A 66% DAA discount, in the comparison of screen-and-treat versus screen-and-treat/monitor all HCV-infected pregnant women, would be cost-effective at a threshold of €20,000 per QALY gained, in different cohorts of pregnant women. 66% discount, is comparable with the discount rate from biologicals versus biosmilars in the Netherlands, therefore in the future screen-and-treat could also be a cost-effective scenario compared to screen and monitoring [43].…”

Section: Discussionmentioning

confidence: 73%

Cost-effectiveness of hepatitis C virus screening, and subsequent monitoring or treatment among pregnant women in the Netherlands

et al. 2020

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Background The prevalence of diagnosed chronic hepatitis C virus (HCV) infection among pregnant women in the Netherlands is 0.26%, yet many cases remain undiagnosed. HCV screening and treatment of pregnant HCV carriers could reduce the burden of disease and limit vertical transmission from mother to child. We assessed the impact of HCV screening and subsequent treatment with new direct-acting antivirals (DAAs) among pregnant women in the Netherlands. Methods An HCV natural history Markov transition state model was developed, to evaluate the public-health and economic impact of HCV screening and treatment. Besides all 179,000 pregnant women in the Netherlands (cohort 1), we modelled 3 further cohorts: all 79,000 first-time pregnant women (cohort 2), 33,000 pregnant migrant women (cohort 3) and 16,000 first-time pregnant migrant women (cohort 4). Each cohort was analyzed in various scenarios: i no intervention, i.e., the current practice, ii screen-and-treat, i.e., the most extensive approach involving treatment of all individuals found HCV-positive, and iii screen-and-treat/monitor, i.e., a strategy involving treatment of symptomatic (F1–F4) patients and follow-up of asymptomatic (F0) HCV carriers with subsequent treatment only at progression. Results For all cohorts, comparison between scenarios (ii) and (i) resulted in ICERs between €9,306 and €10,173 per QALY gained and 5 year budget impacts varying between €6,283,830 and €19,220,405. For all cohorts, comparison between scenarios (iii) and (i) resulted in ICERs between €1,739 and €2,749 per QALY gained and budget impacts varying between €1,468,670 and €5,607,556. For all cohorts, the ICERs (scenario iii versus ii) involved in delayed treatment of asymptomatic (F0) HCV carriers varied between €56,607 and €56,892, well above the willingness-to-pay (WTP) threshold of €20,000 per QALY gained and even above a threshold of €50,000 per QALY gained. Conclusion Universal screening for HCV among all pregnant women in the Netherlands is cost-effective. However, it would be reasonable to consider smaller risk groups in view of the budget impact of the intervention.

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Section: Discussionmentioning

confidence: 73%

Cost-effectiveness of hepatitis C virus screening, and subsequent monitoring or treatment among pregnant women in the Netherlands

et al. 2020

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“…Biosimilars offer considerable advantages to healthcare systems. In general, the use of biosimilars leads to cost savings, price competition, increased patient access, improved cost effectiveness, incremental innovation, and might contribute to prevention of drug shortages [10,37]. Although there is probably not an access issue in Belgium, healthcare budgets under pressure are of considerable concern.…”

Section: Avenues and Recommendations To Increase Competition In Belgimentioning

confidence: 99%

Biosimilars in Belgium: a proposal for a more competitive market

Moorkens

Vulto

Huys

2020

Acta Clinica Belgica

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More than ten years after the first biosimilars were authorized for use in the European Union, Belgium still experiences limited competition from biosimilars, as exemplified by low market shares. Achieving high biosimilar market shares is not necessarily a goal in itself, as cost savings are also realized by mandatory price reductions on originator medicines in Belgium. However, we believe that biosimilars play a role in ensuring the long-term sustainability of the off-patent biologicals market. It is therefore crucial to list what has been done and what is needed to support the Belgian government in establishing a policy framework for a competitive offpatent biologicals market. We provide a comprehensive overview of the Belgian biosimilar market, including existing hurdles for biosimilar use in Belgium. Based on these hurdles and supplemented with learnings from other European countries, we propose practical recommendations that can be implemented to overcome them. Several Belgian stakeholders had the opportunity to comment on these recommendations. Specifically, we suggest to evolve towards a long-term consistent, integrated policy framework via i) the creation of a proactive and transparent climate supporting a level playing field for both biosimilar and reference product, including public dissemination of how savings at the level of the Belgian healthcare system are used, ii) investment in educational activities, including raising awareness of societal responsibility, iii) enforcement of the practical implementation of public procurement law, and iv) the development of incentives for physicians, who are key stakeholders in the Belgian offpatent biologicals market.

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“…The ‘consensus’ icon indicates that all stakeholders (physicians, payers, policy advisors, manufacturers, pharmacists, and patients) agreed on that point. Benefits, such as expanded access, have also been noted in the literature [ 9 ].…”

Section: Figurementioning

confidence: 99%

“…Thus, biosimilars are manufactured following the same strict standards of quality, safety, and efficacy observed for the reference product [ 5 , 7 ]; this is reflected in the development cost, which ranges from $100 to 300 million [ 8 ]. Biosimilars can broaden product choice and have the potential to reduce prices, whilst continuing to support a high standard of patient care [ 9 ]. In the United States, potential cost saving from switching from originator biologics to biosimilars is projected to be between $40 and 250 billion by 2025, and in Europe, cost savings are already estimated to be more than €10 billion [ 2 , 10 , 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review

et al. 2020

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Introduction: Biosimilars have the potential to enhance the sustainability of evolving health care systems. A sustainable biosimilars market requires all stakeholders to balance competition and supply chain security. However, there is significant variation in the policies for pricing, procurement, and use of biosimilars in the European Union. A modified Delphi process was conducted to achieve expert consensus on biosimilar market sustainability in Europe. Methods: The priorities of 11 stakeholders were explored in three stages: a brainstorming stage supported by a systematic literature review (SLR) and key materials identified by the participants; development and review of statements derived during brainstorming; and a facilitated roundtable discussion. Results: Participants argued that a sustainable biosimilar market must deliver tangible and transparent benefits to the health care system, while meeting the needs of all stakeholders. Key drivers of biosimilar market sustainability included: (i) competition is more effective than regulation; (ii) there should be incentives to ensure industry investment in biosimilar development and innovation; (iii) procurement processes must avoid monopolies and minimize market disruption; and (iv) principles for procurement should be defined by all stakeholders. However, findings from the SLR were limited, with significant gaps on the impact of different tender models on supply risks, savings, and sustainability. Conclusions: A sustainable biosimilar market means that all stakeholders benefit from appropriate and reliable access to biological therapies. Failure to care for biosimilar market sustainability may impoverish biosimilar development and offerings, eventually leading to increased cost for health care systems and patients, with fewer resources for innovation.

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Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!

Abstract: Biosimilar medicines have shown similarity with the originator biologic and offer a similar clinical

Cited by 91 publications

References 33 publications

Cost-effectiveness of hepatitis C virus screening, and subsequent monitoring or treatment among pregnant women in the Netherlands

Cost-effectiveness of hepatitis C virus screening, and subsequent monitoring or treatment among pregnant women in the Netherlands

Biosimilars in Belgium: a proposal for a more competitive market

Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review

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