Biologicals and Biosimilars in Hematology: The Case of Rituximab

Vulto, Arnold G.

doi:10.1097/hs9.0000000000000322

Cited by 8 publications

(13 citation statements)

References 23 publications

(45 reference statements)

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“…By helping to drive down the prices of the reference biologics themselves, as well as across product classes, the overall pricing impact of biosimilars is significant and likely to increase. 12 , 13 …”

Section: Solutionsmentioning

confidence: 99%

Fair Pricing of Innovative Medicines: An EHA Position Paper

et al. 2020

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High prices keep innovative medicines out of reach for many patients across Europe, resulting in growing inequalities in accessibility and standards of care. Budgetary pressures compel payers and insurers to make increasingly difficult choices, at the expense of patients and investment in innovation. Costly new therapies become available only for the lucky few -or for no one in those countries that lack the purchasing power or are left out of manufacturers' marketing strategies altogether. With expensive combination therapies adding to the problem, the potential of scientific and medical innovation remains underused, not least in hematology. By severely limiting the uptake of novel gene and cell therapies, high prices are undercutting efforts to increase, personalize and optimize treatment options for patients suffering from blood disorders. 1 CausesHigh prices result from a complex set of interrelated factors. Causes can roughly be divided into three categories: Business modelsManufacturers are primarily driven by the need to recoup the costs of research and development-of products that eventually make it onto the market and of those that don't-and by a desire to offer substantial return on investment to investors. In a system that rewards patent rights with market exclusivity and which obscures R&D costs, price-setting and profit levels, bringing a profitable drug to market continues to be the main incentive, not the patient and public interest. Market accessThe authorization of drugs for the European market is based exclusively on criteria of safety and efficacy. As long as these are not supplemented by affordability, added-value and quality-of-life criteria, profit-driven development will prevail over models that put the patient and public interest first.

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Section: Solutionsmentioning

confidence: 99%

Fair Pricing of Innovative Medicines: An EHA Position Paper

et al. 2020

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“…One should also look at the benefits in terms of cost reduction and increase in access to necessary biological therapies, resulting from a competitive market. Because increased competition due to biosimilar market entry may also induce price reductions of the reference product, or even competing products within the same or other therapeutic classes, both biosimilar and original biological products may contribute to these benefits (Vulto, 2019a). As a result, the term best-value biological is to be preferred instead of biosimilar or original biological.…”

Section: Introductionmentioning

confidence: 99%

Off-Patent Biological and Biosimilar Medicines in Belgium: A Market Landscape Analysis

et al. 2021

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Background and objective: Best-value biological medicines may generate competition in the off-patent biologicals market, resulting in having more resources available to provide patients with access to necessary medicines while maintaining high-quality care. Belgium is a country known to have low biosimilar market shares, suggesting a malfunctioning market for off-patent biologicals. This study aims to gain an in-depth understanding of the Belgian off-patent biologicals market, by looking at the evolution in volumes and costs of the relevant products in the market.Methods: This study included a combination of quantitative and qualitative research methods. The quantitative part of this study consisted of the analysis of market data obtained by the National Institute for Health and Disability Insurance (NIHDI) for all relevant products in the Belgian off-patent biologicals market (i.e. TNF-inhibitors, insulins, granulocyte colony-stimulating factors, epoetins, rituximab, trastuzumab). In addition, for the qualitative part of this study, semi-structured interviews with Belgian stakeholders were conducted between December 2019 and March 2020.Results: Belgian market data and stakeholder perceptions suggest a suboptimal market environment for off-patent biological and biosimilar medicines. Shifts are observed after loss of exclusivities of originator biologicals toward second-generation products or new therapeutic class products, at a higher cost and often limited added value. Moreover, cost reductions for off-patent biologicals after biosimilar market entry are mainly determined by mandatory price reductions applicable to both originator and biosimilar products, and not by lower prices induced by competition. For products used in the retail setting, significant mandatory price reductions for both originator and reference products with low biosimilar volumes were pointed out as the main reasons for the lack of price competition. For products dispensed in hospitals, the hospital financing system is important. First, it does not always encourage the use of lower cost alternatives. Second, competition mainly takes place at the level of confidential discounts in tenders. Most interviewees acknowledged the lack of a competitive environment, which is not supportive of a sustainable Belgian off-patent biologicals market.Conclusion: Market data and stakeholder perceptions indicate that the sustainability of the Belgian market for off-patent biologicals is challenged. A sustainable market ensures access to biological therapies now and in the future.

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“…Also, marketing authorization frameworks, pricing and reimbursement regulation, and biosimilar policies vary between countries [5,6]. Examples relate to a variety of products given that market dynamics differ between classes of biosimilars (and biologics) depending on, for example, product features, observability of effect, duration of clinical experience, and use in supportive or therapeutic care [7].…”

Section: Introductionmentioning

confidence: 99%

A health economic guide to market access of biosimilars

Simoens

Vulto

2021

Expert Opinion on Biological Therapy

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Introduction:Little is known about market access to biosimilars from a health economic perspective, except for studies that compute the budget impact of biosimilar use.Areas covered: This comprehensive health economic guide to the market access of biosimilars focuses on the role of biosimilars in pharmaceutical innovation and competition, the objective of biopharmaceutical policy, the budget impact of biosimilars, and the cost-effectiveness of biologic therapy in the presence of biosimilars. Expert opinion: We argue that the objective of biopharmaceutical policy in a health system should be to create a competitive and sustainable market for off-patent reference biologics, biosimilars, and nextgeneration biologics that makes biologic therapy available to patients at the lowest cost. Market access of biosimilars can contribute to this objective as a result of the lower price of biosimilars and price competition with alternative therapies. The resulting improvement in the cost-effectiveness of biologic therapy needs to be accounted for by revisiting reimbursement decisions and conditions. When examining the cost-effectiveness of biologic therapy following patent expiry, stakeholders need to consider residual uncertainties at the time of biosimilar marketing authorization, the nocebo effect, market entry of a second-generation reference biologic with a different administration form than the biosimilar, and value-added services.

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Biologicals and Biosimilars in Hematology: The Case of Rituximab

Cited by 8 publications

References 23 publications

Fair Pricing of Innovative Medicines: An EHA Position Paper

Fair Pricing of Innovative Medicines: An EHA Position Paper

Off-Patent Biological and Biosimilar Medicines in Belgium: A Market Landscape Analysis

A health economic guide to market access of biosimilars

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