Biosimilar Policies Research Articles

PHP52 - Biosimilar Infliximab Utilization After Patent Expiry: The Case of Colitis Ulcerosa and Rheumatoid Arthritis in Hungary

The importance of biosimilars is increasing as more and more biologicals with significant budget impact are going to lose market exclusivity in upcoming years. Due to expected price erosion, decision makers can improve the allocative efficiency of scarce resources by increasing the utilisation of biosimilars. This study aims to evaluate the impact of the Hungarian reimbursement policy on the uptake of biosimilar infliximab, the first monoclonal antibody (mAB) infliximab with patent expiry in 2013. The utilization of biologicals were analysed retrospectively on individual patient-level data between 2013-2016 provided by the National Institute of Health Insurance Fund Management (NIHIFM). We aggregated patient numbers on mABs, and analysed the initial therapy of new patients and switching rates between mABs in colitis ulcerosa (CU) and rheumatoid arthritis (RA). Data shows that overall market share of biosimilar infliximab in CU increased after patent expiry (33.7%), while in RA it remained marginal (0.2%) by the end of 2016. Compared to other single source biologicals the proportion of new CU and RA patients on infliximab were 50.9% and 2.5%, respectively, all these patients were started on biosimilars. During the study period 25% of CU patients with therapy switch from adalimumab to infliximab were switched to the original product and 75% of the patients were switched to the biosimilar alternative. Majority of RA patients were switched between seven patented active substances and only few patients were switched to multisource infliximab (1.6%). In Hungary the current biosimilar policy shows mixed results in incentivizing the increased uptake of multisource biologicals. Although new patients treated with infliximab started on biosimilars, but majority of RA patient started on other patented products. Policy tools and measures should be developed by the NIHIFM to facilitate biosimilar use, including single switch to biosimilars, and monitor outcomes.

Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts.

This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.

Policies for biosimilar uptake in Europe: An overview.

BackgroundAcross European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.ObjectivesThe aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake.MethodsAn overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake.ResultsIn all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution.ConclusionsMost countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Supply-side and demand-side policies for biosimilars: an overview in 10 European member states

ABSTRACTObjective: This study aimed to provide an overview of biosimilar policies in 10 EU MSs.Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries.Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries. Regarding demand-side policies, pharmaceutical prescription budgets or quotas and monitoring of prescriptions (with potential financial incentives or penalties) are in place in eight and in seven countries respectively. Switching is generally allowed, but is solely the physician’s responsibility. Automatic substitution is not recommended, or even forbidden, in most EU MSs. Prescription conditions or guidelines that apply to biosimilars are established in nearly all surveyed EU MSs.Conclusions: Important heterogeneity in policies on biosimilars was seen between (and even within) selected countries, which may partly explain variations in biosimilar uptake. Supply-side policies targeting price have been reported to limit biosimilar penetration in the long term, despite short-term savings, while demand-side policies are considered to positively impact uptake.

Policy Practices to Maximise Social Benefit from Biosimilars

Biosimilar medicines can generate savings to the society. However, if patient access to original biologic medicines is limited, the main benefit of biosimilar medicines is to treat more patients from the same health care budget and hence generate more health gain. The aim of this policy paper is to provide recommendations on how to maximise the value proposition of biosimilar medicines in lower income countries with more limited health care resources. From the clinical perspective, first line use of multi-source, off-patent biologics should be considered for all treatment naive patients before prescribing any other patented biologic therapies without major added benefit. Systematic literature reviews indicate that significant and quantifiable economic benefits from switching patients on maintenance biologic to biosimilars should not be sacrificed for non-quantifiable and fairly low risks of immunogenicity, hence a single switch of patients from an original biologic to its biosimilar alternative under medical supervision should be mandated after patent expiry. From the health economic perspective authors advocate the use of cost-utility analysis to evaluate the full economic value of biosimilars. In sensitivity analyses decision-makers can explore the level of risk associated with immunogenicity, where switch of patients treated by original biologics is not the preferred policy approach anymore. However, authors still advocate the collection of real world pharmacovigilance data after switching patients to biosimilars, and reassessment of cost-effectiveness ratio after more real-world data becomes available. Appropriateness of biosimilar drug policies is equally important to market access of new biologic therapies in lower income countries.

PHP321 - Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

The European Union Member States (EU MS) are seeking for effective cost-containment measures to ensure sustainability of health care systems. With growing budget impact of costly biologic medicines, biosimilar promises for health care cost-savings are thoroughly scrutinised by payers. This study aimed to provide an overview of biosimilar policies implemented in selected EU MS. Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden and UK) were selected. A comprehensive review of the literature was performed to identify publications describing 1) supply-side policies and 2) demand-side policies in place in the selected countries through Medline, Embase, Cochrane library databases, GaBi, ISPOR and HTAi websites, National Health Authorities websites and grey literature. 1) Supply-side policies for biosimilars: price linkage and tendering were common practices in almost all countries, while pricing through internal or external reference pricing was more scattered between countries; health technology assessment was reported to be conducted in six countries. 2) Demand-side policies for biosimilars: six countries reported different approaches to control biosimilar prescription through pharmaceutical prescription budgets and/or prescription quotas, sometimes applying financial incentives or penalties measures. Except for Poland, switching and automatic substitution are generally not recommended, and decisions lie with physician’s responsibility; despite not being enforced, France was the first EU MS which legislated biosimilar substitution for naïve patients. Patient co-payment system is in place in all countries; specific co-payment systems to favor use of the cheaper treatment are reported in some countries. Education and information tools retrieved for biosimilars did not generally target a specific audience. Important heterogeneity was seen between (even within) selected countries in policies towards biosimilars; information was generally scarce on educative measures implemented to enhance biosimilar adoption by different stakeholders. This heterogeneity might contribute to explain differences in biosimilar uptakes reported across EU MS.

The Impact of the Entry of Biosimilars: Evidence from Europe

Biologic drugs (therapeutic proteins or “large-molecule drugs”) represent large and growing share of all drug spending in the United States, accounting for less than 1% of prescriptions filled but nearly 28% of drug spending. Whereas traditional (chemically-synthesized, “small-molecule”) drugs have historically faced price competition from generic drugs after patent expiration, biosimilars – biologic drugs that have been shown to be therapeutically equivalent to an already approved original biologic drug – have only been approved in the United States since 2015. Europe has had biosimilar entry since 2006. This paper considers how competition from biosimilars may impact the U.S. biosimilar market by examining data from the first eight years of biosimilar competition in 23 European countries. A major contribution of this project is the completion of a detailed survey, allowing us to precisely characterize European biologic drug procurement institutions over time. Using data from three classes of biosimilar drugs, we analyze how market features and public policies predict entry, market prices, and penetration of biosimilars. We find significant heterogeneity across countries and drug classes in all of these outcomes. While we observe that effective buyer institutions (in particular, committed tenders) are associated with increased biosimilar entry and penetration, price patterns are more difficult to glean from the available data. Our estimates can inform ongoing policy discussions on both sides of the Atlantic about the economic implications of biosimilar policies.

Biosimilar substitution policies vary between countries

Biosimilar substitution policies vary between countries

Biosimilars and Emerging Markets: Historical and Bioethical Considerations

There is not a more fundamental or personal topic than healthcare. In fact, the durability of this statement is proven across cultures, races, economies, and geopolitical boundaries. Healthcare captures the notion of well-being; a sense of being free from pain and the notion of normalcy in society. Irrespective of the methods and operational minutiae of global drug regulators, on a basic level, all share the common goal of ensuring that the healthcare needs of those they serve are being met. This goal is elusive, though, being often unfulfilled. Unfortunately, rather than being rooted in science and compassion, healthcare often becomes a function of economy and circumstance; leaving a trail of ethical principles in the wake of its shortcomings. A common denominator across all governments is the challenge of managing healthcare systems for maximum utility while controlling costs. Today, these governments are being given a new tool to maximize the effectiveness of their healthcare systems, the biosimilar. The seemingly simple concept of creating a cost-effective, similar complex recombinant antibody has become a topic for both scientific and public debate. The intent of this paper is to provide an overview of different forces shaping biosimilar policy in the traditional emerging market countries focusing on related bioethical issues.