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Institute Report
Spotlight on Biosimilars
Optimising the Sustainability of Healthcare Systems
Jun 24, 2021
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About the Report

The global biologic medicines market is a growing and increasingly important portion of pharmaceutical expenditure for countries and managing this becomes a necessary part of sustainable healthcare systems. The concept of ‘biosimilar sustainability’ has therefore become increasingly important for all stakeholders to understand. This report highlights examples of the benefits biosimilar competition can create as well as how these benefits can be unlocked through optimisation. In this report, the sustainability of the biosimilars marketplace was assessed across a set of five European countries with a broad spectrum of systems and approaches.

Report Summary

In this report, countries benefit from an independent view on the current system. To date, countries have made progress toward sustainable practises in many markets. However, our study of these markets revealed the following three themes as the most common hurdles to biosimilar sustainability: unsustainable purchasing policies for the procurement of biologics; limited tangible benefits offered to prescribers to encourage the use of biosimilars; and lack of physician and patient education on biosimilars. Although many of the best practice approaches that support biosimilar sustainability are already present somewhere in Europe, they are not consistently implemented in every country. As each country has a unique policy footprint and has started from different positions, the journey toward a sustainable market is different for each individual market. It is in the best interests of all stakeholders to learn from the issues that have arisen, gather perspectives from other countries, and implement targeted approaches for their individual markets that will work into the future to optimise the system and unlock the full benefits of biosimilars.

Key exhibits

Definition of ‘Biosimilar Sustainability’

  • ‘Sustainability’ in a healthcare context is a journey in which, ideally, all stakeholders within a market can function effectively. It is the creation of a system that benefits all stakeholders, focussing on the patient, and ultimately ensures the longevity of a system.
  • The concept of ‘biosimilar sustainability’ was advanced in 2018 as an approach to deliver on the promise of biosimilars. They can balance pharmaceutical spending, unlock savings for future innovation, and ultimately improve access to biologic therapies  through competition.
  • Experts - from policymakers to clinicians - agree with the definition and mention the necessity to emphasise the high quality of biosimilars and achievable savings, and often highlighting that authorities and payers are focused mostly on savings, with other factors (patient access, level of supply) being less of a priority.
  • The long-term sustainability of a marketplace is an important concept to understand for all stakeholders in the healthcare system, given the increasing importance of biologics and of leveraging biosimilar competition.

 

Criteria for a sustainable market

  • Reviewing the healthcare systems across the individual elements of the ‘Biosimilar Sustainability Assessment Framework’ shows areas that have a positive improvement or pose a potential risk to sustainability.
  • By working closely with experts in each of the chosen countries and regions, we were able to highlight examples of sustainable practises within their systems. The report focuses on the positives, highlighting examples of best practise and policy hurdles using the framework below.
  • Each country has a unique policy footprint and has started from different positions. The journey to a sustainable market is therefore different for each country, but using this approach highlights the common opportunities to optimise the system and unlock the benefits.
  • A deep dive on these countries and regions is provided in the appendix of the report to provide some example of markets studied.

 

Herfindahl-Hirschman Index of Market Concentration (ordered by date of biosimilar entry)

  • For the countries in scope, low levels of competition can often be a consequence of other issues rather than a cause. While historic perspectives on biosimilars have focussed on key performance indicators dedicated to uptake curves and market share, increasingly our approach has been updated to focus on ‘level of competition.’
  • A comparative analysis using Sweden viewed single and multi-winner tenders and found that multiple-winner tenders may result in lower average net molecule costs per defined daily dose (DDD) for a region overall. Cost savings occur since price reductions are obtained on all contracted products (often including the originator) in multiple-winner tenders rather than only on one product in single-tender winner scenarios. Multi-winner tenders also keep multiple manufacturers actively engaged, commonly reduce prices of all winning brands, respect physician’s choice, and enable patient continuation on current treatment.
  • In a sustainable market, originators can continue to play a role alongside biosimilars. However, originators may have high market share due to several non-sustainable reasons: reluctance of HCPs (lacking education, awareness or clear evidence for biosimilars safety and quality), key opinion leaders sticking to originators in some regions, novel route of administration introduced, or simply due to high competition in some regions with high volumes available.
  • Those with unsustainable practises will not be able to achieve long-term savings through continued competition.

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