Abstract
Biologic medicines have revolutionised the management of many serious diseases over the last three decades. However, the potential of biologic medicines has not been fully realised, as many patients who could benefit from these state-of-the-art treatments do not have real access to them.1,2
Biosimilar medicines – Benefits to all stakeholders
Biosimilar medicines, which are developed to be equivalent to the existing biologic medicines, provide an opportunity to significantly increase access to biologic medicines and thereby increasing the therapeutic options for physicians, both in terms of the number of patients who can be treated as well as considering them earlier in the treatment cycle when medically appropriate. For instance, following the entrance of biosimilar infliximab (reference product: Remicade®) in the UK, NICE, the body responsible for prescribing guidelines, now also recommended the use of infliximab in additional indications (e.g. for adults with non-radiographic axial spondyloarthritis) where it was previously not recommended due to cost constraints. Also, for filgrastim (reference product: Neupogen®), the launch of the biosimilar version led to NICE revising its treatment guidelines, and the use of filgrastim is now also recommended for primary prophylaxis of neutropenia, which triggered a significant increase in patient access through medically appropriate early treatment.
Biosimilar medicines thus present not only a high-quality and effective treatment alternative to their reference product. Through their competitive prices, they bring relief to highly pressured healthcare systems and afford a greater range of treatment options for doctors and patients.
Currently approved biosimilar medicines in the EU (1 February 2017)
Biosimilar medicines offer the potential to improve healthcare access and sustainability exponentially. Worldwide, biologic medicines with sales over $83 billion have lost or are expected to lose their protection by 2020. 3 Over 50 biosimilar products are currently in development and are expected to come to market in the next five years and could deliver estimated savings in the EU-5 and United States of between €49 billion and €98 billion. 4 This money could be reinvested to treat the 30–40% of patients in need in Europe and the United States that are currently denied access to biologic medicines.
Need for multi-stakeholder approach and healthy competition
To achieve the full potential of biosimilar medicines for doctors and patients, stakeholders need to work together to create a sustainable biosimilar medicines market in the long run. For this reason, the Biosimilar Medicines Group of Medicines for Europe commissioned Simon-Kucher & Partners to study the key enablers and success principles from both the payer and manufacturer perspective. Specifically, Simon-Kucher looked into the context of clinical use of biosimilar medicines, governance practices and their impact on the markets across a variety of healthcare systems in Europe (EU-5 + Norway and Poland).
The major challenge is to align both payer and manufacturer’s perspectives, as their respective definitions of a sustainable biosimilar medicines market can differ. From a biosimilar manufacturer perspective, a sustainable biosimilar medicines market is defined as ‘a predictable market supporting the co-existence of biosimilar manufacturers and a price-volume combination that enables continuous investment in further innovation’. From a payer perspective, a sustainable biosimilar market is defined as ‘a market in which biosimilar medicines create financial savings without jeopardizing the current treatment standards’. However, the biosimilar medicines market will only remain sustainable and generate continued benefits for all stakeholders in the future if manufacturer and payer perspectives meet.
Taking into account these perspectives, the report outlines several principles to create a sustainable biosimilar medicines market. The role of biosimilar medicines in the sustainability of healthcare system and in increasing patient access to state-of-the-art treatments will be amplified if healthcare systems adopt measures that encourage investment in the biosimilar sector.
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The following factors were identified as key enablers:
It is crucial that payers and biosimilar manufacturers work together to create a sustainable biosimilar medicines market so that the patients and healthcare professionals, as well as the payers and the biosimilar manufacturers, continue to reap the benefits of competition in the biologic medicines market. Continued benefits of biosimilar medicines over the long term will only be possible if there is healthy competition among manufacturers:
^ Limited changes to the pricing and market access policies over time reduce payer efforts and increase predictability for the industry. ^ Procurement practices should encourage multiple manufacturers to supply the market (e.g. multiple tender lots). Single-lot tenders increase the risk of supply disruptions. ^ Tender decisions go beyond the absolute lowest price and reflect a value-based approach, taking into consideration multiple influencing factors apart from price (e.g. supply guarantee, provision of education, value-added services, etc.). To maintain healthy competition, pricing and market access policies should enable a sustained market attractiveness from a combined manufacturer and payer perspective:
^ A balanced relationship between price erosion and clinical use of biosimilar medicines is needed. Policies enforcing lower biosimilar medicine prices compared to their originators have to be accompanied by specific guidance on biosimilar medicines use and prescribing incentives. ^ Unnecessarily aggressive pricing policies (as the savings from biosimilars tend to be cumulative over many years) will reduce competition in the long run and negatively impact the willingness of the industry to develop future biosimilar medicine competition. ^ Gainsharing models, in which the gains of increased use of biosimilar medicines are shared among the different stakeholders (e.g. prescribers, patients, payers and manufacturers), have proven to be a successful driver of clinical use of biosimilar medicines. ^ Physician education, communication and incentivizing are essential to ensure appropriate and cost-conscious prescribing.
With the right framework in place, biosimilar medicines can transform healthcare, by prioritising greater patient access to biologic medicines treatment and supporting the sustainability of healthcare systems in the long run. Aligning payer and manufacturer understanding of the short-, medium- and long-term benefits of biosimilar medicines is a cornerstone of sustainable biosimilar policy making. Gainsharing in particular has proven to be a successful driver of clinical use of biosimilar medicines,
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and policy makers, in collaboration with physicians and patients, should be encouraged to implement more of these programs.
Continuous efforts needed
With more than 10 years of treatment experience for over 20 products, we have seen first-hand the value biosimilar medicines provide to patients, physicians and healthcare systems. New biosimilar medicines offer an opportunity to significantly improve treatment access for millions of patients. However, if we would like to fully realise this opportunity, now is the time for action. Patients, physicians, payers and industry have to work together and increase their efforts to develop a sustainable biosimilar medicines market. Working in partnership and alignment on short and long-term benefits of biosimilar medicines will we be essential to ensure that all stakeholders continue to enjoy the incredible opportunities afforded by biosimilar medicines.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.