The Need for and Realities of Biosimilars in Generating Health System Savings

The Biosimilars Commercialisation Summit 2019 is held under Chatham House Rules, which stipulate that speakers cannot be identified.

During the Biosimilars Commercialisation Summit 2019, held May 14-15 in Amsterdam, the Netherlands, among the key topics of discussion was the sustainability of the world’s healthcare systems and the need to create savings in order to continue to advance the treatment of cancer and chronic diseases.

In an opening presentation, a European oncologist said that the world of disease is changing into an era in which noncommunicable disease is dominant, and patients will require treatment with greater activity and less toxicity. The United Kingdom alone expects a 29% rise in the incidence of diabetes by 2025, as well as a doubling of the incidence of arthritis by 2030. Precision medicine means, he said, that in the future, rheumatoid arthritis may be divided into as many as 10 different disease states, each with a targeted treatment approach.

Yet, as medicine begins to rely further on biologics, he said, it will be necessary to control costs. The median cost of a cancer biologic in 2017 was US $150,000 for the UK system, he said, and at his hospital, providers were asked to find a 4% cost savings in their drug budget despite rising costs.

Furthermore, as has been demonstrated in various studies, patient access correlates strongly with the wealth of individual countries, and access to much-needed biologics remains a struggle for patients in low-resource nations. In fact, only 2 European countries—Germany and the United Kingdom—typically have access to 70% or more of innovative cancer medicines within 2 years of launch. Even in wealthy countries, of course, cost can limit patient access; in the United States, 20.5% of patients, he said, abandon therapy with brand-name prescriptions, largely due to cost constraints.

These facts, taken together, suggest that there is a global market to be gained for those who can deliver biologics at an affordable price, and that such cost-saving products will be crucial to create headroom for innovation by providing savings that do not compromise care.

In a separate talk, a pharmaceutical executive for a biosimilar development company indicated that biosimilars have begun to deliver on the promise of access to therapy. He pointed to experience with biosimilar filgrastim, saying that “the driver is not lowering the cost and treating the same number of patients. That is not the inspiration” for the company’s product.

Instead, he said, the biosimilar allowed for substantially increased use of filgrastim for the prophylaxis of chemotherapy-induced neutropenia. Since the biosimilar became available, he said, Austria’s filgrastim use has increased by 185%, Italy’s by 222%, Bulgaria’s by 390%, Hungary’s by 429%, and Slovakia’s by 515%. High-quality competition with the originator product, he indicated, has been the key to creating the price reductions that have led to this patient access.

Another pharmaceutical executive from a biosimilar development company, in his own presentation, tempered some enthusiasm about the savings provided by biosimilars, however.

He indicated that, in speaking with European clinicians who work in healthcare systems that have adopted biosimilars, physicians have suggested that their hospitals and centers do not necessarily see a clear benefit from biosimilar savings. Instead, the benefits are absorbed into other areas of the larger health system, and direct patient benefits are not always easy to identify.

This lack of transparency, he suggested, breeds a lack of trust among some clinicians who might be asked to adopt biosimilars. In the northern region of Europe, he said, physicians have been more willing to adopt biosimilars than their colleagues in the southern region. In countries with robust and clear policy related to biosimilars and how they will be used within the health system to generate savings, it is easier to gain these clinicians’ trust.

However, where there is a lack of policy and transparency, physicians lack an incentive to change their prescribing habits. He cited Spain as an example of a country where physicians have not had a large role in forming national policies, and where these physicians have become wary of biosimilars because they have had such a limited role in the wider conversation about biosimilars’ role in creating sustainability.

European countries are starting, however, to assess one another’s policies and attempt to replicate useful approaches, he indicated. The United Kingdom’s approach to implementing biosimilar adalimumab into the National Health Service, for example, mirrors Denmark’s approach in some aspects of its tender system, and it is possible that other nations will follow in the same pattern as they seek to replicate Denmark’s biosimilars successes.