This article first appeared in the Info-BioSim e-newsletter produced by Panacee Conseil Inc., April 2018.

With almost 40 biosimilars licensed over the past 12 years by the European Medicines Agency, it is safe to say the licensing pathway is well established. Hundreds of thousands of European patients are using biosimilars, and there has not been a single serious incident with any of them. Moreover, pharmacovigilance programs have shown that the risks involved in using biosimilars are no different than with the innovator products.

However, if we look at biosimilars in Europe, we see a large variation in the uptake of these low-cost alternatives to high-cost innovative biologics. The northwestern part of Europe (Scandinavia, United Kingdom, Germany, the Netherlands) have seen big cost reductions due to the use of biosimilars, while in the southern part of Europe the uptake is much lower, which raises the question: Why is that so?

In the Netherlands, hospital pharmacists and medical specialists joined forces to develop a “best practices” toolbox for the successful introduction of biosimilars. In creating this toolbox, we examined the kinds of approaches taken in various countries in Europe, and came up with four basic principles that are required to build a successful and competitive biosimilars environment at your institution.

1. A multi-stakeholder approach

Norway planned its transition from Remicade to an infliximab biosimilar very carefully over a period of more than a year. In that year all aspects of biosimilars were discussed with hospital management, medical doctors, pharmacists, and even lay persons (i.e., potential patients). This advance preparation generated strong support as the parties realized the potential for cost savings. However, there were still some outstanding questions (uncertainty) that needed to be addressed.

Out of that came the NorSwitch trial, which is considered a landmark study into the feasibility of switching patients, across a range of immunological diseases, from an innovator product to a biosimilar. This approach generated unprecedented support for the nationwide introduction of the infliximab biosimilar. The result was impressive—a tender discount of around 60% in comparison to the innovator—and subsequent uptake by doctors and patients was very rapid.

2. The “one voice” principle

It is critical that all healthcare staff be on the same page and convey the same message when talking to patients. Doctors who express opinions like “Management is forcing us to prescribe this cheap alternative” induce a negative perception of biosimilars among patients, subsequently leading to what is called the “nocebo effect.”

It is clear that there is a psychological component to patient outcomes, and this effect has been known for several decades. It can be seen in the power of the doctor’s words when informing a patient.

For example, in the NorSwitch trial, it was observed that physicians did not see any difference in objective disease parameters under treatment with the reference product or the biosimilar. However, patients perceived a disease worsening, which occurred in both (blinded) arms of the study. It was the expectation that an individual could be assigned to the biosimilar arm that induced this effect.

At the Maartens rheumatology clinic in the Netherlands, a similar situation occurred when transitioning patients from the originator product to the infliximab biosimilar. When investigating the matter, the medical staff learned of some of the negative expectations induced by small talk at the clinic, and it was decided to publish the proceedings of this investigation in full detail. In a subsequent transition from Enbrel to the etanercept biosimilar, the strategy was modified. All staff were trained about how best to inform patients, address questions, and avoid negative language.

In other words, “one voice” means that all healthcare staff should bring a single positive message to the patient about the new treatment option: “it is equally effective and more patients can be treated with the same budget”, which is a positive message, in contrast to the negative “cheap alternative” message.

3. Shared decision making

In Western Europe, and likely also in Canada, a real revolution has occurred in the role patients have assumed in taking responsibility for their own treatment. This can only happen if patients are well informed. We have learned that, in this way, patient empowerment may actually increase treatment effects. But at the same time, it could also be a passing fashion. Whatever it is, we have learned that it may be wise to inform patients about the nature of their drug treatment.

In starting a freshly diagnosed patient with a biosimilar, physicians generally do not encounter much opposition. In this situation, treatment with a biosimilar is as good as treatment with any other licensed medicine. But, when a patient is already undergoing treatment with a biologic innovator product, it is now common practice to inform them when transitioning begins to a biosimilar.

However, it is not easy to do this properly. Initially, Dutch patients got suspicious when they were briefed extensively on a change to a biosimilar. So, we reduced the level of detail when informing patients about transitioning.

The Dutch Medicines Board issued a special patient leaflet on biosimilars, explaining the various aspects of biosimilar treatment. In this way it is believed that patient empowerment will actually help patients and society alike.

4. Gain sharing

Gain sharing is the final component of a successful biosimilar policy. If a patient undergoing chronic treatment is switched to a biosimilar, there will be some financial benefit, but where do those savings go, and will the people who made it happen be rewarded in some way? Do the savings go to the medical department that initiates the change, the hospital drug budget, the hospital’s general budget, or do they simply disappear into the pockets of third party payers or insurance companies? This last option is not very rewarding for those who actually did the work.

A good example of gain sharing was described by the Department of Gastroenterology at Southampton University Hospital. The specialist who led the change, Dr. Fraser Cummings, negotiated with the commissioner of the National Health Service to have 50% of the savings reinvested in the department to improve medical care. In this way a strong incentive was created to accept biosimilars as a fully viable alternative in biologic treatment. In the meantime, this approach has been adopted in various countries across all sorts of institutions.

Conclusion

Introducing biosimilars is like setting up a project. When these four principles are followed, the odds of enjoying the full benefits of the savings are greater, and the situation with staff and patients is undeniably improved.