Europeans Devise Checklist for Promoting Biosimilar Use

Investigators derived a set of recommendations for improving biosimilar use from 44 interviews with physicians, hospital pharmacists, nurses, patients (or their representatives), and regulators across Europe.

According to the authors, both health care professionals and patients are reluctant to switch from reference products to biosimilars “because of a lack of trust in and understanding of [biosimilars].”

Their recommendations ranged from individual clinician behaviors to national policies. The recommendations addressed how to implement a switch, minimize the nocebo effect following a switch, communicate with patients about biosimilars, and appropriately incentivize health care professionals to prescribe biosimilars.

Switching Patients Safely

The health care professionals interviewed broadly agreed, based on the available data, that patients can be safely switched to biosimilars. However, some patients “requested studies over a longer timeframe to better evaluate the long-term effects of switching.”

Stakeholders preferred a structured and collaborative approach when implementing a switch, citing the need for a clear European regulatory position on interchangeability and switching, along with guidance on multiple switching.

Stakeholders generally opposed forced switching. According to the authors, “forcing a switch was believed to be counterproductive and could result in distrust of biosimilars.”

Patients favored starting only biologic-naïve patients on biosimilars. Health care professionals agreed this was appropriate in some circumstances, such as shorter treatment periods.

Minimizing the Nocebo Effect

Although the majority of studies on switching have not reported any major safety, efficacy, or immunogenicity issues, use of biosimilars is sometimes discontinued by patients who perceive problems. The authors noted, “a number of real-world studies have reported a relatively high therapy discontinuation rate among patients after switching, which was mostly attributed to the occurrence of the nocebo effect.”

Most stakeholders considered physician confidence essential to minimizing the nocebo effect. One interviewee commented, “the patient is confident when the physician is confident.”

Although most health care professionals thought patients should not be involved in making the decision to switch, some reasoned involving the patient in the decision-making process would “reduce reluctance, avoid nocebo effects, and build trust.”

Some regulators suggested that clinicians and patients be informed that biosimilars “are only authorized if their efficacy and safety profiles are shown to be equal to those of the reference product.”

Communicating With the Patient

Overall, health care professionals said they have a difficult time determining the appropriate amount and type of information to provide to patients. Tailoring the communication to each individual patient was considered important.

Several nurses stressed that communication should not be complicated. Health care professionals overall agreed that communication should focus on “explaining that the biosimilar is equally as safe and effective as the reference product and that patients may expect the same outcomes.” One nurse, speaking of her experience of working with patients who were switched to a filgrastim biosimilar, said, “as it was communicated that the product had all the same side effects and the same precautions were needed, there was no big deal about it.”

Similarly, some stakeholders argued that putting too much emphasis on the switch and spending too much time discussing the switch could unintentionally cause the patient to worry and trigger a nocebo effect.

Several interviewees stressed the importance of taking patient concerns seriously. They commented on the sensitive nature of switching a patient away from a drug that had brought them into remission from a serious disease.

Patients pointed out that cost savings are a motivator only for some patients. According to the authors, “the willingness to switch may be greater in settings where these medicines are only partly reimbursed.” Other stakeholders stressed, the authors said, “it should be made clear to the patient that less expensive does not equal inferior.”

Physicians and pharmacists also voiced concern that the benefits of biosimilar use are an important motivator, but often are not communicated clearly.

Pharmacist Substitution

Most physicians and pharmacists favored substitution at the pharmacy level, provided the physician is informed about it. Patients also favored pharmacy substitution, given that the patient is told. Physicians generally opposed automatic substitution. They wanted to be able to know which product the patient received when a problem arises. The nocebo effect was also a concern. The authors said, “this study found that stakeholders are concerned about mandated switching, as this may result in worse patient-perceived treatment outcomes because of a possible nocebo effect.”

Appropriate Incentives

Several regulators, physicians, and pharmacists agreed drugs should be used in a cost-effective manner for the common good. However, physicians also noted the substantial time and effort required to switch a patient from a reference product to its biosimilar may discourage prescription of biosimilars.

Most physicians and nurses and some regulators viewed tangible incentives as appropriate but direct financial benefits as inappropriate. The idea of gainsharing, allocating biosimilar savings toward improving patient care, was embraced by most interviewees as a positive motivator, because “savings could partially serve to improve local clinical care.” Some examples of gainsharing mentioned were financial support for a hospital ward, hiring new staff, or reinvesting biosimilar savings to enhance monitoring of patients.

Recommendations

The investigators concluded with 11 key recommendations derived from their interviews:

Addressing health care professionals’ needs regarding switching and biosimilar use

• Communicate about study results and clinical experience on switching.
• Express a clear, consistent EU regulatory position on biosimialr interchangeability.
• Develop a multistakeholder protocol to guide switching in clinical practice.
• Develop tangible and intangible incentives for stakeholders to use biosimilars.

Recommendations regarding switching decisions

• Apply a pragmatic switch approach.
• Avoid mandatory switching but allow communication between stakeholders.

Recommendations for long-term sustainable competition with a biosimilar presence

• Raise awareness about drug prices and societal responsibility to prescribe and use drugs cost-effectively.
• Actively and publicly communicate the benefits of biosimilar use.
• Share biosimilar uptake and prescribing data “to allow peer-to-peer benchmarking.”
• Report the savings allocation from biosimilar use transparently.
• Develop policies with a long-term vision beyond short-term cost savings.

Reference

Barbier L, Simoens S, Vulto AG, Huys I. European stakeholder learnings regarding biosimilars: part II–improving biosimilar use in clinical practice. BioDrugs. Published online October 15, 2020 Oct 15. doi:10.1007/s40259-020-00440-z