Policy Recommendations for Improving Biosimilar Uptake in Belgium

Increasing the use of biosimilars in Belgium will require realigning financial incentives and providing more information to medical professionals, according to authors of a study that proposed policy recommendations.

They said that biosimilar uptake and competition “continues to lag behind” in Belgium compared to other countries in Europe, due to a lack of structured biosimilar introduction or switching plans. “Policies to ensure a sustainable off-patent [biologics] climate, with sustainable competition from biosimilars, are currently missing in Belgium,” they wrote.

Their study aimed to develop recommendations to inform biosimilar policy making in Belgium, especially on switching, using structured discussions between health care professional stakeholders. The 13 physician specialists and hospital pharmacists who participated in discussion groups “voiced challenges with the use of biosimilars and switching in practice, and a lack of incentives to use them.”

Belgium’s current system, according to the authors, is “mainly built on generating short-term savings through mandatory price decreases of the originator product.” This may disincentivize biosimilars and limit market entry of new biosimilar products over the long term, they warned.

Physician specialists and hospital pharmacists involved in purchasing, prescribing, switching and dispensing biologics, from university and regional hospitals across different geographical areas were invited to participate. Policy recommendations were developed and then graded by priority in 3 in-person group discussions, each involving 3 to 6 participants.

Policy Recommendations

Six areas for policy development were identified, and specific consensus-based recommendations were developed for each. Additionally, principles for switch management were generated.

1. Address stakeholder hesitations regarding the safety of (multiple) switching

Participants “largely expressed to be sufficiently assured” that switching from a reference product to a biosimilar is safe. However “they indicated that this was not always the case for their peers.” There is hesitation among health care professionals especially regarding multiple switches, according to the participants.

There was strong consensus that clear and transparent position statements on interchangeability, switching and multiple switching are needed from both the Belgian Federal Agency for Medicines and Health Products (FAMHP) and professional medical and scientific associations. Although FAMHP has released a supportive statement regarding switching, the authors said, “some participants requested a more explicit and detailed guiding statement which includes information about multiple switching and guidance on which measures to consider when conducting such a switch.”

To “instill further trust” in biosimilars and “overcome hesitations” among stakeholders, the proactive sharing of switch experiences between hospitals and active communication of clinical switch data to health care professionals were proposed. There was also moderate consensus that additional data on long-term outcomes of switching and on multiple switching is needed.

2. Guiding healthcare professionals with product decision-making

There was strong consensus among participants that greater awareness about cost-effective prescribing is necessary for health care professionals.

Participants believed the government should support hospitals in their tender organization process by communicating anticipated biosimilar market entry dates and providing guidance on appropriate tender criteria for off-patent biologics and biosimilars.

Participants also recommended with high consensus reforming the hospital financing system “to make hospitals less financially dependent on the revenue generated from discounts in pharmaceutical product procurement.” The current system, according to the authors, incentivizes hospitals to choose products with high list prices.

In the ambulatory care setting, there was moderate consensus that prescription guidelines or treatment decision trees should be developed to promote cost-effective prescribing, as they believed “price is not routinely taken into account” by prescribers.

3. Provide meaningful incentives for involved stakeholders

The authors found that, despite their overall confidence in biosimilars, participants believed there is “a clear lack of motivation and incentives” for health care professionals to choose biosimilars for their patients. Overall, they perceived a lack of benefits for patients, prescribers, and payers, leading to limited motivation to switch a patient who is currently being treated with a reference biologic. Participants felt they were not informed about the actual amount of savings associated with biosimilars, and with strong consensus, expressed a need for transparent reporting about the savings derived from biosimilar use and how those savings are allocated.

Gainsharing programs for hospital and ambulatory care centers and patient-level incentives at the ambulatory care level, such as lowering the patient’s co-payment for biosimilars, were also suggested with moderate consensus.

4. Align practical product differences to the extent possible

Participants pointed out that in some cases, there are differences between reference products and their biosimilars regarding approved indications, reimbursement, and medical need programs, and these differences may complicate the choice to prescribe a biosimilar. They recommended aligning and eliminating these differences where possible, “to ensure a level playing field between reference and biosimilar product.” In particular, aligning reimbursement conditions was considered a high-priority recommendation by the participants.

5. Involving health care professionals in policy making

With moderate consensus, participants thought that involving health care professional stakeholders in policy making on biosimilars, such as in incentive design, could help increase support for policies, align policies with physician perspectives, and lead to the development of measures that could improve patient care.

6.Providing practical switch support and patient information material, especially in the ambulatory setting and for subcutaneous products

Participants noted a lack of practical, non-industry sponsored information and guidance for switch management and patient communication, and recommended with strong consensus that these materials be made available. This was considered a high priority recommendation. With moderate consensus, they said these materials were especially needed to support health care professionals managing a switch to a self-administered, subcutaneous biosimilar product in the ambulatory setting.

Also, there was strong consensus that educational materials should be made available not only to specialists and hospital pharmacists but to community pharmacists and general practitioners, since biosimilars for some molecules—such as insulin, adalimumab, and etanercept—are becoming available in community pharmacies.

Principles for Switch Management

In addition to policy recommendations, participants developed a list of principles they considered important when planning a switch. These included: following a structured switch plan; providing an opportunity prior to the switch for the patient to discuss with a physician or nurse; to assess the information need of the individual patient but generally keep patient information simple; educating and training staff about general concepts of biosimilars and the switch process; involving patients in decision-making for self-administered subcutaneous products; framing the switch positively with a focus on the equality of the treatments; and finally, allowing for the possibility that a patient will object to the switch.

According to the authors, their study “advances a set of concrete policy recommendations” that will help Belgium to promote biosimilar market entry, incentivize biosimilar uptake, create sustainable competition in the off-patient biologics market, and support health care professionals with switch management.

Reference

Barbier L, Simoens S, Declerck P, Vulto AG, Huys I. Biosimilar use and switching in Belgium: Avenues for integrated policymaking. Front Pharmacol. 2022;13:821616. doi:10.3389/fphar.2022.821616