Adoption Across European Markets
Throughout Europe, payers are employing a range of tools to incentivize adoption of the anti-TNF biosimilars. These include a mix of tendering (similar to bid requests in the United States), a competitive bidding process designed to reward the party or parties offering the best prices; and prescribing targets (ie, goals for prescribing biosimilar treatments in a predetermined percentage of patients). Due to legal restrictions surrounding interchangeability, national guidelines recommend biosimilars in naive patients, while leaving most switching decisions to the prescriber. Regional and local protocols are more actively promoting switching in order to drive cost savings, and markets in Germany, Italy, and the United Kingdom are using prescribing quotas and targets to support this.
However, national authorities are becoming more proactive in supporting interchangeability. In the United Kingdom, the National Health Service (NHS) recently announced a biosimilar adoption framework whereby the idea of switching patients to a biosimilar will be inserted into clinical practice with incentive offerings for staff to offset switching costs. The NHS is projecting significant savings from this program, the goal of which is to have 90% of new patients prescribed the best value biologic with projected savings of £200 to £300 million by 2021.9 Some organizations are skeptical of these projected savings, as regional uptake and utilization of biosimilars varies significantly from region to region.
That variation can often be explained by the use of gain-share agreements, a mechanism whereby the budget holder (ie, the Clinical Commissioning Groups) split the cost savings with the provider (ie, the Hospital Trust). Unless a physician can benefit from the cost savings that biosimilars bring, there is no incentive to invest the time and effort involved in convincing the patient to switch.
Understanding these quirks in the system—and the incentives and disincentives that may exist—can be essential to unlocking the cost-saving potential for biosimilars. By way of example, in France, there is no direct incentive for physicians to prescribe subcutaneous anti-TNF biosimilars because these are funded via the retail channel, with no direct financial benefit to the hospital.
What to Expect in the United States
In the United States, attitudes of patients and physicians toward biosimilars will likely resemble what has been seen in the EU. Patients who are therapy-naive will be viewed, for the most part, as the best candidates for biosimilars. Depending on the disease state, switching stable patients will gradually become more acceptable. The speed with which this occurs will be driven by a multitude of factors such as regulatory guidance, financial incentives, the Centers for Medicare and Medicaid Services (CMS) reimbursement policies, and patient demand.
Initially, Food and Drug Administration (FDA) guidance will have the most impact regarding indication extrapolation. To the extent that this concept is well explained and accepted, uptake should be enhanced. The next influence from the FDA will be final guidance on interchangeability. How interchangeability will impact overall uptake is difficult to anticipate. Initially, manufacturers will have to decide whether they want to seek an interchangeability designation. This decision will be driven by the cost of achieving said designation as offset by expected sales increases as a result of a 12-month exclusivity period for the first manufacturer to gain interchangeability. The value of the interchangeability designation will also need to be balanced against the state laws that address biosimilar interchangeability; currently, approximately 35 states have passed legislation addressing biosimilars.10
Finally, the question of how the public and prescribers will view biosimilars without an interchangeable designation compared with those that will need to be considered. It is possible that those biosimilars not having the designation will be viewed as inferior to those that do. On the legal front, payers and prescribers may view biosimilars without the interchangeable designation as a potential risk if the patient has a negative outcome. Resolution of these issues will only come with time, but it is expected that the interchangeability designation will be viewed as differentiating and sought out by manufacturers.