There remain many uncertainties and questions around the success of these agents. It is therefore critical for sponsors and other stakeholders to consider some of the potential hurdles and policy shifts facing anticancer biosimilar uptake and ultimately reimbursement in the United States.
The biosimilar field is set to become more crowded in 2019, as multiple anticancer products enter the US market. Anticancer agents like Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) are among the most utilized in oncology, and a landscape shift is anticipated with the entrance of their biosimilars. Just recently, Amgen and Allergan launched the first anticancer biosimilars: Mvasi (bevacizumab) and Kanjinti (trastuzumab). Other FDA-approved biosimilars include the trastuzumab products Ontruzant, Trazimera, Herzuma, and Ogivri, as well as the rituximab biosimilars Truxima and Ruxience, and the bevacizumab biosimilar Zirabev.
Though knowledge around biosimilars has increased over the years, the oncology space is still new to this class of drugs. There remain many uncertainties and questions around the success of these agents. It is therefore critical for sponsors and other stakeholders to consider some of the potential hurdles and policy shifts facing anticancer biosimilar uptake and ultimately reimbursement in the United States.
We have witnessed a slow uptake of immunology biosimilars across the United States, especially when compared to EU counterparts, where at the forefront of biosimilar acceptance has been stakeholder education. To facilitate provider acceptance of anticancer biosimilars, consistent education on the value of these agents must be delivered.
Patient Support Programs
In a class of drugs where a “better price” has been the key rationale for use, what level of differentiation can patient support programs bring? Are patient support programs/hub programs a must-have or a nice-to-have in the oncology space? These remain open questions.
Extrapolation and Off-Label Use
We all know by now that biosimilars do not need to go through as rigorous a clinical trial program as originators do, and that the FDA will extrapolate a biosimilar’s approval across the originator’s portfolio of indications. The practice of extrapolation across immunology biosimilars brought up much uncertainty for utilization due to a lack of indication-specific evidence. It is likely that similar questions will arise in the anticancer space as more biosimilars come to market, especially as therapies like rituximab, trastuzumab, and bevacizumab are indicated for multiple tumor types. Furthermore, oncology products are often used as off-label in different indications or in different combinations, evidence permitting.
Important questions to consider here are whether generation of real-world data can close these existing evidence gaps in the oncology space. If so, what are the best means to generate evidence, especially when the notable clinical endpoint in oncology is overall survival?
The Oncology Care Model
The CMS-developed reimbursement model, the Oncology Care Model (OCM), will run at least until 2022 and is aimed at improving the quality of cancer care while keeping costs within a prespecified range. The OCM may cause physicians and overall oncology practices to be more aggressive in managing cancer treatment through the lens of cost versus value. This may prove to be a boon for biosimilars, especially as more oncology practices join into the OCM and considering the number of Medicare patients undergoing cancer treatment.
Key questions to consider are how biosimilar sponsors can leverage the OCM to improve access to anticancer biosimilars. Can alternative innovative and value-based reimbursement models tie into the oncology landscape from the payer perspective?
CMS’ decision to reimburse Medicare Part B biosimilars through individual Q codes, rather than a bundled single J code in the Healthcare Common Procedure Coding System, helped lessen uncertainty around biosimilar prescribing and payments from the provider and payer perspectives. However, difficulties with billing, such as lack of Q-code knowledge or training, can create administrative barriers to biosimilar access that must be considered by sponsors.
340B Hospital Price Cuts and Pass-Through Status
While discussions around 340B price cuts remain ongoing, biosimilar sponsors are still able to apply for pass-through status, receiving 3 years of exemption from lower 340B reimbursement rates. How can sponsors optimize commercialization and leverage the benefits of pass-through status across stakeholders?
Step Therapy in Medicare Part B for New Starts
CMS has introduced the concept of step therapy on new starts in Medicare Part B plans, including Medicare Advantage. Step therapy has traditionally been a common utilization management tool implemented from the payer perspective to keep costs low by mandating use of a lower cost medication before stepping through to a more expensive alternative.
Biosimilars may be in an advantageous position with the introduction of step therapy in Medicare Part B: This proposal may allow biosimilars to be an initial step or an earlier step to branded medications due to cost implications. Further, restricting step therapy to new starts may decrease concern around switching those already receiving anticancer medications.
As has been noted, there are multiple factors impacting the reimbursement and successful uptake of biosimilars in the anticancer setting. Even though uncertainties around biosimilars remain, sponsors can ensure they are maximizing commercial pull-through efforts across stakeholders by proactively addressing these critical access considerations.