From The Editor | August 27, 2020

Oncology Biosimilars: Prepare For A Non-Buy & Bill World

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By Anna Rose Welch, Editorial & Community Director, Advancing RNA

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A few weeks ago, I attended a webinar hosted by MJH Life Sciences entitled “How Biosimilar Rebates Shape Payer Policies, Provider Behavior.” This topic has been crossing my desk more regularly lately. In fact, the increasingly complex payer dynamics in the oncology space was discussed in a pair of recent Biosimilar Development articles. Though the barriers and best practices to biosimilar adoption in oncology were highlighted in the MJH webinar, I appreciated the focus on the data providers have turned to in evaluating biosimilar products. In a previous article, Timothy Chiu, a pharmacist from Kaiser Permanente (KP), shared what clinical data have proven valuable for telling each KP institutional biosimilar’s “story”  and what other types of information could be proffered to earn health system buy-in to biosimilars.  

Outside of integrated systems like Kaiser, it is highly likely that payer policy will dictate product choices as the increase in biosimilar competitors begins seducing payers away from parity. (A great example of this is the latest news out of Express Scripts: Coherus’ Udenyca lost its preferred status in favor of Mylan’s Fulphila and Sandoz’s Ziextenzo.) However, that does not mean that providing certain types of data on your biosimilar product will not be valuable for physicians — especially at sites of care capable of establishing an “institutional biosimilar.”

Ali McBride, clinical coordinator of Hematology/Oncology for The University of Arizona Cancer Center in Tucson, raised some interesting points during the webinar about additional data that could promote oncology biosimilar uptake. Given the financial toxicity and evolutions in oncology reimbursement models, he believes the biosimilar discussion will need to evolve in a few key ways.

What Biosimilar Knowledge Gaps In Oncology Must Be Filled?

As this webinar revealed, payer influence on product choice can pose several tricky logistical and financial challenges for independent clinics (i.e., costly administration errors and/or unmet GPO performance-based contracts). Given these financial challenges, McBride sees an opportunity to better educate on how biosimilars fit into oncology reimbursement. As he highlighted in this OncLive article, there is a general lack of reimbursement knowledge in clinics across the U.S., despite the fact that the oncology world is no stranger to high-cost, innovative treatments and financial toxicity. Even among those oncology practices that are familiar with concepts like Medicare pass-through status, for example, oncologists are not always aware of how biosimilars currently (or can) function within those reimbursement structures, he explained.  

When asked what he envisioned five years down the line for biosimilars, McBride said the discussion will not be focused on the buy-and-bill reimbursement model; it will likely be centered around alternative payment models. In recent years, there has been a flurry of activity by CMS’ Center for Medicare and Medicaid Innovation (CMMI) to create such models to encourage greater cost-consciousness and value-based prescribing. One of the most commonly discussed is the Oncology Care Model, which has already spurred oncology clinics to make the jump to biosimilars. McBride also identified the forthcoming Oncology Care First (OCF) model (set to begin in January 2021) and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), through which the Quality Payment Program was created. Under the QPP, several quality-based payment incentive programs were launched, including the Merit-based Incentive Payment System (MIPS).

All of these programs — despite their implementation and outcomes differences — are striving to move reimbursement away from volume-based care toward value-based care. In many of these programs, certain payments are provided when clinics reach a specific milestone, whether that be a practice-wide cost reduction or accomplishment of some type of clinical, quality, or operational performance measure. For instance, in the OCF model, a participating practice would shoulder the total cost of care in return for reimbursement via alternative payment mechanisms (i.e., a monthly population payment for Medicare oncology beneficiaries and a potential performance-based payment). As McBride pointed out, biosimilars will need to be one of the tools practices use to meet their established benchmarks.

“We regularly hear about the high cost of medicines today, but we’re not talking about how these new models will require practices to increase uptake of biosimilars to reduce their overall spending,” he explained. “Moving forward, we need to hear more about how clinics establish strategies to implement biosimilars and what the overall cost reduction from this transition means for OCM, OCF, or MACRA MIPS metrics across the country.”

How Can Biosimilar Makers Fit Their Products Into This Discussion?

In addition to transparent discussion amongst oncology clinics, biosimilar makers will also need to ensure their products contribute data on how their use will impact a site of care’s bottom line — especially in what may be the non-buy-and-bill world of the future.

McBride argues there is a greater need for pharmacoeconomic data so practices can best determine the total cost of care when using certain treatments individually or in combination—for example, the overall financial impact of using a biosimilar or originator trastuzumab in combination with pertuzumab (Perjeta). Similarly, depending on the clinic and patient, providers may choose to administer pegfilgrastim the same day as chemotherapy. This would mean a patient — especially those that live farther away from the clinic — do not need to return for treatment the next day. Though Neulasta OnPro was launched to solve this logistical challenge, the use of the same-day use of the originator or biosimilar pegfilgrastim could lead to overall cost savings. This option, however, is not routinely embraced by certain payers, McBride shared.

The patient benefits of creating a new formulation for a legacy product are well known; however, the economics of transitioning to these newer formulations still raise questions for providers. This will be particularly important to dig into in oncology given the arrival of two subcutaneous options: Hycela (Rituxan) and Hylecta (Herceptin). As McBride pointed out, physicians still need to understand the cost comparisons between a subcutaneous originator compared to an IV biosimilar. Though the subcutaneous option would reduce a patient’s chair time in a clinic, this doesn’t necessarily mean it will be the most cost-effective option.  

“Overall, there’s a lot of opportunity for institutions, payers, and pharma companies to address the implications of using a biosimilar or a brand on total cost of care,” McBride concluded. “Increased research in this area will ensure oncologists have the same aggregate number when considering a specific treatment or treatment policy.”