Improving Biosimilar Adoption Rates and Affordability With Oncology Pathways

J Clin Pathways. 2022;8(6). doi:10.25270/jcp.2022.09.2

Biologic drugs are molecular compounds derived from living organisms. They help treat many complex conditions, including cancer. Because they are created from living systems, biologics are difficult to replicate and often priced at a premium.

According to the US Food and Drug Administration (FDA), biological products are the fastest growing class of therapeutic products in the United States.¹ The US biologics market is growing significantly faster than nonbiologics, with a 14.6% compound annual growth rate (CAGR) over the past 5 years compared to a 6.1% CAGR for the total market.² As of 2019, biologic drugs accounted for 43% of invoice-level medicine spending in the United States, reaching a total of $211 billion.²

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing biologic drug.¹ Biosimilars must demonstrate that they are as safe and effective as the original reference product. Slightly more than half (51%) of the molecules representing biologic spending face biosimilar competition today or will face it within the next 10 years.² This presents opportunities for cost savings of billions of dollars if biosimilars are made available to patients with no sacrifice to the quality of care.

Three of the biologic drugs commonly used for cancer treatment (trastuzumab, rituximab, and bevacizumab) have FDA-approved biosimilars available (Table 1). The reference product for trastuzumab is Herceptin, and the biosimilars are Herzuma (trastuzumab-pkrb), Kanjinti (trastuzumab-anns), Ogivri (trastuzumab-dkst), Ontruzant (trastuzumab-dttb), and Trazimera (trastuzumab-qyyp). The reference product for rituximab is Rituxan, and the biosimilars are Ruxience (rituximab-pvvr), Truxima (rituximab-abbs), and Riabni (rituximab-arrx). The reference product for bevacizumab is Avastin, and the biosimilars are Mvasi (bevacizumab-awwb) and Zirabev (bevacizumab-bvzr).

The Centers for Medicare & Medicaid Services (CMS) uses information provided by manufacturers to report average sale prices (ASPs) for drugs.³ The ASPs for trastuzumab and bevacizumab’s reference products (Herceptin and Avastin) are about 20% to 22% higher than the ASPs for their biosimilars. The ASP for rituximab’s reference product (Rituxan) is more than 25% higher than its biosimilars.⁴ As part of the CMS standard fee schedule methodology, the biosimilar reimbursement rate is based on the cost of the biosimilar product, plus the CMS allowed 6% of the reference product’s ASP. Therefore, the use of biosimilars will not result in lost revenue.

Despite the proven efficacy and reduced cost of biosimilars, utilization remains low for oncology indications compared to reference products when an effective mechanism of steerage is not in place. To improve biosimilar adoption in cancer treatment, payer and provider groups are deploying various management strategies.

eviCore Healthcare (eviCore), a medical benefits management company, uses an innovative clinical decision support model to assist providers in selecting the most clinically appropriate, highest-value cancer regimens. Biosimilar utilization is improved with prior authorization and redirection through oncologist-led peer-to-peer consultation and education.

Beginning July 1, 2020, eviCore offered the option for its payer clients to implement a biosimilar preferencing policy (BPP), which requires the use of a biosimilar drug before reference brand usage for three chemotherapy drugs—trastuzumab, bevacizumab, and rituximab. Exceptions to the BPP are made for patients already using the brand drug or for those with clinical circumstances that preclude the use of any available biosimilar product.

Between July 1, 2020, and June 30, 2021, the BPP was adopted by eight of eviCore’s payer clients (policy group). eviCore’s remaining payer clients (control group) did not have a BPP in place for these three biologics during this time period. A trastuzumab, rituximab, and bevacizumab (TRB) management flag was created to identify payers with a biosimilar preferencing policy in place.

In this retrospective cohort study, the  two cohorts were stratified to isolate the impact of the biosimilar preferencing policy and control for the background trend of biosimilar adoption with an index date for the BPP of July 1, 2020. This date had been set across all payers, although some did not implement the policy until after the index date. This index date was to simplify the presentation of results, and the bias introduced was conservative in that the impact for payers who were late adopters of the BPP is understated.

By using clients’ paid medical claims, we are able to validate that providers are using the approved biosimilars. However, for simplicity and consistency across plans, we used the International Business Machines (IBM) MarketScan dataset for all cost estimates in the Results section. (Any analysis, interpretation, or conclusion based on these data is solely that of the authors and not IBM Corporation. Copyright 2018 and 2019 IBM Watson Health.)

Figures 1-3 track the biosimilar adoption rate of trastuzumab, rituximab, and bevacizumab, respectively. A single line is used prior to July 1, 2020, and tracks the combined populations. The lines are separated at the biosimilar preferencing index date between the two cohorts.

In the 6-month period before implementation of the BPP, biosimilar adoption was increasing organically at a modest rate. Biosimilar usage increased by an average monthly rate of 4.8% for trastuzumab, 3.8% for rituximab, and 3.5% for bevacizumab.

When payers adopted the BPP, there was an immediate, significant impact that was sustained over time. In the period from July 1, 2020, through June 30, 2021, the control group saw biosimilar usage increase by an average monthly rate of 0.9% for trastuzumab, 2.2% for rituximab, and 2.5% for bevacizumab. In the policy group, even after controlling for the rate of adoption already occurring, biosimilar usage increased 285% more quickly for trastuzumab (3.6%/month), 153% for rituximab (5.5%/month), and 53% for bevacizumab (3.8%/month), than in the control group.

By June 2021, patients in the policy group were receiving biosimilars more than 85% of the time across the three biologics (87.7% for trastuzumab, 87.6% for rituximab, and 85.8% for bevacizumab). By comparison, patients in the control group were receiving biosimilars for an average of 56.2% of the time for trastuzumab (31.5% less than the policy group), 47.5% for rituximab (40.1% less than the policy group), and 69.9% for bevacizumab (15.9% less than the policy group).

Even with strict biosimilar preferencing in place, eviCore still approves some episodes for the reference product. The primary reason that exceptions were granted was due to continuation of care (99.6% of exceptions), where it may not be preferable to move a patient to the biosimilar mid-therapy. With this in mind, approvals and requests for the reference product should trend down as continuation patients complete their therapy.

Using IBM MarketScan data from 2018 and 2019, we estimate the impact of eviCore BPP on therapy and payer costs.

In 2019, trastuzumab, rituximab, and bevacizumab accounted for $3.04 per member per month (PMPM) medical claim cost and 23% of total medical benefit oncology PMPM medical claim cost. The average cost of a year of therapy on trastuzumab, rituximab, and bevacizumab was $94,640, $48,824, and $66,757, respectively. Assuming the standard ASP biosimilar markdown, we estimate the average cost on the biosimilar therapies to be $78,867, $39,060, and $55,630, respectively (Table 2).

Table 3 describes the biosimilar utilization in the first 12 months of preferencing management for eviCore’s managed clients and the control group (no active preferencing in place).

Using the above cost and utilization numbers, we calculated the adjusted average cost for 1 year of therapy for each drug across the managed and control groups (Table 4).

After 12 months of biosimilar preferencing, eviCore reduced the average cost of a year of therapy by 13% to 16% compared to when only the reference drugs were available, and by 4% to 8% when compared to background provider trends toward biosimilar products. This leads to a PMPM medical claim cost reduction of $0.42 compared to the market prior to biosimilar introductions for these reference products, and a $0.15 (5.4%) reduction in PMPM medical claim cost compared to plans with no active management strategy in place.

Payers that implemented eviCore’s BPP showed significantly higher increases in biosimilar usage compared to payers that have not adopted a preferencing policy. While there was some organic movement to adopt biosimilars among the control group, it occurred at a much slower rate. Active management was able to achieve higher rates of biosimilar adoption more quickly and resulted in significant cost savings without reducing clinical efficacy.

The proliferation of biologic drugs and biosimilars creates more complexity for clinicians, as they seek to stay abreast of the latest medical advancements. Most clinicians in the policy group were comfortable changing from the reference drug to a biosimilar, which indicates that the slower organic adoption of biosimilars is likely not because clinicians have concerns about them as a treatment option, but rather because clinicians tend to prescribe the product(s) they are more familiar with. In such a situation, the use of a clinical decision support model, such as eviCore’s, to assist providers in selecting the most clinically appropriate, highest-value treatment regimens can have a significant impact on outcomes and affordability. eviCore‘s  model also supports health plan-specific preferred biosimilars, which drives additional trend reduction.

These findings demonstrate that active management can play a critical role in the coming years as the biologic market continues to grow and more biosimilars receive FDA approval. With these innovative medical breakthroughs come high costs. Managing those costs in a way that continues to achieve the best possible clinical outcomes for patients will be important for the long-term stability and vibrancy of the entire health care system. This study demonstrates the value that active biosimilar preferencing can drive and inspire hope that the increased competition that is forecast in the biosimilar space can be effectively leveraged to improve the affordability of cancer care for more patients.

Authors: Stephen Hamilton, MD^1,2; Kathryn Christensen, MS^1,2; Margaret Rausa, PharmD^1,2; Nick Andrews, PharmD^1,2; Timothy Dollear, MS^1,2; Christopher Linkimer, CPA^1,2; Eric Gratias, MD, FAAP^1,2

Affiliations: ¹eviCore Healthcare, Bluffton, SC; ²Cigna, Bloomfield, CT

Address Correspondence to: Stephen Hamilton, MD
eviCore Healthcare
400 Buckwalter Place Blvd
Bluffton, SC 29910
Phone: (405) 850-7531
Email: stephen.hamilton@eviCore.com