Interchangeability Is Finally a Reality

In a long-awaited first, the Food and Drug Administration has approved Viatris’ biosimilar insulin candidate Semglee® as interchangeable, meaning it can be substituted automatically at the pharmacy if the prescription is written for the reference product Lantus®. As allowed by individual state laws, substitution does not require the pharmacy to notify a prescriber.

This marks the first interchangeable biosimilar approval of any type in the US. The nonproprietary name given for Semglee is insulin glargine-yfgn. It is approved for use for any approved glargine indication.

In the FDA’s press release announcing the approval, Acting Commissioner Janet Woodcock, MD, stated, “This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs. Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

The FDA specifies that an approved interchangeable biosimilar can be expected to produce the same clinical result as the reference biologic in any given patient. The patient should not experience any addition risk in terms of safety or lower efficacy than if the patient continued to receive the reference product.

Something that may get lost in this momentous announcement is that the approval of Semglee also marks the first approval of a biosimilar insulin in the US. This is a bit of a misnomer, however. Earlier copies of insulin glargine (e.g., Basaglar®) were approved under the 505(b)2 pathway before the March 2020 transition to 351(k) approval. Like Basaglar, Semglee was originally approved (in June 2020) under the 505(b)2 pathway and launched in the US in August 2020. However, Viatris (then Mylan) decided to file for biosimilar status, likely in the hope of securing the interchangeability designation. At the time of last year’s launch, partners Biocon and Mylan indicated that it would discount the price of Semglee by 65% (a wholesale acquisition cost of $147.98 per package of five pens holding 3 mL each) compared with the 2020 price of Lantus.

Viatris is also working on a biosimilar of insulin aspart. The 351(k) application for this product is expected to be submitted before the end of the year.

The next FDA decision on interchangeability is likely that for Boehringer Ingelheim’s adalimumab biosimilar Cyltezo®.

The value of interchangeability, both to payers and to manufacturers, is not yet known. It should provide some leverage for plans who want to quickly shift marketshare from a reference product, allowing them to maximize anticipated cost savings. Yet, the insulin glargine space already has several brand-name competitors; it will be interesting to see whether the new interchangeable entering the market moves the needle on insulin glargine pricing or biosimilar uptake. Since Semglee was already available and the list price heavily discounted, this may tamp down the reaction by payers.

From the perspective of the adalimumab marketplace, the value of interchangeability seems cloudier, because of the sequential launch of biosimilars entering settlements with AbbVie, and the presence of two biosimilars who may decide to launch even earlier.

In any case, this has been a very long slog to reach this first. Enough speculating. Let’s see what really happens.

The FDA’s Aducanumab Affair and How It Relates to Biosimilars

The baffling early June decision by the Food and Drug Administration (FDA) to approve Biogen’s Alzheimer’s disease drug and ignore the recommendation of its Advisory Committee has been covered and chronicled to the level of the COVID-19 pandemic. On another platform, I put in my two cents on how payers may step in to save the FDA from itself.

In this post, I want to weigh in on two aspects of this lamentable episode that affects the biosimilar sector. First is the obvious: An erosion of confidence in the FDA’s ability and incentives in carrying out its mission—ensuring that drugs approved for use in the US are safe and effective. Based on the available evidence, arguments can be made that the risks of aducanumab well outweigh the potential benefits. That is what the FDA’s own staff reviewers thought when giving their assessment for the drug evaluation.

Another unassailable argument can be made for the risk for rewards for Biogen. The projected price point ($56,000) and the potential number of patients for whom it can be prescribed under the broad indication originally approved (though the FDA has backtracked and tried to narrow the indication) could set Biogen up for multibillion product sales for at least 12 years into the future. Now word has come out that FDA has had subsequent discussions with Biogen that seemed to affect the FDA’s final decision. Now, those optics are about as bad as it gets—for the FDA and for Biogen. Acting FDA Commissioner Janet Woodcock has ordered an investigation by the Health and Human Services Inspector General into the process—the result of excellent journalism uncovering these secretive talks by STAT. If I were a provider, patient, or payer who was not yet convinced of the armada of proof of the safety and efficacy of biosimilars, this is a big deal. The FDA approves a product for which safety is an issue and for which its clinical effectiveness is seriously in doubt.

In the case of the FDA’s decision, Patrizia Cavazzoni, MD, went all in on the fact that aducanumab removes amyloid plaque from the brains of patients with mild disease. However, this has not yet been shown, in several clinical trials, to result in any clinical improvement or delayed progression of the Alzheimer’s disease process. In other words, she and her colleagues at FDA believe that removing amyloid plaque is a proxy for a positive outcome, which one day will be confirmed to be true.

Don’t forget that FDA made a similar bet on proxies for clinical outcomes in the biosimilar field: That the similarity in physiochemical structure of biosimilars would result in clinical outcomes that were equivalent to those produced by biosimilars. They’ve cashed in on that bet; it has been backed up with plentiful phase 3 clinical trial evidence and switching studies. Those proxies are particularly important in terms of extrapolated indications, for which there were no late-stage clinical studies.

The second piece to this is Biogen’s role as a player in the biosimilar market. Biogen is a major shareholder in Samsung Bioepis, and will be marketing the latter’s biosimilars like denosumab, ranibizumab, and others in the US. Biogen already markets several biosimilars in Europe, including a version of adalimumab. It is also working with Bio-Thera to bring its tocilizumab biosimilar to market.

If Biogen is found to have had inappropriate communications with the FDA that materially contributed to obtaining approval for aducanumab, then stakeholders may have reason to hold Biogen to a different standard for both new innovator drugs and biosimilars. All we can do is speculate at the moment. The industry is on the precipice of launches of new ophthalmologic biosimilars and of course for the white whale—adalimumab. Potentially damaging questions about a major biosimilar manufacturer and marketer are not at all welcome.

Amgen Crosses Biosimilar Misinformation Line, Says FDA

On July 7, the FDA issued a warning letter to Amgen regarding an advertisement it ran promoting Neulasta® OnPro®, its on-body injector version of Neulasta (pegfilgrastim). In the animated advertisement, “the banner makes false or misleading claims and representations about the benefit of Neulasta,” states the letter. “These violations are concerning from a public health perspective, because this promotional communication’s misleading claims could cause healthcare providers to conclude that Neulasta delivered via the Onpro on-body injector (OBI) is more effective than Neulasta delivered via prefilled syringe (PFS) or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are delivered via PFS.”

At issue is a study cited by Amgen in the banner ad, claiming that:

  • “In a real-world study with nearly 11,000 patients, pegfilgrastim PFS resulted in a significantly higher risk of [febrile neutropenia or FN] vs. Onpro
  • “Across all cycles of chemotherapy, the incidence of FN associated with [PFS] was 1.7% (n = 455) vs 1.3% (n = 126) for Neulasta Onpro
  • “A large presentation of an upward arrow containing the claim, ‘31%* *P = .01’

The FDA took issue with Amgen’s misleading claim that this extremely small absolute percentage difference represented a significant difference. This is certainly not clinically significant, stated the FDA, despite its apparent statistical significance. Furthermore, the numeric difference may have resulted from at least two factors: “The study was not designed to ensure that patients with FN were appropriately identified for inclusion in the analysis.” Furthermore, the agency argued that “the study was not designed to ensure that the PFS and OBI patient populations were adequately balanced or controlled for potential bias.” Therefore, the FDA stated that the statistical significance of the finding may not be accurate.

Finally, the letter points out that Amgen suspiciously used the term “pegfilgrastim PFS” in describing the PFS arm of the study, rather than Neulasta PFS, which was actually used. This infers that biosimilar pegfilgrastims may have been included in the PFS arm, which was apparently not the case. “Healthcare providers could conclude that a biosimilar pegfilgrastim product delivered via PFS is not as effective as Amgen’s OBI product.”   

The FDA warning letter concluded that the advertisement “misbrands Neulasta within the meaning of the FD&C Act,” and mandates a response within 15 days and action to cease violations of the Act.

One of the strategies used by Amgen to ward off erosion of its pegfilgrastim market has been to convert much of its original Neulasta PFS business to OnPro. That has been largely successful: According to March 2021 figures from Bernstein Research, OnPro has held onto approximately 55% of the marketshare in the face of four biosimilar PFS competitors. Neulasta PFS still held 15% marketshare, but this has declined steadily since the introduction of the biosimilars.

You might expect biopharmaceutical companies to know better, especially if they produce both biosimilars and reference products. Amgen ran afoul of the FDA’s push to restrict misinformation about biosimilars, and in doing so, also threw one of their own reference products under the bus.

An Update on Legislation on Biosimilars and Patents

Held June 22–23, 2021, the American Conference Institute’s 12th annual Biosimilars and Innovator Biologics conference focused on the legal and patent issues affecting the biosimilar industry. In this article, we note some of the takeaways of the presentations.

The Year in Review panel focused on recently enacted and proposed legislation. Hans Sauer, Deputy General Counsel and Vice President of Intellectual Property, BIO, noted the Purple Book Continuity Act, which was promulgated in December 2020. The Purple Book will, for the first time, include patent information. The new listings will specify the patent list submitted by the reference manufacturer once the patent dance begins. Mr. Sauer explained that “This will lead to earlier identification of patents than what would have been the case otherwise. The first biosimilar manufacturer will not have a benefit, but the second or third biosimilar manufacturer will have that information in hand” when readying their product for commercialization.

It should be noted that to this point, the Purple Book has been a reference of only limited use. Information about the patents a reference manufacturer is most interested in defending is a welcome addition. Yet, the patent dance is optional; if the first biosimilar manufacturer decides not to participate, those patents are not listed.

The Record on PTAB Decisions

Mr. Sauer added, “When we look at patents being challenged versus those litigated later in court, they often go after [in the PTAB route] composition of matter rather than manufacturing patents. It will be interesting to see if the advance listing of these patents changes those dynamics over the next year or two.”

In a related session, John Josef Molenda, Partner, Co-Chair, Healthcare & Life Sciences Practice, Steptoe & Johnson LLP, described the growing experience with the interpartes review (IPR) process to date. The number of IPR filings peaked at 90 in 2017 but averaged 25 filings per year more recently. “Not all of these were related to biosimilars,” cautioned Mr. Molenda. “All involved biologic products, but some were filed by the manufacturers of innovator products.”

Forty-five percent of the IPR patent challenges related to methods of treatment, 19% to method of manufacture, 25% involved composition of matter, and 11% involved varying formulations. Mr. Molenda said, “In 75% of the cases, at least one claim was found to be unpatentable. Two percent found that no claims were unpatentable.” Importantly, in cases involving composition of matter patents, IPR found that 90% were unpatentable. Seventy-three percent of the IPR decisions were affirmed in Appellate Court; 12% of these decisions were dismissed and 15% of the IPR decisions were vacated or remanded.

Two pieces of proposed legislation attempt to address “product hopping,” or the attempts of an innovator company to create follow-on products and switch patients to those new agents to avoid loss of revenue from older agents at the end of their patent life. Consider the example of AbbVie’s introduction of Skyrizi® and moves to gain new starts or convert patients from Humira®.

David Korn, VP, IP & Law, PhRMA, pointed to the companion Senate and House bills S. 1435 and H.R. 2873 (Affordable Prescriptions for Patients Act of 2021 and Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, respectively). Both bills would affect “hard switches” and “soft switches.” The first one introduces a new product and excludes coverage of the older product. The second one only disadvantages the older product.

Antitrust Implications for Patent Settlements

Is this an antitrust issue? “I’m not sure why the Federal Trade Commission (FTC) wouldn’t have authority to act in these cases [without these bills],” he said. Mr. Sauer clarified that the courts have ruled in past that if consumer choice is removed, a ruling of antitrust is more likely. If the consumer has a choice, however, the courts view this as normal competition.

Putting this into context, if the FTC has the authority to address antitrust issues involving reference biologics, it has been extremely reluctant to use it. Members of the House of Representatives wrote to the FTC in May 2021, citing AbbVie’s own internal review that it was expecting biosimilar competition in 2017. The agreements it signed with biosimilar manufacturers delayed market entry of these competitors until 2023, allowing AbbVie greater than $75 billion in US sales of Humira. Of course, no one twisted the arms of the biosimilar makers to sign the agreements (well, to be fair, maybe their lawyers did).

Both S. 1435 and H.R. 2884 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) have another notable provision to address the infamous patent thicket problem. Both proposals would impose a cap on patent assertions at 20 (only 10 of which may be newer ones).

Enticing Patients to Switch to Infliximab Biosimilars

The move away from Johnson & Johnson’s originator product has been slow, due to the Pfizer’s flawed launch pricing of its biosimilar, J&J’s actions to defend marketshare, and residual reluctance by gastroenterologists to switch patients whose Crohn’s disease is in remission with Remicade®. According to March data from Bernstein Research, Remicade maintained about 81% marketshare in the US.

One perceived barrier to biosimilar uptake has been the lack of a consumer incentive to switch from a reference product. The vast majority of health plans and insurers have not yet implemented lower cost sharing for biosimilars. This was partly because no biosimilar has been covered under the pharmacy benefit, with its varied and flexible copay and co-insurance tiers.

Without the member’s motivation to save money, biosimilar marketshare may be more dependent on payer formulary decisions and provider reimbursement policies. Whereas the uptake of the oncology biosimilars has equaled or outpaced the reference products in a short time span, the same cannot be said for the infliximab category.

In the past, health plans and insurers have attempted to persuade members to change their preferences or behaviors through a bevy of incentives. For example, if a person enrolled in a 1990s disease management program, they would get a free gym membership. If they agreed to a 2010 medication therapy management review, they might receive a gift card.

Cigna is poised to use this tactic in its new biosimilar policy. increase member willingness to switch to a biosimilar. The insurer announced that beginning in July, it will move two infliximab biosimilars to preferred status. It will offer a one-time $500 gift card to patients who were taking the reference product Remicade and switch to either Avasola® or Inflectra®.

Ste4ve Miller, MD

In the post, Cigna’s Chief Clinical Officer, Steve Miller, MD, wrote that the company was paying on average $30,000 per year for Remicade, but this figure could be higher based on sites of infusion. Cigna is offering the gift card not only for switching to an infliximab biosimilar, but also if the patient switches to a preferred medicine in a related autoimmune class.

In correspondence with Fierce Healthcare, Dr. Miller explained that this biosimilar switching incentive, called the Shared Savings Program (sound familiar?), will be rolled out to 7000 eligible Cigna members.

The offer was piloted to members who were given the opportunity to switch from the interleukin 17A–inhibiting medication secukinumab (Cosentyx®) to the insurer’s preferred agent for treating psoriasis, ixekizumab (Taltz®).

Apparently, the organization wants to save money on the utilization of these expensive specialty biologics. The gift card program gives members a chance to “share in the savings,” but quite unlike Medicare does with its own shared savings programs.

Until cost-sharing policies are changed for biosimilars, this biosimilar switching incentive may be the most direct approach to demonstrating a financial impact to consumers, even if it is a one-time giveaway. If this approach works and saves Cigna significant money, expect the same to be used with the first biosimilar adalimumab preferred by the insurer in 2023.

In other biosimilar news…Samsung Bioepis and Biogen announced a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on its ranibizumab biosimilar SB11. A decision from the US FDA is expected in the fourth quarter of this year.   

Today’s Supreme Court Decision Saves the US Biosimilar Regulatory Framework

On June 17, 2021, the US Supreme Court announced its long-awaited decision on the severability of the Affordable Care Act (ACA) from the individual mandate. The Supreme Court sidestepped the basic question, instead ruling 7-2 that the plaintiffs did not have any standing to sue.

If the Supreme Court ruling had struck down the ACA, it could have also struck down the underpinnings of the US biosimilar approval process. The Biologics Price Competition and Innovation Act (BPCIA) was promulgated as part of the ACA.

Supreme Court

For the last three years, the case California v. Texas (previously Texas v. USA) had pinballed between lower courts and the appellate system. The gist of the case, brought by Republicans set on repealing the ACA, was that the individual mandate, which Congress elected not to enforce in 2017, was a central underpinning of the legislation. Without the individual mandate, they argued, the entire ACA was invalid. The initial district court ruling agreed with the plaintiffs, claiming that the individual mandate was not severable from the ACA overall, and the appeals court agreed that the individual mandate was not constitutional, but did not address the severability question.

The majority ruled that the petitioners did not have standing, because they failed to prove that they suffered or would suffer any sort of direct injury from the ACA remaining in force. The Supreme Court decision, written by Justice Stephen Breyer, did not address severability at all. A dissent written by Justice Samuel Alito with concurrence by Justice Neil Gorsuch, focused on whether the plaintiffs had standing. Justice Breyer’s dissent did argue for inseverability of any major portion of the ACA.

Had the dissenting opinion won the day, the burden may have fallen upon Congress to (1) reconstruct and (2) pass both the ACA and the BPCIA. There is little doubt, based on the widespread acknowledgement of the value of biosimilars, that the biosimilar pathway would be resurrected. Maybe not that quickly though—what types of amendments might have been attached to the legislation? Might there have been a second chance on tackling the ugly patent questions?

Thank goodness this did not send Congress back to the drawing board on either the ACA or the BPCIA. Based on the success of the ACA, I can’t help but wonder what the outcome would be today, with the political climate in Congress. It is a relief now that we’ll never know.  

This is an updated and corrected post. In the original, we had listed Justice Clarence Thomas as concurring on the dissenting opinion. This was in fact Justice Neil Gorsuch.

Bending the Reference Biologic Price Curve

One of the most obvious components of savings associated with biosimilars is their effect on competition, driving prices down. One of the more overlooked components of biosimilar savings is another characteristic of competition: Once launched, the cost of reference products stop rising.

That seems intuitive, but the extent of list price increases for reference biologics not facing biosimilar competition underscores the point. A post co-written by Xcenda and the Biosimilars Forum quantified this effect for a number of biologics already affected by biosimilar launches. They examined a 6-year window ending in 2021 and estimated the average sales price (which considers discounts and rebates) of each reference agent had biosimilar competition not occurred. For example, they forecast that the ASP price of Remicade® would be 150% greater than it is today. Neulasta® would be selling for 96% more than we are actually paying today. The reference epoetin alpha agents would be 61% more.

Drug rebates

In general, the older the biosimilar launch, the greater the difference between the actual ASP and what it would have been without competition. That makes sense. Also, the newer biosimilars (e.g., trastuzumab, bevacizumab, and rituximab) have a smaller spread, partly because they would not have been subject to several additional years of price increases.

On the other hand, the prices of etanercept and adalimumab have continued to climb. Although not reflecting the ASPs of these reference agents, we estimated cumulative price increases (based on WAC) of more than 50% through 2023 for adalimumab. This should come to an abrupt halt with the introduction of the first biosimilar in 2023 for adalimumab, but not for etanercept, which may not face direct competition until the end of the decade because of a flawed patent system.

In other biosimilar news… AbbVie keeps playing the patent game in its battle to keep upstart Alvotech from launching its biosimilar version of Humira® before 2023. Big Molecule Watch reported that Humira’s manufacturer launched another patent suit against Alvotech. Apparently, when Alvotech provided its notice of commercial marketing in May as part of ongoing legal proceedings, AbbVie believes that the manufacturer demonstrated its intent to launch its biosimilar at risk. AbbVie wants to enforce 58 patents that it originally declined to litigate against Alvotech. The IP games continue…

Tanvex BioPharma Receives Complete Response Letter on Its Filgrastim Biosimilar Application

On May 20, 2021 Tanvex BioPharma, Inc. issued a press release announcing that the FDA has not approved its 351(k) application for TX01, a biosimilar version of filgrastim.

In the announcement, Tanvex cited the FDA’s need to complete manufacturing site inspections, which have been altered by COVID-19 pandemic restrictions. It is unclear whether any additional information related to the product’s development is being requested by the FDA. Tanvex stated, “Based on the [complete response letter], Tanvex will continue to update FDA with supplemental information and the Company plans to work closely with FDA to get the application approved.”

Tanvex is seeking to launch the third filgrastim biosimilar on the market.

In other biosimilar news… On June 1,Biogen and Bio-Thera presented results from its phase 3 study of BAT1806, an investigational biosimilar referencing tocilizumab. The study tested the biosimilar against the reference product Actemra® (EU-licensed) in 621 patients with moderate-to-severe rheumatoid arthritis who had inadequate response to methotrexate therapy.

The partners announced that “the study met its primary endpoints, demonstrating equivalence to the reference medicine,” based on the primary endpoint of American College of Rheumatology 20% response (ACR20). If approved by the FDA, Biogen would market the agent throughout the world, excluding China and Taiwan. Globally, Roche earned roughly $340 million on Actemra in the first quarter of 2021 (or an estimated $1.4 billion extrapolated in annual sales) in the US, across indications.

Lupin’s Pegfilgrastim Biosimilar 351(k) Application Being Evaluated by FDA

Mumbai, India-based Lupin Ltd is attempting to enter the US biosimilar market for the first time with its version of pegfilgrastim. First approved and marketed in India in 2015, Lupin’s pegfilgrastim application was accepted on June 2 by the Food and Drug Administration.

The development of this agent included three double-blind, controlled trials, comprising more than 3,000 patients, in addition to the analytical, pharmacokinetic, and immunogenicity studies expected to support a 351(k) biosimilar application.

Based on the filing date, an FDA decision may be expected in Q2 2022. If approval is received, Lupin will be entering a crowded market as the fifth biosimilar pegfilgrastim. Currently, the pegfilgrastim category is dominated by the on-body injector Neulasta® product OnPro as well as the biosimilar brands Udenyca®, Fulphila®, Nyvepria®, and Ziextenzo®.

Lupin is not a stranger to the biosimilar area. Besides pegfilgrastim, the company launched its version of etanercept in the European Union as well as Japan and India, and it has a phase 3 study underway for a biosimilar of ranibizumab. To date, Lupin has not announced any marketing agreements with other manufacturers on the biosimilar front. The company has a strong US presence (based in Baltimore) for its generic business.

Are Biosimilars and the Oncology Care Model a Perfect Fit?

In shared-savings reimbursement models in healthcare, physicians have an incentive to use health resources more efficiently: They may receive bonuses based on the money that they save compared with a benchmark. The accountable care organization model, Medicare shared-savings model, and the oncology care model (OCM) are a few examples. These started as demonstration projects created by the Centers for Medicare and Medicaid Services in an attempt to give physicians skin in the game—to spur them to take a more active role in improving the efficiency of healthcare spending.

Logically, the use of biosimilars might be a natural prescribing tool to achieve these goals. If biosimilars were successful in contributing to savings bonuses, it would help solidify their uptake, the financial security of their manufacturers, and improve the profitability of the physician practice. After all, biosimilars cost less (at least on an average sales price [ASP] basis) than reference drugs and may allow more patients to access these valuable biologics.

The Contribution of Biosimilars to OCM Savings

More specifically, the agents approved for the direct or supportive treatment of cancer would seem to be a perfect fit for physician practices participating in the OCM. This is not necessarily the case, according to panelists at the Association for Accessible Medicine’s (AAM’s) Access 2021 annual meeting. Nick Adolph, Associate Principal, Market Access Strategy Consulting, IQVIA told virtual meeting attendees, “The OCM participants are more likely than not to utilize biosimilars. Oncology biosimilars have ASPs that are about 10% to 20% below that of the reference product,” but he also added, “reimbursement is variable. It could hinder or help. We don’t know the answer to this yet.”

John Brooks, JD,Partner, South Capitol Consultants, commented that part of the issue is that the OCM itself has not yet demonstrated big savings. On the other hand, “If we do see those results come through, then it can really support the idea of improved patient access to biosimilars,” he said.

The problem is that the savings generated by the OCM model have been underwhelming. The last three-year evaluation of the OCM model by Abt Associates revealed no material savings in spending, hospitalization, or emergency department visits for patients receiving active treatment of cancer.

Started in 2016, the OCM was slated to end its demonstration period this year. It will be replaced by the Oncology Care First (OCF) model, which moves away from fee-for-service payment to a bundled payment. This could potentially raise the stakes further in favor of biosimilar utilization.

Oncology biosimilars have been a market success story in the US. However, if the shared savings model itself fails to deliver promised benefits, could a heavier influx of biosimilar utilization turn the tide for the overall model? On a small scale, it seems possible, at least according to one study. This is probably not the case on a larger scale, with only the filgrastim/pegfilgrastim, bevacizumab, trastuzumab, and rituximab biosimilars available.

Disappointing Savings in the OCM Overall

As part of the Abt Associates’ evaluation of the OCM performance, the consultants analyzed the use of filgrastim and pegfilgrastim in patients with low or intermediate risk of febrile neutropenia during the course of their cancer treatment. They did not note any strong trends in the greater utilization of these agents during the evaluation period, although biosimilar pegfilgrastim was recently introduced. They saw mixed results, varying by risk of neutropenia and by specific cancer state. However, an important trend was evident: “During episodes when filgrastim (originator or biosimilar) was used, OCM episodes had faster adoption and greater use of biosimilar filgrastim than comparison episodes. Rates of biosimilar use were generally similar in OCM and comparison episodes [early on], but use increased more in OCM episodes during the [latter two evaluation periods]. OCM practices’ emphasis on biosimilar rather than originator filgrastim reflects a straightforward strategy of therapeutic substitution that reflects more value-based use of the granulocyte-colony stimulating factors.”

At AAM’s meeting, Mr. Adolph presented data showing physicians who were in buy-and-bill practices have demonstrated a greater preference for biosimilars compared with physicians who receive their patients’ medications through specialty pharmacy delivery. As the OCM model was still founded on a fee-for-service basis, this is not really surprising. That trend has become stronger among the 2019 biosimilar (oncology) launches, noted Mr. Adolph. For those receiving “white-bagged” pharmaceuticals, they have no financial incentive to choose a reference or biosimilar product (the administration fee is the same).

It may well be that the OCM did not demonstrate greater savings because the tools available to oncology practices were somewhat limited. Perhaps the savings goals and benchmarks were not well aligned. I’d like to think that given enough time to work their magic and with an extended study in the alternative payment model setting, oncology biosimilars can produce the kind of attitude or policy change that results in more visible savings. That may only be seen if the OCF model and its bundled reimbursement approach proceeds.