Is Differential Cost Sharing an Incentive for Biosimilar Uptake in Commercial Patients?

One of the most attractive reasons for easy access to biosimilars was their inherent promise that lower costs would reduce patient out-of-pocket expenses. We’re not alluding to the potential for lower total health spending resulting in reduced plan premiums. That may actually happen over the long term, if biosimilars ever become pervasive. Specifically, we thought biosimilars uptake would allow invaluable medicines to be more affordable to the patients themselves.

Consider the following scenario, which likely has occurred in a few physician offices around the country. Ms. Pamela Townshend is told by Dr. Robert Daltrey, “Pamela, I’m going to write you a prescription for Remicade® for your moderate-to-severe Crohn’s disease symptoms.” (Sorry, I never get tired of hearing this naturally occurring phrase in broadcast commercials.) “We first have to file the prior authorization paperwork for your medication with your plan before you can come in for your first infusion.” Ms. Townshend goes home, goes online, and finds that Remicade is on her plan’s specialty tier—subject to 20% co-insurance. Her plan has a maximum payment of $225 in place, but she will reach that, assuming the drug is covered by the medical benefit (not the pharmacy benefit, which has a $500 deductible). Knowing that she will be taking the drug for some time, she’s alarmed at the annual out-of-pocket cost. Frantic, she phones Dr. Daltrey’s office, pleading for a lower-cost alternative.

Of course, we think, “Biosimilars to the rescue!” And of course, that’s not quite right. Instead, it’s “copay coupon to the rescue.” Even if her plan was one of the minority that preferred biosimilar Inflectra® or Renflexis®, and thus required a lower out-of-pocket payment, Ms. Townshend would still be offered a coupon from Janssen that would reduce her personal costs to as little as $5 per infusion. In fact, she may have been informed of this before exiting the doors of the Moon Medical Group, allaying any panic about the affordability of her medicine. Often, the medical group’s billing office can start the copay coupon application process at the time of the office visit.

Realistically, very few in the general population will worry that Remicade costs the health plan over $3,000 per infusion (for a 60-kg person) when they have to pay over $200 out of pocket. One can make the argument that the patient is even less concerned about the real cost of the medication when their cost share is only $5. Here’s the main point: Every reference biologic manufacturer facing biosimilar competition (except the makers of reference epoetin) has a copay coupon program (Table). The biosimilar manufacturers also provide copay coupons (e.g., Pfizer enCompass or Coherus Complete). In other words, the cost-sharing differential in preferring biologics may play a limited role in patients migrating towards biosimilar use.

Reference Brand Patient Assistance Program Copay Costs to Patient After Coupon
Remicade Janssen CarePath $5 per infusion
Humira Humira Complete $5 per month
Neupogen Amgen Assist 360 $0 to $5 per dose or cycle
Neulasta Amgen Assist 360 $0 to $5 per dose or cycle
Herceptin Genentech BioOncology Co-pay Asssistance Program® $5 per dose
Avastin Genentech BioOncology Co-pay Asssistance Program $5 per dose

To the extent that patients do not have to pay the full, intended cost share and then receive a rebate later from the patient assistance program, they would not be subject to sticker shock.

We sought data on whether virtually all biologic manufacturers provided copay coupon programs; it seems this specific data point does not exist or at least not been published. Holly Campbell at PhRMA pointed me to a study using 2013 data by Pat Gleason and colleagues at Prime Therapeutics, showing that drug coupons were used in 44% of 264,801 specialty prescriptions in their analysis. In the anti-inflammatory area, that percentage was 61%. (Note that this was before the approval of any biosimilar competition.) They also found that these coupons reduce did directly lead to less prescription abandonment.

Michael Kleinrock, Research Director at the IQVIA Institute for Human Data Science, shared with us the latest information they had compiled. He noted that overall, “18% of brand scripts use a coupon” and “there are high profile cases like the autoimmune category where lots of the drugs are couponing to $5.”

Biologic copays
Luke Greenwalt, IQVIA

Copayment use in certain biologic markets can be extremely high. According to Luke Greenwalt, VP, Market Access of IQVIA’s Admundsen division, “If you look at autoimmune, we see 80-90% copay penetration rates for commercial markets—meaning that nearly all patients who can use a card do so.” He explained, “That is driven by competitive pressures, wide proliferation of cards, direct-to-consumer [messaging] that references patient-savings programs, high utilization of hubs/specialty pharmacies who know how to get access to programs, and high copays. In general we also see that the more a patient is asked to pay, the more likely they are to use a copay card—regardless of class.”

In doing a random survey of biologic manufacturers, we couldn’t identify any that didn’t employ a copay coupon program. Highly experienced pharmacy executives like James Kenney, Jr., MS, RPh, President of the Academy of Managed Care Pharmacy, confirmed that they also couldn’t recall any biologic drug makers that don’t offer copay coupon programs today.

Simply because the copay assistance programs are ubiquitous does not mean they are used every time a prescription is written. There is good reason to expect that they will be used more often in the future, not less. It does mean patient cost-sharing differentials for those covered by private, commercial insurance is not yet a real factor in choosing biosimilars. Health plans and insurers that want to increase biosimilar uptake can simply exclude coverage of the reference product. This has not been the case, of course, with infliximab. Payers can use copay accumulators that prevent the copay card savings from being applied to any deductible the patient may owe. Patients don’t really understand how these work, and to be honest, I doubt I could pass a test on them.

The use of a simple, unique biosimilar tier, with relatively low copayments, might help spur patients to ask for the biosimilar. These special tiers have not been implemented, largely because so few biosimilars are available for prescription today.

The Association of Accessible Medicines, in their Failure to Launch White Paper (part 2), stated “patients do not seek out biosimilars from their providers because the difference in their cost-sharing is rarely communicated to the patient or the provider.” I’ll go one step further: Because of copay coupons, the final cost difference to the patient may be far less than one thinks.

How Confusing Is Biologic and Biosimilar Substitution?

Evidence is mounting, especially from Europe that biosimilars to a single reference product result in the same clinical outcomes, with no appreciable safety issues. Evidence of this type from America will take time to accumulate, because competition in categories with multiple biosimilar options has been much more limited.

British Columbia biosimilar uptake

The recent announcement in British Columbia of the province’s decision to switch patients with inflammatory bowel disease from Remicade® to biosimilars has once again inflamed some passions. This is part of a broader effort by the Canadian province to increase utilization of biosimilars to gain economic savings. The Canadian GI Society, an advocacy group, published a letter firmly against the plan. They believe only the physician and patient should decide whether a biosimilar switch should occur. The British Columbia government, on the other hand, will pay for either Renflexis® or Inflectra® but not Remicade® after March 5, 2020. Even if patients have been taking the reference product, they will have to switch to one biosimilar or the other.

The Biosimilar Switching Argument

With medical experience supporting the case for switching, the argument by this Canadian advocacy group is less than solid. There may be the need for a medical exception for the infrequent patient taking infliximab, but these drugs can be effectively switched: there is no meaningful difference in effectiveness and safety outcomes on a population-wide basis among infliximab choices.

That said, here is where the supporting arguments get somewhat messy. The Food and Drug Administration (FDA) approves a biosimilar based on its equivalence to a reference product (not to other biosimilars). At the implementation of the Biologics Price Competition and Innovation Act, a biosimilar manufacturer has been required to show that its biosimilar was comparable in physiochemical, pharmacokinetic, and clinical studies to a designated reference product (i.e., US-licensed version of the originator). That required some manufacturers to first prove the equivalence of the US-licensed version to the EU-approved originator in a “bridging study.” This requirement was borne from the understanding that the US- and EU-licensed originator biologics make not be exactly the same either—biosimilars of each other. With more experience, the FDA has backed away from this requirement, understanding that the clinical outcomes differences between two licensed originator products are negligible.

The Laws of Transitivity and Biosimilar Switching

However, the FDA has not revised its opinion on whether two drugs proved to be biosimilar to one reference product are biosimilar to each other. Nor whether an interchangeable biosimilar might be considered interchangeable with other biosimilars. The answer remains: The evaluation process does not require such testing to gain basic biosimilar approval. In other words, the evidence did not yet exist.

This all relates to the basic premise of so-called “nonmedical substitution.” The issue is whether a payer-initiated change with a noninterchangeable biosimilar is considered to be more like therapeutic or generic substitution. Therapeutic interchange or substitution takes place when a drug is switched for another in the same category (e.g., switching Lipitor for a different statin rather than the generic atorvastatin).

Therapeutic Interchange vs. Biologic Substitution

A payer would be hard pressed to justify an unauthorized switch of adalimumab for infliximab. They are very different TNF-inhibitors. Patient outcomes would likely be affected in some way. Are Inflectra and Renflexis—different infliximab biosimilars—to be considered wholly different biologics? Because the FDA does not endorse that Inflectra and Renflexis are biosimilar to each other, it does imply (whether wrongly or rightly) that they are different biologic brands. If this was considered in the traditional sense, switching might be construed as an example of therapeutic interchange.

Framing the argument in this manner can drive patient and provider resistance to biosimilar uptake. Misinformation? Rather, I believe that this is an embodiment of the ambiguity of our regulatory policies. Certainly, payers don’t subscribe to it; they cover one versus another based more on net costs—certainly not on clinical outcome differences. For payers, it is more black and white; for certain other groups, much remains gray, especially when people believe more decision-making authority is being challenged. Only greater biosimilar clinical utilization, proof of savings, and better dissemination of education about this experience will change advocacy’s perspective .

New Managed Care Pharmacy Survey Shows Broad Support for Biosimilar Adoption

According to a study published in the Journal of Managed Care and Specialty Pharmacy, managed care pharmacy executives are fully onboard with encouraging the use of biosimilars: Eighty-four percent agree that these FDA-approved agents are safe and effective for use in patients who are taking a reference product.

The researchers sent survey invitations to more than 10,000 members and contacts of the Academy of Managed Care Pharmacy. The survey, conducted in October 2018 was limited to the first 300 respondents. All potential pharmaceutical industry participants were excluded through the use of screening questions. Roughly two-thirds of those participating were pharmacy directors or clinical pharmacists.

The survey asked whether they believed certain policies would improve biosimilar uptake. The results indicated respondents’ belief that prescriber education was still a principal problem (Table). However, they also looked inward, as formulary policies and reduced patient cost sharing may also be key opportunities for improving uptake. Indeed, only 20% of those surveyed were working in health plans or insurers that have established preferences and policies to promote biosimilars over reference products. Eleven percent (at the time of the study) preferred biologics to biosimilars. This may have changed significantly, based on UnitedHealthcare’s recent moves to favor reference agents.

TABLE: LIKELIHOOD THAT SPECIFIC STRATEGIES CAN OVERCOME BARRIERS TO BIOSIMILAR UPTAKE

Strategy Extremely or Likely to Be Successful
Prescriber education on switching studies 91%
Clear FDA guidance on substitution 90%
Formulary policy for treatment-naïve patients 88%
Prescriber education on real-world studies 86%
Expanded Medicare/Medicaid policies 84%
Reduced patient cost sharing for biosimilars 80%
Formulary policies for switching 73%
Government-funded interchangeability studies 70%

When asked about how formidable these challenge were to overcome, 61% said that provider education was “extremely difficult” or “difficult” to overcome. The inevitable pricing and contracting issues were a close second, at 57%. Respondents offered that this was a competitive hurdle that biosimilar manufacturers must tackle—they need to be more aggressive at launch in terms of discounts off of retail prices and contracting. Concerns about biosimilar safety and efficacy among payers were the least worrisome, with only 23% rating this challenge difficult or extremely difficult.

Only 9 months ago, when the survey was conducted, the US biosimilar arena was far different. It took place after approval and launch of the first pegfilgrastim biosimilar but before the launch of the cancer-treating biosimilars. The discussion of rebate safe harbors was in full swing, the federal government was thinking through its approach to peeling back the patent thicket, and a war on drug pricing was being waged. Today, only the drug pricing efforts are still ongoing. Any hopes for an adalimumab biosimilar launch before 2023 have disappeared. However, a handful of critical launches (e.g., Udenyca®, Kanjinti®, Mvasi®) have pressed more immediate discussion of biosimilar uptake.

The results of this survey demonstrate once again that pharmacists working in managed care organizations are very open to helping spur biosimilar access. Both the manufacturers and payers need to take advantage of this opportunity today.

Even in Europe, Biosimilar Uptake Depends on MD Comfort Levels

Sometime ago, the European Crohn’s and Colitis Organization (ECCO) found that sequential surveys had demonstrated improving physician comfort with prescribing biosimilar infliximab. This resulted in ECCO’s change in its position on switching infliximab. As one can imagine, this occurs only with experience, and often that experience is gained first by using the drugs in new patients only.

According to Ha Kung Wong, Partner, Venable LLP, physician comfort and education is still the primary determinant of biosimilar uptake, even in Europe. In his remarks at the recent ACI Biosimilar Summit in New York City, Mr. Wong emphasized that although price will enable a biosimilar to gain a foothold, it is not the only or most important factor. This is somewhat surprising; the competitive tendering system in many countries have resulted in significant price variation, including steep discounts in some locations.

Ha Kung Wong
Ha Kung Wong

Mr. Wong explained that in Norway and Denmark, Remsima uptake has risen through deep discounts, though in other countries, discounts were far less extreme. On the other hand, less variation has been seen with trastuzumab pricing. Mr. Wong said, “Regardless, the uptake of biosimilars has been quite high across the EU. For example, Samsung’s Imraldi reached 60% uptake in Germany after only a very short time.”

He pointed out that “price does increase marketshare. But growth in uptake is still driven by biosimilar use in new patients.” Ha Kung Wong said that even in the EU, resistance to switching patients from a reference product to a biosimilar continues.

“The number 1 factor is MD resistance to switching,” he stated, although patient resistance is also apparent. Considering the heavy involvement of EU countries in educating doctors and patients with regard to biosimilars, more needs to be done if systematic switching of patients to biosimilars will contribute more fully to the industry’s success.

This experience in Europe is extremely pertinent to the situation in the US. Physicians are beset by costly administrative efforts to meet payers’ prior authorization and step edit requirements, and they may be also less experienced in the prescribing of biosimilars than their European colleagues. If the relative value of the biosimilar is not substantial enough, expect that prescriber uptake will grow only slowly. Consider not necessarily the case of infliximab, but the newest categories to likely hit the market—the biosimilars for the treatment of cancer (e.g., trastuzumab and bevacizumab). These prescribers will need some time to become comfortable with treating their vulnerable patients with biosimilars, and the requirement for use in “new” patients may not apply. It would be feasible to switch cancer treatment after completion of any cycle, as well as for recurrent tumors.

In Moving Patients to Biosimilars, Transferring Patient Services Is Key

John Q. Smith, a patient of Dr. Kelly’s has been receiving his biologic therapy for rheumatoid arthritis for more than a decade. He has been in contact with the reference manufacturer’s patient services hub for several years, and utilizes it both for payment assistance and for nurse support. He appreciates the co-pay coupon, which can save him hundreds of dollars, especially since his health plan has a high deductible.

The following year, his employer has changed its sponsored plan, and Mr. Smith finds himself in a situation where originator biologic is no longer preferred (or even excluded). Barring a successful medical exception appeal, he will have to start biosimilar therapy. He worries not only about whether the biosimilar will be as effective and safe, but also whether he will have to bear more of the cost of treatment. I might argue that the biosimilar drug maker’s hub services are extremely important to gaining uptake for patients and even some providers.

From a 30,000-foot view, this may not be as widely considered as contracting with payers and health systems. Early on, I assumed that all manufacturers’ patient/provider hub services were as similar as the biosimilarity of the drugs. However, it is one of the ground-level details that optimizes (or undercuts) an opportunity for gaining biosimilar uptake.

Consider if a biosimilar maker’s services program exposed its patient population to significantly greater cost sharing. The collective howl would certainly be heard by their doctors (and probably their plan or insurer). If the physicians’ offices received worse coordination services or administrative assistance from the new hub provider, the push back would be considerable as well.

The bar for patient and provider hub services is pretty high, but it is consistent. For example, Janssen’s CarePath covers the bases for Remicade®. Merck’s Renflexis® Access Program focuses on copay and ongoing financial assistance for patients and on coverage/reimbursement/prior authorization support and answering coding questions for doctors’ offices. Pfizer’s enCompass offers similar support functions.

When biosimilar manufacturers do receive the opportunity for plan coverage, they must ensure a transition of services that feels seamless to the patient and provider. Otherwise, John Q. Smith and his brethren will make their dissatisfaction (and challenges) known to anyone who will listen. Without a smooth transition, biosimilar makers risk not only drug coverage, but their reputation as well.

Implications of UnitedHealthcare’s Preference of Remicade and Neulasta to Their Biosimilars

In a significant coverage move, UnitedHealthcare (UHC) has signaled that its commercial and Medicaid medical policies on infliximab and pegfilgrastim have changed direction in favor of the reference drugs.

UnitedHealthcare and biosimilars

Effective July 1, 2019, approximately 22.5 million commercial and 6 million Medicaid UHC members will not be able to access these biosimilars without trying the reference agents first (virtually eliminating biosimilar use). Both infliximab and pegfilgrastim are covered generally under the medical benefit as office-based infusions, and preferring Remicade® and Neulasta® (including OnPro®).

This move is important for a few reasons. First, it reverses UHC’s previous position, which preferred the biosimilars over the two originator products.

Second, it promotes a prior authorization practice that makes little sense—since the biosimilar and reference products are expected to work in the same way and produce similar outcomes, why would a patient who fails Remicade then be given Renflexis® instead of a different biologic medicine like adalimumab, ustekinumab, or others?

Third, it implies that both manufacturers have further reduced the net cost of these drugs to UHC and its customers, undercutting the current deals offered by the biosimilar manufacturers. If accurate, this is a positive development in that infliximab and pegfilgrastim prices are continuing to come down due to competition. It would also indicate that Amgen, maker of the pegfilgrastim originator Neulasta, is beginning to defend its prefilled syringe market more aggressively. This is significant, because Amgen had been more focused on defending the marketshare of its on-body injector (Onpro), which is dominant. Alternatively, Amgen may be bundling its filgrastim and pegfilgrastim products more effectively. Coherus and Mylan had previously announced pricing that would be one-third less than the list price of Neulasta. Coherus had specifically indicated that it would be seeking targeted deals with payers to ensure at least parity position for its prefilled syringe product Udenyca®. It did not, however, mention UHC as one of those payers.

Fourth, this move puts a further dent into the sustainability of the US biosimilar market. Obviously, preferring the originators will make access to their biosimilars considerably more expensive for patients. It can only promote greater price cuts by the competing brands and thus reduce profit margins for the biosimilar manufacturers. In the US, biosimilar makers need a little encouragement to stay in the market, as very few have had positive experiences to date (e.g., Pfizer, Boehringer Ingelheim, Momenta, Apobiologix to name a few).

No one denies the benefits of the increased competition meaning a halt to price increases and significantly lower net costs, but those benefits need to be extended across other biologic categories. Without a viable biosimilar industry, access to lower-cost biologics can only happen through price controls.

Managed Care Pharmacists Survey: We’re on Board With Biosimilars, and Maybe Even Switching

Few suspected that payers were doubters of the clinical value of biosimilar agents, and as the first biosimilars were approved (2015-2016) managed care medical and pharmacy executives were somewhat reluctant to embrace them. However, within the past couple of years, managed care pharmacists told me these concerns were dissipating rapidly. (See the recent interview with Steven Avey as an example.)

A new survey on biosimilars released by the Academy of Managed Care Pharmacy (AMCP) confirmed that managed care pharmacists are on-board with biosimilar safety, efficacy, and the potential for switching. Conducted in October 2018, this survey offers solid evidence of the most recent thinking by pharmacy professionals on biosimilar access and promise.

Investigators from the Academy, PRIME Education, and the University of Pennsylvania analyzed the first 300 responses to their broad solicitation of AMCP members and associated professionals. Thirty-eight percent worked within a health plan or insurer setting, 22% in a pharmacy benefit management organization, and 40% in a specialty pharmacy.

The researchers stated, “84% agreed or strongly agreed that FDA-approved biosimilars are safe and effective for patients who switch from a reference biologic.” Although this does not specifically endorse switching to biosimilars from reference products, it does imply that the payers have no problem with the concept. They were still a bit wary of extrapolation of indications, however. A slight majority (54%) agreed or strongly agreed that extrapolation of indications for biosimilars was safe and effective.

The surveyed payers were asked to select the most effective strategies for increasing biosimilar utilization (i.e., overcoming barriers to biosimilar use). The responses rated the following strategies “extremely likely to be effective”:

  1. Clear FDA guidance for substituting reference biologics with lower-cost biosimilars that meet requirements for interchangeability (54%)
  2. Expanded Medicare and Medicaid policies that promote biosimilar use (41%)
  3. Educational programs for prescribers focusing on evidence from studies in which patients switched from reference biologics to biosimilars (39%)
  4. Formulary policies that promote biosimilar use for treatment-naive patients (39%)
  5. Educational programs for prescribers focusing on real-world evidence from postmarketing studies on biosimilars, including European studies (34%)
  6. Reduced cost sharing for patients using biosimilars (34%)
  7. Incentivizing providers by adjusting fee schedules for biosimilars (34%)

It should be noted that of the 16 potential strategies presented, only 2 (see below) did not garner more than 50% of respondents believing that they were at least “likely” to be effective.

In contrast, the strategies least likely to be effective were:

  1. Requiring therapeutic drug monitoring for patients who switch to biosimilars to address concerns about immunogenicity (28%)
  2. Incentivizing providers by using quotas for prescribing biosimilars to treatment-naïve patients (28%)
  3. Educational programs for prescribers focusing on streamlined billing, coding, and reimbursement processes for biosimilars (12%)
  4. Laws that promote greater public transparency on pricing of biosimilars and reference biologics (11%)

This survey does demonstrate that pharmacists’ comfort levels with biosimilars are fairly high. At the time of the study, it is likely that they had significant experience with only filgrastim and infliximab biosimilars (based on launch dates of the other approved agents, including epoetin and pegfilgrastim).

Challenges Extremely Difficult Difficult or Extremely Difficult
Concerns about biosimilar safety and efficacy among prescribers 16% 61%
Pricing and contracting issues 22% 57%
State laws for substitution and interchangeability 17% 53%
Concerns about biosimilar safety and efficacy among patients 13% 49%
Formulary management issues 8% 35%
Concerns about biosimilar safety and effiacy among payers 7% 23%
Data adapted from
https://www.jmcp.org/doi/full/10.18553/jmcp.2019.18412 .

In terms of these pharmacists’ opinions as to the most challenging barriers to biosimilar adoption, they rated as “extremely difficult”: pricing and contracting issues (22%), state substitution and interchangeability laws (17%), and prescriber concerns about efficacy and safety of biosimilars (16%).

When asked what biosimilar manufacturers can do, their responses emphasized pricing: Use contracting “to overcome the current [biologic reference] products’ substantial rebated dollars” and “come to market with more aggressive discounts off [average wholesale price].”

Even Today, Patients and Payers Hold the Key to Biosimilar Uptake Success

Reading the white paper co-published March 19 by the US-based Biosimilars Forum and UK-based Medicines for Europe highlighted for me the importance of an essential roadblock to increased biosimilar uptake in the US.

The white paper outlined structural market changes needed in the US to gain comparable conversion of marketshare in the European market. Without a doubt, barrier number 1 is the patent thicket erected by biologic makers and the resulting patent litigation. This causes barrier number 2: the signing of licensing arrangements that prevent biosimilar makers from entering the market at the earliest possible date.

However, this still doesn’t address the lack of biosimilar uptake for infliximab: Inflectra® has been available for use since 2016. Whereas I placed considerable blame for this on Pfizer, which underestimated payers’ reaction to its initial discount on Inflectra. Today, I place more of the responsibility on the health plans and insurers for lacking the backbone needed to ensure a vibrant biosimilar market for infliximab. The health system can gain the greatest savings by converting to biosimilar infliximab compared with any currently launched biosimilar. With that in mind, let’s consider these agents.

According to the white paper, “Full buy-in is needed from payers to sustain a competitive market that values the most cost-effective medicines. This includes proactive incentivizing of biosimilar prescriptions, educating stakeholders on the promise of biosimilars, and requiring commercial insurers to provide access to biosimilars.”

I will take this one step further. Patients need to act on their desire for less-expensive alternatives at the physician’s office. Two things must occur to produce this result: (1) the provision of more accurate, less misleading information to patients relating the quality of biosimilars and their clinical efficacy and safety, and (2) financial incentives for patients to specifically request biosimilars.

There is no question that patients are often confused by the contradictory information they receive on biosimilars. This harkens back to generic–branded drug battles of decades ago. Without accurate education, patients will not reliably consider a biosimilar alternative to products like Remicade® . Much has been published on this issue already, and several biologic makers have been castigated about their contributions to misinformation. This must intensify if the second “pull-through” for biosimilar uptake is to be successful.

Any American patient who has faced high cost sharing or deductibles has considered ways to lower his or her costs. That includes making the decision to not refill their prescription or take their medications as directed. Infliximab is only available today as an office-based infusion, but should a subcutaneous version be approved, this, too, would be more directly in the patient’s hands.

The only way this will occur is if patients are given an appropriate choice by their health plans and insurers: lower cost sharing for biosimilars. This is accomplished easily, through the creation of a specialty biosimilar tier (or assignment of biosimilar agents on a fixed cost, tier 3–type payment). With the reference product strictly on tier 4 or 5 (co-insurance tiers with high dollar maximums), this would be the practical step to move the needle. For Medicare Part D beneficiaries, this could be as high as 33% co-insurance.

With the exception of very few payers, this has not occurred for Inflectra. It did occur for Zarxio®, as early as 2017, but it is not used for a chronic medication. When patients begin asking for lower-cost alternatives and payers provide cost-sharing structures that favor biosimilar use, Inflectra or Renflexis® uptake will begin to increase. That means payers foregoing short-term rebate revenue for longer-term cost savings. But one cannot occur without the other.