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.

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.

Lessons From a New Report: Do More Biosimilar Approvals Necessarily Mean Greater Access to Biologics?

By 2025, biosimilars may well fulfill their potential in the US, and we will be awash in biosimilars approved by the Food and Drug Administration, which have cleared patent issues through expiration, settlement, or litigation. Beyond meaning that we will finally have several adalimumab biosimilars on the market and perhaps even an approved pegfilgrastim biosimilar, access to biosimilars will almost certainly be widespread at that time.

Biosimilar concept art.5-15-2017A new study from Avalere, funded by the Biosimilars Council, was released this week, and its principal finding is that by 2025, an additional 1.2 million US patients could gain access to biologics owing to the availability of biosimilars. The implication is that current restrictions by private, Medicaid, and Medicare Advantage plans on the use of expensive biologics will be eased once less-expensive biosimilars come to the market and that lower costs will result in more patients being able to utilize biologics than before.

Although I’m not aware of any studies specifying the percentage of the insured population (public or private insurance) who do not have access to biologics, we do know a good deal about the way payers approach them in general. One of the greatest priorities of plans and insurers is to manage the specialty pharmaceutical category. The stated goal is to ensure that patients have access to appropriate therapy (not all therapy). The most common way to achieve this is through the use of stringent prior authorization criteria or step therapy. For noncancer biologics, virtually no payer or purchaser (including government and employers) would allow first-line access of a biologic without trials of conventional treatment first. This is done to limit costs of treatment as well as to mitigate the risk of adverse events.

Another routine mechanism for controlling costs of these agents is to leverage their net costs by offering preferred or exclusive coverage to one or two agents in a category. For patients in the US, this means that the vast majority of insured patients may have access to 2 or 3 anti-TNF agents, but not all of them. The introduction of lower-cost biosimilars may influence this, as it could be possible that payers include a wider choice of biologic medications once biosimilars for all of these products are available. The reference products may also benefit, in that the competition-driven lower costs may well allow for wider choice of medicines within a class.

It is questionable whether lower costs will permit the wholesale removal on restrictions of biologics in a category. Will a biologic be available for use as a first-line agent rather than a third-line agent? The major professional autoimmune disorder societies have not written clinical guidelines that urge biologics use far earlier. That is partly because each of these agents carries significant, serious risks, which cannot be minimized. They may occur infrequently, but they can be devastating in patients unfortunate enough to experience them.

In the Avalere report, researchers cite the European experience, in which “introduction of biosimilars led to an average increase in utilization, compared to the year prior to the biosimilar entrance, of 32%.” If that did occur in the US, it would be a boon to manufacturers.

They pointed to the lower costs being the primary driver of greater use. Gillian Woollett, MA, DPhil, Senior Vice President, Avalere Health, confirmed via Email that “[increased biosimilar availability] will disproportionately benefit women and low-income individuals. The assumption is two-fold: That biosimilar competition will lead to better access due to lower-cost products (either the biosimilar or reference biologic or both). Additionally, competition between biosimilars and their reference products is expected to improve tiering through placement on lower tiers, higher rates of coverage, earlier use, etc.”

Their results were based on an evaluation of seven blockbuster biologics in particular: adalimumab (Humira®), bevacizumab (Avastin®), etanercept (Enbrel®), infliximab (Remicade®), pegfilgrastim (Neulasta®), ranibizumab (Lucentis®), and rituximab (Rituxan®). All of these products are expected to be marketed by 2025, although patent litigation could, of course, change this scenario.

The present assumption is that a significant portion of nonoptimized utilization of biologics like Humira is due to high cost-sharing requirements. With the wider availability of biosimilars, special biosimilar tiers (with relatively lower cost sharing) may be a good bet in the future. Dr. Woollett stated, “While the analysis doesn’t specifically assume the increased utilization due to specific actions (we don’t ascribe X% better access to more biosimilars tiers, etc.), we do assume that payers respond with efforts to incent utilization of either the biosimilar or the reference biologic (depending on contracting) and that leads to better access.”

Will Oncology Biosimilars Ease US Access Problems?

Among the broad arguments for the rapid introduction of biosimilars is that they will increase patient access to expensive biologic therapies. This may be true theoretically from a patient cost-sharing perspective. If the biosimilar is priced sufficiently less than the originator product, health plans and insurers may elect to prefer the biosimilar and place it on a more affordable coinsurance or copayment tier.

This is not generally the case for the 2 nononcology biosimilar products launched to date. With shallow discounts for the biosimilars, the originator’s manufacturer can simply match the net cost through deeper rebates; the payer would have little reason to change the formulary tiering of the biologic.

The title is sort of a trick question. It assumes that there is a problem accessing oncology agents in our nation today. A 2015 study of 150 oncologists indicates that this is not the case. None of the respondents reported that obtaining Image result for Truxima imageRituxan for their oncology patients (chronic lymphocytic leukemia or non-Hodgkin’s lymphoma) was a problem. The researchers also surveyed doctors in Brazil, Mexico, Russia, and Turkey. In Russia, 12% indicated that access to Rituxan was indeed difficult, as did 17% in Turkey. The researchers also stated that Russia and Mexico, compared with the other countries included in the study, had the greatest share of patients who did not have any insurance. Of course, it must be noted that the cost of Rituxan is far less in the other countries studied, compared with the US.

Another way in which the introduction of a Rituxan biosimilar could improve access is to alleviate present or future drug shortages. Drug shortages are commonly the result of a couple of factors: manufacturing plant slowdowns or shutdowns (often related to quality issues or the need for maintenance); lack of available drug components, such as its active ingredients or excipients; lack of profit driving generic manufacturers out of the business.

According to the Food and Drug Administration, which is responsible for tracking drug supply shortages, Rituxan has not been subject to any supply notifications, nor have any of the biologicsSupply Chain. However, oncology has not been immune from drug shortages (e.g., daunorubicin liposomal injection, leucovorin injection). In a recent post, I emphasized that the need for anything less than a water-tight drug supply record can torpedo and sink biosimilar marketing efforts. In this instance, one can also make the case that oncology biosimilars like rituximab, trastuzumab, and bevacizumab could serve as a stalwart against potential biologic supply issues.

The outlook for the patient’s ability to pay for expensive medications is cloudier by the day. Access to these drugs is not an issue in the US today, but what about a year from now? How will efforts to change the pre-existing exclusion rules alter the landscape for covering any of the biologic products? Then, biosimilars may be in a real position to maintain or improve access.

The first oncology biosimilars are very close: Decisions from the Food and Drug Administration on biosimilars for trastuzumab and bevacizumab are expected in the third quarter of this year. Celltrion expects to file its 351(k) application for rituximab in June.