Q&A: Biosimilar Access, Pricing in the Spotlight

Lakesha Farmer, Senior Director, Strategic Accounts, ION Oncology Practice Network at Cencora, sat down with Drug Topics at AXS24, the Asembia Specialty Pharmacy Summit, to discuss the biosimilar adoption, access, and pricing.

Drug Topics: What is being done to incentivize the adoption of biosimilars by providers?

Lakesha Farmer: The obvious incentive is lower costs; this is why they were brought to market. Biosimilar agents are, on average, about 50% lower in cost across all specialties in comparison to their reference products. This is a major win for providers in health care systems. Since their introduction to the market, we have seen some very unique pricing incentives and strategies created to incentivize the adoption of these agents. Most recently, we have seen manufacturers take a non-branded and branded approach to the launch of their biosimilars, which offers a low wholesale acquisition cost [WAC] and a high wholesale acquisition cost. This new pricing approach is currently being seen with insulin biosimilars as well as adalimumab biosimilars. By taking the low-WAC and high-WAC approach to pricing, this caters to all payers and plans based upon preference and increases coverage in access to biosimilars for patients.

Biosimilars are increasingly important in the health care system. | image credit: lexiconimages - stock.adobe.com

Another unique pricing strategy that I will go over is the Mark Cuban Cost Plus program. This program aims to lower patient out-of-pocket costs by offering Yusimry [adalimumab-aqvh] in adalimumab biosimilars to patients for about $569. According to drugs.com, the average cash price for Humira is about $7300. As you can see, by offering this biosimilar at a cash price of $569 to uninsured patients, as well as an option for commercially insured patients with high deductibles, high copays, and high coinsurances, this patient-centered approach can be a game changer in the adalimumab competitive market. However, in this current market, $569 is still very high in terms of a sticker price for most Americans. Although this unique pricing strategy is not the best option for all patients, I can certainly see this as a step in the right direction for increasing biosimilar adoption and patient access. It continues to drive competition in the biosimilar market.

Lastly, from a reimbursement perspective, the most notable incentive is the add-on payment for physician-administered biosimilars that was introduced under the Inflation Reduction Act. Under this provision, biosimilar reimbursement is stated [as] [average sales price (ASP)] plus a percent of the reference products’ ASP, which is higher than the reference product add-on of about ASP plus 6%. The higher reimbursement rate through Medicare provides community-based providers with a greater incentive to use biosimilars for their patients and continues to push the adoption of biosimilars in the community practice space.

Drug Topics: What are some strategies that have been utilized to improve patient access in the current biosimilars landscape?

Farmer: From a distribution perspective, my company Cencora has worked closely with all biosimilar manufacturers to gain access to every single biosimilar that is currently on the market in the US. This ensures that our customers have access to every product that they need to provide their patients with these lower cost options. From a [group purchasing organization (GPO)] perspective, our specialty GPO teams collaborate with all manufacturers to help negotiate and curate unique and competitive GPO contracts that provide lower cost options for biosimilars through invoice discounts as well as rebates.

We also offer market access resources and services to our manufacturer partners to assist them with the creation of patient assistance programs for biosimilar agents during the pre-commercialization process. Because the vast majority of biosimilars are marketed as branded products, most biosimilar suppliers offer robust patient access programs similarly to that of their reference products, which helps to level the playing field in this competitive landscape. Offering things like copay assistance programs, free drug programs, discount cards, and things of that nature can make access to these agents a little bit more attractive and affordable for patients. The heart of the issue is that patient access programs have to decrease financial toxicities that currently exist in a lot of the disease states that biosimilars are used to treat, and this is why it is extremely vital to make sure these programs continue to exist in this competitive space.

Drug Topics: How is the current legislative and regulatory landscape impacting the future of biosimilars in the United States?

Farmer: As we know, biosimilars are becoming increasingly important in the health care system as they offer lower cost alternatives to biologic agents, which can be extremely expensive for patients, providers, pharmacies, the government, [pharmacy benefit managers], and payers. In my opinion, the regulatory landscape for biosimilars is still evolving and there are still several legislative efforts currently in motion to address several perceived impediments to the biosimilar approvals and launches that we see today.

To address some of these impediments, various bills have been introduced since Congress passed the Biologics Price Competition Innovation Act of 2009. So, one of the most recent examples of this is a bill that was introduced to Congress prohibiting product hopping, where an innovator product company seeks to extend their products’ exclusivity by switching patients to new or slightly changed versions of that reference product. As we know, tactics like this can stall the ability to introduce new biosimilars to the market as well as possibly hinder approved biosimilars from having full access to all of the originator products’ indications, which forces them to have a skinny label approval.

Although skinny labels have shown some added benefit in the biosimilar space due to their ability to avoid originator patent walls and eliminate the need to wait for full patent, we also know that skinny labels could possibly hinder the adoption of biosimilars because some providers may just be reluctant to prescribe a biosimilar that is not FDA approved for all indications. Not to mention, this could also hinder payer coverage for biosimilars, which can also decrease access for the patient. The good news is although we are still making strides from a legislative standpoint, I do believe that those strides are moving in the right direction. I am very hopeful and optimistic that we can expect to see even more legislative support of the biosimilar industry as it continues to grow in the coming years.

Drug Topics: What are some of the legislative and regulatory issues impacting the biosimilar landscape, and how have those issues impacted uptake and access?

Farmer:The one issue that stands out to me the most is that various states and payers still have not allowed pharmacist-level substitutions for biosimilars without the FDA-approved interchangeable designation. This serves as a hurdle because in order for a biosimilar to achieve approval for interchangeable status, the FDA requires that that agent undergo an extensive switch study whereby the study participants alternate between the reference product and the biosimilar product to prove that the biosimilar is highly similar in nature and non-inferior to the reference product.

As we know, drug studies in general are typically pretty expensive, right? So, these switch studies can cost millions of dollars. It can also cause further delays to the market for biosimilar products. To address this issue, the Biosimilar Red Tape Elimination Act was introduced in July 2023. This field seeks to eliminate the need for the interchangeable designation for biosimilars by removing the requirement for switch studies. Currently, this requirement only exists in the United States, and other countries around the world acknowledge [that] all biosimilars [are] interchangeable upon market approval. So, if the interchangeability requirements are removed, this could positively impact the adoption of biosimilars and allow for automatic substitutions at the pharmacy level, similar to what we currently see with generic medications. Also, if this bill is passed at the federal level, this could result in sustainability in the market due to the elimination of switch studies, which will allow for less expensive go-to-market strategies for manufacturers. If all things align, it will inevitably result in more affordable medications for the US health care system and for our patients.

AXS24, the Asembia Specialty Pharmacy Summit, was held April 28 to May 2 in Las Vegas, Nevada. Click here for more of our coverage from AXS24.