Ashley Gallagher is an associate editor for Pharmacy Times.

Ashley Gallagher

Dr Lakesha Farmer Discusses Biosimilar Education

Lakesha Farmer, PharmD, MBA, senior director, strategic accounts, ION Oncology Practice Network at Cencora, outlined educational resources on biosimilars that are already available to patients as well as how her organization ensures that patients are aware of biosimilars and are comfortable with switching products.

Could you share insights into patient and provider education efforts regarding biosimilars, and how these efforts have evolved to address misconceptions or concerns?

So as we know, education is one of the most important factors in the acceptance and adoption of biosimilars for both providers and patients. When I was in practice as a pharmacy administrator, the largest misconception I faced was that biosimilar studies were inferior to their reference products' because they utilized extrapolation studies to gain approval for all indications. In my role as the director of pharmacy and co-chair of the P&T [pharmacy and therapeutics] committee, I was responsible for educating my providers and nursing staff on how extrapolated indications were granted by regulatory bodies and how critical quality and analytical attributes were used to establish scientific justifications for biosimilarity and FDA approval. 

Also, while I was in that role, I worked closely with our physician leaders and nursing administrators to create consent forms for patients who were being switched from a reference product to a biosimilar. We made sure that thorough education was provided to all patients to ensure that they were all well aware of what a biosimilar agent was and to set the expectation that they would still receive the same level of high quality care with their new agent. 

Outside of resources being created internally at the practice level, there have been several educational resources created for patients and providers by external organizations like manufacturers, distributors, medical professional organizations, as well as the FDA. 

Now that I'm out of clinical practice and have the opportunity to sit on the other side of the table as a distributor and GPO [group purchasing organization] partner, my organization, Cencora, has also contributed to making sure our patients and providers are well educated by creating several educational resources for our downstream and upstream customers that can be found in our biosimilar information hub.

From a patient-centered perspective, what are some of the most important considerations when promoting awareness and acceptance of biosimilars as viable treatment options?

So as we all know, patients are at the heart of what we do. So more patient-centered approaches to improving patient care and increasing cost savings directly to the patient is going to be paramount. You would think that because biosimilars are provided at a much lower cost to providers that the cost to patients would also be much lower. Well, unfortunately, that's not always the case. 

Although biosimilar competition decreases the cost of the health care system, this does not always translate to lower out-of-pocket costs, especially for commercially-insured patients. 

Therefore, this highlights the need for more patient-centric and targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability directly to the patients who need affordable biologic agents for the treatment of their chronic and sometimes, unfortunately, life-threatening conditions.

Videos

Cencora's Lakesha Farmer, PharmD, MBA, discusses efforts that health care organizations can take to better educate patients and providers on biosimilars to improve biosimilar acceptance and achieve cost savings associated with these products.

Dr Lakesha Farmer Highlights Current Biosimilar Education, Acceptance Efforts

Insights From Cencora's Lakesha Farmer: Innovative Biosimilar Adoption Strategies

Lakesha Farmer, PharmD, MBA, senior director, strategic accounts, ION Oncology Practice Network at Cencora, explains new strategies being used to incentivize biosimilar adoption and market competition in a world where reimbursement and rebate policies cater more towards innovator products.

Can you discuss any innovative pricing and reimbursement models that have been implemented to incentivize biosimilar adoption and market competitiveness?

Sure, since the introduction to the market, we've seen some very unique pricing incidences strategies created to incentivize adoption of biosimilar agents. So, most recently, we've seen manufacturers take a nonbranded and branded approach to the launch of their biosimilars, which offers a low wholesale acquisition costs are WAC and the high WAC option. This pricing approach is currently being seen with insulin biosimilars and adalimumab biosimilars.

For example, the adaIimumab biosimilars Cyltezo was initially launched as a branded, high WAC product that offer about 5% discount to the originator (Humira). The makers of Cyltezo saw that the uptake of the medication was pretty slow, and that not all PBMs [pharmacy benefit managers] and insurers were receptive to adding the slightly discounted medication to their formularies. So, about 3 months after their launch, the manufacturer decided to launch an unbranded, low WAC version of the medication, which was surprisingly about 81% less than the originator product's price. So, by taking this low WAC/high WAC approach to pricing, this caters to all PBMs and issuer plans based upon their preference and increases coverage and access to biosimilar for patients.
The only possible downside to this pricing strategy that I can possibly foresee is that the heavily discounted low WAC options could possibly impact a manufacturer's ability to offer co-pay assistance programs and other patient access resources.

The second unique pricing strategy that incentivizes patients access to biosimilars is the Mark Cuban Cost Plus Program. This program aims to lower patient out-of-pocket costs by offering your Yusimry, an adalimumab biosimilar, to patients for a low cost of $569 [per month]. According to Drugs.com, the average cash price for Humira is about $7,300. As you can see, by offering this biosimilar at a cash price of $569 to uninsured patients, as well as a possible option for commercially insured patients with high deductibles, co-pays, and/or co-insurances can definitely be a game changer.

Now moving on to address the unique reimbursement incentive. Currently, 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 set at ASP [average sales price] plus 8% of the reference product's ASP, which is higher than the reference product's reimbursement, which is set at ASP plus 6%. This higher reimbursement rate, provided through Medicare, provides community based providers with a greater incentive to use biosimilars for their patients.

Lakesha Farmer, PharmD, MBA, from Cencora discusses innovative pricing and reimbursement models incentivizing biosimilar adoption and competitiveness, including dual pricing strategies and the Mark Cuban Cost Plus Program, while highlighting potential impacts on patient assistance programs.

Insights From Cencora's Dr Lakesha Farmer: Innovative Biosimilar Adoption Strategies

Julie Reed, executive director of the Biosimilars Forum, explains the thought process behind launching adalimumab biosimilars at 2 wholesale acquisition costs (WACs), whether this pricing strategy actually helps patients, and if the United States will see it permeate into other markets.

Several of the companies that launched adalimumab biosimilars in 2023 chose to use a dual-pricing strategy, where the biosimilar was priced at 5% and 55% lower than the originator Humira. Why did these companies chose to do this and do you expect a similar strategy to be used for future launches in other highly-competitive markets?

Unfortunately, yes. And we saw that with the Biocon Semglee [insulin glargine biosimilar] as well—they were forced to do that. Why they are being asked to do that is the product that only has the 5% discount, is a high WAC and highly rebated. So, they would—and I think most biosimilar manufacturers would—prefer to launch with the big discount. To get access to a formulary and access to the market, they're being required to put a high rebate on. And so the patient's out-of-pocket cost on a high rebate product are going to be based off of a 5% discount, not a 45% or 55% discount. That's not fair to the patients.

I think another piece, which is a concern—and we saw this before early in the biosimilars marketplace—we continue to see that the reference product, the brand is on the formulary at something called parity so everybody's equal. Well, biosimilars require incentives; there's a reluctance. [Patients think], "Well, if I think continue on my brand, why change?" And really, if it's a high rebated product, there's no incentive for the patient because they're out-of-pocket costs because of the rebate are not going to be lower. So I think that's key.

Also a concern is that we're seeing something called a step through on the PBM [pharmacy benefit manager] formularies, where a patient would have to step through the [reference product] before they could get the biosimilar. It's also called fail first. Well, I sat next to [Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars]—I think most know she's a board-certified adult rheumatologist—and from a physician standpoint, if you fail on the [reference product], the physician is not going to prescribe you the biosimilar. It's unethical. They are the same drug.

So why would any PBM put a step through on the reference to the biosimilar? It's medically unethical, so why? Because they want to limit the access to the biosimilar. This is something I think Congress needs to look into, the Federal Trade Commission needs to look into. [This is] not the right thing to do, and it's of grave concern.

Why are companies pricing their adalimumab biosimilars with 2 prices? Can the United States expect more of this pricing strategy for future biosimilar launches? Julie Reed, executive director of the Biosimilars Forum, has the answers.

Why Are Companies Launching Biosimilars With 2 Prices? Julie Reed Explains

Julie Reed, MS, executive director of the Biosimilars Forum, weighed in on some of the biggest policy changes that could impact biosimilars, including the implementation of the reauthorization of the Biosimilars User Fee Amendment (BsUFA III) and the investigation into pharmacy benefit manager (PBM) practices.

What are some of the big biosimilar policy changes that the industry should be keeping an eye on and what actions can providers and administrators take to push them forward?

Absolutely. There's a couple key ones right now—and I sound like broken record so I apologize—but right now, the Senate Finance Committee and Congress are looking at PBM transparency. And I think that's a good start, but it doesn't go far enough, especially for biosimilars. We know what the problems are. We know that they're not providing competitive access to biosimilars. They're not preferring biosimilars. They're not supporting their uptake and lower cost. They're asking for high rebates, which the opposite of what we're trying to do. We don't want to add cost, we don't want to add rebates to a biosimilar. We want to give the lower list price and lower patients out-of-pocket [costs].

I think another key piece is—and we're excited about—is under the BsUFA III user fee negotiations. We will be working with the FDA to streamline development of biosimilars, which is a critically important. We're partnering with the FDA and bringing our collective experience with getting approvals across the world for biosimilars and the decades we've been doing this. There's ways we can create efficiency within biosimilar development. And I think that'll be key. If you can approve a biosimilar in less than 10 years, which we should be able to do, and if we can reduce the costs, that will have an impact on the outcome for patients' costs and what we can do for them, and so I think that's right. 

We will continue to work closely with CMS. The biosimilar special rule was part of the Inflation Reduction Act, and that is part of the the drug negotiation package that they're implementing. We continue to to work with CMS and that team so that will this special rule is implemented in an effective and positive manner for the long-term sustainability of the biosimilars industry. So, I think those are the 3 key things and, of course, will always be weighing in on patent reform and reducing barriers to bringing biosimilars to the US marketplace.

Julie Reed, MS, executive director of the Biosimilars Forum, takes a look at the 3 policy initiatives that could have the greatest ramifications for the US biosimilars industry.

The Top 3 Policy Initiatives That Could Impact the US Biosimilar Market

Unless pharmacy benefit managers (PBMs) stepping up to support biosimilars and provide broad access to these lower-cost products, the promised savings from ranibizumab and adalimumab biosimilars are going to develop slowly and a healthy competitive marketplace will be in jeopardy, said Juliana (Julie) Reed, executive director of the Biosimilars Forum, in an interview from Asembia 2023.

Although anticipated savings related to adalimumab and ranibizumab biosimilars are expected to develop over a long period of time, how long do you think the US will have to wait to see big price changes, and what needs to happen to ensure ample competition between products?

So I think that we could see immediate savings if the PBMs [pharmacy benefit managers] changed their model—they embrace biosimilars, they embrace competition, and they moved towards providing that and providing access. Otherwise, the savings will be slow. And it's not because [the Forum's] members did not develop or take all this time. If we have [9] biosimilars to Humira [adalimumab] is launching at 10 years of development, that's [90] years of development, and over $2 billion spent. And that's the concern—that all this time, these years, and all this money but PBMs won't provide access, and I mean preferred access. They need to support the industry. They need to support the competition. 

IQVIA and other economists have said that we could see close to $155 billion in savings by 2025. That's 2 years from now and that has a lot to do with those biosimilars launching. Those are real numbers and there's concern that those savings will not be realized. And I think the question will be why? Because we certainly we developed the biosimilars and we're bringing them to the marketplace, and we know they're safe and efficacious and approved by the FDA. So if we don't achieve those savings, the question is why, and we know that it's because we don't have access to the market and we're not able to compete.

Juliana (Julie) Reed, executive director of the Biosimilars Forum, predicts how long it will take for savings from adalimumab and ranibizumab biosimilar competition to fully manifest and how stakeholders can champion for better market competition for biosimilars.

Ashley Gallagher

Dr Lakesha Farmer Highlights Current Biosimilar Education, Acceptance Efforts

Insights From Cencora's Dr Lakesha Farmer: Innovative Biosimilar Adoption Strategies

Why Are Companies Launching Biosimilars With 2 Prices? Julie Reed Explains

The Top 3 Policy Initiatives That Could Impact the US Biosimilar Market

Julie Reed: When the US Could See Meaningful Savings From Adalimumab, Ranibizumab Biosimilar Competition