Expert Discusses Biosimiliars Influencing Pricing of Biologic Drugs

Denise Giambalvo, director of Member Engagement & Business Strategy at the Washington Health Alliance and recently led a biosimilars initiative for the coalition, discusses biosimilar influence of pricing for biologic drugs, trends to expect in 2024, and why education on biosimilars are important for patients, pharmacists, prescribers, and more. She also addresses barriers that pharmacists could encounter for the adoption and acceptance of biosimilars and challenges that patients and health care prescribers face when navigating the biosimilar landscape.

Q: How have biosimilars influenced the pricing of biologic drugs, and what role do they play in making these medications more affordable for patients?

Denise Giambalvo: In the United States, since the biosimilars have come to market and been available through the medical plan, we've seen a per unit cost decline of about somewhere between 10% to 20%. In the second year of their availability, new this year is having access to biosimilars on the [pharmacy benefit manager (PBM)] side. We're anticipating what's going to happen with price reduction on that side of the market.

Q: As more biosimilars begin to get approved and hit the market, what trends can we expect in 2024?

Denise Giambalvo: We’re expecting to see big changes. So IQVIA has estimated a savings of $140 billion by 2024. If you went back 5 years ago, you would see numbers like $240 million dollars, so just to put it into perspective, the potential change that we can see next year. A lot of that is attributed to HUMIRA and having biosimilars now available in that drug classification. We’ve seen HUMIRA cost patients anywhere between 64,000 to like 84,000 annually, so expecting to see a good reduction. They’re estimating an average sales price [(ASP)] reduction, or what they've been seeing in the market over the past decade, is anywhere from 4% to 52% ASP reduction, so significant variation there. Time will tell.

Q: What potential barriers or concerns do pharmacists have regarding the adoption and acceptance of biosimilars among health care providers and patients, and how can these be addressed?

Denise Giambalvo: Barriers that pharmacists may be encountering. There's a few. First and foremost is the availability on formulary. If it's not covered, there's not going to be any advantage to the patient to prescribe a biosimilar because it'll just be pure out of pocket for them, so that's an important piece. But the other big one is really all the talk on interchangeability. We've created a great deal of confusion by adding approval for interchangeability in the United States that doesn't exist anywhere else. Europe has had biosimilars available for decades, and they have been transitioning [patients] to biosimilars with no problems. There’s really no reason to question the ability to do that. The clinical difference isn't there. We don't have evidence of that. There's been many research projects that have shown no difference in outcomes or effectiveness yet. Pharmacists are having to overcome these concerns with patients and providers.

Education continues to be very important at the patient level and the provider level for them to understand where the value is in transitioning a patient to a biosimilar. It really at the end of the day is about the cost. What is it costing the patient to receive their drug? And we want to we want to bring that down for them.

Q: How does insurance coverage and reimbursement for biosimilars compare to that of the reference biologic drugs, and what challenges do patients and health care providers face in navigating this landscape?

Denise Giambalvo: That's a great question because there's certainly opportunities to create differences in insurance coverage. I often look at this from the self-insured employer perspective, where they have the ability to make adjustments to their plan design, and they can look at cost and identify what will be the least expensive for everyone, and then adjust plan designed to fit that. First and foremost is adopting the biosimilars on formulary. As I mentioned earlier, if it's not on formulary, there's no advantage to prescribing it for the patient because they'll pay full out of pocket. But if they could treat them like a generic drug, so I'm not implying that a biosimilar should be for $5 copay or a $10 copay, but copay tiers can be created. The biosimilar could be placed at a lower copay than the originator, making it more affordable for the patient.

There can also be a cap on the out of pocket, and so a patient is going to pay a percent of the total cost of the drug. A cap can be put on that, you could say, “they're going to say pay a percent up to $50, $150, $250, whatever that may be.” There's also the ability to say “we're going to put a cap within a drug classification.” Getting really specific with that because if we look at total cost, I think this is a really important piece that 40% of our spend for drugs through the pharmacy benefit is on specialty, and they represent 2% of the prescriptions being dispensed. It's why there's so much attention here because, again, we want to we want to reduce the price, we want to make this more accessible for the patients more affordable, and [there are] so many ways to do that.

Another thing that an employer can consider, or a union trust, is to carve out specialty, so they can set up a specialty pharmacy contract with a specialty pharmacy, outside of their PBM. They can also completely carve out specialty drugs by going to a PBM that just specializes in specialty. A number of different ways to kind of overcome barriers and make this more accessible for the for the patient and, frankly, make it easier for the pharmacist in dispensing. They know that if they make a decision to override providers’ decision to dispense an originator that they will be providing a biosimilar that would be more affordable to the patient.

Q: What resources and training opportunities are available to pharmacists to stay informed about the latest developments in biosimilars and their impact on drug pricing and patient care?

I'm going to say employers and pharmacists, because, again, I just find it so important for our employers, our purchasers of health care; I don't want to leave out our union trust because they're certainly purchasing for our workforce also. They both play a role in in educating and staying up on this. The National Alliance of Health Care Purchaser Coalitions put out a playbook on biosimilars that is very helpful to our purchasers. Biosimilars forum, great resources for both purchasers and pharmacists. I say looking to IQVIA for the research that they've been doing. They continue to put out excellent research, and they're always looking at not just efficacy, but cost, so they've got the value piece built right into their research and what is in the patient's best interest, so a wonderful place for them to go. Then the purple book that the FDA puts out, pharmacists can go to that and also look at the most recent biosimilars on the market and gain clinical information on those.