The Great 2023 Humira Biosimilars Watch Is On – Here’s Where to Focus

You don’t need to be a specialty pharmacist to be excited about a big year coming for biosimilars. Nevertheless, we tapped Rx Savings Solutions’ resident “biosims” expert,?Dr. Bryan Schuessler,?to shed light on what the buzz is all about.

Patients, providers, payers and many others will be watching how things unfold as a wave of Humira??biosimilars enters the market. What should we be watching for, specifically?

Bryan: Right now, we know at least eight different?biosimilars?are scheduled to launch in 2023, and it could be as many as 10. Amgen’s Amjevita? will be first on Jan. 31. Then it’s five months before the next four will launch, along with at least three more in the second half of the year.

Three key developments will be important to track, starting with Amjevita:

• Inclusion by national PBM formularies – OptumRx announced it will offer Amjevita and two other biosimilars alongside Humira but hasn’t indicated which ones or on which formulary tiers. Cigna/Express Scripts has said they intend to carry Humira biosimilars but haven’t announced specific plans as of Dec. 20. No official word yet from CVS on whether or which products they will carry.
• List prices and lowest net cost?Humira – Compared to Humira, which can cost upwards of $80,000 for 12 months of treatment, will these biosimilars fall in the predicted 30%-40% savings neighborhood or somewhere else? Will prices of those already on the market change when the next one is launched? How will rebates factor into lowest net cost, now and in the future?
• Utilization uptake – We’ll want to see how many patients switch to biosimilars or stick with Humira, and how often providers prescribe them. Will plan designs make utilization optional or mandatory? We’ll look at that data closely in the first half of the year, which may help predict what happens when the remaining Humira biosimilars launch in the second half.

Speaking of the second half, is there a reason why seven of the eight Humira biosimilars won’t come out until then?

Bryan: One factor is the product’s FDA approval timeline and any remaining patent litigation. Biosimilar production and distribution are also more complex than with conventional drugs. If a drugmaker only recently received FDA approval for their product, they need time to ramp up sufficient supply for the US market. There is also a significant education and training component that can take time.

There could also be some competitive strategy behind it. Some manufacturers may want to wait and see how the market reacts to previous launches for anything they can leverage to negotiate a better market entry.

Why should plans watch how their PBMs update their formularies throughout the year? What should they be watching for, specifically?

Bryan: There is huge financial interest in Humira because it’s such a significant annual spend for patients and payers. Whatever your plan’s strategy is with these biosimilars, you’ll want to see how the competition affects pricing and how the PBM’s formulary aligns with your plan design.

That’s important in developing or evolving the?message you send?to affected member populations about what the plan is doing to support them, and which options members have moving forward. You’ll want to communicate that information clearly, and the sooner you can get ahead of it the better.

Does a biosimilar’s interchangeability status with the reference product have any cost savings implications over those that aren’t interchangeable?

Bryan: Thus far, only one Humira biosimilar will carry the interchangeability designation. Cyltezo? will launch in the second half of year and can be substituted for Humira at the pharmacy counter. That will remove the barrier of having to go back to the provider and ask for a new prescription.

Is that going to be the lowest-cost decision? It depends on where Cyltezo comes in on price, but it could mean your members can transition to a lower-cost product more quickly. Without knowing the price, I would say the logistics aspect will probably lead to a better member experience with the interchangeable product.

How will RxSS handle Humira biosimilars?

We’ll have all these drugs in our database the minute each one drops. Our?team of pharmacists?will have them mapped to any indication or reference product where they might be a suggestable lower-cost alternative.

Since our solution?aligns with a plan’s benefit design?and strategy, it will lock in and start alerting members to the appropriate options immediately. That’s going to drive a client’s strategy forward—the way we get these in quickly and then message correctly to members and their providers. That’s how we ensure we’re all aligned top to bottom.