By Shannon Holden, PharmD
Vizient Senior Clinical Manager, Pharmacy
Come Jan. 31, Humira (adalimumab), the highest spend drug of all time, will lose its exclusivity, opening the door for the eight approved adalimumab biosimilars to come to market by the end of 2023. (And there may even be more!)
While we take a deeper dive into the attributes that will impact the adalimumab biosimilar utilization in the Winter 2023 Pharmacy Market Outlook, now is a great time to discuss the differences between these biosimilar products, what will drive utilization, attributes that impact prescribing and patient selection, and payer preference.
But, before we get started, let's talk about biosimilars and what exactly they are.
What is a biosimilar?
Biosimilar products have been available in the U.S. market since 2015, and while the industry has come a long way in the past eight years in terms of both development and perception of biosimilars, wide adoption of biosimilars has been a challenge. In fact, it's only been in recent years that we've seen biosimilars enter the outpatient arena, enabling patients to self-administer insulin products. To date 40 biosimilars (eight of which are adalimumab biosimilars) have been approved by the Food and Drug Administration. This market increase in utilization can largely be attributed to ongoing physician education, improved awareness of cost savings associated with biosimilar products and published effectiveness.
Biosimilars are based on the foundational perspective that they are the same as the originator biologic in relation to safety and efficacy, but there will still be differences in product formulation, such as strength or delivery device, and other parameters including interchangeability status and manufacturer's patient assistance programs, as opposed to clinical performance. These factors, along with physician concerns around biosimilar effectiveness, access to the medications and operational challenges, impact decisions on whether to switch a patient's current therapy to a biosimilar or to start a new patient on a biosimilar. Patients, too, will likely have concerns around effectiveness, ease of delivery device, payer coverage and patient assistance programs.
So, how do we differentiate between these products and will one product become more likely to be utilized than the other? Let's take a look at what attributes may impact utilization.
Differences driving utilization
First and foremost is the formulation of the biosimilar product. Currently, 80% of the Humira market share is in the high-concentration, citrate-free formulation. This formulation is preferred among patients because it is less painful to inject and has a lower reported site reaction to the injection. Of the eight products currently approved, most are citrate-free, but currently only one is an approved high-concentration, citrate-free product. Four biosimilars are currently seeking approval for the high-concentration, citrate-free formulation. Unfortunately, the first adalimumab biosimilar product to launch is low-concentration, citrate-free and therefore utilization will likely be minimal at this time.
Another piece of the puzzle is the device itself. The Humira autoject devices have been out for some time and have been very successful in providing patients an easier method for injection as opposed to the pre-filled syringe. Upwards of 90% of patients use the autoject Humira pen, but not all the approved biosimilars will offer an autoject device. In fact, two biosimilars will only be available as pre-filled syringes. While many of these autoject devices are similar, there is one that is different: Hadlima. Instead of using a push button, the patient will press the entire pen into the skin, triggering the autoject needle and medication delivery. This device may prove beneficial for rheumatology patients with dexterity issues.
Interchangeability and what it means to me
The interchangeable designation means that the pharmacist may switch a patient from the originator to an interchangeable biosimilar without requiring physician permission. Currently, only one product (Cyltezo) has this designation with several other products pending interchangeability approval.
Most states have interchangeability laws that dictate the requirements a pharmacist must follow to use an interchangeable biosimilar. While the interchangeability designation has some benefits, it's not imperative to the successful uptake in utilization of a biosimilar.
If your organization uses collaborative practice agreements (CPA) that allow for pharmacists to assist with the biosimilar transition process, it can help decrease provider workload. In a case like this, the interchangeability designation may be less important as utilization and switching patients from the originator to the biosimilar would be dictated by the CPA.
Payer preference and strategies available
Other considerations that will differentiate these products is their payer preference and patient assistance programs. Three scenarios for payer strategy exist:
- prefer Humira and not cover the biosimilar products
- cover biosimilars at parity (no preference for Humira and selected biosimilars)
- prefer only biosimilars
Recently two large national payers have announced that they will cover a few biosimilar products at parity, which will help patients transitioning to a cost-effective biosimilar.
The other ingredient in the financial mix is patient assistance. Many patients on Humira receive patient assistance from AbbVie and have little to no copay. Biosimilar products will need to consider making similar programs available to patients for them to financially be able to switch to a biosimilar.
Understanding these differences between the adalimumab biosimilars as well as educating staff, physicians and patients will become increasingly important as these products hit the market in 2023. Providers also can access additional information and resources via the Biosimilar Strategy and Adoption website.
About the author
Shannon Holden, PharmD, is a Senior Clinical Manager with the Center for Pharmacy Practice Excellence. Prior to joining the Vizient team, Holden worked for MultiCare developing an ambulatory care pharmacy position in heart failure at the Pulse Heart Institute. However, most her ambulatory pharmacy work was done previously at Providence, expanding their ambulatory pharmacy services to include anemia, diabetes, neurology, gastroenterology and rheumatology. Holden holds a Pharm.D. from Washington State University, School of Pharmacy, and is Board-Certified in Ambulatory Care Pharmacy.